Gates v. C R Bard Incorporated et al

Filing 5

CERTIFIED TRANSFER ORDER transferring case to Western District of North Carolina. (Attachments: #1 MDL Certified Docket, #2 Case Management Order, #3 Motions in Limine Orders, #4 Deposition Designation Orders, #5 Discovery and Privilege Orders, #6 Master and Short-Form Pleadings, #7 Daubert Orders, #8 Miscellaneous Orders, #9 Case Management Orders, #10 Discovery Orders)(rth)

Case 2:15-md-02641-DGC Document 9775 Filed 01/23/18 Page 1 of 2

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products Liability

No. MDL 15-02641-PHX DGC

Litigation,

CASE MANAGEMENT ORDER
NO. 30

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The Court held a fourteenth case management conference on January 19, 2018.

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The conference occurred after oral argument on various expert motions and addressed

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ongoing matters identified in the parties’ joint report. Doc. 9645.

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A.

Motion Hearings.

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The Court heard oral argument on motions relating to experts Muehrcke, Hurst,

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Eisenberg, and Betensky. The parties and the Court agreed that oral argument is not

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needed on motions related to experts McMeeking, Morris, Grassi, Garcia/Streiff, criminal

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law standards, and Ritchie. The Court will rule on these motions during the month of

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February. The Court will also rule on the motion in limine recently filed by Plaintiffs on

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the use of FDA-related evidence at trial.

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B.

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Plaintiffs may use up to five pages for a motion in limine on the issue of non-

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Other Matters.

parties at fault. Defendants may file a five-page response.

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Defendants may file a motion in limine of up to ten pages on when evidence

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regarding the Recovery filter may be introduced. Plaintiffs may file a ten-page response,

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and Defendants may file a five-page reply, if needed.

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Case 2:15-md-02641-DGC Document 9775 Filed 01/23/18 Page 2 of 2

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The parties will confer about bifurcating the Booker trial under Georgia law. If

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such bifurcation occurs, evidence regarding Defendants’ net worth, as possibly relevant

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to the issue of punitive damages, will be postponed until after the jury rules on whether

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punitive damages should be awarded. If the punitive damages phase is needed, the

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parties agreed that it will be short and will occur immediately after the jury’s general

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verdict. The Court reminded the parties that any time devoted to this punitive damages

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portion of the trial must be counted against the hours allotted to each side in Case

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Management No. 29.

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Plaintiffs requested permission to conduct limited punitive damages discovery.

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The Court concludes that the parties should confer to see if they can agree on an

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exchange of information, in admissible form, that will eliminate the need for additional

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discovery.

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deposition under Rule 30(b)(6) for up to two hours. The deposition will be completed

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before the final pretrial conference on March 2, 2018.

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If the parties are unable to reach agreement, Plaintiffs may take one

The final pretrial conference will begin at 10:00 a.m. on March 2, 2018. The
Court will reserve the balance of the day to address any and all pretrial matters.

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The parties asked that the Court rule on the Jones summary judgment motion as

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soon as possible, but agreed that the expert motions and the motions in limine to be filed

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on January 26, 2018, take priority. The Court will use its best effort to rule on the Jones

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motion before the end of February.

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The parties and the Court did not set another status conference. If issues arise that

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require the Court’s attention, the parties should place a joint telephone call to the Court so

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that such a conference can be scheduled. The next scheduled hearing in this case will be

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the final pretrial conference.

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Dated this 23rd day of January, 2018.

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Case 2:15-md-02641-DGC Document 9861 Filed 01/26/18 Page 1 of 4

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Ramon Rossi Lopez - [e-mail]
(California Bar Number 86361; admitted pro hac vice)
Lopez McHugh LLP
100 Bayview Circle, Suite 5600
Newport Beach, California 92660
949-812-5771
Mark S. O’Connor (011029) – [e-mail]
Gallagher & Kennedy, P.A.
2575 East Camelback Road
Phoenix, Arizona 85016-9225
602-530-8000

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Co-Lead/Liaison Counsel for Plaintiffs
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UNITED STATES DISTRICT COURT

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DISTRICT OF ARIZONA

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In Re Bard IVC Filters Products
Liability Litigation

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No. MD-15-02641-PHX-DGC
JOINT STIPULATION ON MOTION IN
LIMINE

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(Assigned to the Honorable David G.
Campbell)

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(Oral Argument Requested)

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JOINT STIPULATION ON MOTIONS IN LIMINE

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The parties have reached a stipulation and agreement regarding several issues that

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would otherwise be the subject of a motion in limine. The parties stipulate that they are

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prohibited from making any reference or argument, or adducing any evidence or

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attempting to elicit any evidence in front of the jury suggesting and/or concerning the

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following topics, unless the issue is first raised with the Court outside the presence of the

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jury:

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1. Domestic violence charges, allegations or evidence related to the domestic
violence incident;

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2. Abortions or healthcare services related to Plaintiff’s pregnancies;

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3. Plaintiff conceiving child out of wedlock;

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4. Whether a venereal disease was the cause of Plaintiff’s cervical cancer;

Case 2:15-md-02641-DGC Document 9861 Filed 01/26/18 Page 2 of 4

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5. A misdemeanor charge against Plaintiff for leaving her children in a car;

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6. Plaintiff’s prior claims from a 1996 auto accident involving a fractured foot and

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back/neck injuries;

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7. Termination of Plaintiff’s employment prior to her open chest surgery;

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8. Plaintiff’s relationship with the father of second child while married;

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9. Plaintiff's receipt of compensation from some source other than the damages

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sought against Defendant. (collateral source);

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10. Advertising by Plaintiff’s counsel, Plaintiff’s counsel specializing in personal

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injury and/or products liability litigation, contingency fee agreements, and/or advertising

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by any counsel nationally for Bard IVC Filter cases and/or any other IVC filter cases;

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11. Other lawsuits or claims against Defendants;

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12. Plaintiff could not pay her medical bills or reference to medical liens due to

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lack of health insurance/financial resources;

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13. C.R. Bard’s 1994 criminal conviction.

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Nothing in this stipulation prohibits any party from raising these issues with the

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Court outside the presence of the jury, in the event they believe that evidence or events at

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trial render the topics relevant and admissible.

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RESPECTFULLY SUBMITED this 26th day of January 2018.
GALLAGHER & KENNEDY, P.A.
By: s/Mark S. O’Connor
Mark S. O’Connor
2575 East Camelback Road
Phoenix, Arizona 85016-9225
LOPEZ McHUGH LLP
Ramon Rossi Lopez (CA Bar No. 86361)
(admitted pro hac vice)
100 Bayview Circle, Suite 5600
Newport Beach, California 92660
Co-Lead/Liaison Counsel for Plaintiffs

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Case 2:15-md-02641-DGC Document 9861 Filed 01/26/18 Page 3 of 4

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By: s/Richard B. North, Jr.___
Richard B. North, Jr.
Georgia Bar No. 545599
Matthew B. Lerner
Georgia Bar No. 446986
NELSON MULLINS RILEY &
SCARBOROUGH, LLP
Atlantic Station
201 17th Street, NW / Suite 1700
Atlanta, GA 30363
PH: [phone]
FX: [phone]
[e-mail]
[e-mail]
James R. Condo (#005867)
Amanda Sheridan (#027360)
SNELL & WILMER L.L.P.
One Arizona Center
400 E. Van Buren
Phoenix, AZ 85004-2204
PH: [phone]
[e-mail]
[e-mail]

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Attorneys for Defendants C. R. Bard, Inc. and
Bard Peripheral Vascular, Inc.

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Case 2:15-md-02641-DGC Document 9861 Filed 01/26/18 Page 4 of 4

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CERTIFICATE OF SERVICE
I hereby certify that on this 26th day of January 2018, I electronically transmitted

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the attached document to the Clerk’s Office using the CM/ECF System for filing and

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transmittal of a Notice of Electronic Filing.

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s/Richard B. North, Jr.
Richard B. North, Jr.

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Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 1 of 8

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products Liability

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Litigation,

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___________________________________

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Sherr-Una Booker, an individual,

No. MDL 15-02641-PHX DGC

No. CV-16-00474-PHX-DGC

Plaintiff,

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v.

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C. R. Bard, Inc., et al.

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ORDER

Defendants.

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This multidistrict litigation proceeding (“MDL”) involves thousands of personal

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injury cases related to inferior vena cava (“IVC”) filters manufactured and marketed by

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Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”).

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Plaintiff Sherr-Una Booker, who had a Bard filter implanted ten years ago, brought one

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of the MDL cases. Plaintiff Booker’s case has been selected as one of several bellwether

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cases and is set for trial in March 2018.

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Plaintiffs have filed a motion in limine based on Federal Rules of Evidence 402

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and 403 to preclude evidence of (1) the premarket clearance of Bard IVC filters by the

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Food and Drug Administration (“FDA”), and (2) the lack of FDA enforcement action

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against Bard. Doc. 9529. The motion is fully briefed, and the parties agree that oral

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argument is not necessary. The Court will deny the motion.

Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 2 of 8

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I.

Background.

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The IVC is a large vein that returns blood to the heart from the lower body. IVC

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filters are small metal devices implanted in the IVC to catch blood clots before they reach

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the heart and lungs. Seven different versions of Bard IVC filters are at issue in this MDL

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– the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali.

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IVC filters and other medical devices must be approved or cleared for market by

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the FDA. The FDA may approve a medical device that is shown to be safe and effective

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through a process known as “premarket approval[.]” 21 U.S.C. § 360e(a). Such approval

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is not required, however, for most medical devices. Through a less rigorous process

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known as section “510(k)” review, a manufacturer can obtain “clearance” to market a

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device by showing that it is substantially equivalent to a device already on the market.

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21 U.S.C. § 360c(f)(1)(A). Each Bard IVC filter at issue in this MDL received FDA

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clearance through 510(k) review.1

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Plaintiffs allege that Bard filters are more dangerous than other IVC filters because

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they have a higher risk of tilting, perforating the IVC, or fracturing and migrating to

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neighboring organs. Plaintiffs further allege that Bard failed to warn physicians and

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patients about these higher risks. Doc. 303-1. Bard disputes Plaintiffs’ allegations,

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contending that overall complication rates for Bard filters are comparable to those of

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other IVC filters and that the medical community is aware of IVC filter risks.

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Plaintiff Booker was implanted with a G2 filter in June 2007 and suffered injuries

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from the filter’s failure. She asserts various claims against Defendants under Georgia

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law. Doc. 1, CV-16-00474-PHX-DGC. The following claims remain for trial: design

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defect, failure to warn, and punitive damages. See Doc. 8874 at 22.

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II.

Federal Rules of Evidence 401, 402, and 403.

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The relevance and admissibility of evidence at trial is governed in part by

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Rules 401, 402, and 403. Evidence is relevant under Rule 401 if it has any tendency to

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For further discussion of IVC filters and the FDA regulatory process, see the
Court’s order regarding preemption. Doc. 8872 at 2-5.
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Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 3 of 8

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make a material fact more or less probable. Fed. R. Evid. 401(a)-(b). Rule 402 provides

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that relevant evidence is admissible unless otherwise excluded by the rules, a federal

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statute, or the Constitution; irrelevant evidence is not admissible. Fed. R. Evid. 402.

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Under Rule 403, relevant evidence may be excluded if its probative value is substantially

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outweighed by the danger of “unfair prejudice, confusing the issues, misleading the jury,

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undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed. R. Evid.

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403. Trial courts have discretion to limit or exclude evidence under Rules 402 and 403.

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United States v. Scholl, 166 F.3d 964, 971 (9th Cir. 1999).
III.

Discussion.
A.

The FDA’s Clearance of the G2 Filter Under 501(k) Review.

Plaintiffs argue that Defendants intend to assert an “FDA defense” at trial by
implying that the 510(k) clearance process demonstrates filter “safety and effectiveness”
and the reasonableness of Bard’s conduct. Plaintiffs contend that such evidence is not
relevant to any issue in the case and should be excluded under Rule 402. Doc. 9529
at 1-2. The Court does not agree.
Georgia courts have adopted a risk-utility analysis for design defect claims like
those asserted by Plaintiff Booker. This analysis incorporates negligence principles and
the “concept of ‘reasonableness,’ i.e., whether the manufacturer acted reasonably in
choosing a particular product design[.]” Banks v. ICI Ams., Inc., 450 S.E.2d 671, 673
(Ga. 1994).

One of the many factors a jury may consider in its reasonableness

determination is the manufacturer’s compliance with federal regulations. Id. at 675
& n.6. Compliance with the regulations may not render a manufacturer’s design choice
immune from liability, but it can be a “piece of the evidentiary puzzle.” Doyle v.
Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997); see Duran v.
Paccar, Inc., 549 S.E.2d 755, 762 (Ga. Ct. App. 2001) (“[C]ompliance with federal
standards or regulations is probative of Paccar’s reasonableness under the risk-utility
analysis.”). Given these principles of Georgia law, the Court finds that evidence of
Bard’s compliance with the 510(k) process, while certainly not dispositive, is nonetheless
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Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 4 of 8

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relevant to the reasonableness of Bard’s conduct and whether the company defectively

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designed the G2 filter.

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The evidence is also relevant to Plaintiff’s punitive damages claim.

Under

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Georgia law, punitive damages may be awarded only where the defendant’s actions

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showed “willful misconduct, malice, fraud, wantonness, oppression, or that entire want of

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care which would raise the presumption of conscious indifference to consequences.”

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Ga. Code Ann. § 51-12-5.1(b). Compliance with federal regulations is not sufficient to

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preclude an award of punitive damages, see Doc. 8874 at 18, but it is probative of

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whether the manufacturer acted with conscious indifference to the dangers posed by its

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device. See Stone Man, Inc. v. Green, 435 S.E.2d 205, 206 (Ga. 1993) (noting that

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generally “compliance with county, state, and federal regulations is not the type of

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behavior which supports an award of punitive damages”); Barger v. Garden Way, Inc.,

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499 S.E.2d 737, 743 (Ga. Ct. App. 1998) (same).

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Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence,

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not device safety. Doc. 9529 at 2 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 493

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(1996)).

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reasonableness of Bard’s conduct. The FDA grants 510(k) clearance only where the

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device “is as safe and effective as a [predicate device] and does not raise different

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questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of

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1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii). The 510(k) process may not speak directly

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to the applicable standard of care under Georgia law, but it does have probative value in

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the determination of this action. See Winebarger v. Boston Sci. Corp., No. 3:15CV211-

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RLV, 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (“The fact that BSC followed

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the requisite 510(k) protocol – limited as it is – prior to marketing its [medical] device

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has minimal probative value regarding BSC’s efforts to adhere to FDA processes and

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procedure generally.”).

But this does not render evidence of the 510(k) process irrelevant to the

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The Court, according to Plaintiffs, already “found that 510(k) clearance is

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irrelevant to Plaintiffs’ state law claims.” Doc. 9529 at 2. The Court made no such

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Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 5 of 8

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finding, and has not previously addressed the question now before it – whether evidence

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of the 510(k) process is relevant to the claims and defenses in the Booker case.2

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In their reply brief, Plaintiffs cite a suggested Georgia jury instruction for the

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proposition that juries are limited to considering only those regulations related to

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“safety.” Doc. 9824 at 2. Plaintiffs note that the cases cited in support of the instruction

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are the very cases Defendants cite in arguing that a jury may consider federal standards.

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Id.; see Doc. 9842-1 at 3 (citing Banks and Doyle). But in Banks, the Georgia Supreme

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Court made clear that in determining the reasonableness of a manufacturer’s conduct,

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“no finite set of factors can be considered comprehensive or applicable under every

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factual circumstance, since such matters must necessarily vary according to the unique

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facts of each case.” Banks, 450 S.E.2d at 675. And nothing in Doyle suggests that only

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safety regulations may be relevant in design defect cases. See Doyle, 481 S.E.2d at 521.

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Plaintiffs contend that 510(k) evidence should be excluded under Rule 403

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because any probative value it may have is substantially outweighed by the risk of

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confusion as to whether Bard filters were found by the FDA to be safe and effective.

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Doc. 9526 at 3-6.

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cause the case to devolve into a series of mini-trials regarding the 510(k) process and

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Bard’s compliance with it. Id. Plaintiffs note that other courts, including the district

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court in Cisson, have excluded 510(k) evidence under Rule 403. Id. at 3-5 & n.2.

Plaintiffs further contend that admission of such evidence would

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In Cisson, the court was concerned that allowing 510(k) evidence would create a

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“substantial risk of misleading the jury to believe that FDA 510(k) clearance might be

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In its ruling on Defendants’ preemption motion, the Court noted that “[m]any
cases interpret Riegel and Lohr to mean that PMA approval preempts different or
additional requirements imposed by state tort law, while 510(k) clearance does not.”
Doc. 8872 at 11. The Court then provided a string cite of these cases that included
Cisson v. C. R. Bard, Inc., No. 2:11-cv-00195, 2013 WL 5700513, at *12 (S.D. W. Va.
Oct. 18, 2013), with this parenthetical quote from Cisson: “[T]he 510(k) process does not
address product safety and efficacy and therefore is not relevant to Bard’s obligations
under Georgia state tort law.” Id. Plaintiffs cite this citation as support for their claim
that the Court has resolved the issue in this motion in limine, but that is a real stretch.
Not only was the Court not addressing any evidentiary issue in the preemption
discussion, it was not even approving the cases included in the string cite. To the
contrary, two pages later the Court held that the 510(k) process can in some
circumstances preempt state law claims. Id. at 13-14.
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dispositive of the plaintiffs’ state law claims” and would result in a “mini-trial on the

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510(k) process and enforcement[.]” In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab.

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Litig. (Cisson), No. 2:10-CV-01224, 2013 WL 3282926, at *2 (S.D.W. Va. June 27,

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2013).

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addressed without excluding relevant evidence to the detriment of Defendants.

The Court understands these concerns, but believes they can be adequately

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Both sides, through appropriate expert testimony or other admissible evidence,

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will be permitted to tell the jury about the role of the FDA in its oversight of medical

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device manufacturers, the regulatory clearance process for devices such as IVC filters,

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and Bard’s participation in the 510(k) process and its compliance (or lack thereof) with

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that process. See Doc. 9433 at 8-9, 16; Block v. Woo Young Med. Co., 937 F. Supp. 2d

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1028, 1047 (D. Minn. 2013) (allowing expert witness to testify to “the general nature of

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the FDA’s approval and regulatory process, the FDA’s general expectations with respect

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to testing and marketing of new products, and [the defendant’s] actions in that respect”);

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Musgrave v. Breg, Inc., No. 2:09-CV-01029, 2011 WL 4620767, at *3 (S.D. Ohio Oct. 3,

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2011) (denying Rule 403 challenge to 510(k) evidence and noting that the plaintiffs “may

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argue about what it means, but they cannot keep the jury from hearing the fact that the

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FDA cleared . . . the [device]”). Defendants will not, however, be permitted to present

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evidence or argument that the FDA “approved” the G2 filter for market, or that clearance

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of the device under 510(k) review constitutes a finding by the FDA that the filter is “safe

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and effective.” As relevant FDA regulations explain: “Any representation that creates an

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impression of official approval of a device because of complying with the [510(k)]

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premarket notification regulations is misleading[.]”

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certainly will be free to present evidence and argument that the 510(k) process is a

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comparative one that requires only substantial equivalence to a predicate device, that

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510(k) regulations are not safety regulations, and – as Plaintiffs claim – that Bard

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withheld information from the FDA and otherwise failed to fully comply with the 510(k)

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regulations.

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21 C.F.R. § 807.97.

Plaintiffs

Case 2:15-md-02641-DGC Document 9881 Filed 01/29/18 Page 7 of 8

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Moreover, any potential confusion can be cured, if necessary, by a limiting

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instruction regarding the nature of the 510(k) process.

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5567578, at *7 (finding 510(k) evidence admissible with “a limiting instruction that

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510(k) clearance is not to be considered as evidence that the FDA authorized the [device]

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as safe and approved its intended use as such,” or that the defendant “satisfied any

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standard of care in designing the . . . device”).

See Winebarger, 2015 WL

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It is worth noting that the absence of any evidence regarding the 510(k) process

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would run the risk of confusing the jury as well. Many of the relevant events in this case

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occurred in the context of FDA 510(k) review, and much of the evidence is best

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understood in that context. Attempting to remove any references to the FDA from the

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trial would risk creating a misleading, incomplete, and confusing picture for the jury.

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Additionally, the Court is not convinced that all FDA-references could be removed, given

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that much of the evidence – such as the MAUDE database – comes from the FDA. And

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if the evidence was half-baked, containing some references to the FDA but not explaining

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what role the FDA played with respect to the Bard filters, the jury would be left to

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speculate about the FDA’s involvement and conclusions.

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The Court is also convinced that efficient management of the evidence and

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adherence to the Court’s time limits will avoid any risk of unnecessary or time-

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consuming mini-trials. Plaintiffs argue that the parties’ regulatory experts likely will take

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a day each for direct and cross-examination, and that the time limitations set by the Court

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will prove prohibitive. Doc. 9529 at 6 & n.4. The Court does not agree. The Court is

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confident that counsel for each side will be able to adequately and efficiently try this case

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in the time allotted by the Court. See Doc. 9415 at 2.

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B.

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Plaintiffs argue that evidence of the lack of FDA enforcement action against Bard

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is irrelevant, and that it would be misleading and prejudicial for Bard to suggest to the

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jury that the lack of enforcement signifies product safety. Doc. 9529 at 6-8. Whether

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evidence that the FDA took no enforcement action against Bard is relevant and otherwise

The Lack of FDA Enforcement.

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admissible will depend heavily on the context in which the evidence is offered, including

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evidence presented by Plaintiffs (such as the FDA warning letter). The Court will make

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this ruling during trial.

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IT IS ORDERED that Plaintiffs’ Motion in Limine #1 to exclude evidence of
FDA 510(k) clearance and lack of FDA enforcement (Doc. 9529) is denied.
Dated this 29th day of January, 2018.

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Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 1 of 7

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products Liability

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Litigation,

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___________________________________

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Sherr-Una Booker, an individual,

No. MDL 15-02641-PHX DGC

No. CV-16-00474-PHX-DGC

Plaintiff,

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v.

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C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

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ORDER

Defendants.

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The parties have filed various motions in limine (“MIL”) in advance of the Booker
bellwether trial. This order will rule on some of those motions.

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A.

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Plaintiffs wish to introduce a photograph of Michael Randall, Bard’s G2 Platinum

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project leader, flipping off the camera. Plaintiffs contend that the photograph is relevant

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because it was included in an internal Bard Powerpoint on the G2 Platinum. Bard asserts

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that the photograph was included in the Powerpoint presentation as an internal joke.

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Plaintiffs admit that “we don’t know to whom this gesture was directed” (Doc. 9911

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at 3), but they argue that it nonetheless is relevant as an indication of Bard’s cavalier

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corporate culture.

Defendants’ MIL No. 4 (Photograph of Michael Randall).

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 2 of 7

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Because even Plaintiffs don’t know to whom the gesture was directed, the Court

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cannot conclude that it is relevant to any claims or defenses in this case. And even if the

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photograph were to have some marginal relevancy, such relevancy is substantially

4

outweighed by the danger of unfair prejudice. Fed. R. Evid. 403. Even Plaintiffs admit

5

that “the middle finger picture is indeed inflammatory.” The motion in limine (Doc.

6

9865) is granted. The photograph will not be admitted.

7

B.

8

Defendants seek to exclude evidence that Plaintiffs’ expert witness, Dr. Thomas

9

Kinney, was an expert witness for Bard in two prior IVC filter cases and was a paid

10

consultant to Bard for several years. Doc. 9868. Plaintiffs argue that this prior work is

11

relevant because it “provides context for his opinions and his motivation to become an

12

expert witness for the Plaintiffs,” shows Bard’s “lack of transparency with doctors and

13

consultants, and the seriousness of the problems with its IVC filters,” and shows a

14
15
16
17
18

Defendants’ MIL No. 5 (Dr. Kinney’s work for Bard).

“corporate culture within Bard that disregarded concerns of consultants and patient
safety.” Doc. 9914 at 2-3.
The Court is not persuaded by Plaintiffs’ arguments. In opposing Defendants’
motion to disqualify Dr. Kinney on the basis of his prior work for Bard, Plaintiffs argued
vigorously that the prior work had nothing to do with this lawsuit. Plaintiffs asserted that

19
20
21
22
23
24

“[n]one of [Dr. Kinney’s consulting] work related to the issues discussed, subject matter,
or bases of the opinions rendered in his report in this MDL.” Doc. 5803 at 6, n.2.
Plaintiffs argued that his work for Bard from 2005 to 2008 had “absolutely nothing to do
with the issues and causes of action in this MDL.” Id. at 9. And they claimed that his
work as an expert witness for Bard did not “even remotely relate[] to the issues and

25

subject matter of Dr. Kinney’s expert report in this MDL.” Id. at 3. Given these

26

strenuous assertions, the Court cannot accept Plaintiffs current argument that

27

Dr. Kinney’s work for Bard provides “context for his opinions,” shows “a lack of

28

transparency” with respect to the issues in this case, or shows a corporate culture of

-2-

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 3 of 7

1

disregard for patient safety. Doc. 9914 at 2-3. By Plaintiffs’ own declaration, his prior

2

work for Bard is simply not relevant to the issues in this case. The Court will grant

3

Defendants’ motion in limine. Doc. 9868. Plaintiffs may not question Dr. Kinney about

4

his prior work for Bard, and should instruct him not to mention it in his testimony. If

5

Plaintiffs believe Defendants make the prior work relevant by the nature of their cross

6

examination at trial, they can raise that issue with the Court outside the hearing of the

7

jury.

8

C.

9
10
11
12

Plaintiffs’ MIL No. 2 (benevolent activities).

Plaintiffs seek to exclude evidence and argument relating to (1) any alleged
benevolent activities such as charitable acts or services Bard provides to patients or
society, (2) Bard’s “good character” in general, and (3) the quality and intent of its
workforce as a whole. Doc. 9866. In response, Defendants state that they will not

13
14
15
16
17
18

present evidence that they “engaged in benevolent activities such as providing
scholarships or making charitable contributions.” Doc. 10053 at 1 n.1. Defendants do
intend, however, to present evidence regarding the nature, quality, and usefulness of their
products, the conscientiousness of their employees, references to their mission statement,
and the fact that their products are designed to promote health and save lives. Id. at 2-3.

19

Defendants assert that such evidence is relevant background information and is also

20

necessary to rebut Plaintiffs’ punitive damages claim that Defendants acted in a willful,

21

malicious, and reckless manner.

22

The Court concludes that some evidence regarding the nature of Defendants’

23

business is relevant to the jury’s understanding of the issues in this case. The Court also

24

concludes that Defendants’ must be permitted to rebut Plaintiffs’ themes, stated

25

repeatedly throughout briefing on the expert motions, that Defendants knowingly

26

disregarded patient safety, used patients for experimentation, and placed profits over

27

safety.

28

-3-

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 4 of 7

1

Countering Plaintiffs’ punitive damages arguments does not mean, however, that

2

Defendants can present irrelevant evidence or try this case on the basis of corporate

3

character. See Fed. R. Evid. 404(a). The Court will draw appropriate lines on the basis

4

of objections made during trial. Plaintiffs’ motion in limine (Doc. 9866) is denied.

5

D.

6

Plaintiffs ask the Court to exclude evidence and argument relating to failure rates,

7

complication rates, percentages, or comparative analysis of any injuries that were not

8

produced to Plaintiffs during discovery. Doc. 9870. Defendants assert that all such

9

information was produced. Doc. 10060. Plaintiffs’ motion in limine (Doc. 9870) is

10

denied as moot. If Plaintiffs believe Defendants are using undisclosed evidence at any

11

time during trial, they may object.

Plaintiffs’ MIL No. 5 (evidence not produced in complaint files).

12

E.

13

Plaintiffs seek to exclude evidence and argument relating to prior judicial opinions

14

about Plaintiffs’ experts, including the number of times their testimony has been

15

precluded in other cases. Doc. 9872. Defendants state that they do not intend to mention

16

such evidence during opening statements, but it may become relevant during trial. The

17

Court concludes that the rulings of other judges in other cases addressing other claims are

18

not relevant to this case, and will grant the motion in limine. Doc. 9872. If Defendants

19

believe such rulings become relevant in light of an expert’s testimony, they may raise the

20

issue with the Court outside the hearing of the jury.

Plaintiffs’ MIL No. 7 (prior judicial opinions).

21

F.

22

Plaintiffs assert that Defendants must be precluded from arguing at trial that a

23

verdict against them will have an adverse impact on the medical community, future

24

medical device research or costs, and the availability of medical care.

25

Plaintiffs also argue that Defendants must be precluded from mentioning tort reform or

26

any perceived “litigation crisis.” Id. Defendants state that they do not intend to mention

27

such matters during opening statements, but they may become relevant during trial. The

28

Court concludes that the matters identified in Plaintiffs’ motion are not relevant to this

Plaintiffs’ MIL No. 8 (adverse impact of a plaintiff’s verdict).

-4-

Doc. 9873.

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 5 of 7

1

case, and will grant the motion in limine. Doc. 9873. If Defendants believe such matters

2

become relevant during trial, they may raise the issue with the Court outside the hearing

3

of the jury.

4

G.

5

Plaintiffs seek to exclude evidence and argument relating to the “Permission For

6

Operation And/Or Procedure” form Ms. Booker signed prior to insertion of her IVC

7

filter. Doc. 9876. Plaintiffs argue that the form is not specific to IVC filters or Bard

8

filters, and therefore is irrelevant and likely to confuse the jury. Id.

Plaintiffs’ MIL No. 11 (informed consent form).

9

Defendants state that they have “no intention of arguing that the Consent Form

10

warned the Plaintiff about the potential risks of the G2® Filter.” Doc. 10061 at 2. But

11

Defendants argue that the consent form “is still relevant and material to establish that the

12

Plaintiff and her implanting physician, Marcus D’Ayala, M.D. . . . discussed a course of

13

treatment that included implanting a G2® Filter, and that the Plaintiff agreed to this

14

course of treatment.” Id.

15

Plaintiffs’ failure to warn claim alleges that Bard “knew or reasonably should have

16

known that the users of Bard IVC Filters, including Plaintiffs, would not realize or

17

discover on their own the dangers presented by Bard IVC Filters.” Doc. 364, ¶ 213. The

18

complaint further alleges that “Bard breached [its] duties by failing to provide adequate

19

warnings to Plaintiffs communicating the information and dangers described above

20

and/or providing instruction for safe use of Bard IVC Filters.” Id., ¶ 216. Georgia law,

21

which will apply in Ms. Booker’s case, includes the “learned intermediary” doctrine.

22

Under this doctrine, a medical device manufacturer has no “duty to warn the patient of

23

the dangers involved with the product, but instead has a duty to warn the patient’s doctor,

24

who acts as a learned intermediary between the patient and manufacturer.” McCombs v.

25

Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) (citing Ellis v. C. R. Bard, Inc., 311

26

F.3d 1272, 1279-80 (11th Cir. 2002)). Thus, what Dr. D’Ayala knew about the risks of

27

IVC filters, and what he told Ms. Booker, are relevant to the failure to warn claim.

28

-5-

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 6 of 7

1

The consent form signed by Ms. Booker states that Dr. D’Ayala “has fully

2

explained to me the nature and purpose of the operation/procedure and has also informed

3

me of expected benefits and complications, attendant discomforts and risks that may

4

arise, as well as possible alternatives to the proposed treatment[.]” Doc. 9876-2, ¶ 2.

5

This document is plainly relevant to Plaintiffs’ failure to warn claim. The arguments

6

made in Plaintiffs’ motion – that the form is not specific to IVC filters or Bard filters, and

7

therefore does not show what Ms. Booker knew about risks of Bard filters – can be

8

made to the jury. The Court does not find that the jury will be confused by admission

9

of the form, assuming it satisfies other evidentiary rules. Plaintiffs’ motion in limine

10

(Doc. 9876) is denied.

11

H.

12

Plaintiffs seek to exclude evidence and argument related to Dr. Brandon Kang’s

13

Twitter and Facebook accounts and his use of the terms “lasso,” cowboy,” “GTFO” (Get

14

The Filter Out), “#filterout,” “#IRad,” and a cowboy emoji, as well as comments, posts,

15

photos, or videos that Dr. Kang posted on his social media accounts.

16

Plaintiffs assert that the posts were not made until 2017, years after Dr. Kang’s treatment

17

of Ms. Booker, and are irrelevant and unfairly prejudicial. Id.

Plaintiffs’ MIL No. 12 (Dr. Kang’s social media posts).

Doc. 9877.

18

Defendants argue that Dr. Kang’s social media posts “reflect his approach and

19

attitude about filter removal.” Doc. 10063 at 2. Defendants argue that “[a] disputed issue

20

in this case is whether Dr. Kang’s failed retrieval attempt, which admittedly damaged

21

Ms. Booker’s tricuspid valve, was unduly aggressive. Plaintiffs claim Dr. Kang acted

22

appropriately. Bard, however, will present expert and other evidence that Dr. Kang

23

should have followed a more conservative approach.” Id.

24

Although Dr. Kang’s attempt to retrieve Ms. Booker’s filter is plainly relevant to

25

whether Defendants or Dr. Kang caused some of her injuries, the Court cannot conclude

26

that his subsequent social media posts – which were not about Ms. Booker’s case and

27

which were made approximately three years after the attempted removal – are relevant.

28

Even if it could be argued that they reflect Dr. Kang’s reckless character, the Court

-6-

Case 2:15-md-02641-DGC Document 10075 Filed 02/15/18 Page 7 of 7

1

concludes that such marginally probative character evidence would not be admissible

2

under Rule 403. Any relevancy would be substantially outweighed by the danger of

3

unfair prejudice. The Court will grant Plaintiffs’ motion in limine. Doc. 9877.

4

I.

5

Plaintiffs seek to exclude argument or evidence relating to the religion, religious

6

beliefs, religious activities, church membership, church affiliation, socioeconomic status,

7

marital status, parental relationships, family health status, and children of Defendants’

8

current and former employees and other witnesses.” Doc. 9879. Plaintiffs contend that

9

Defendants may seek to elicit such information to cause jury sympathy. Id.

Plaintiffs MIL No. 14 (personal traits of employees and witnesses).

10

Defendants agree that “no party should elicit information from any witness

11

regarding their religion, religious beliefs, religious activities, church membership or

12

affiliation.” Doc. 10064 at 2 (emphasis added). Defendants argue, however, that some

13

background information will be needed to introduce witnesses to the jury and to help

14

them become comfortable in the courtroom. Defendants also note that at least one of its

15

witnesses has a heavy foreign accent, and a brief explanation may be needed for the jury.

16

The Court agrees that neither side should elicit evidence barred by Rule 610

17

(“Evidence of a witness’s religious beliefs or opinions is not admissible to attach or

18

support the witness’s credibility.”). Some background information will be necessary to

19

introduce witnesses to the jury, but questions designed to prompt sympathy or empathy

20

are not proper. The Court will rule on objections during trial. In light of this general

21

guidance, the Court will deny Plaintiffs’ motion in limine as moot. Doc. 9879.

22

Dated this 15th day of February, 2018.

23
24
25
26
27
28

-7-

Case 2:15-md-02641-DGC Document 10235 Filed 02/22/18 Page 1 of 2

1
2
3
4
5
6
7

IN THE UNITED STATES DISTRICT COURT

8

FOR THE DISTRICT OF ARIZONA

9
10
11

IN RE: Bard IVC Filters Products Liability
Litigation

___________________________________
Sherr-Una Booker, an individual,

12
13

No. MDL15-2641-PHX DGC

Plaintiff,
ORDER

v.

14
15
16

C.R. Bard, Inc., a New Jersey
Corporation, et al.,
Defendants

17
18
19
20

Upon consideration of the parties’ joint stipulation on motions in limine.
Doc. 9861.

21

IT IS ORDERED that the parties’ joint stipulation on motions in limine

22

(Doc. 9861) is granted. The parties are prohibited from making any reference or

23

argument, or adducing any evidence or attempting to elicit any evidence in front of the

24

jury suggesting and/or concerning the following topics, unless the issue is first raised

25

with the Court outside the presence of the jury:

26
27
28

1.

Domestic violence charges, allegations or evidence related to the domestic

violence incident;
2.

Abortions or healthcare services related to Plaintiff’s pregnancies;

Case 2:15-md-02641-DGC Document 10235 Filed 02/22/18 Page 2 of 2

1

3.

Plaintiff conceiving a child out of wedlock;

2

4.

Whether a venereal disease was the cause of Plaintiff’s cervical cancer;

3

5.

A misdemeanor charge against Plaintiff for leaving her children in a car;

4

6.

Plaintiff’s prior claims from a 1996 auto accident involving a fractured

5
6
7
8
9
10
11
12
13
14
15
16
17

foot and back/neck injuries;
7.

Termination of Plaintiff’s employment prior to her open chest surgery;

8.

Plaintiff’s relationship with the father of second child while married;

9.

Plaintiff’s receipt of compensation from some source other than the

damages sought against Defendant. (collateral source);
10.

Advertising by Plaintiff’s counsel, Plaintiff’s counsel specializing in

personal injury and/or products liability litigation, contingency fee agreements, and/or
advertising by any counsel nationally for Bard IVC Filter cases and/or any other IVC
filter cases;
11.

Other lawsuit or claims against Defendants;

12.

Plaintiff could not pay her medical bills or reference to medical liens due

to lack of health insurance/financial resources;

18

13.

C.R. Bard, Inc.’s 1994 criminal conviction.

19

Nothing in this stipulation prohibits any party from raising these issues with the

20

Court outside the presence of the jury, in the event they believe that evidence or events

21

at trial render the topics relevant and admissible.

22

Dated this 22nd day of February, 2018.

23
24
25
26
27
28
-2-

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 1 of 20

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability
Litigation,

10

___________________________________

11

Sherr-Una Booker, an individual,

12

No. MDL 15-02641-PHX-DGC

No. CV-16-00474-PHX-DGC

Plaintiff,

13

v.

14

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

15
16

ORDER

Defendants.

17
18
19

The parties have filed various motions in limine (“MIL”) in advance of the Booker

20

bellwether trial. The Court ruled on some of the motions in an earlier order. Doc. 10075.

21

This order will rule on the remaining motions.

22

A.

23

Plaintiff Booker was implanted with a Bard G2 filter in June 2007. The filter later

24

tilted, migrated, and fractured. Ms. Booker had surgeries to remove the filter and several

25

fractured struts, but one strut remains embedded in the wall of her inferior vena cava

26

(“IVC”). Defendants seek to exclude evidence of complications with an earlier version

27

of the Bard IVC filter – the Recovery filter – arguing that those complications are not

28

“substantially similar” to the issues with Ms. Booker’s G2 filter. Doc. 9862 at 5-7.

Defendants’ MIL No. 1 (Recovery filter complications).

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 2 of 20

1

The Recovery was Bard’s first generation of retrievable IVC filters, and was on

2

the market from the beginning of 2003 to the fall of 2005. The Recovery was followed

3

by the G2. As Defendants explain in their motion: “Based on clinical experience with

4

the Recovery Filter, Bard made several significant changes to the G2 Filter: the filter

5

hook wire diameter was increased, the filter arm tips were curved, the curvature radius of

6

the filter arms at the sleeve were increased, and the spline was modified to accommodate

7

the other dimensional changes.” Id. at 4. Because Ms. Booker received a G2 filter, and

8

that filter had been changed significantly from the Recovery filter, Defendants argue that

9

problems with the Recovery have “absolutely no relevance to the issues in this case.” Id.

10

The Court does not agree.

11

Plaintiffs claim that Bard negligently and defectively designed the G2 filter, failed

12

to warn of its risks, and did so with a mindset worthy of punitive damages. In response,

13

Defendants will argue, among other points, that the FDA cleared the G2 filter for market.

14

Defendants vigorously opposed Plaintiffs’ motion to exclude evidence of the FDA’s

15

510(k) clearance process, arguing that the steps a manufacturer must take before a

16

product is cleared by the FDA are “highly relevant to a case . . . like this one,” and that

17

compliance with the 510(k) process “is certainly probative under Georgia law on the

18

issues of reasonableness of the design, manufacture, and warnings of the G2 Filter, as

19

well as whether Bard’s conduct rises to the level justifying punitive damages[.]”

20

Doc. 9690 at 3. The Court agreed with Defendants, noting that the FDA grants 510(k)

21

clearance “only where the device ‘is as safe and effective as a [predicate device] and does

22

not raise different questions of safety and efficacy than the predicate device.’” Doc. 9529

23

at 4 (citation omitted).

24

Bard identified the Recovery filter as the predicate device for the G2, and avowed

25

to the FDA that the “design, material, components, fundamental technology (mode of

26

device function/operation) and intended use featured with the [G2]” are “substantially

27

equivalent to those featured with the predecessor Recovery Filter System[.]”

28

Doc. 10068-1 at 25. Defendants assert that “one of Bard’s goals in developing the G2

-2-

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 3 of 20

1

Filter was to reduce the number of incidents of filter fracture and migration that Bard had

2

observed with the Recovery Filter.” Doc. 9862 at 4.

3

Given these facts, the Court concludes that Bard’s knowledge of problems with

4

the Recovery filter is relevant to central issues in this case – whether Bard properly

5

designed the G2 to correct those problems, whether Bard failed to warn physicians and

6

patients about problems shared by the Recovery and G2, and whether Bard’s alleged

7

failure to correct or warn about known problems justifies an award of punitive damages.

8

The Court also concludes that it would be difficult to try this case without evidence of the

9

Recovery filter and the problems it encountered. Defendants’ evidence regarding FDA

10

clearance will necessarily include the fact that the Recovery filter was the predicate

11

device for the G2 and was substantially equivalent to the G2. In showing Bard’s care in

12

designing the G2, Defendants almost certainly will argue that Bard carefully tracked

13

problems encountered by the Recovery, dutifully reported those problems to the FDA,

14

and took specific steps to correct those problems in the G2. Defendants will use this

15

evidence to show that Bard did not negligently or defectively design the G2 and did not

16

fail to warn of its risks. It is only fair that Plaintiffs be permitted to present evidence to

17

support their claim that the Recovery was known to be more hazardous than Bard

18

admitted publicly or to the FDA, and that it involved problems that were not corrected in

19

the G2 and Bard failed to warn physician and patients of those known problems.

20

Defendants cite a number of cases for the proposition that other instances of

21

product failure are admissible only if the instances are substantially similar to the product

22

failure at issue in this case. Id. at 5. For example, the Ninth Circuit has held that

23

“[a] showing of substantial similarity is required when a plaintiff attempts to introduce

24

evidence of other accidents as direct proof of negligence, a design defect, or notice of the

25

defect.” Cooper v. Firestone Tire & Rubber Co., 945 F.2d 1103, 1105 (9th Cir. 1991).

26

For three separate reasons, the Court does not find this case law controlling.

27

First, Ms. Booker alleges that her G2 filter tilted, perforated her IVC, fractured,

28

and migrated. Doc. 10068 at 7. These methods of failure include virtually all of the

-3-

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 4 of 20

1

known methods of failure for the Recovery filter.

2

Second, the facts of this case distinguish it from many of the cases cited by

3

Defendants. This is not simply a product defect case in which Plaintiffs seek to introduce

4

evidence of other potentially unrelated product failures. As already noted, the Recovery

5

was the predicate for the G2 and Bard sought FDA clearance on the basis that the G2 was

6

substantially equivalent to the Recovery. Bard intends to present evidence of that FDA

7

clearance during trial. Defendants surely will note that the clearance required an FDA

8

determination that the G2 was as safe and effective as the Recovery. In this context,

9

evidence regarding the safety and effectiveness of the Recovery filter is plainly relevant,

10

particularly where Plaintiffs claim that the Recovery was not as safe and effective as Bard

11

represented to the FDA. Further, Defendants claim to have designed the G2 to overcome

12

known defects in the Recovery, making the extent and severity of those defects relevant

13

to the adequacy of Bard’s design of the G2.

14

Third, although substantial similarity is required by the Ninth Circuit for direct

15

evidence of negligence, design defect, or notice, it is not required when other examples of

16

product failure are used to impeach an expert’s testimony that a product is safe. Cooper,

17

945 F.2d at 1105. The parties do not address whether the evidence in this case would be

18

used for impeachment or direct evidence.

19

Defendants also seek to exclude evidence of complications involving cephalad

20

migration (toward the heart), asserting that such evidence is irrelevant because

21

Ms. Booker’s filter migrated in a caudal direction (away from the heart). Doc. 9862

22

at 7-8. Plaintiffs respond that Bard combined caudal and cephalad migration in tracking

23

adverse events internally and in reporting migration rates to the FDA. Doc. 10068 at 9

24

(citing Doc. 10068-9 at 2-4). On this record, however, the Court cannot determine

25

whether evidence of cephalad migration is relevant to Ms. Booker’s claims. The parties

26

should be prepared to address this issue at the final pretrial conference – specifically,

27

what instances of cephalad migration Plaintiffs intend to present at trial, and why those

28

instances are relevant.

-4-

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 5 of 20

1

Finally, Defendants contend that the probative value of the Recovery filter

2

evidence is substantially outweighed by the risks of unfair prejudice, misleading and

3

confusing the jury, and wasting time. Doc. 9862 at 8-9; Fed. R. Evid. 403. Defendants

4

claim that admission of such evidence will require Bard to introduce its own evidence

5

regarding the design of the Recovery, the technology available at the time, and Bard’s

6

investigation of adverse event reports. Id. at 9. This may be true, but that often is the

7

result of admitting relevant evidence. With the possible exception of cephalad migration,

8

the Court concludes that known complications with the Recovery filter are plainly

9

relevant to this case. It will not, in the Court’s view, mislead or confuse the jury, waste

10

time, or result in unfair prejudice. The motion in limine (Doc. 9862) is denied, subject to

11

the Court’s consideration of cephalad migration at the final pretrial conference.

12

B.

13

Defendants seek to exclude specific evidence relating to the development of the

14

Recovery device: (1) migration resistance tests, (2) testimony from Dr. Asch regarding

15

his clinical trial of the Recovery, and (3) testimony from Bard employee Kay Fuller

16

regarding the 510(k) submission to the FDA. Doc. 9863 at 2-3. Defendants claim that

17

this “bad act” evidence is irrelevant and inadmissible under Rules 404 and 403. Id. at 3-4.

18

The Court cannot conclude that development of the Recovery filter is irrelevant to

19

the G2 filter claims in this case. Bard based its request for FDA clearance of the G2 on

20

the claim that it was substantially equivalent to, and as safe and effective as, the

21

Recovery. Defendants intend to argue at trial that the resulting FDA approval shows that

22

Bard acted responsibly and produced a safe and effective filter. In this context, evidence

23

that the Recovery filter was itself the result of inadequate and incomplete testing, that a

24

doctor involved in the testing concluded that it was inadequate and incomplete, and that a

25

Bard employee reached the same conclusion, is plainly relevant. After considering the

26

Ninth Circuit’s four-part test, see Duran v. City of Maywood, 221 F.3d 1127, 1132-33

27

(9th Cir. 2000), the Court concludes that such evidence is admissible under Rule 404(b)

28

as probative of Bard’s knowledge, intent, and lack of mistake, and that its probative value

Defendants’ MIL No. 2 (development of the Recovery).

-5-

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 6 of 20

1

is not substantially outweighed by the potential dangers set forth in Rule 403.

2

Defendants’ motion in limine (Doc. 9863) is denied.

3

C.

4

Defendants seek to exclude a 2015 FDA warning letter, contending that it is

5

irrelevant because it constitutes an informal advisory statement by the FDA issued more

6

than seven years after Ms. Booker received her G2 filter. Doc. 9864 at 2-3. Defendants

7

also contend that specific topics in the warning letter are not related to the G2 filter or

8

any other issues in this case. Plaintiffs counter that the letter is an essential piece of

9

evidence to rebut Bard’s suggestion that the FDA took no action against Bard and

10

expressed no concerns about Bard filters. Doc. 9927 at 2. Other than one sentence,

11

however, Plaintiffs do not address Defendants’ argument that topics in the letter are not

12

related to issues in this case. That sentence argues only that deficiencies in Bard’s

13

handling and reporting of filter failures are relevant to this case. Id.

Defendants’ MIL No. 3 (FDA warning letter).

14

Many topics in the warning letter lack probative value. Topics 1 and 2 concern the

15

Recovery Cone retrieval system, which is not at issue in this case. See Doc. 9864-1.

16

Topic 4(a) concerns the filter cleaning process, which does not appear to be at issue here.

17

Topics 4(b), 5, and 6 concern the Denali filter, a generation of filter developed after the

18

G2 received by Ms. Booker. Topics 3, 7, and 8 concern Bard’s complaint handling and

19

reporting processes, but Plaintiffs have not shown why the specific issues raised in those

20

three topics are relevant to this case.

21

The Court concludes that topics 1, 2, 4(a), 4(b), 5, and 6 are not relevant to this

22

case, and will grant the motion in limine with respect to them. The Court cannot tell on

23

the present record whether topics 3, 7, and 8 are relevant; that decision must be made at

24

trial. To avoid the potential prejudice that will result if the warning letter is mentioned

25

but irrelevant, the Court directs Plaintiffs to raise the potential admissibility of topics 3, 7,

26

and 8 outside the hearing of the jury before mentioning the warning letter to the jury.

27

A few other comments are warranted. Plaintiffs argue that Defendants intend to

28

present evidence of the lack of FDA enforcement actions, and to argue that the “FDA’s

-6-

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1

decision not to take any enforcement actions against Bard is probative as to whether Bard

2

acted reasonably in its design and manufacture of the G2 line of filters.” Doc. 9690 at 9.

3

In response, Plaintiffs argue, they should be allowed to show that the FDA did issue a

4

warning letter to Bard. But Plaintiffs’ statement of Defendants’ position is too broad.

5

Defendants argue that they should be permitted to present evidence of “FDA’s lack of

6

enforcement action regarding Bard’s G2 line of filters.” Doc. 9690 at 8 (emphasis

7

added). The warning letter did not concern the G2 line of filters, and was issued in 2015,

8

long after Ms. Booker received her G2 filter in 2007. If Defendants open the door at trial

9

by arguing generally that the FDA has never taken enforcement action of any kind, the

10

Court will entertain a request to admit some or all of the FDA warning letter. But on the

11

present record, the Court concludes that the warning letter does not concern issues in this

12

case, with the possible exception of topics 3, 7, and 8, as noted above.

13

If the warning letter becomes relevant, the Court concludes that it should not be

14

barred as hearsay. The public records exception applies to documents that describe

15

“a matter observed while under a legal duty to report” or contain “factual findings from a

16

legally authorized investigation[.]” Fed. R. Evid. 803(8)(A)(ii)-(iii). The warning letter

17

reports the FDA’s factual findings and matters observed under the agency’s investigatory

18

authority, and Defendants have not shown that the letter lacks trustworthiness. Fed. R.

19

Evid. 803(8)(B). The Court will not exclude the letter on hearsay grounds. See Guthrie

20

v. Ball, No. 1:11-cv-333-SKL, 2014 WL 5314576, at *4 (E.D. Tenn. Oct. 17, 2014)

21

(“Courts have held that FDA warnings . . . are admissible under the public records

22

hearsay exception in Rule 803(8).”) (citations omitted); Sadler v. Advanced Bionics, Inc.,

23

No. 3:11-CV-00450-H, 2013 WL 1311148, at *2 (W.D. Ky. Mar. 26, 2013) (finding

24

FDA warning letter admissible under the public records exception where “FDA officials

25

conducted the investigation themselves as a neutral party with motivations to protect

26

public health and safety”); Sabel v. Mead Johnson & Co., 737 F. Supp. 135, 140-41

27

(D. Mass. May 14, 1990) (finding FDA letter recommending a warning label admissible

28

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1

as a public record where it was based on an investigation pursuant to the FDA’s

2

regulation of the safe marketing of prescription drugs).

3
4

Defendants’ motion in limine (Doc. 9864) is granted, subject to Plaintiffs’ ability
to show that topics 3, 7, and 8 are relevant to issues in this case.

5

D.

6

Plaintiffs seek to preclude Defendants from putting on a “filters saves lives”

7

defense, or from describing Bard filters as “lifesaving” or “life-extending.” Doc. 9867.

8

Plaintiffs state that IVC filters are designed to prevent blood clots from reaching the heart

9

and lungs and any other presumed benefit is “speculative.” Id. at 2. But preventing

10

blood clots from reaching the heart and lungs saves lives. Defendants cite statistics

11

showing that some 300,000 people die each year from pulmonary embolisms.

12

Doc. 10059 at 2 n.1. Plaintiffs’ own expert has testified that the purpose of IVC filters is

13

to prevent pulmonary embolisms, and in this sense the filters can be lifesaving devices.

14

Doc. 10059-3 at 3-4 (Kinney Dep. Tr. 111:17-112:2).

Plaintiffs’ MIL No. 3 (IVC filters as “lifesaving” devices).

15

Georgia law, which applies in this case, includes a risk-utility analysis for design

16

defect claims. This analysis involves balancing “the risks inherent in a product design”

17

against “the utility or benefit derived from the product.”

18

S.E.2d 671, 673 (Ga. 1994). Evidence concerning the benefits of IVC filters is directly

19

relevant to this analysis. Plaintiffs’ motion in limine (Doc. 9867) is denied.

Banks v. ICI Ams., Inc., 450

20

E.

21

Plaintiffs seek to exclude evidence and argument that IVC filters are the

22

“gold standard” or the “standard of care” for the treatment of pulmonary embolisms.

23

Doc. 9869. In response, Defendants state that they will not characterize IVC filters as the

24

“gold standard.” Doc. 10054 at 2, n.1. The Court need not address this issue further.

Plaintiffs’ MIL No. 4 (IVC filters are the “gold standard”).

25

Defendants do intend to present evidence that IVC filters, including the G2, are

26

within the standard of care for the medical treatment of pulmonary embolisms. Id.

27

Defendants assert that such evidence is relevant to the risk-utility analysis for the design

28

defect and negligence claims, and that admission of the evidence will not confuse the jury

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1

or result in a mini-trial. Id. at 2-4. The Court agrees. Evidence regarding the use and

2

benefits of IVC filters, and when they are called for, will be relevant to the jury’s risk-

3

utility analysis, as well as evaluation of the failure to warn claims and Dr. D’Ayla’s

4

decision to implant the G2 in Ms. Booker.

5

Plaintiffs express concern that reference to the “standard of care” will confuse the

6

jury concerning the standard of care to be applied in this case. But the standard of care

7

for Bard’s design and marketing of IVC filters is entirely distinct from the medical

8

standard of care for when filters should be used to treat patients. To avoid confusion, the

9

parties should refer to the “medical standard of care” when referring to the standard for

10

implanting filters. The parties may also seek a clarifying jury instruction if warranted.

11

Plaintiffs’ motion in limine (Doc. 9869) is denied.

12

F.

13

Georgia’s nonparty at fault statute provides that the “[n]egligence or fault of a

14

nonparty shall be considered if . . . the defending party gives notice not later than 120

15

days prior to the date of trial that a nonparty was wholly or partially at fault.” O.C.G.A.

16

§ 51-12-33(d)(1). When such notice is given, evidence of the nonparty’s fault may be

17

presented to the jury and the jury may apportion fault and damages between the plaintiff,

18

the defendant or defendants, and the nonparty. Id., § 51-12-33(b)-(c).

Plaintiffs’ MIL No. 6 (nonparties at fault).

19

Defendants filed a timely notice identifying Dr. Sarwat Amer as a nonparty at

20

fault. Doc. 8844. The notice states that “Dr. Amer was the diagnostic radiologist who

21

read [Ms. Booker’s] lumbosacral spine x-ray on March 26, 2009, which showed her G2®

22

Filter had fractured but with all struts adjacent to the filter in the IVC. Dr. Amer reported

23

only: ‘IVC Filter is noted.’” Id. at 2. Defendants contend that Dr. Amer failed to

24

properly report the condition of the G2 filter to Ms. Booker’s treating physicians, and

25

therefore prevented the physicians from fully evaluating her medical condition and

26

treatment options. Id. Defendants further contend that this alleged failure “constituted

27

the sole proximate cause and/or contributing cause to [Ms. Booker’s] injuries.” Id.

28

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1

Plaintiffs seek to exclude evidence and argument related to (1) the fault or

2

negligence of nonparties not included in Defendants’ notice, and (2) the “standard of

3

care” of Ms. Booker’s healthcare providers not identified in the notice. Doc. 9871 at 1.

4

Plaintiffs argue that the notice identifies only Dr. Amer as a nonparty at fault, and

5

evidence and argument relating to the negligence or fault of any others is improper under

6

§ 51-12-33. Id. at 2. For the same reason, Plaintiffs argue that it would be improper for

7

Defendants to present evidence or argument that treatment by other healthcare providers

8

fell below the medical standard of care. Id.

9

Defendants state that they will not seek to have the jury apportion fault or damages

10

under the Georgia statute for any healthcare provider other than Dr. Amer. Doc. 10055

11

at 3. Defendants argue, however, that they should be permitted to present evidence of

12

intervening causes of Ms. Booker’s injuries. Id. Specifically, Defendants contend that

13

“the jury is entitled to hear evidence that Dr. Brandon Kang tore Ms. Booker’s tricuspid

14

valve during his attempt to retrieve a fractured strut in her right ventricle,” necessitating

15

open heart surgery to repair the valve. Id. Defendants intend to argue that Dr. Kang’s

16

“medical treatment relates to [Ms. Booker’s] damages claim and constitutes an

17

intervening act that severed Bard’s liability.” Id.

18
19

The parties’ arguments require the Court to examine Georgia law related to
nonparties at fault and intervening causation.

20

The nonparty at fault statute provides that the “[n]egligence or fault of a nonparty”

21

may be considered by the jury when appropriate notice is given. § 51-12-33(d)(1). The

22

meaning of “negligence” is clear, and the Georgia Supreme Court has defined “fault” to

23

mean “any breach of a legal duty that sounds in tort for the protection of the plaintiff, the

24

breach of which is a proximate cause of the injury about which he complains[.]”

25

Zaldivar v. Prickett, 774 S.E.2d 688, 694 (Ga. 2015). Thus, notice is required before a

26

defendant can argue that a nonparty’s negligence or other breach of duty proximately

27

caused the plaintiff’s injuries, and that some portion of liability and damages should

28

therefore be allocated to the nonparty.

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1

A defendant in Georgia can also escape liability by showing that an intervening

2

cause broke the chain of causation between the defendant and the plaintiff. The Georgia

3

Supreme Court has held that the intervening cause need not be “wrongful or negligent.”

4

Jordan v. Everson, 806 S.E.2d 533, 534 (Ga. 2017). That court has also held that

5

“[f]or an intervening act ‘to become the sole proximate cause of a plaintiff’s injuries, the

6

intervening act must not have been foreseeable by [the] defendant, must not have been

7

triggered by [the] defendant’s act, and must have been sufficient by itself to cause the

8

injury.’” Zaldivar, 774 S.E.2d at 698 (quoting Ontario Sewing Machine Co. v. Smith,

9

572 S.E.2d 533 (Ga. 2002)). “[I]f the character of the intervening act . . . was such that

10

its probable or natural consequences could reasonably have been anticipated,

11

apprehended, or foreseen by the original wrong-doer, the causal connection is not

12

broken.” Id. (quotation marks and citation omitted).

13

From these authorities, the Court reaches four conclusions:

14

First, with the exception of Dr. Amer, Defendants may not assert at trial that other

15

medical providers, including Dr. Kang, should be apportioned fault under § 51-12-33.

16

For the jury to apportion fault to a nonparty under the statute, Defendants must have

17

given notice regarding the nonparty. See Monitronics Int’l, Inc. v. Veasley, 746 S.E.2d

18

793, 804 (Ga. Ct. App. 2013) (noting that Georgia’s nonparty at fault statute “mandates

19

strict compliance”) (emphasis in original). The instructions and verdict form will not

20

permit the jury to apportion fault to any nonparty other than Dr. Amer.

21

Second, Defendants may assert the separate legal doctrine of intervening cause

22

with respect to Dr. Kang or other nonparties not named in the notice. The Court cannot

23

conclude that failure to identify Dr. Kang in the notice forecloses the defense of

24

intervening cause. The nonparty at fault statute specifically provides that “nothing in in

25

this Code section shall eliminate or diminish any defenses or immunities which currently

26

exist, except as expressly stated in this Code section.” O.C.G.A. § 51-12-33(e). The

27

Code section says nothing about the intervening cause defense.1

28
1

The statute does state that negligence or fault of a nonparty “shall be considered”
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1

Third, to prevail on their intervening cause defense, Defendants must show that

2

Dr. Kang’s intervening act, or the intervening act of any other nonparty, (1) was not

3

foreseeable by Bard, (2) was not triggered by Bard’s act, and (3) was sufficient by itself

4

to cause Ms. Booker’s injury. See Zaldivar, 774 S.E.2d at 698. The jury will be so

5

instructed.

6

Fourth, although Defendants will be precluded from arguing that Dr. Kang or

7

others (besides Dr. Amer) were negligent or at fault for purposes of apportioning liability,

8

the Court cannot conclude that they should be precluded from asserting the fault of these

9

nonparties as an intervening cause of Ms. Booker’s damages. Georgia law states that an

10

intervening cause need not be negligent or wrongful, but it also recognizes that such a

11

cause can be negligent or wrongful. See Jordan, 806 S.E.2d at 534; Vega, 670 S.E.2d

12

at 122. It appears that Defendants intend to suggest to the jury that Dr. Kang was at fault.

13

In a separate motion in limine, Plaintiffs sought to exclude evidence related to Dr. Kang’s

14

social media accounts. Doc. 9877. Defendants opposed the motion, asserting that a

15

central issue is “whether Dr. Kang’s retrieval was unduly aggressive in this case.”

16

Doc. 10063 at 2. Defendants stated that they “will present expert and other evidence that

17

Dr. Kang should have followed a more conservative approach.” Id. Defendants may

18

make this argument as part of their intervening cause defense. The Court will instruct the

19

jury carefully, making clear that the fault or actions of Dr. Kang (or similarly situated

20

nonparties) may be considered only if the three requirements for intervening cause set

21

forth above are satisfied, while the fault of Dr. Amer may be considered by the jury in

22
23
24
25
26
27
28

only if proper notice is given. § 51-12-33(d)(1). Arguably, this phrase could be read
broadly to suggest that the jury may consider evidence of a nonparty’s negligence or fault
– for any purpose – only if notice is given. The Court reads the phrase more narrowly.
Section 51-12-33 specifically focuses on apportionment of damages, and the Court
concludes that “shall be considered” means “considered” in apportioning damages. This
reading is reinforced by the statute’s express statement that it does not eliminate other
defenses, and seems to comport with Georgia case law. See Vega v. La Movida, Inc., 670
S.E.2d 116, 122 (Ga. Ct. App. 2008) (finding that the defendant was entitled to argue that
a nonparty’s act was an intervening cause of the plaintiffs’ injuries and noting that § 5112-33 concerns apportionment of damages and therefore was inapposite).

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Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 13 of 20

1

apportioning fault.

2

Ms. Booker’s injuries or may be applied to only a discrete part of them is an issue the

3

parties should be prepared to address when jury instructions and the verdict form are

4

finalized.2

Whether the intervening cause defense must apply to all of

5

Plaintiffs’ motion in limine (Doc. 9871) is granted in part and denied in part.

6

The Court will limit Defendants’ nonparty-at-fault and apportionment arguments to

7

Dr. Amer, but deny the motion to the extent Plaintiffs seek to preclude Defendants from

8

asserting that the conduct of Dr. Kang or others constituted an intervening cause.

9

G.

Plaintiffs’ MIL No. 13 (the alleged fault of Dr. Amer).

10

In a related motion, Plaintiffs seek to exclude evidence regarding the alleged fault

11

of Dr. Amer on the ground that Defendants have no expert testimony to support a

12

causation finding by the jury. Doc. 9878. In their notice of nonparty at fault, Defendants

13

state that they rely on the expert reports and deposition testimony of Drs. Daniel Cousin

14

and Piotr Sobieszczyk. Doc. 8844 at 2. Defendants argue that, under Georgia law,

15

causation may be established by linking the testimony of different expert witnesses, and

16

that in this case Dr. Cousin opines that Dr. Amer fell below the standard of care and

17

Dr. Sobieszczyk provides the causation opinion. Doc. 10066 at 2-5.

18

Dr. Sobieszczyk’s report references several imaging studies Ms. Booker received,

19

including the radiological exam performed by Dr. Amer in March 2009. Doc. 10067 at 9.

20

He notes that Dr. Amer’s exam “showed an IVC filter with one short fragment separated

21

from the filter and pointing up above the filter tip,” and another fragment “separated from

22
23
24
25
26
27
28

2

Defendants argue that they can use the intervening cause defense to assert that
Dr. Kang “contributed to” Ms. Booker’s injuries. Doc. 10055 at 3. This is not correct.
Either his conduct became an intervening cause and broke the causal chain between
Defendants and Ms. Booker, eliminating Defendants’ liability, or it did not. True, if
Defendants are able to show that his actions were the intervening cause for some discrete
part of her injury (say, her heart surgery), it may have the same effect as if the jury
apportioned fault and assigned 100% of the heart surgery responsibility to Dr. Kang. But
the jury could reach this result only through the intervening cause analysis and a finding
that the three elements set forth above are satisfied. Defendants cannot use the
intervening cause defense to essentially argue for equitable apportionment – that the jury
should divide the liability between Defendants and Dr. Kang on the basis of their
respective degrees of fault.
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1

the filter and moved towards the midline.” Id. He refers to the imaging studies as

2

“missed opportunities,” opining that they “clearly defined progressive tilting and strut

3

movement” and “[r]ecognition of this process would have allowed timely retrieval of the

4

filter.” Id. at 11, ¶ 2.

5

The Court finds that this opinion, when combined with Dr. Cousin’s opinion

6

regarding the standard of care (Doc. 9878-4 at 4), is sufficient to create a jury issue on

7

whether Dr. Amer is at fault for allegedly failing to report the condition of Ms. Booker’s

8

filter to her treating physicians.

9

regarding causation are peculiarly questions for the jury except in clear, plain, palpable

10

and undisputed cases.” Moore v. Singh, 755 S.E.2d 319, 323-24 (Ga. Ct. App. 2014)

11

(citation omitted). This is not one of those cases. See id. at 324 (“Based on the combined

12

expert testimony, we conclude that Moore presented evidence creating a jury issue as to

13

whether Dr. Singh would have discovered the fracture if she had properly complied with

14

the standard of care [and] . . . whether the failure to diagnose the fracture during that time

15

led to further complications[.]”). Plaintiffs’ motion in limine (Doc. 9878) is denied.

Georgia courts have made clear that “[q]uestions

16

H.

17

Plaintiffs seek to exclude evidence of “statements from various associations, trade

18

groups, organizations, societies of physicians, [and] medical providers[.]” Doc. 9874

19

at 1. Plaintiffs first contend that such statements constitute inadmissible hearsay, and

20

possibly hearsay within hearsay. Id. at 2. Plaintiffs also contend that admission of such

21

statements through non-experts would evade Daubert scrutiny and would violate

22

Rule 403.

23

particular association, the Court cannot grant Plaintiffs’ motion. But the Court will

24

address some of the parties’ arguments.

Plaintiffs’ MIL No. 9 (statements from associations and other groups).

Id. at 2-3.

Because Plaintiffs identify no specific statement from any

25

Defendants argue that statement by medical societies may be relevant even if they

26

are not offered for the truth of the matter asserted. Doc. 10058 at 2. Defendants note, for

27

example, that the risk-utility test of Georgia law permits a jury to consider “the gravity

28

and severity of the danger posed by [a product’s] design; the likelihood of that danger;

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1

the avoidability of the danger, i.e., the user’s knowledge of the product, publicity

2

surrounding the danger, or the efficacy of warnings, as well as common knowledge and

3

the expectation of danger[.]” Banks, 450 S.E.2d at 675 n.6. Defendants argue that

4

statements from the Society of Interventional Radiologists (“SIR”) about the risks of IVC

5

filters are relevant to several of these factors – the user’s knowledge of the product,

6

publicity surrounding the product’s danger, and the common knowledge the danger –

7

regardless of whether the SIR’s statements are true. Admission for these non-truth

8

purposes, Defendants assert, would not implicate the hearsay rules. Whether statements

9

should be admitted for these purposes must be decided at trial.

10

Defendants also contend that statements by medical societies are admissible under

11

Rule 803(18) even if offered for the truth of the matter asserted. Doc. 10058 at 3.

12

Rule 803(18) provides that a statement contained in a treatise or periodical is excluded

13

from the hearsay rule if (1) “the statement is called to the attention of an expert witness

14

on cross-examination or relied on by the expert on direct examination,” and (2) “the

15

publication is established as a reliable authority by the expert’s admission or testimony,

16

by another expert’s testimony, or by judicial notice.” Fed. R. Evid. 803(18)(A)-(B).3

17

If deemed admissible, “the statement may be read into evidence but not received as an

18

exhibit.” Id. “This limitation ensures that the jurors will not be unduly impressed by the

19

treatise, and that they will not use the text as a starting point for conclusions untested by

20

expert testimony.”

21

803(18)’s requirements are satisfied requires a statement-by-statement inquiry, which

22

must be determined at trial. The party proposing to use a statement under Rule 803(18)

23

must be prepared to show that both requirements are met.

5 Weinstein’s Federal Evidence § 803.20[1].

Whether Rule

24

Plaintiffs further contend that testimony from non-expert witnesses about

25

statements from medical societies such as the SIR would allow Bard to avoid the scrutiny

26
3

27
28

On the second requirement, Weinstein’s explains: “To establish a proper
foundation, the proponent must show that the author of the treatise or article in question
is an authority.” 5 Jack B. Weinstein & Margaret A. Berger, Weinstein’s Federal
Evidence § 803.20[2] (2d. ed. 2018).
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Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 16 of 20

1

of Daubert. Id. Defendants avow that they will not attempt to offer any expert opinion

2

about such statements through a fact witness. Doc. 10058 at 3. Defendants do state,

3

however, that SIR guidelines were discussed routinely among Bard employees, and that

4

fact witnesses should be permitted to testify about the things they said and the actions

5

they took concerning SIR guidelines. Id. at 3-4. If a discussion at Bard that included

6

reference to SIR statements is relevant to an issue in this case and not otherwise

7

objectionable, then a lay witness’s recounting of the discussion may be appropriate.

8

The Court will defer ruling on any objections until trial.

9

Defendants contend that even if SIR guidelines are themselves inadmissible on

10

hearsay or other grounds, their experts may rely on the guidelines under Rule 703.

11

Defendants assert that some of their experts have relied on the guidelines in forming their

12

opinions and were not challenged by Plaintiffs in any Daubert motion. Doc. 10058 at 3.

13

But even if an expert is allowed to state an opinion formed in part by reliance on the SIR

14

guidelines, that does not mean that the guidelines themselves may be disclosed to the

15

jury. “Rule 703 is not, itself, an exception to or exclusion from the hearsay rule or any

16

other evidence rule that makes the underlying information inadmissible.” 4 Weinstein’s

17

Federal Evidence § 703.05[2]. Rule 703 generally does not permit an expert to relay

18

inadmissible evidence – as opposed to the expert’s own opinion based on such evidence –

19

to the jury. Indeed, there is “a presumption against disclosure to the jury of information

20

used as the basis of an expert’s opinion and not admissible for any substantive purpose,

21

when that information is offered by the proponent of the expert.” Fed. R. Evid. 703

22

(2000 Advisory Committee’s Note).

23

inadmissible information may be disclosed to the jury under Rule 703 only if the

24

proponent shows that “the probative value of the information in assisting the jury to

25

evaluate the expert’s opinion substantially outweighs its prejudicial effect.” Id.; Fed. R.

26

Evid. 703.

Thus, if an objection is made, otherwise

27

If the Court sustains an objection to the admission of the SIR guidelines through

28

expert testimony, and Defendants’ believe that the probative value of the guidelines in

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Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 17 of 20

1

helping the jury evaluate the expert’s opinion substantially outweighs any prejudicial

2

effect, Defendants are instructed to raise this issue with the Court outside the hearing of

3

the jury. If the Court concludes that the SIR guideline evidence may be disclosed to the

4

jury under Rule 703, Plaintiffs may request a limiting instruction that the evidence may

5

be used only for evaluating the expert’s opinion and not for substantive purposes.

6

Plaintiffs assert that Bard intends to use the SIR guidelines to establish acceptable

7

failure rates for IVC filter manufacturers, and that use of the SIR guidelines in this way

8

would be misleading and result in unnecessary mini-trials. Doc. 9874 at 3. Plaintiffs

9

further assert that statements from professional organizations with lofty names have

10

limited probative value that is substantially outweighed by the risk of unfair prejudice,

11

confusion, and delay. Id. at 3-4. Efficient management of the evidence and adherence to

12

the trial time limits will avoid the risk of mini-trials and delay. Doc. 10058 at 4. The

13

Court cannot conclude on the present record that any probative value the SIR guidelines

14

may have is substantially outweighed by the danger of unfair prejudice. Plaintiffs may

15

object during trial if they believe specific SIR guideline evidence is inadmissible.

16

Finally, Plaintiffs seek to exclude evidence regarding the lack of statements from

17

the SIR and similar organizations. Doc. 9874 at 1-2. Plaintiffs cite to the testimony

18

of one of Bard’s experts that, to her knowledge, no medical society has taken the position

19

that Bard retrievable filters carry more risks than other IVC filters. Doc. 9874-2 at 3

20

(Roberts Dep. Tr. 78:9-79:6). Defendants counter that what organizations like the SIR do

21

not say about the risks of IVC filters is relevant to the jury’s consideration of the design

22

defect and failure to warn claims. Doc. 10058 at 3. Whether such evidence is relevant

23

and otherwise admissible will depend heavily on context. The Court will make rulings as

24

necessary during trial.

25

Defendants assert that testimony regarding the absence of a statement is not

26

hearsay. Doc. 10058 at 3 n.1 (citing Llamas v. Seibel, No. 16-CV-05812-WHO, 2017

27

WL 3782175, at *8 (N.D. Cal. Aug. 31, 2017)). Although this generally is true, silence

28

can be a “statement” for purposes of the hearsay rules where the person “intended it as an

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Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 18 of 20

1

assertion.” Fed. R. Evid. 801(a); see McGiboney v. CCA W. Props., Inc., No. 1:13-cv-

2

00214-REB, 2016 WL 843253, at *7 (D. Idaho Mar. 1, 2016) (Rule 801 “explicitly

3

requires that the declarant must actually intend his statement (even if it consists

4

of silence) as an assertion”); Weinstein’s Federal Evidence § 801.10[2][b] (“Even silence

5

may be intended as an assertion”). If Plaintiffs believe that testimony regarding the

6

absence of statements from medical societies constitutes inadmissible hearsay, they may

7

object. Plaintiffs’ motion in limine (Doc. 9874) is denied.

8

I.

9

Plaintiffs seek to exclude evidence or argument that Bard needed the FDA’s

10

consent to add warnings to its labels, send warning letters to physicians and consumers,

11

or recall the G2 filter. Doc. 9875. Defendants do not dispute that a medical device

12

manufacturer may send warning letters and voluntarily initiate a recall without FDA

13

consent. Doc. 10062 at 2-4. Defendants will be precluded from presenting evidence or

14

argument to the contrary. Defendants may, however, present evidence and argument

15

explaining the FDA’s potential involvement in any recall effort and the reasons why Bard

16

filters were not recalled. Id. at 4.

Plaintiffs’ MIL No. 10 (FDA consent for warnings or recalls).

17

Defendants dispute that manufacturers may add warnings to device labels without

18

FDA consent. Defendants cite 21 C.F.R. § 807.81, but this regulation says nothing about

19

adding warnings to labels. Rather, the significant changes or modifications that may

20

require FDA premarket notification are those affecting the intended use of the device or

21

the “design, material, chemical composition, energy source, or manufacturing process.”

22

21 C.F.R. § 807.81(a)(3)(ii)-(iii). None of these constitutes adding a warning to a label.

23

Defendants also cite an FDA guidance document that notes that a labeling change

24

“meant to significantly improve clinical outcomes, to mitigate a known risk, or in

25

response to adverse events . . . likely requires submission of a new 510(k).” Doc. 10062

26

at 2.4 As the Court previously noted, this document is meant only to provide guidance

27
4

28

See FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device,
Guidance for Industry and FDA Staff, at 19 (Oct. 25, 2017), available at https://www.fda
.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm
- 18 -

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 19 of 20

1

and does not bind the FDA or device manufacturers. Doc. 8872 at 24 n.13. Moreover,

2

the document provides that “manufacturers should monitor device usage and promptly

3

revise the warnings and precautions based on user experience,” and that “[s]ubmission of

4

new 510(k)s for such labeling changes are generally not required.” Guidance Doc. at 22.

5

Defendants cite a regulation that requires FDA approval for label changes or

6

product comparisons, but that regulation applies only to prescription drugs. See 21

7

C.F.R. § 201.57(c) (“The requirements in this section apply only to prescription drug

8

products described in § 201.56(b)(1)[.]”).

9

regarding clinical trials concerns the FDA’s approval of new drugs, not medical devices.

10

Similarly, the regulation Defendants cite

See 21 C.F.R. § 314.126.

11

Plaintiffs’ position, according to Defendants, is that “Bard could have added

12

warnings regarding ‘the increased risks’ of complications ‘associated with its products.’”

13

Doc. 10062 at 2. Defendants contend that the concept of “increased risks” necessarily

14

requires a comparison of the G2 and other filters based on medical device reports

15

(“MDRs”) and data from the FDA’s Manufacture and User Facility Device Experience

16

(“MAUDE”) database, and Plaintiffs’ proposed warning regarding increased risks runs

17

afoul of FDA regulations governing what content may be used in device instructions for

18

use. Id. (citing 21 C.F.R. § 201.57(c)). As noted above, however, the cited regulation

19

applies only to prescription drugs. Moreover, Plaintiffs’ motion states that Bard could

20

have warned about increased risks by voluntarily sending letters to physicians and

21

patients. Doc. 9875. Defendants cite no FDA rule or regulation prohibiting such letters.

22

Defendants note that MDR and MAUDE data “alone cannot be used to . . .

23

compare event rates between devices” and cannot be “used in isolation to reach

24

conclusions about the existence, severity, or frequency of problems associated with

25

devices.” Doc. 10062 at 2.5 This appears to be correct, but Defendants have not shown

26
27
28

514771.pdf (last visited Feb. 21, 2018).
5

See FDA MAUDE Database, available at https://www.accessdata.fda.gov/scripts
/cdrh/cfdocs/cfmaude/search.cfm (last updated Jan. 31, 2018; last visited Feb. 27, 2018).
- 19 -

Case 2:15-md-02641-DGC Document 10258 Filed 03/01/18 Page 20 of 20

1

that FDA consent would be required to provide a warning about increased risks based on

2

other reliable sources.

3

Plaintiffs’ motion in limine (Doc. 9875) is granted in part. Defendants will be

4

precluded from presenting evidence or argument that Bard needed FDA consent to add

5

any warning to its labels, send warning letters to physicians and patients, or recall its

6

filters. Defendants may, however, present evidence and argument explaining the reasons

7

why Bard filters were not recalled, the FDA’s potential involvement in any recall effort,

8

and the fact that warnings about failure rates and increased risks could not be based on

9

MDR and MAUDE data alone.

10

Dated this 1st day of March, 2018.

11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

- 20 -

Case 2:15-md-02641-DGC Document 10382 Filed 03/09/18 Page 1 of 4

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability
Litigation,

10

___________________________________

11

Sherr-Una Booker, an individual,

12

No. MDL 15-02641-PHX-DGC

No. CV-16-00474-PHX-DGC

Plaintiff,

13

v.

14

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

15
16

ORDER

Defendants.

17
18
19

In the parties’ proposed pretrial order, Defendants objected to Plaintiffs’ use at

20

trial of the depositions of three defense expert witnesses, Drs. Moritz, Rogers, and Stein,

21

who originally were retained by Defendants but have since been withdrawn. Doc. 10255

22

at 2. Defendants assert that the depositions constitute hearsay and are not admissible as

23

admissions of a party-opponent. Id. (citing Fed. R. Evid. 801(d)(2)(C); Glendale Fed.

24

Bank, FSB v. United States, 39 Fed. Cl. 422, 425 (1997); In re Hanford Nuclear Res.

25

Litig., 534 F.3d 986, 1016 (9th Cir. 2008)). Plaintiffs counter that once a party has

26

offered opinions through deposition or expert reports, those opinions do not belong to

27

that party alone, but rather are available for all parties to use at trial. Id. at 26 (citing

28

NetAirus Techs., LLC v. Apple, Inc., No. LA CV10-03257 JAK, 2013 WL 9570686, at *3

Case 2:15-md-02641-DGC Document 10382 Filed 03/09/18 Page 2 of 4

1

(C.D. Cal. Nov. 11, 2013)).

2

At the final pretrial conference, the Court directed the parties to file memoranda

3

addressing the issue of whether the depositions are admissible under Federal Rule of

4

Civil Procedure 32(a)(4) and Federal Rule of Evidence 804(b)(1). See Doc. 10323 at 3.

5

The parties have now done so. Docs. 10343, 10345.

6

Plaintiffs contend that depositions of the withdrawn experts are admissible

7

because a party may use “for any purpose” the depositions of unavailable witnesses under

8

Rule 32(a)(4), and the depositions fall within the “former testimony” exception to the

9

hearsay rule set forth in Rule 804(b)(1). Id. at 1-2 (citing Tatman v. Collins, 938 F.2d

10

509, 511 (4th Cir. 1991)). Defendants acknowledge that several courts have held that a

11

withdrawn expert’s deposition may be used at trial under Rule 32(a)(4). Doc. 10343

12

at 2-3. Defendants assert that the depositions nonetheless should be excluded under Rule

13

804 unless Plaintiffs have used reasonable but unsuccessful means to procure live

14

testimony from the experts, and unless Defendants had a “similar motive” to develop the

15

testimony during the deposition.

16

withdrawn experts are unavailable for purposes of Rule 804(a)(5) and that any attempt by

17

Plaintiffs to subpoena them would be futile. Nor do Defendants explain why they did not

18

have a similar motive to develop the experts’ testimony during the depositions. Once it

19

was clear that the experts were giving answers helpful to Plaintiffs, Defendants had

20

sufficient incentive to clarify or cross-examine on those answers. Defendants have not

21

shown that the depositions are inadmissible on hearsay grounds.

Id. at 2.

But Defendants do not dispute that the

22

Defendants argue that even if the depositions can be used at trial, it would be

23

unfairly prejudicial under Rule 403 to disclose to the jury that the experts originally were

24

retained by Defendants.

25

prejudice of informing the jury that the expert presently testifying for one party was

26

originally designated, retained, or consulted by the opposing party.” House v. Combined

27

Ins. Co. of Am., 168 F.R.D. 236, 243 (N.D. Iowa 1996) (citing Peterson v. Willie, 81 F.3d

28

1033, 1037 (11th Cir. 1996) (collecting cases)); Healy v. Counts, 100 F.R.D. 493, 496 (D.

Several courts have recognized “the significant potential

-2-

Case 2:15-md-02641-DGC Document 10382 Filed 03/09/18 Page 3 of 4

1

Colo. 1984); Rubel v. Eli Lilly & Co., 160 F.R.D. 458, 460 (S.D.N.Y. 1996) (noting that

2

one leading commentator “aptly has characterized the fact of the prior retention by the

3

adversary as ‘explosive’” (quoting 8 Wright, Miller & Marcus, Federal Practice &

4

Procedure § 2032, at 447 (1994)). As one court explained:

5
6
7
8
9

The admission of this evidence . . . would only serve to unfairly prejudice
the [opposing party]. Jurors unfamiliar with the role of counsel in
adversary proceedings might well assume that . . . counsel had suppressed
evidence which he had an obligation to offer. Such a reaction could destroy
counsel’s credibility in the eyes of the jury.
Granger v. Wisner, 656 P.2d 1238, 1242-43 (Ariz. 1982).

10

Plaintiffs contend that Defendants should not be able to “hide” their experts’

11

unfavorable opinions from the jury. Doc. 10345 at 2. But disclosing the fact that

12

Defendants have withdrawn the experts could be unfairly prejudicial, leading the jury to

13

speculate as to why the experts were withdrawn and, potentially, to conclude that

14

Defendants or their counsel attempted to engage in dishonest or unethical behavior. And

15

such information has little relevance to the substance of the experts’ opinions on any

16

claim or defense in this case. See Granger, 656 P.2d at 381 (finding the fact of the prior

17

consultation irrelevant to the issue of negligence); House, 168 F.R.D. at 243 (“House has

18

asserted as an argument for permitting her to offer [the expert’s] testimony the assertion

19

that [the defendant] is trying to hide [the] opinion from House and the jury. However, the

20

court in Peterson recognized the prejudice that results from informing the jury that an

21

expert had originally been consulted by the opposing party.”).

22

The Court concludes that Plaintiffs may use portions of the experts’ depositions

23

that support Plaintiffs’ case, but may not disclose to the jury, through argument or

24

deposition excerpts, that the experts originally were retained by Defendants. The Court

25

concludes that the probative value of such arguments or deposition excerpts would be

26

substantially outweighed by the danger of unfair prejudice. Fed. R. Ev. 403.

27

The Court is also concerned about the presentation of cumulative evidence. The

28

Court has made clear that it will not permit either side to use multiple experts at trial to

-3-

Case 2:15-md-02641-DGC Document 10382 Filed 03/09/18 Page 4 of 4

1

address the same issue. Thus, before the deposition of any withdrawn expert may be

2

used at trial, “there should be some showing . . . that no other expert of similar

3

qualifications is available or that the unavailable expert has some unique testimony to

4

contribute.” Carter-Wallace, Inc. v. Otte, 474 F.2d 529, 536-37 (2d Cir. 1972). If

5

Plaintiffs make this showing for any of the withdrawn experts, the Court will allow the

6

expert’s deposition to be used at trial subject to the Rule 403 decision above and any

7

other evidentiary objections Defendants may assert. See Doc. 10343 at 3. Defendants

8

will be permitted to counter-designate other relevant portions of the deposition transcript.

9

See Doc. 10255 at 25.

10

Dated this 9th day of March, 2018.

11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

-4-

Case 2:15-md-02641-DGC Document 10489 Filed 03/19/18 Page 1 of 3

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability

10

Litigation,

11

___________________________________

12

Sherr-Una Booker, an individual,

No. MDL 15-02641-PHX-DGC

No. CV-16-00474-PHX-DGC

Plaintiff,

13
14

v.

15

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

16
17

ORDER

Defendants.

18
19
20

Near the close of trial last week, Plaintiff objected to Defendants presenting

21

evidence of complications associated with Bard’s Simon Nitinol Filter (“SNF”). In

22

addition to arguments made in court, the parties have filed memoranda addressing the

23

issue. Docs. 10487, 10488.1

24

In seeking to prove her claim that Defendants defectively designed the G2 filter

25

and failed to warn about its risks, Plaintiff has claimed during trial that the G2, and its

26
1

27
28

Each party also provided the Court with a USB flash drive containing SNFrelated documents. Defendants’ documents consist of medical literature about SNF
complications, expert reports citing some of those articles, and documents produced to
Plaintiff during discovery. Plaintiff’s documents consist largely of internal Bard
communications about the safety and effectiveness of the SNF.

Case 2:15-md-02641-DGC Document 10489 Filed 03/19/18 Page 2 of 3

1

predicate device, the Recovery filter, were considerably less safe that the SNF.

2

Defendants intend to rebut this evidence by presenting medical literature about SNF

3

failure rates and expert testimony that failures with the SNF, as a permanent filter, are

4

reported less frequently than failures for retrievable filters.

5

Plaintiff claims that Defendants should be prevented from presenting this evidence

6

because she was barred from conducting relevant discovery, citing Case Management

7

Order No. 10 (“CMO 10”). See Doc. 1319. Defendants argue that Plaintiff’s reliance on

8

CMO 10 is misplaced because the order afforded Plaintiff significant discovery

9

concerning the SNF, all of Bard’s adverse event data concerning the SNF were produced,

10

and the only materials not produced were SNF design and testing documents.

11

Doc. 10487 at 2.

12

Plaintiff sought production of six categories of documents related to the SNF:

13

(1) design materials, (2) testing information, (3) regulatory communications, (4) sales and

14

marketing materials, (5) information comparing the SNF to other filters, and (6) internal

15

Bard communications related to these subjects. Doc. 1161 at 1-2. The Court permitted

16

discovery regarding topics (4), (5), and (6), and Defendants agreed to produce the

17

documents on topic (3). Doc. 1319 at 4-5. The only discovery not allowed by CMO 10

18

was on topics (1) and (2) – the design and testing of the SNF. The Court foreclosed this

19

discovery because Plaintiff did not contend then, and does not contend now, that the SNF

20

is defective.

21

Plaintiff argues that discovery regarding the design and testing of the SNF would

22

somehow have permitted her to challenge Bard’s assertion that the SNF has had as many

23

failures as the Recovery and G2. Doc. 1048 at 2. But Plaintiff was not precluded from

24

conducting discovery of SNF failures. CMO 10 specifically permitted Plaintiff to obtain

25

“documents comparing filter performance and failure rates to the SNF.” Doc. 1319 at 4.

26

True, Plaintiff was precluded from conducting discovery into the design and testing of the

27

SNF, but that was because she does not claim that the SNF was designed defectively.

28

Rather, she asserts that the SNF is a markedly safer filter than the Recovery and G2. The

-2-

Case 2:15-md-02641-DGC Document 10489 Filed 03/19/18 Page 3 of 3

1

Court cannot see, and Plaintiff does not explain, how discovery into the design and

2

testing of the SNF would have produced any information on failure rates the SNF

3

experienced after it was on the market.

4

Plaintiff argues that the SNF received design changes through 1995 and that she

5

will be unable to contradict the medical literature Defendants intend to present because

6

those articles depend on the precise version of the SNF filter at issue. But Plaintiff never

7

made this argument in connection with CMO 10, and, in arguing that the SNF is a safe

8

and effective filter, Plaintiff has never distinguished between different versions.

9

Nor has Plaintiff shown that she will be unable to rebut the medical literature

10

Defendants intend to present. To the contrary, Plaintiff has identified multiple internal

11

Bard documents showing that failure rates for the SNF were much lower than Recovery

12

and G2 rates. This information was produced by Defendants during discovery. Plaintiff

13

has already presented much of it during trial, will present more, and will be free to cross-

14

examine witnesses with this evidence.

15

Plaintiff may make appropriate evidentiary objections to any evidence Defendants

16

seek to present, but the Court will not preclude Defendants from presenting their SNF

17

evidence on the basis of a discovery ruling. The Court does not agree that Plaintiff was

18

foreclosed from obtaining relevant evidence for rebuttal.

19

Dated this 19th day of March, 2018.

20
21
22
23
24
25
26
27
28

-3-

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 1 of 6

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability
Litigation,

10

___________________________________

11

Doris Jones, an individual,

12

No. MDL 15-02641-PHX-DGC

No. CV-16-00782-PHX-DGC

Plaintiff,

13

v.

14

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

15
16

ORDER

Defendants.

17
18
19

The Court held a hearing with the parties on April 13, 2018, to discuss matters

20

decided for the Booker trial that the parties wish to have reconsidered for the Jones trial.

21

The Court took two matters under advisement: whether evidence of the complications,

22

testing, and design of the Recovery filter should be admitted in the Jones trial, and

23

whether evidence of deaths caused by cephalad migration of the Recovery filter should

24

be admitted. These matters were the subject of briefing before the hearing and argument

25

during the hearing. See Docs. 10677, 10707.

26

Plaintiff Doris Jones was implanted with a Bard Eclipse filter in August 2010.

27

The filter later fractured, and a strut migrated to Ms. Jones’ lung. She asserts claims for

28

defective design, failure to warn, fraudulent concealment, and punitive damages.

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 2 of 6

1

A.

2

Defendants note that the relevant progression of their retrievable filter line is as

3

follows: Recovery, G2, G2X, Eclipse. They argue that the Eclipse filter at issue in this

4

case is three generations removed from the Recovery filter and that complications with

5

the Recovery therefore are not relevant to the alleged design defects or failure to warn

6

related to the Eclipse.

Evidence of Recovery Filter Complications, Testing, and Design.

7

Plaintiff claims that design defects in the Eclipse trace directly back to the

8

Recovery, and that those defects can be understood only in the context of the entire filter-

9

line development. Plaintiff asserts that problems with the Recovery led directly to a

10

poorly-tested set of changes in the G2 filter; that those changes created other problems in

11

the G2, including tilt, fracture, and caudal migration (away from the head); that the G2X

12

and Eclipse filters were essentially the same as the G2, adding only a retrieval hook and

13

electropolishing; and that Bard acted unreasonably in failing to implement effective tests

14

and design changes when developing the G2, and, later, in failing to correct apparent G2

15

problems, leading directly to the Eclipse defects that caused Ms. Jones’ injury.

16

Doc. 10707.

17

The Court concludes that the Recovery filter’s complications, testing, and design

18

are relevant to this case. Those events help explain the testing, development, and design

19

of the G2, and Plaintiff contends that the G2 was essentially the filter she received. The

20

history of the Recovery and how it led to the G2 tends to make a fact in dispute – the

21

allegedly defective design of the Eclipse – more probable. Fed. R. Evid. 401.

22

The Court cannot conclude that evidence of the Recovery’s complications, testing,

23

and design should be precluded under Rule 403. The Court does not find such evidence

24

to be unfairly prejudicial – it is a relevant part of the Eclipse filter’s design history.

25

Further, Plaintiff’s counsel presented much of the same evidence during the Booker trial.

26

Although the Court felt that Plaintiff’s counsel were less efficient in that trial than they

27

could have been, the Court will hold Plaintiff to the established time limits in this case

28

-2-

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 3 of 6

1

and concludes that Recovery filter evidence will not result in a waste of time or confusion

2

of the issues. See Doc. 10587.

3

B.

4

Deaths caused by the Recovery filter’s cephalad migration (toward the head)

5

present a different question. Such deaths might clear the threshold for relevancy in Rule

6

401 because, as explained above, they are part of the history of the filter line’s

7

development. But for several reasons the Court finds this relevancy to be marginal in

8

Ms. Jones’ case.

Evidence of Deaths Caused by Recovery Filter Cephalad Migration.

9

First, the complication of cephalad migration did not continue in any significant

10

degree beyond the Recovery filter. As Plaintiff’s counsel admitted during the April 13

11

hearing, changes made in response to cephalad migration largely eliminated that direction

12

of migration in the G2 and later filters. The Court’s notes from the Booker trial reflect

13

that Plaintiff identified only one instance of cephalad migration by a G2 filter. And

14

Plaintiff’s counsel acknowledged during the hearing that they are not aware of any

15

instances of death caused by cephalad migration of G2, G2X, or Eclipse filters.

16

Second, the cephalad migration deaths all occurred before the Recovery filter was

17

taken off the market in late 2005. Ms. Jones did not receive her Eclipse filter until

18

January of 2010. The passage of more than four years and three filter generations makes

19

the cephalad migration deaths remote in time.

20

Third, the cephalad migration deaths say nothing about several of Ms. Jones’

21

claims in this case: strict liability design defect, strict liability failure to warn, negligent

22

failure to warn, or fraudulent concealment. Proof of the cephalad migration deaths from

23

the Recovery filter in 2004 and 2005 does not show that the Eclipse filter had a design

24

defect when it left Defendants’ control several years later, or that Defendants’ later

25

warnings regarding the Eclipse were inadequate or fraudulent.

26

The cephalad migration deaths arguably are more relevant to Ms. Jones’ negligent

27

design defect claim because they help show the extent to which Defendants allegedly

28

failed to exercise reasonable care in designing and testing the G2 filter. But the things

-3-

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 4 of 6

1

Defendants allegedly failed to do in developing the G2 – perform a viable root cause

2

analysis, test adequately, follow established design principles – can all be shown through

3

Plaintiff’s experts and without mention of the cephalad migration deaths. The deaths

4

arguably could make these failures appear even more negligent because Defendants were

5

aware of severe consequences from the Recovery’s design, but they do not prove the

6

negligence. Evidence of the deaths remains marginal – it adds some weight to Plaintiff’s

7

negligence claim, but it is not central to proof of design negligence.

8

Fourth, Plaintiff asserts a claim for punitive damages and argues that the cephalad

9

migration deaths are relevant to whether Defendants acted with the state of mind needed

10

for such damages: willful misconduct, malice, fraud, wantonness, oppression, or that

11

entire want of care that would raise the presumption of conscious indifference to

12

consequences. Doc. 10588 at 29. Under Georgia law, which governs Plaintiff’s claims,

13

“evidence of other incidents involving the product is admissible, and relevant to the

14

issues of notice of a defect and punitive damages, provided there is a showing of

15

substantial similarity.” Gen. Motors Corp. v. Moseley, 447 S.E.2d 302, 306 (Ga. Ct.

16

App. 1994) (citing Mack Trucks v. Conkle, 436 S.E.2d 635 (Ga. 1993)). “‘Without a

17

showing of substantial similarity, the evidence is irrelevant as a matter of law.’” Id.

18

(quoting Carlton Co. v. Poss, 183 S.E.2d 231 (Ga. Ct. App. 1971)); see also State Farm

19

Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 422 (2003) (“A defendant’s dissimilar

20

acts, independent from the acts upon which liability was premised, may not serve as the

21

basis for punitive damages.”).

22

In denying Defendants’ request for summary judgment on Plaintiff’s punitive

23

damages claim, the Court found generally that Plaintiffs have shown a substantial

24

similarity between filters – between the Eclipse filter and the Recovery and G2 filters.

25

Doc. 10404 at 19. But the Court concludes that instances of cephalad migration resulting

26

in death are not substantially similar to complications experienced by the G2, G2X, or

27

Eclipse. As noted above, cephalad migration was largely eliminated by the design of the

28

G2, and Plaintiff has identified no cephalad migration deaths caused by any of the G2

-4-

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 5 of 6

1

line of filters, including the Eclipse. The deaths therefore do not meet the substantial

2

similarity requirement of Georgia law.

3

The deaths would be clearly relevant to punitive damages if they were caused by

4

the Eclipse or its predicate device – if Defendants continued to market the Eclipse in the

5

face of unusually high patient deaths. But Defendants did not do that; the cephalad

6

migration deaths stopped when the Recovery was taken off the market in 2005. Plaintiffs

7

do contend that Defendants continued to market the G2, G2X, and Eclipse with

8

knowledge of other complications, but none of those complications included cephalad

9

migration. The deaths shed little light on Defendants’ state of mind when marketing

10

different filters with different complications, years later. See Gen. Motors, 447 S.E.2d at

11

307 (finding reversible error where counsel for plaintiffs referenced deaths and other

12

lawsuits during trial without first making a showing of substantial similarity to the

13

incident at issue); Ray v. Ford Motor Co., 514 S.E.2d 227, 230-31 (Ga. Ct. App. 1999)

14

(affirming decision to exclude evidence about a Ford database listing prior instances of

15

inadvertent vehicle movement where the plaintiff failed to establish that the incidents

16

were substantially similar to his accident).1

17

Thus, when all of the issues in this case are considered, the cephalad migration

18

deaths have, at most, marginal relevancy. Given this level of relevancy, the Court finds

19

that the probative value of the death evidence is substantially outweighed by the danger

20

of unfair prejudice. “Unfair prejudice is an undue tendency to suggest decision on an

21

improper basis, commonly, though not necessarily, an emotional one.” United States v.

22

Haischer, 780 F.3d 1277, 1281 (9th Cir. 2015) (citation and quotation marks omitted).

23

The fact that several patients died when their Recovery filters migrated in a cephalad

24
25
26
27
28

1

To the extent Plaintiff suggests that Defendants’ alleged indifference during the
marketing of the Recovery shows that Defendants were also indifferent when marketing
the Eclipse, they suggest a propensity use of the evidence that is prohibited by Rule
404(a) and (b). Plaintiff has not argued that cephalad migration deaths should be
admitted under one of the permissible purposes in Rule 404(b)(2). But even if Plaintiff
made this argument, the Court can see no permitted use of the death evidence in that rule.
And, in any event, Rule 404(b) analysis remains subject to Rule 403, and the Court
concludes in this order that admission of the death evidence would violate Rule 403.
-5-

Case 2:15-md-02641-DGC Document 10819 Filed 04/18/18 Page 6 of 6

1

direction would have an undue tendency to prompt a jury decision based on emotion.

2

The Court concludes that the danger of this emotional reaction substantially outweighs

3

any marginal relevancy of the death evidence in this case, and therefore will exclude the

4

evidence under Rule 403.

5

The Court reached a different conclusion in Booker, holding that evidence of

6

cephalad migration deaths could be admitted. Doc. 10323 at 4. But Booker concerned a

7

G2 filter for which the Recovery was the predicate device. Defendants represented to the

8

FDA – and, in essence, to the jury – that the G2 was as safe and effective as the

9

Recovery. This put the safety and effectiveness of the Recovery filter squarely at issue.

10

And even with this greater relevancy, the Court in Booker expressed concern that too

11

heavy an emphasis on the cephalad migration deaths would result in unfair prejudice that

12

substantially outweighed the probative value of the evidence. Id.

13

In this case, the Court finds that deaths caused by a non-predicate device, and by a

14

form of migration that was eliminated years earlier, are of sufficiently limited probative

15

value that their relevancy is substantially outweighed by the danger of unfair prejudice.

16

IT IS ORDERED: At trial, Plaintiff may present evidence of the complications,

17

testing, and design of the Recovery filter, but not of deaths caused by cephalad migration

18

of the Recovery filter.

19

Dated this 18th day of April, 2018.

20
21
22
23
24
25
26
27
28

-6-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 1 of 7

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability
Litigation,

10

___________________________________

11

Doris Jones, an individual,

12

No. MDL 15-02641-PHX-DGC

No. CV-16-00782-PHX-DGC

Plaintiff,

13

v.

14

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

15
16

ORDER

Defendants.

17
18
19

Plaintiff Doris Jones has filed a motion for reconsideration of the Court’s order

20

excluding evidence of deaths caused from cephalad migration of the Recovery filter

21

under Rule 403. Doc. 10873. Defendants have filed a response. Doc. 10899. The Court

22

will deny the motion in part as set forth below.

23

I.

Background.

24

The Court held a hearing with the parties on April 13, 2018, to discuss matters

25

decided for the Booker trial that the parties wish to have reconsidered for the Jones trial.

26

Doc. 10805. The Court took two matters under advisement: whether evidence of the

27

design, testing, and complications of the Recovery filter should be admitted in the Jones

28

trial, and whether evidence of deaths caused by cephalad migration of the Recovery filter

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 2 of 7

1

should be admitted. These matters were the subject of briefing before the hearing and

2

argument during the hearing. See Docs. 10677, 10707.

3

Several days later, the Court issued an order finding that evidence of the design,

4

testing, and complications of the Recovery filter is relevant to Ms. Jones’ case and should

5

not be excluded under Rule 403. Doc. 10819 at 2-3. The Court further found, however,

6

that evidence of deaths caused by Recovery filters migrating to a patient’s heart has only

7

marginal relevance in Ms. Jones’ case. Id. at 3-5. The Court held that the minimal

8

probative value of the evidence is substantially outweighed by the danger of unfair

9

prejudice because the death evidence may prompt a jury decision based on emotion. Id.

10

at 5-6.

11

II.

Discussion.

12

Plaintiff argues that the Court’s decision is based on a false premise because

13

cephalad migration continued to be associated with deaths in later devices, including the

14

Eclipse. Doc. 10874 at 4-5. Plaintiff further argues that cephalad migration is relevant

15

and substantially similar to her claims. Id. at 6-7. Finally, Plaintiff contends that the

16

death evidence cannot reasonably be extracted from the overall complication evidence,

17

and its exclusion would unreasonably curtail her proof in this case. Id. at 7-10.

18

Plaintiff’s arguments and supporting evidence could have been presented to the

19

Court in earlier briefing and argument.

20

legitimate basis for reconsideration. See LRCiv 7.2(g)(1); Nicole-Pickett v. Wells Fargo

21

Bank, N.A., No. CV-16-03262-PHX-DGC, 2016 WL 7187988, at *1 (D. Ariz. Dec. 12,

22

2016); Sch. Dist. No. 1J, Multnomah Cty., Or. v. ACandS, Inc., 5 F.3d 1255, 1262-63 (9th

23

Cir. 1993). Because of the importance of this issue, however, the Court will address each

24

of Plaintiff’s arguments.

As a result, Plaintiff has not identified a

25

A.

26

At the April 13 hearing, counsel for Plaintiff agreed that there has been very little

27

cephalad migration after the Recovery filter, in part because the G2 filter was given a

28

wider design to correct the cephalad migration problem. Doc. 10874-1 at 4. Counsel was

The Evidentiary Basis for the Court’s Ruling.

-2-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 3 of 7

1

not able to identify any instance of cephalad migration causing death in the G2 or later

2

filters. Id. at 3-4. Plaintiff now claims that a review of thousands of complaints in Bard’s

3

Trackwise database shows that cephalad migration was not eliminated by later-generation

4

filters, and that deaths caused by cephalad migration continued after the Recovery.

5

Doc. 10874 at 4-6. A careful review of Plaintiff’s evidence shows otherwise.

6

1.

Evidence of cephalad migration deaths.

7

Plaintiff claims that two cases of cephalad migration by Eclipse filters resulted in

8

patient deaths. Doc. 10874 at 5 (citing Complaint Nos. 313635, 354264); Doc. 10874-2

9

at 2-3, 33-99. Although both cases involved cephalad migration of an Eclipse filter and a

10

patient’s death, the evidence presented by Plaintiff does not show that the migrations

11

caused either of the deaths.

12

In the first incident, records provided by Plaintiff show that the Eclipse filter did

13

not migrate to the patient’s heart; it migrated above the renal veins due to a large clot

14

burden. Doc. 10874-2 at 34. The patient later died due to pulmonary embolism, but the

15

death occurred after the Eclipse filter had been removed and replaced with a competitor’s

16

device. According to the records provided by Plaintiff, the treating physician reported

17

that “the Bard filter did its job.” Id.

18

In the second incident, the Eclipse filter migrated “within proximity to the right

19

atrium” of the heart due to a “clot burden within the filter extending down into the

20

patient’s legs.” Id. at 73-76. The patient later died, possibly due to pulmonary embolism.

21

Id.

22

determined because the coroner chose not to do an autopsy, and also states that the

23

physician “did not feel that the filter was related to the patient’s death.” Id.

The record provided by Plaintiff suggests that the cause of death was never

24

These are the only records provided by Plaintiff to support her claim that G2,

25

G2X, or Eclipse filters caused death by cephalad migration. They do not support the

26

claim. Thus, one of the fundamental grounds for the Court’s previous order – that

27

cephalad migration deaths stopped after the Recovery filter – remains intact.

28

-3-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 4 of 7

1

2.

Evidence of other cephalad migrations.

2

Plaintiff cites eight other complaint files purportedly showing cephalad migration

3

by the G2-line of filters. Docs. 10874 at 3, 10874-2 at 2-4. One involved a G2 filter

4

(No. 260851), two involved Eclipse filters (Nos. 291446 and 383261), and five involved

5

G2X filters (Nos. 239963, 248122, 250927, 273135, and 283282). Doc. 10874-2 at 2-4.

6

The last two G2X cases did not involve cephalad migration of a properly deployed filter,

7

but instead resulted from faulty deployment. Id. at 4 (Nos. 273135 and 283282).1

8

Thus, out of approximately 180,000 G2 and G2X filters sold (according to

9

Defendants (Doc. 10899 at 3)), Plaintiff provides evidence of cephalad migration by one

10

G2 and three G2X filters. And out of approximately 66,000 Eclipse filters sold (again,

11

according to Defendants (id.)), Plaintiff provides evidence of four cephalad migrations.

12

Another premise of the Court’s previous order thus remains intact – cephalad migrations

13

largely ceased due to changes made to the G2-line of filters.

14

3.

Plaintiff’s other arguments.

15

Plaintiff argues that ongoing cephalad migration played a role in the contemplated

16

redesign of the Eclipse shortly after it was launched. Doc. 10874 at 4-5. But the

17

documents relied on do not support this assertion. The memo from Bard employee Brett

18

Baird largely addresses whether the introduction of electropolishing was well received by

19

customers, and says nothing about cephalad migration. Doc. 10874-4. The Idea POA

20

Eclipse Anchor Filter document contemplates the addition of anchor hooks to the Eclipse

21

due to the “increased frequency of migration in the caudal direction with the G2 and

22

G2X as compared to the Recovery.” Doc. 10874-5 at 2 (emphasis added). Although the

23

document noted generally the need for a long-term filter that “[s]tays in the deployed

24

location without migrating cranially or caudally,” the addition of caudal anchors was

25

meant to “[r]educe caudal migrations [and] tilt, fracture, and penetration secondary to

26

caudal migrations.” Id. at 2-3. These documents simply do not show that cephalad

27
28

1

Plaintiff cites one additional complaint of cephalad migration, but it is of a
Recovery filter, not a G2, G2X, or Eclipse. Id. (No. 257249).
-4-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 5 of 7

1

migration continued to be a significant problem after the Recovery.

2

After considering the evidence cited in Plaintiff’s motion for reconsideration, the

3

Court continues to conclude that Recovery filter cephalad migration deaths are only

4

marginally relevant in this Eclipse filter case. The Court also continues to find that the

5

limited relevancy of this evidence is substantially outweighed by the danger of unfair

6

prejudice, and that the death evidence is therefore inadmissible under Rule 403.

7

B.

8

In its previous order, the Court cited Georgia case law holding that “evidence of

9

other incidents involving the product is admissible, and relevant to the issue[] of . . .

10

punitive damages, provided there is a showing of substantial similarity.” Doc. 10819 at 4

11

(quoting Gen. Motors Corp. v. Moseley, 447 S.E.2d 302, 306 (Ga. Ct. App. 1994)).

12

Plaintiff’s Eclipse filter did not migrate in a cephalad direction to her heart or any other

13

organ. Rather, the filter fractured and one of its struts travelled to her lung. Because

14

deaths by cephalad migration of Recovery filters are not substantially similar to

15

Plaintiff’s alleged injury from her Eclipse filter, the Court continues to conclude that they

16

are not substantially similar for purposes of punitive damages.

Substantial Similarity.

17

Plaintiff argues in this section of her motion that the Recovery deaths are a

18

“direct cause” of the design change to the G2, asserting that Defendants’ efforts to

19

address cephalad migration resulted in a poorly-tested widening of the G2 filter that in

20

turn led to new complications that adversely affected Plaintiff. Doc. 10874-2 at 6. Even

21

if this causal chain were to be accepted, it represents the marginal relevancy the Court

22

recognized in its original order – limited relevancy the Court finds to be substantially

23

outweighed by the danger of unfair prejudice.

24

C.

25

Plaintiff asserts for the first time in her motion for reconsideration that cephalad

26

migration death evidence cannot reasonably be extracted from the overall Recovery-filter

27

complication evidence, and that eliminating the death evidence would hamstring her

28

ability to prove that the Eclipse lacked the necessary design changes to make a safe and

Impact of Excluding Cephalad Migration Death Evidence.

-5-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 6 of 7

1

non-defective filter. Doc. 10874 at 7-10. Plaintiff claims that there is no testimony

2

regarding Defendants’ cephalad migration investigation or root cause analysis that is

3

independent of the deaths. Id. at 9. Defendants counter that Plaintiff’s concerns are

4

overblown, that the parties can work together to review and edit the death evidence as

5

needed, and that Plaintiff has substantial non-death evidence at her disposal. Doc. 10899

6

at 9.

7

On this record, the Court cannot determine whether exclusion of all cephalad

8

migration death references would seriously hinder Plaintiff’s ability to prove her claims.

9

The Court will address this issue in more detail at the final pretrial conference on

10

May 4, 2018. If the Court finds that removing all references to cephalad migration

11

deaths will seriously hinder Plaintiff’s presentation of her claims, it will consider

12

allowing some references. The purpose of allowing these references, however, will be to

13

make key evidence understandable, not to allow Plaintiff to rely on the death evidence to

14

support her claims. The purpose of considering this issue on May 4 is not to reconsider

15

whether Plaintiff may make the cephalad migration deaths a component of her case – the

16

Court’s Rule 403 ruling stands. The purpose will be to consider whether some references

17

to death must remain in the evidence in order for Plaintiff to effectively present evidence

18

of Recovery filter complications, testing, and design.

19

At the final pretrial conference, Plaintiff may present up to six key trial exhibits

20

and three depositions to illustrate how death references cannot be removed without

21

seriously impairing her ability to prove her case. Plaintiff shall provide the selected

22

evidence to Defendants by the close of business on May 1, 2018, and the parties shall

23

confer in good faith before the final pretrial conference to identify areas of disagreement.

24

The Court will rule on the admissibility of the exhibits and deposition testimony and, as

25

necessary, draw lines for the parties to apply to other evidence.

26

IT IS ORDERED:

27

1.

28

Plaintiff Doris Jones’ motion for reconsideration (Doc. 10873) is denied in

part as set forth above.

-6-

Case 2:15-md-02641-DGC Document 10920 Filed 04/27/18 Page 7 of 7

1

2.

In light of the issue to be addressed at the final pretrial conference, the

2

April 30 deadline for submitting deposition designations that include cephalad migration

3

is extended to May 7, 2018.

4

Dated this 27th day of April, 2018.

5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28

-7-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 1 of 11

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9
10
11
12

IN RE: Bard IVC Filters Products Liability
Litigation,
___________________________________
Doris Jones, an individual,

15
16

No. CV-16-00782-PHX-DGC

Plaintiff,

13
14

No. MDL 15-02641-PHX-DGC

v.
C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

ORDER

Defendants.

17
18
19
20

The case brought by Plaintiff Doris Jones has been selected as one of several

21

bellwether cases and is set for trial this month. The parties have filed various motions in

22

limine (“MIL”) in advance of trial. This order will rule on those motions.

23

I.

Background.

24

In August 2010, before gastrointestinal surgery, Plaintiff was implanted with a

25

Bard Eclipse filter due to recurrent deep vein thrombosis. Five years later, Plaintiff went

26

to the emergency room with complaints of lightheadedness and arm pain. A chest scan

27

revealed a fractured filter limb that had embolized in her right pulmonary artery. The

28

filter was removed, but the fractured filter limb remains in place.

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 2 of 11

1

Plaintiff alleges that Bard filters are more dangerous than other IVC filters because

2

they have higher risks of complications, including fracture. Plaintiff further alleges that

3

Bard failed to warn physicians and patients about these higher risks. Plaintiff asserts

4

various state law claims under Georgia law. The following claims remain for trial:

5

design defect, failure to warn, and punitive damages. See Docs. 10404, 10732.

6

II.

Discussion.

7

A.

8

Plaintiff has filed three motions seeking to exclude evidence of purported

9

unrelated medical issues under Rules 402 and 403: (1) her anemia, hypertension, and

10

vitamin B12 deficiency, and her alleged failure to take prescribed medications for those

11

conditions; (2) her use of nonsteroidal anti-inflammatory drugs (“NSAIDs”) and failure

12

to follow medical advice against the use of those drugs; and (3) her treatment from

13

Dr. Colleen Taylor for gastric bleeding in March 2016.

14

contends that this evidence is not relevant to any issue in this case, and that any probative

15

value is substantially outweighed by the danger of unfair prejudice and juror confusion.

16

Plaintiff’s MILs Nos. 1-3 (Other Medical Issues).

1.

Docs. 10813-15.

Plaintiff

Anemia, Hypertension, B12 Deficiency, and Prescriptions.

17

When doctors discovered in April 2015 that Plaintiff’s Eclipse filter had fractured,

18

they also found that she was anemic, had a B12 deficiency, and suffered from

19

hypertension. Doc. 10814 at 2. Dr. Kristen Nelson, an interventional radiologist, took

20

charge of Plaintiff’s care for the fractured filter, and Dr. David Chodos prescribed

21

medications for Plaintiff’s other conditions.

22

concerning those other conditions and her inability to obtain the prescriptions due to her

23

limited access to healthcare is irrelevant and unfairly prejudicial. Id. at 2-3.

Id.

Plaintiff contends that evidence

24

Defendants contend that Plaintiff’s anemia is relevant to the issues of causation

25

and damages, but make no such argument with respect her hypertension and B12

26

deficiency. Doc. 10905 at 1-2. The Court will grant the motion in limine on her

27

hypertension and B12 deficiency. Defendants are precluded from presenting evidence or

28

argument about Plaintiff’s hypertension and B12 deficiency and her alleged failure to

-2-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 3 of 11

1
2

take prescribed medications for those conditions.
Evidence of Plaintiff’s anemia is relevant to causation and damages.

Under

3

Georgia law, “evidence concerning a plaintiff’s ‘other’ injuries may be admissible to

4

show that the injuries currently at issue are not the result of the defendant’s alleged

5

negligence.” Lindsey v. Turner, 631 S.E.2d 789, 791 (Ga. Ct. App. 2006) (citing Wages

6

v. Sibran, Inc., 318 S.E.2d 679, 680 (Ga. Ct. App. 1984)); see Kilday v. Kennestone

7

Physicians Ctr., L.P., 676 S.E.2d 271, 273 (Ga. Ct. App. 2009) (same). In this case,

8

Plaintiff claims that her tiredness is related to the Eclipse filter fragment lodged in her

9

pulmonary artery. Doc. 10900-1 at 3. But Dr. Chodos has testified that one of the

10

primary symptoms of anemia is fatigue (Doc. 10905-4 at 3), and Plaintiff complained of

11

fatigue even before she received the filter implant (Doc. 10902-2 at 2). Given this

12

evidence, Plaintiff’s anemia is relevant to whether the filter fragment is a proximate cause

13

of her fatigue, and the amount of any damages award based on fatigue. The Court will

14

deny the motion in limine with respect to evidence of Plaintiff’s anemia. See Lindsey,

15

631 S.E.2d at 791; Levine v. Choi, 522 S.E.2d 673, 674 (Ga. Ct. App. 1999) (“Evidence

16

that plaintiff’s injuries were pre-existing is sufficient for a jury to find the accident did

17

not proximately cause the injuries.”); Blosfield v. Hall, 511 S.E.2d 196, 197-99 (Ga. Ct.

18

App. 1999) (affirming judgment for the defendant on a negligence claim where he

19

presented evidence that the plaintiff’s injuries were not caused by the accident).

20

Defendants also assert that evidence of Plaintiff’s failure to take prescribed

21

medication for her anemia is relevant to causation. Doc. 10905 at 3. The Court agrees,

22

but, as noted below, will allow evidence of Plaintiff’s inability to pay for the medication

23

if Defendants pursue this line of defense.

24

On a related matter, Defendants do not assert a comparative negligence defense.

25

Docs. 10930, 10932; see Ga. Code. Ann. § 51-12-33(a); Ga. Pattern Jury Instruction

26

§ 60.141. Defendants do request a jury instruction on the duty to mitigate damages, but

27

they do not raise this as a disputed issue in the proposed pretrial order. Docs. 10930-4

28

at 13, 10932 at 12-13. The parties should be prepared at the final pretrial conference to

-3-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 4 of 11

1
2

discuss whether failure to mitigate damages will be asserted in this case.
2.

Use of NSAIDs and March 2016 Treatment from Dr. Taylor.

3

Plaintiff suffers from migraine headaches. Doc. 10813 at 2. Against the advice of

4

her doctors, she treats the headaches with NSAIDs such as Ibuprophen and “Goody’s”

5

headache powder. Id. Plaintiff also suffers from ulcers and gastric bleeding, and the use

6

of NSAIDs exacerbates this condition. Id. In March 2016, Plaintiff was treated by

7

Dr. Taylor for gastric bleeding that was caused in part by her use of NSAIDs. Id.;

8

Doc. 10815 at 2.

9

Various medical records and physician testimony designated by Defendants,

10

including testimony from Dr. Taylor, concerns Plaintiff’s failure to follow medical advice

11

with respect to the use of NSAIDs. Plaintiff contends that there is no evidence that

12

taking NSAIDs impacted the Eclipse filter or the fragment that remains in her pulmonary

13

artery, and that her use of the drugs is not related to any of her claims or injuries.

14

Doc. 10813 at 2-3. Plaintiff claims that Defendants seek to present the evidence in an

15

attempt to portray her as irresponsible and somehow at fault for her condition. Id.; see

16

Doc. 10815 at 3.

17

Defendants counter that Plaintiff’s medical conditions are interrelated and she

18

placed the conditions at issue when she filed suit. Doc. 10902 at 1-2. Defendants claim

19

that the gastric bleeding caused by Plaintiff’s use of NSAIDs is one of the reasons she

20

cannot take anticoagulants, thereby increasing the risk of future clotting. Doc. 10908

21

at 2. Defendants claim that they should be allowed to cross-examine Plaintiff’s expert

22

witnesses about whether she can take anticoagulants if she stops using NSAIDs, and that

23

it is for the jury to decide whether her use of the drugs contributed to her current

24

condition. Id. at 3; 10902 at 3.

25

As noted above, however, Defendants do not assert the defense of comparative

26

negligence. Thus, whether Plaintiff contributed to her need for the filter is not relevant.

27

And Plaintiff has made clear that her injuries related to the filter do not include her

28

gastrointestinal problems or any of the symptoms for which she obtained treatment from

-4-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 5 of 11

1

Dr. Taylor. Doc. 10815 at 2. Given this position, it is irrelevant whether Plaintiff failed

2

to mitigate those conditions.

3

The motions in limine (Docs. 10813, 10815) are granted.

Defendants are

4

precluded from presenting evidence or argument about Plaintiff’s use of NSAIDs and any

5

testimony from Dr. Taylor regarding the same.1

6

B.

7

Plaintiff seeks to exclude evidence that she smokes cigarettes.

Plaintiff’s MIL No. 4 (Tobacco Use).
Doc. 10816.

8

Plaintiff admits to smoking about a half-pack a day for the past 20-30 years, but claims

9

that evidence of this habit is irrelevant and carries the risk of unfair prejudice. Id. at 1-3;

10

Doc. 10905-2 at 2. Defendants argue that the jury should be entitled to consider whether

11

smoking is a cause of Plaintiff’s shortness of breath. Doc. 10911 at 2. Defendants

12

further argue that they should be allowed to cross-examine Plaintiff’s experts on whether

13

smoking is an independent risk factor for pulmonary embolism, and whether smoking

14

was accounted for in determining Plaintiff’s normal life expectancy. Id. at 2-3. The

15

Court agrees with Defendants in part.

16

Plaintiff claims her shortness of breath is related to the Eclipse filter fragment in

17

her pulmonary artery. Doc. 10909-1 at 3. But Dr. Taylor prescribed an Albuterol

18

bronchodilator inhaler for Plaintiff’s shortness of breath in part because of her “long

19

history of smoking.”

20

Plaintiff’s claim that the filter fragment is the cause of her shortness of breath.

Doc. 10911-2 at 3-4.

This evidence is directly relevant to

21

Plaintiff contends that Defendants should be barred from presenting evidence that

22

she smokes because they have no expert to opine that smoking has caused any of her

23

symptoms. Doc. 10816 at 3. Under Georgia law, issues of causation generally “are for

24

the jury to resolve . . . except in plain and undisputed cases.” Ogletree v. Navistar Int’l

25

Transp. Corp., 535 S.E.2d 545, 548 (Ga. Ct. App. 2000). Expert testimony is required

26
27
28

1

Plaintiffs contend that any failure on her part to seek follow-up care from
Dr. Taylor’s treatment is irrelevant. Doc. 10815 at 3. This issue is moot because
Defendants do not intend to present Dr. Taylor’s testimony on this topic. Doc. 10908
at 1 n.1.
-5-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 6 of 11

1

to establish causation only where medical questions are involved and the causal link

2

“cannot be determined from common knowledge and experience.” Nixon v. Pierce Cty.

3

Sch. Dist., 746 S.E.2d 225, 228 (Ga. Ct. App. 2013) (citation omitted).

4

It is common knowledge that long-term smoking can cause shortness of breath and

5

shorten a person’s life expectancy. See FDA v. Brown & Williamson Tobacco Corp., 529

6

U.S. 120, 138 (2000) (finding that “the adverse health consequences of tobacco use [are]

7

well known,” including that “cigarette smoking causes . . . chronic bronchitis and

8

emphysema”); Spain v. Brown & Williamson Tobacco Corp., 363 F.3d 1183, 1194 (11th

9

Cir. 2004) (ordinary consumers “with access to knowledge common to the community,

10

could not be unaware of the dangers of smoking”); Guilbeault v. R.J. Reynolds Tobacco

11

Co., 84 F. Supp. 2d 263, 273 (D.R.I. 2000) (taking judicial notice of “the community’s

12

common knowledge of the general disease-related health risks of smoking”); Johnson v.

13

Brown & Williamson Tobacco Corp., 122 F. Supp. 2d 194, 204 (D. Mass. 2000) (“[T]his

14

Court is firmly convinced that the risks of smoking were quite clear to the population at

15

large before 1969.”); Paugh v. R.J. Reynolds Tobacco Co., 834 F. Supp. 228, 231 (N.D.

16

Ohio 1993) (“[T]he risks of smoking are an inherent characteristic of cigarettes, and . . .

17

knowledge of these risks has been common to the community since well before 1966.”).

18

The same cannot be said, however, with respect to pulmonary embolism.

19

Defendants cite a medical article published in late 2013 for the proposition that smoking

20

is a risk factor for pulmonary embolism, but the article makes clear that this theory

21

“remains controversial.”2

22

smoking and pulmonary embolism can be “determined from common knowledge and

23

experience.” Nixon, 746 S.E.2d at 228. Nor have Defendants identified an expert who

24

will testify to this causal link.

Defendants have not shown that the causal link between

25

The motion in limine (Doc. 10816) is granted in part and denied in part.

26

Defendants will not be permitted to present evidence or cross-examine Plaintiff’s experts

27
2

28

See Current and Former Smoking and Risk for Venous Thromboembolism:
A Systematic Review and Meta-Analysis, http://journals.plos.org/plosmedicine/article?id=
10.1371/journal.pmed.1001515 (last visited May 2, 2018).
-6-

Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 7 of 11

1

on whether smoking contributes to the risk for pulmonary embolism. Defendants may,

2

however, present evidence to show that smoking is a cause of Plaintiff’s shortness of

3

breath. Defendants also may cross-examine Plaintiff’s experts on whether smoking was

4

accounted for in determining her life expectancy.

5

Plaintiff’s reliance on Seymour Electric & Air Conditioning Service, Inc. v.

6

Statom, 710 S.E.2d 874 (Ga. Ct. App. 2011), is misplaced. That case involved the

7

potential exposure to carbon monoxide from a negligently installed furnace.

8

plaintiffs “failed to come forward with any evidence that a physician ever tested them

9

for carbon monoxide poisoning or diagnosed them as having that condition.” 710 S.E.2d

10

at 877. In this case, by contrast, Plaintiff admits to a long-term smoking habit. A jury

11

reasonably could find, without the need for expert testimony, that smoking contributes to

12

her shortness of breath and may shorten her life expectancy.

The

13

Plaintiff notes that other courts have excluded evidence of smoking under

14

Rule 403. Doc. 10816 at 2-3. Those cases are inapposite. See Nolte v. AbbVie, Inc., No.

15

14 C 1748, 2018 U.S. Dist. LEXIS 2547, at *205-06 (N.D. Ill. Jan. 6, 2018) (finding that

16

the evidence had limited probative value where the doctor did not address whether it was

17

significant that the plaintiff had quit smoking three years prior to his pulmonary

18

embolism); Allegro Ventures, Inc. v. Almquist, No. 11-cv-2009-L (WVG), 2014 WL

19

1871628, at *4 (S.D. Cal. May 8, 2014) (“[I]t is clear that evidence of Almquist’s

20

smoking and drinking do not bear on the threshold issue of Almquist’s status as an

21

employee or as a seaman.”); In re Prempro Prods. Liab. Litig., No. 4:03CV1507-WRW,

22

2006 WL 3806391, at *4 (E.D. Ark. Dec. 27, 2006) (issuing summary ruling excluding

23

evidence of smoking unless the defendant could show “heavier evidence than they

24

presented during the hearing”).

25

C.

26

Two Bard employees testified in the Booker trial that their relatives had received

27

Bard filter implants. Doc. 10817 at 2. Plaintiff seeks to exclude similar testimony in her

28

case as irrelevant and otherwise inadmissible under Rule 403. Id. Defendants counter

Plaintiff’s MIL No. 5 (Other Bard Filter Implants).

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Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 8 of 11

1

that such evidence is highly relevant to the claims in this case, particularly punitive

2

damages, and that the evidence is necessary to rebut any attacks by Plaintiff on the

3

credibility of Bard witnesses. Doc. 10896 at 2-3.

4

The Court generally agrees with Plaintiff that any probative value of this evidence

5

is outweighed by the dangers set forth in Rule 403, at least to the extent that a Bard

6

witness offers gratuitous testimony that a relative received a Bard filter implant. See

7

Doc. 10567 at 108. But such testimony may be appropriate if the line of questioning

8

suggests that the Bard witness viewed adverse event data only in terms of “numbers” and

9

“rates” rather than “people with names.” Doc. 10584 at 80-81.

10

The motion in limine (Doc. 10817) is granted.

Defendants shall not elicit

11

testimony on direct examination that Bard employees or their relatives have received

12

Bard filter implants. If Defendants believe such testimony becomes appropriate during

13

trial, they can raise that issue with the Court outside the hearing of the jury.3

14

D.

15

In the Booker trial, counsel for Defendants asked Dr. Robert McMeeking whether

16

he was retained in the Cook IVC filter litigation by some of the same attorneys that had

17

retained him in this litigation. He answered, “Yes, some of them are the same attorneys.”

18

Doc. 10818 at 1-2.

Plaintiff’s MIL No. 6 (Experts Retained in Other Litigation).

19

Plaintiff seeks to exclude similar testimony in her trial, claiming that the “implicit

20

message is that Plaintiff’s attorneys are driving the litigation, hiring experts to sue

21

multiple manufacturers in lawsuits all over the country.” Id. at 2. The Court does not

22

agree. As Plaintiff concedes, it is entirely appropriate to ask an expert how many times

23

he has been retained by the same attorneys. Id. at 3; see Doc. 10895 at 2-3 (citing cases).

24
3

25
26
27
28

In the Booker trial, the Court sought to strike a balance by allowing some
evidence regarding the nature of Bard’s business and the conscientiousness of Bard
employees without having the case tried on the basis of specific employee conduct.
Doc. 10075 at 3-4. The Court excluded a photograph of a Bard employee flipping off the
camera and the “better stay away from the buffet line” comment by a Bard executive.
The Court found this evidence unfairly prejudicial to Bard and not highly probative to
any issue in the case. Similarly, evidence that relatives of Bard employees have received
Bard filters has, at most, only marginal relevancy and may prove unfairly prejudicial to
Plaintiff.
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Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 9 of 11

1

Plaintiff states that none of her attorneys were involved in actually preparing

2

Dr. McMeeking for his testimony in the Cook litigation, but he did not testify that the

3

attorneys did so. To the extent Plaintiff believes that any testimony by Dr. McMeeking

4

on this point is not entirely accurate or complete, she may clarify matters on re-direct.

5

The motion in limine (Doc. 10818) is denied.

6

E.

7

In the Booker trial, the parties stipulated to the exclusion of evidence regarding

8

contingency fee agreements, Plaintiff’s counsel specializing in personal injury and

9

products liability litigation, and advertising by Plaintiff’s counsel or any counsel

10

nationally for IVC filter cases. Doc. 10235 at 2. Defendants have refused to enter into a

11

similar stipulation in this case, contending that the growing trend in product liability

12

litigation is to admit evidence of attorney advertising where it is probative of credibility

13

regarding the plaintiff’s injuries. Doc. 10914 at 2-3. Defendants, however, provide no

14

basis for the admission of evidence regarding (1) contingency fee agreements or

15

(2) Plaintiff’s counsel specializing in personal injury and products liability litigation. The

16

motion in limine (Doc. 10811) will be granted on these two subjects.

Plaintiff’s MIL No. 7 (Attorney Advertising).

17

Defendants claim that the testimony of Plaintiff’s husband about how he first

18

contacted counsel is relevant to whether Plaintiff filed suit because of symptoms she was

19

experiencing with her Eclipse filter or in response to attorney advertising. Id. The Court

20

does not agree. In response to a question about why he decided to file suit, Mr. Jones

21

explained as follows:

22

27

I never decided to file. I was worried about my wife’s health being she had
this strut stuck in her and was told that the procedure was supposed to be a
permanent procedure. But then that happened, it broke, and she had to go
back under and have it removed. And I just was just looking for some
answers. . . . I was looking on Facebook and a little pop-up – and when it
popped up, that’s what took my mind back to thinking about my wife more
so. And I was wondering if I could get further any information about
filters, not looking to go as far as suing.

28

Doc. 10811-2 at 4-5. This testimony has, at most, only marginal relevancy to Plaintiff’s

23
24
25
26

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Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 10 of 11

1

claimed injuries. The testimony does not show that Plaintiff and her husband were

2

prompted by attorney advertising to file suit. To the contrary, Mr. Jones testified that he

3

was not looking to sue. Id. at 5. Moreover, any probative value of the evidence is

4

substantially outweighed by the danger of unfair prejudice and juror confusion. The

5

motion in limine will be granted with respect to evidence that Plaintiff did not report

6

complaints about her Eclipse filter and the fractured strut until after her husband saw

7

information about IVC filters on Facebook.

8

Defendants contend that evidence of an attorney advertising website,

9

www.filterlaw.com, is necessary to refute Plaintiff’s evidence that the change in brand

10

name to Eclipse was to create a “break with the baggage” associated with the G2 line of

11

filters. Doc. 10914 at 3-4. Defendants assert that the “baggage” Bard was referring to

12

was the filter law website. Id. at 4 (citing 10914-2 at 3). The Court will defer ruling on

13

this issue until trial. If Plaintiff presents the “break with baggage” evidence at trial and

14

Defendants believe that evidence of the filter law website is relevant, they may raise that

15

issue with the Court outside the hearing of the jury.

16

F.

17

Defendants seek to exclude evidence of Plaintiff’s financial status, including her

18

inability to pay for medical expenses or obtain medical care. Doc. 10808. Defendants

19

contend that such evidence is irrelevant and highly prejudicial because it may garner

20

sympathy from the jury. Id. at 2. Plaintiff counters that Defendants have chosen to make

21

this a material issue by seeking to present evidence that Plaintiff failed to take

22

medications and otherwise follow-up on her medical care. Doc. 10916 at 2.

Defendants’ MIL No. 1 (Financial Information).

23

As explained above, the Court finds that evidence of Plaintiff’s failure to take

24

prescribed medication for her anemia is relevant to causation. To the extend Defendants

25

argue that this failure has caused her shortness of breath, the Court will allow evidence of

26

Plaintiff’s inability to pay for the medication. The Court otherwise finds evidence of

27

Plaintiff’s financial status to be irrelevant and potentially prejudicial.

28

///

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Case 2:15-md-02641-DGC Document 10947 Filed 05/03/18 Page 11 of 11

1

G.

2

In the Booker trial, the parties stipulated to the exclusion of evidence of other

3

lawsuits against Defendants. Doc. 10235 at 2. Plaintiffs contend that the other lawsuits

4

will be material in this case if Defendants are allowed to offer evidence that Plaintiff filed

5

suit in response to attorney advertising. Doc. 10915 at 2. The Court has excluded this

6

evidence for reasons set forth above. Defendants’ motion in limine (Doc. 10809) is

7

therefore granted.

8

Defendants’ MIL No. 2 (Other Lawsuits).

Dated this 3rd day of May, 2018.

9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
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25
26
27
28

- 11 -

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 1 of 12

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products Liability
Litigation,

10

___________________________________

11

Doris Jones, an individual,

12

No. MDL 15-02641-PHX-DGC

No. CV-16-00782-PHX-DGC

Plaintiff,

13

v.

14

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

15
16

ORDER

Defendants.

17
18
19
20

The Court has entered two previous orders finding that evidence of deaths caused

21

by cephalad migration of Recovery filters is marginally relevant to this case, and that the

22

limited relevance is substantially outweighed by the danger of unfair prejudice.

23

Docs. 10819, 10920. As a result, the Court has concluded that the death evidence is

24

inadmissible under Rule 403.

25

In the second order, which ruled on a motion for reconsideration filed by Plaintiff,

26

the Court addressed a new argument: that cephalad migration death evidence cannot

27

reasonably be extracted from the overall Recovery filter complication evidence, and that

28

eliminating the death evidence would hamstring Plaintiff’s ability to prove that the

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 2 of 12

1

Eclipse filter lacked the design changes necessary to make it a safe filter. Doc. 10920

2

at 5. Because the Court could not resolve that issue on the existing record, the Court

3

instructed the parties to address it more fully at the final pretrial conference on May 4,

4

2018. Id. at 6. Plaintiff’s counsel presented six exhibits and three deposition excerpts at

5

the conference, and argued extensively. Defense counsel presented four of the same

6

exhibits with death evidence redacted, and also argued.

7

A.

8

The Court previously held that evidence regarding the complications, testing, and

9

design of the Recovery filter are relevant to Plaintiff’s claims in this case. Docs. 10819,

10
11
12
13
14

General Observations.

10920. As the Court explained:
Those events help explain the testing, development, and design of the G2,
and Plaintiff contends that the G2 was essentially the filter she received.
The history of the Recovery and how it led to the G2 tends to make a fact in
dispute – the allegedly defective design of the Eclipse – more probable.
Doc. 10819 at 2 (citing Fed. R. Evid. 401).

15

The Court also concluded, however, that evidence of deaths from cephalad

16

migration was only marginally relevant. This is because cephalad migration did not

17

continue in any significant degree beyond the Recovery filter; cephalad migration deaths

18

all occurred before the Recovery filter was taken off the market in late 2005; the deaths

19

say nothing about three of Ms. Jones’ four claims in this case: strict liability design

20

defect, strict liability failure to warn, or negligent failure to warn; although the evidence

21

may add some weight to her fourth claim – negligent design – it is not central to proof of

22

design negligence; and instances of cephalad migration resulting in death are not

23

substantially similar to complications experienced by Ms. Jones and therefore do not

24

meet the Georgia standard for evidence on punitive damages. Id. at 3-4. Given the

25

limited relevancy of the cephalad migration death evidence, the Court found that its

26

probative value was substantially outweighed by the danger of unfair prejudice and

27

therefore was inadmissible under Rule 403. Id. at 5-6.

28

When the Court agreed to hear more of Plaintiff’s arguments regarding the

-2-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 3 of 12

1

difficulty of excising death evidence from other relevant evidence, it specifically advised

2

the parties that this would not be another opportunity to argue the Rule 403 ruling:

3

The purpose of considering this issue on May 4 is not to reconsider whether
Plaintiff may make the cephalad migration deaths a component of her case
– the Court’s Rule 403 ruling stands. The purpose will be to consider
whether some references to death must remain in the evidence in order for
Plaintiff to effectively present evidence of Recovery filter complications,
testing, and design.

4
5
6
7
8

Doc. 10920 at 6 (emphasis in original). At the final pretrial conference, Plaintiff’s

9

counsel nonetheless felt compelled to argue again that the cephalad death evidence is

10

relevant to her claims. The Court will address briefly some of the arguments made.

11

Plaintiff’s counsel argued that the 2004-2005 cephalad migration deaths show that

12

the Recovery filter was not performing as advertised, that is was adulterated and

13

misbranded, that it was therefore being marketed illegally, and that Defendants should

14

have removed it from the market. If the Recovery filter was removed from the market,

15

Plaintiff argues, it could not have served for the predicate device for the G2 filter, and,

16

without the G2, Plaintiff’s Eclipse filter never would have been sold by Defendants.

17

But this case does not include a claim that Defendants negligently failed to recall

18

the Recovery filter. It includes claims that the Eclipse filter was defectively designed and

19

that Defendants failed to warn about the risks of the Eclipse filter. The Court can see no

20

clear connection between the design of and warnings about the Eclipse filter in 2010, and

21

Defendants’ alleged failure to remove the Recovery filter from the market in 2004 and

22

2005. Plaintiff may have an attenuated “but for” argument – that but for Defendants’

23

failure to remove the Recovery filter from the market, the G2 and G2X never would have

24

been marketed, and the Eclipse never would have been available to hurt her – but such a

25

domino-like causal link does not help prove that the Eclipse was designed defectively or

26

that Defendants’ 2010 warnings about the Eclipse were inadequate. Thus, the Court

27

cannot conclude that Plaintiff should be permitted to present evidence of Recovery filter

28

cephalad migration deaths in order to convince the jury that Defendants should have

-3-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 4 of 12

1

removed the Recovery filter from the market years before Plaintiff received her later-

2

generation filter.

3

Plaintiff’s counsel argued that the medical community should have been warned

4

about the cephalad migration deaths – that Defendants should have described the deaths

5

in the Instruction for Use (IFU) that accompany each Bard IVC filter. Plaintiff’s counsel

6

further argued that such a warning should have carried forward into the G2 and Eclipse

7

filters. But as noted in the Court’s two prior orders, cephalad migration deaths stopped

8

with the Recovery and did not recur in the G2-line of filters. Docs. 10819 at 3, 10920

9

at 3. Thus, even if Plaintiff could credibly argue that users of the Recovery filter should

10

have been warned of cephalad migration deaths, that argument has no relevancy with

11

respect a later-generation filter that was not causing cephalad migration or such deaths.

12

Plaintiff cannot plausibly claim that the jury should find Defendants liable to her for

13

failure to warn of deaths that occurred five years earlier, from a filter she did not receive,

14

and by a means of migration she did not experience.

15

Plaintiff’s counsel argued that Defendants’ failure to warn Recovery users about

16

the cephalad migration deaths – and failure to warn G2-line users about the Recovery

17

deaths – is a basis for punitive damages. The Court might agree if cephalad migration

18

deaths continued with the G2-line of filters, but they did not. The Court cannot conclude

19

that Defendants should be punished for their sale of an Eclipse filter to Plaintiff because

20

they failed to warn Recovery patients about cephalad migration deaths five years earlier.

21

Nor can the Court conclude that Recovery cephalad migration deaths are “substantially

22

similar” to Plaintiff’s injury from embolization of an Eclipse filter fragment, as required

23

by Georgia law with respect to punitive damages. See Gen. Motors Corp. v. Moseley,

24

447 S.E.2d 302, 306 (Ga. Ct. App. 1994).

25

Plaintiff’s counsel argued that they should be able to show the jury “[h]ow

26

incredibly unreasonable it was that they put out another device only having done bench

27

testing, less bench testing and less animal testing than they did with the Recovery

28

filter[.]” Court’s Livenote Transcript, 5-4-18. But the Court’s ruling does not prevent

-4-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 5 of 12

1

Plaintiff from making this showing. The Court’s exclusion of cephalad migration death

2

evidence does not limit her ability to show what testing was done or not done on the G2

3

filter.

4

Plaintiff’s counsel argued that Defendants will assert at trial that IVC filters save

5

lives, and “we’re not going to be able to establish that these things could actually cause

6

people to lose their lives.” Id. Not so. The Court has not ruled that Plaintiff is precluded

7

from asserting that filter migration, tilt, fracture, and perforation can cause serious health

8

effects including death. The Court has not barred Plaintiff from asking her experts what

9

consequences could arise from the complications seen in the G2-line of filters. The Court

10

has held only that Plaintiff cannot present evidence of Recovery filter deaths caused by a

11

complication that did not continue in the G2-line.

12

Plaintiff’s counsel argued that evidence of the cephalad migration deaths shows

13

that Defendants “overreacted” to the deaths and hastily placed a faulty G2 filter on the

14

market. If Plaintiff’s argument is that cephalad migration of the Recovery filter caused

15

Defendants to widen the filter’s diameter in order to prevent cephalad migration, they can

16

make that showing with the evidence of cephalad migration discussed below.

17

Plaintiff’s argument is that patient deaths caused the company to overreact and seek to

18

correct the problem too quickly, it is hard to see how that argument supports Plaintiff’s

19

claim that this was a callous and indifferent company that did not care about patient

20

health.

21
22
23
24
25
26
27
28

If

The Court previously acknowledged that the fact of the deaths could be viewed as
making Defendants’ conduct in creating the G2 look more negligent:
The cephalad migration deaths arguably are more relevant to Ms. Jones’
negligent design defect claim because they help show the extent to which
Defendants allegedly failed to exercise reasonable care in designing and
testing the G2 filter. But the things Defendants allegedly failed to do in
developing the G2 – perform a viable root cause analysis, test adequately,
follow established design principles – can all be shown through Plaintiff’s
experts and without mention of the cephalad migration deaths. The deaths
arguably could make these failures appear even more negligent because
Defendants were aware of severe consequences from the Recovery’s
-5-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 6 of 12

1
2

design, but they do not prove the negligence. Evidence of the deaths
remains marginal – it adds some weight to Plaintiff’s negligence claim, but
it is not central to proof of design negligence.

3
4

Doc. 10819 at 3-4.

The Court found that this marginal benefit was substantially

5

outweighed by the risk of unfair prejudice. Id. at 5-6.

6

What is more, the thrust of Plaintiff’s claim, as was apparent in the Booker trial, is

7

that Defendants learned of a variety of new complications with the G2 – established by

8

the Everest study and other events – and yet continued to market the G2 and its later

9

iterations without correcting those new complications. Indeed, Plaintiff claims that these

10

are the complications that caused her injuries, not cephalad migration.

11

At the end of the day, Plaintiff’s counsel seems to be asserting that elimination of

12

the death evidence will impair Plaintiff’s ability to present the death evidence. Of course

13

it will. That is the purpose of the Court’s ruling. The relevant question is whether

14

elimination of the death evidence will impair Plaintiff’s ability to prove the Recovery

15

filter’s complications as part of explaining how the G2-line of filters came into existence

16

with the defects that allegedly injured Plaintiff. As explained below, the Court concludes

17

that elimination of the cephalad migration death evidence will not seriously impair

18

Plaintiff’s ability to prove Recovery filter complications.

19

B.

20

The Court will address each of the exhibits and deposition excerpts presented by

21
22

Specific Evidence.

Plaintiff at the final pretrial conference.
1.

Exhibit 280.

23

This is a June 16, 2005 memorandum written between Defendants’ employees.

24

The subject is “IVC Recovery Filter Adverse Events (Migration/Fractures) – Executive

25

Summary.” The memo explains that it contains an adverse event summary of Recovery

26

filter migrations and fractures through June 14, 2005. Although the memorandum does

27

mention deaths, each of those references could be eliminated from the memorandum

28

without detracting from the following points: (a) 43 filter migrations in excess of two

-6-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 7 of 12

1

centimeters have been reported; (b) 25 of these cases included a filter encased in a large

2

thrombi; (c) in 9 of the cases, the presence of blood clots was unknown; and (d) 12 of the

3

cases involved migration to the heart. Further, a chart at the bottom of the memo

4

indicates that the Recovery filter has a migration rate of 0.099%, which is higher than any

5

of the seven other IVC filters included in the chart, and much higher than Defendants’

6

own Simon Nitinol filter (0.003%).

7

Thus, with all of the references to deaths redacted, this memo shows that Recovery

8

filters were migrating at a rate higher than any other filter considered, and considerably

9

higher than Defendants’ previous version, and in 12 instances the filter had migrated to

10

the heart. It permits Plaintiff to make her point of high rates of Recovery migration.

11

2.

Exhibit 1014.

12

This is a June 11, 2004 Remedial Action Plan (“RAP”) for the “Recovery Filter –

13

Migration.” It is reviewed and approved by numerous Bard executives. With all death

14

evidence omitted, this document still enables Plaintiff to make the following points:

15

(a) on April 14, 2004, Defendants received a message than an IVC filter had migrated;1

16

(b) as of that date, there had been six previous instances of filters migrating more than

17

two centimeters (with the six instances described); (c) as a result of this report, the

18

Recovery filter was placed on hold pending the completion of the RAP; (d) “There were

19

no design or manufacturing defects found to be associated with the filter”;2 (e) a

20

comparison between the Recovery and all other IVC filters will be completed to ensure

21

that adverse events associated with the Recovery are not occurring with excess

22

frequency; (f) the product was removed from hold status; (g) “There has been no device

23

design or manufacturing problem that was identified”; and (h) no field action is

24

recommended.

25

Redactions would eliminate the fact that the April 2004 event was a patient death,

26
27
28

1

The Court will permit the memo to include the following language at the end of
part III.a: “an IVC filter that migrated. (Complaint Report #5922, attached).”
2

Plaintiff’s counsel emphasized the importance of this sentence during argument.
-7-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 8 of 12

1

but it would not change any of the other information about Recovery filter complications

2

– that there had been six previous migrations, the product had been placed on hold, a

3

comparison of filter failure rates would be completed, and, as Plaintiff emphasized, there

4

were no design or manufacturing defects found to be associated with the filter.

5

3.

Exhibit 1020.

6

This is an internal failure investigation “to determine the cause of the filter

7

migration reported on August 23, 2004.” All of the following information would be

8

available if death references were removed from this exhibit:

9

approximately 17,400 Recovery filters distributed. On August 23, 2004, Defendants

10

became aware that a Recovery filter had migrated more than two centimeters in a patient.

11

As of October 12, 2004, there had been 20 instances of filter migration more than two

12

centimeters.

13

enhanced language regarding filter migrations,” and distributing a “Dear Doctor” letter

14

highlighting changes to the IFU. No other remedial action was recommended.

There had been

As a result, Defendants considered updating the Recovery IFU “with

15

The only essential facts removed through redaction would be that the incident that

16

prompted this investigation was a patient death. Eliminating references to the death will

17

not eliminate any information about the fact that the filter migrated and that there had

18

been 20 instances of filter migration of more than two centimeters. Nor would it change

19

the fact that Defendants considered changing the IFU and contacting doctors, but

20

otherwise recommended no action.

21

4.

Exhibit 1022.

22

With death evidence redacted, this exhibit includes the following information:

23

This was another failure investigation to determine the cause of a Recovery filter

24

migration reported on December 7, 2004.

25

approximately 22,471 Recovery filters distributed. In this case, the Recovery filter was

26

found in the patient’s right ventricle.3 From April 2003 to January 20, 2004, there had

As of early 2004, there had been

27
3

28

The only language the Court requires to be redacted from paragraph 5.1 is the
following: “[Redacted] reported that on [redacted] 2004, the patient on the neurological
service collapsed and died in the hospital. An autopsy was performed and . . . ”.
-8-

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 9 of 12

1

been 28 instances of Recovery filter migrations in excess of two centimeters. There was

2

insufficient data to determine the root cause of this failure, and no corrective actions were

3

recommended.

4

Again, the essential information contained in this document remains after

5

redaction of the death evidence – a Recovery filter migrated more than two centimeters,

6

there had been 28 such migrations by this point in time, and no further remedial action

7

was recommended.

8

5.

Exhibit 10322.

9

This is a December 17, 2004 Health Hazard Evaluation. With all death evidence

10

redacted, this document would demonstrate the following: “An analysis of reporting

11

rates of serious adverse events for all inferior vena cava filters, as determined by analysis

12

of the MAUDE and IMS databases by a consultant, revealed that reporting rates for

13

Recovery are significantly higher than other filters.” This warrants further investigation.

14

The frequency of serious injury is 0.153% and the frequency of non-serious injury is

15

0.21%. “Reports of . . . filter migration (movement), IVC perforation, and filter fracture

16

associated with the Recovery filter were seen in the MAUDE database at reporting rates

17

that were 4.6, 4.4, 4.1, and 5.3 higher, respectively, than reporting rates of all other

18

filters. These differences were all statistically significant. Recovery’s reporting rates for

19

all adverse events, filter fracture, filter migration, . . . were found to be significantly

20

higher than those for other removable filters.” “These reported adverse event rates were

21

analyzed in conjunction with a bench test performed at BPV.

22

‘migration resistance’ in a simulated IVC. Recovery had the lowest mean migration

23

resistance (50mm Hg), just below that of the removable Tulip filter (55mm Hg).” “Little

24

formal analysis had been completed with respect to potential clinical trials to obtain more

25

definitive risk/benefit information.” For the Recovery filter, “there were a total of 32

26

reported serious injuries, a reporting rate of 0.153%.” The total adverse event reporting

27

rate for the Recovery filter, including migration, fractures, and perforation, was 0.365%

28

with a serious injury of 0.153%. “From the analysis of the MAUDE and IMS databases,

-9-

This test measured

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 10 of 12

1

Recovery reporting rates are significantly higher than those of other filters.” There

2

appears to be a “significant correlation” of the “migration reporting rates with the

3

simulated migration resistance bench test.”

4

Even with death evidence redacted, this document proves the point the Court has

5

deemed relevant – that the Recovery filter was experiencing complication rates higher

6

than that of other filters. Indeed, this is the basis upon which Plaintiff claims that

7

Defendants undertook to create the G2 in a hasty and poorly-tested manner.

8

6.

Exhibit 2243.

9

This is an email exchange. The first email, dated April 23, 2004, suggests that the

10

data being evaluated was based on deaths. The actual statistical analysis is contained in

11

an email dated May 20, 2004. Natalie Wong concludes that: “[a]t a 95% confidence,

12

there IS a significant difference between Recovery and Gunther Tulip, Birdsnest filter,

13

and SNF.” Thus, without any reference to death evidence, this document demonstrates

14

that the Recovery had a statistically higher complication rate than Defendants’ previous

15

device, the Simon Nitinol filter.

16

7.

Ganser Deposition.

17

The Court has reviewed each of the Plaintiff’s excerpts in this deposition

18

(highlighted in yellow) in light of the death references that would be redacted

19

(highlighted in green). Many of the death references are in the question, not the answer,

20

and the answer does not encompass the death reference. See pages 41, 130, 223, 254, and

21

296. Other questions and answers continue to convey the essence of the testimony

22

without the death reference. See pages 95 (Bard did not share complaint files), 223 (the

23

hold on recovery filters was removed in 2004), and 267 (many of the migration

24

complaints included a large clot burden overwhelming the filter). Some questions and

25

answers would be altered by elimination of the death reference, but the relevancy of the

26

questions and answers is doubtful. See 133 (Defendants elected to continue the Recovery

27

– this seems to be related to Plaintiff’s “but for” recall argument), 237-238 (customers

28

would want to know if a product was causing serious injury and death – this fact about

- 10 -

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 11 of 12

1

patients using the Recovery filter seems irrelevant to patients using the Eclipse filter that

2

did not cause cephalad migration deaths), 244 (although it is not entirely clear, this

3

exchange seems to be the witness describing what he is reading in Exhibit 2243 discussed

4

above, which is not essential to understanding the central point of 2243). Finally, one

5

series of questions and answers concern Natalie Wong’s calculations based on death

6

evidence as noted above with respect to Exhibit 2243, but the Court concludes that the

7

death evidence is not essential to understanding the more relevant point that the Recovery

8

had higher complication rates than the SNF and other filters.

9

Thus, the Court concludes that references to death evidence can be redacted from

10

the Ganser deposition without significantly detracting from Plaintiff’s ability to show

11

Recovery complication rates. None of these references concern G2 testing or design.

12

8.

Decant Deposition.

13

A number of the designated portions of this deposition simply present the death

14

evidence the Court has concluded is inadmissible. See 268 (lines 14-17 and 21-24), 269

15

(lines 1-6), 272 (lines 5-14), 275 (lines 18-21), 312 (lines 9-15), 333 (lines 13, 21), 338

16

(lines 5-8), 349 (lines 2-5), 350 (lines 7-9), 361 (line 1). Other designations include only

17

marginally relevant evidence. See 251, 255. And still other designations communicate

18

the essence of the evidence even if the death reference is removed. See 252, 256, 264,

19

268 (lines 18-20), 269-70, 275 (lines 15-17), 316, 358-59.

20

9.

Orms Deposition.

21

Some of the designated evidence in this deposition simply concerns death

22

evidence the Court has found inadmissible. See 25. Other designations are of marginal

23

relevance. See 29-30 (failure to warn related to the Recovery is not relevant to failure to

24

warn related to the Eclipse), 41 (same). And, with respect to other designations, the

25

essence of the evidence is communicated even if death references are omitted. See 45.

26

C.

27

Having reviewed each of the exhibits and deposition excerpts provided by

28

Plaintiff, the Court concludes that Plaintiff will not be seriously hampered in her ability

Conclusion.

- 11 -

Case 2:15-md-02641-DGC Document 11041 Filed 05/08/18 Page 12 of 12

1

to prove Recovery filter complications, testing, and design when references to cephalad

2

migration deaths are removed. As a result, the Court holds that such references should be

3

redacted from evidence to be presented at trial. Including such evidence that would

4

violate Rule 403 in this Eclipse filter case. See Docs. 10819, 10920.

5

The parties shall provide the Court with additional deposition excerpts as soon as

6

reasonable possibly. With trial only a week away, the Court will do its best to rule on the

7

designations promptly.

8

Dated this 8th day of May, 2018.

9
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ATTYADD,LEAD,MULTI-DISTRICT,PROTO,REMAND,STD

U.S. District Court
DISTRICT OF ARIZONA (Phoenix Division)
CIVIL DOCKET FOR CASE #: 2:15-md-02641-DGC

IN RE: Bard IVC Filters Products Liability Litigation
Assigned to: Judge David G Campbell
Case in other court: Ninth Circuit, 16-16163
Cause: 28:1332 Diversity-Product Liability

Date Filed
05/15/2018

#

Date Filed: 08/17/2015
Jury Demand: Both
Nature of Suit: 365 Personal Injury: Prod.
Liability
Jurisdiction: Diversity

Docket Text

11082 ORDER. At the close of trial today, Plaintiff's counsel again asked the Court to admit
evidence of Recovery filter cephalad migration deaths. Plaintiff argued that
Defendants' opening statement opened the door to such evidence. (1) Plaintiff noted
that Defendants argued that IVC filters are life-saving devices. True, but the Court has
not precluded Plaintiff from presenting evidence that IVC filter complications can also
cause death. Indeed, Plaintiff's counsel stated in his opening statement that
unacceptable risks of Bard filters can include death, severe injury, or permanent
disability. The Court does not find that the "life-saving device" argument has opened
the door to the cephalad migration death evidence the Court has excluded under Rule
403. (2) Plaintiff argued that Defendants emphasized the disclosures contained in the
Eclipse filter IFU, including disclosure of the risk of death, and argued that the
Recovery filter IFU should have described deaths from cephalad migration. When
asked why Recovery filter warnings (or lack thereof) are relevant in this Eclipse filter
failure-to-warn case, Plaintiff asserted that such information would have carried
forward into the Eclipse IFU. The Court cannot conclude, however, that IFU warnings
for the Eclipse filter should have included deaths caused by a different filter, fourgenerations and five-years earlier, through a method of migration that largely ended
after the Recovery filter. Plaintiff's counsel stated that they have no expert, and can cite
no regulation, that would require such warnings. The Court again concludes that the
marginal relevancy of this evidence to the Eclipse failure-to-warn claim is substantially
outweighed by the danger of unfair prejudice. (3) Defendants did assert in their
opening statement that only 16 deaths have been caused by pulmonary emboli (PE) in
patients with Bard IVC filters, and they did not limit this assertion to the Eclipse or G2
line of filters. This statistic was also included in a slide shown to the jury. When the
Court asked defense counsel what witness would present these statistics to the jury, he
said it would be either Mr. Modra or Mr. Carr. The Court is inclined to permit
Plaintiff's counsel to cross-examine the witness on the basis for this calculation,
including what deaths were included in the calculation and the fact that other deaths
have been reported in Bard IVC filter patients, including deaths caused by filter
migration. Certainly other filter-related deaths, even if not caused by a PE, are relevant
to the risk-benefit analysis on which Defendants placed considerable emphasis in their
opening. The Court will make a final decision on this issue after the direct examination
of Mr. Modra or Mr. Carr. Plaintiff's counsel should raise this issue before mentioning

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it in front of the jury, and the Court will decide the proper scope of such crossexamination. Signed by Judge David G Campbell on 5-15-18. This is a TEXT ENTRY
ONLY. There is no PDF document associated with this entry. (DGC) (Entered:
05/15/2018)

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Page 1 of 2

APPEAL,ATTYADD,LEAD,MULTI-DISTRICT,PROTO,REMAND,STD

U.S. District Court
DISTRICT OF ARIZONA (Phoenix Division)
CIVIL DOCKET FOR CASE #: 2:15-md-02641-DGC

IN RE: Bard IVC Filters Products Liability Litigation
Assigned to: Judge David G Campbell
Case in other court: Ninth Circuit, 16-16163
Ninth Circuit, 18-16349
Ninth Circuit, 18-16460
Ninth Circuit, 18-16461
Ninth Circuit, 18-17259
Cause: 28:1332 Diversity-Product Liability
Date Filed
05/29/2018

#

Date Filed: 08/17/2015
Jury Demand: Both
Nature of Suit: 365 Personal Injury:
Prod. Liability
Jurisdiction: Diversity

Docket Text

11256 ORDER. After having heard argument on several issues today, the Court
enters the following orders: (1) Plaintiff proposes to place four redacted
monthly management reports in evidence (Exs. 4504, 4519, 4522, 4528),
with filter-related complaints included. These four reports include 83 filter
complaints and would greatly expand the 40 complaints the Court previously
permitted. Doc. 11157. This number of complaints would raise the concerns
addressed in the Schwartz case previously cited by the Court. See Doc.
11122. The Court concludes that one monthly management report, with
filter-related complaints included, is sufficient to accomplish Plaintiff's
objective of showing that complaints were communicated monthly to senior
management. The Court will admit Ex. 4519, including its filter-related
complaints, for this purpose. The Court will also admit the Rule 1006
summary of complaints received by Defendants (assuming Defendants have
no objection to the chart). (2) The Court concludes that evidence and
argument presented during the trial have made section 3 of the FDA warning
letter relevant, and that its relevancy is not substantially outweighed by the
danger of unfair prejudice. The Court will admit Ex. 1680 as redacted. (3)
The Court has two observations concerning the continued arguments
regarding Recovery filter cephalad migration deaths. (a) Plaintiff continues
to argue that if the Recovery had been recalled there would have been no
predicate for the G2 and, therefore, no Eclipse filter to injure her. In fact,
today Plaintiff's counsel called this a "key" to the case. But as the Court has
noted before, there is no claim in this case for negligent failure to recall the
Recovery filter. The only claims are for design defects and failures to warn
with respect to the Eclipse filter. Thus, even if it is true that there would
have been no Eclipse filter had the Recovery been recalled, that fact does not
prove any of Plaintiff's claims. Nor does it prove that design defects or
failures to warn with respect to the Eclipse filter proximately caused
Plaintiff's injury. The Court is concerned that Plaintiff's counsel will argue in

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CM/ECF - azd

Page 2 of 2

closing that the jury should find in her favor because recall of the Recovery
would have meant no Eclipse, when that fact has nothing to do with any of
her four claims. Plaintiff should be prepared to address this tomorrow
morning. (b) The Court has previously noted that Recovery filter problems
are a relevant part of the overall filter history in this case, but has found the
cephalad migration deaths only marginally relevant in light of the fact that
the G2 line of filters largely eliminated this type of complication. However,
Defendants presented testimony from Dr. DeFord that the Recovery filter
saved many more lives than it put at risk. Given this evidence, why should
Plaintiff not be permitted to present at least some evidence that the Recovery
filter in fact caused several deaths? Defendants should be prepared to
address this tomorrow morning. Signed by Judge David G Campbell on
5-29-18. This is a TEXT ENTRY ONLY. There is no PDF document
associated with this entry. (DGC) (Entered: 05/29/2018)

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6/28/2019

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 1 of 8

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WO

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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9
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IN RE: Bard IVC Filters Products Liability
Litigation,
___________________________________
Lisa Hyde and Mark E. Hyde, a married
couple,
Plaintiffs,

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16
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No. MDL 15-02641-PHX-DGC

No. CV-16-00893-PHX-DGC
ORDER

v.
C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,
Defendants.

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21

The case brought by Plaintiffs Lisa and Mark Hyde is set for a bellwether trial

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later this month. The parties have filed motions in limine (“MILs”) in advance of trial.

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This order will rule on Plaintiffs’ MILs Nos. 4 and 5, which seek to exclude evidence

24

regarding the Bard IVC filter’s instructions for use (“IFU”) and certain guidelines

25

published by the Society of Interventional Radiologists (“SIR”). Docs. 12100, 12101.

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I.

Background.

27

Plaintiff Lisa Hyde received a Bard IVC filter implant in 2011. In 2014, she

28

learned that the filter had tilted, perforated the IVC wall, and fractured. The filter and

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 2 of 8

1

fractured limbs were removed three months later.1

2

Mrs. Hyde and her husband assert various claims. Doc. 364; Doc. 1, Case No.

3

CV-16-00893. Applying Wisconsin law, the Court granted summary judgment on their

4

failure to warn claims (Counts II and VII). Doc. 12007. Plaintiffs continue to assert

5

claims for strict liability design defect (Count III), negligent design (Count IV),

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negligence per se (Count IX), loss of consortium (Count XV), and punitive damages.

7

Id. at 19.

8

II.

9

Discussion.
A.

Parties’ Arguments.

10

Under Wisconsin’s product liability statute, Wis. Stat. § 895.047, a product is

11

defective in design if its foreseeable risks of harm could have been reduced or avoided by

12

the adoption of a reasonable alternative design, and the omission of the alternative design

13

renders the product not reasonably safe. § 895.047(1)(a). Plaintiffs argue that, consistent

14

with the statute, the focus of their case will be on the design of the Bard filter and

15

alternative designs that would have made the filter safe. Doc. 12100 at 2. Plaintiffs

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argue that because the IFU says nothing about the filter’s design, and because the failure

17

to warn claims have been dismissed, the instructions and warnings set forth in the IFU are

18

no longer relevant to any issue in the case and should be excluded under Rules 401 and

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402 of the Federal Rules of Evidence. Id. at 2-3. Plaintiffs further argue that evidence

20

regarding the IFU should be excluded under Rule 403 because it would only confuse the

21

jury. Id. at 3.

22

Plaintiffs seek exclusion of the SIR guidelines for similar reasons. Doc. 12101.

23

They argue that the purpose for which the SIR guidelines were previously admitted – to

24

show knowledge of IVC filter complications in the medical community – is no longer

25

relevant now that the failure to warn claims have been dismissed. Id. at 2. Plaintiffs

26

contend that any defense based on the learned intermediary doctrine is moot without a

27
28

1

The parties dispute whether Mrs. Hyde’s filter was a G2X or an Eclipse, but the
filter type has no bearing on these MILs.
-2-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 3 of 8

1

failure to warn claim, and that the defense otherwise does not apply because Mrs. Hyde,

2

not the implanting physician, is the “ultimate consumer” under Wisconsin product

3

liability law. Id.; Doc. 12100 at 3 (citing Green v. Smith & Nephew AHP, Inc., 629

4

N.W.2d 727, 752 (Wis. 2001) (holding that a product is defective if it is in a condition

5

“not contemplated by the ultimate consumer”)).2

6

Defendants assert that the language of § 895.047(a)(1) reflects Wisconsin’s

7

adoption of § 2(b) of the Restatement (Third) of Torts (1998) (“§ 2(b)”). Docs. 12384

8

at 2, 12385 at 2. The IFU and SIR guidelines are relevant to the design defect claim,

9

Defendants argue, because § 2(b) involves a risk-utility balancing test and consideration

10

of a broad range of factors, including the instructions and warnings accompanying the

11

product. Id. (citing § 2, cmts. d & f). Defendants further argue that Plaintiffs’ reliance on

12

Green and the “consumer contemplation” test is misplaced because the test has been

13

abrogated by Wisconsin’s adoption of § 895.047 and § 2(b). Doc. 12385 at 2 n.2.3

14

B.

15

In 1967, Wisconsin adopted the rule of strict product liability set forth in

16

the Restatement (Second) of Torts § 402A (1965) (“§ 402A”). See Dippel v. Sciano, 155

17

N.W.2d 55, 63-65 (1967). Eight years later, the state explicitly adopted a “consumer

18

contemplation” test. See Vincer v. Esther Williams All-Aluminum Swimming Pool Co.,

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230 N.W.2d 794, 797 (Wis. 1975) (adopting § 402A, cmts. g & i); Green, 629 N.W.2d

20

at 738-39. Under this test, a product “is defective and unreasonably dangerous when it is

21

in a condition not contemplated by the ultimate consumer and unreasonably dangerous to

22

that consumer.” Beacon Bowl, Inc. v. Wis. Elec. Power Co., 501 N.W.2d 788, 809 (Wis.

23

1993) (citing Vincer).

Wisconsin’s Product Liability Law.

24
2

25
26
27

It is not clear under Wisconsin law whether Mrs. Hyde or the implanting
physician was the “ultimate consumer” of the Bard filter for purposes of the design defect
claim. The Wisconsin Supreme Court has not decided whether to adopt the learned
intermediary doctrine, and federal courts applying Wisconsin law are split on the issue.
See Doc. 12007 at 14 n. 6 (citing cases).
3

28

These arguments, and Wisconsin product liability law, are discussed by the
parties more fully in their trial briefs and proposed pretrial order and jury instructions.
Docs. 12358 at 2-15, 12400 at 8-13; Doc. 12388 at 19-22; Doc. 12438 at 34, 45-51.
-3-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 4 of 8

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The consumer contemplation test was challenged in Green. The defendant argued

2

that a pure consumer contemplation test, without consideration of the risks and benefits

3

of the product, would unnecessarily cause many useful products to be taken off the

4

market. Green, 629 N.W.2d at 742. The defendant further argued that foreseeability of

5

the risk of harm should be an element of product liability claims in order to avoid

6

imposing absolute liability on manufacturers. Id. at 744. The defendant urged the court

7

to adopt Restatement § 2(b), which includes an element of foreseeability:

8

[A product] is defective in design when the foreseeable risks of harm posed
by the product could have been reduced or avoided by the adoption of a
reasonable alternative design[,] . . . and the omission of the alternative
design renders the product not reasonably safe[.]

9
10
11

See id. at 751.

12

Green rejected these arguments. Id. at 737-52. The court declined the “invitation

13

to abandon or qualify [Wisconsin’s] exclusive reliance on the consumer-contemplation

14

test.” Id. at 743. The court also declined to adopt § 2(b) because its incorporation of

15

“an element of foreseeability of risk of harm and a risk-benefit test . . . departs from the

16

consumer-contemplation test set forth in [§ 402A], and blurs the distinction between

17

strict products liability claims and negligence claims.” Id. at 751 (noting that a risk-

18

benefit test is included in § 2, comment a). The court was “troubled by the fact that

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§ 2(b) sets the bar higher for recovery in strict products liability design defect cases than

20

in comparable negligence cases” by adding the requirement that “there was a ‘reasonable

21

alternative design’ available to the product’s manufacturer.” Id. The court concluded:

22

Where a manufacturer places a defective and unreasonably dangerous
product into the stream of commerce, the manufacturer, not the injured
consumer, should bear the costs of the risks posed by the product. Because
2(b) unduly obstructs this equitable principle, we refuse to adopt 2(b) into
Wisconsin law.

23
24
25
26

Id.

27

In early 2011, the Wisconsin legislature changed this law by enacting § 895.047.

28

See Gopalratnam v. Hewlett-Packard Co., No. 13-CV-618-PP, 2016 WL 8193573, at *1

-4-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 5 of 8

1

(E.D. Wis. Mar. 11, 2016) (citing Wis. Senate Bill 1, 2011 Wis. Act 2 (Jan. 27, 2011));

2

In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., 218 F. Supp. 3d 700, 723 (N.D.

3

Ill. 2016) (discussing § 895.047 and noting that it was “enacted as a part of a ‘tort reform’

4

initiative in 2011”), aff’d 884 F.3d 746 (7th Cir. 2018). The new statute adopted § 2 of

5

the Restatement (Third). Doc. 12400 at 11. The statute reads:

6
7
8
9

(1) Liability of manufacturer. In an action for damages caused by
a manufactured product based on a claim of strict liability, a manufacturer
is liable to a claimant if the claimant establishes all of the following by a
preponderance of the evidence:

12

(a) That the product is defective because it . . . is defective in design
. . . . A product is defective in design if the foreseeable risks of harm posed
by the product could have been reduced or avoided by the adoption of a
reasonable alternative design by the manufacturer and the omission of the
alternative design renders the product not reasonably safe.

13

§ 895.047(1)(a); see Lexington Ins. Co. v. Whesco Grp., Inc., No. 11-CV-598-BBC, 2013

14

WL 4454959, at *8 (W.D. Wis. Aug. 16, 2013); WIS JI-CIVIL § 3260.1 (2014). Thus, a

15

plaintiff claiming strict product liability under Wisconsin law must now show that the

16

product’s foreseeable risk of harm could have been reduced or avoided by a reasonable

17

alternative design, and that the failure to adopt the alternative design rendered the product

18

“not reasonably safe.” § 895.047(1)(a).

10
11

19

C.

20

Plaintiffs rely on Green in arguing that the IFU and the SIR guidelines have no

21

relevance to the design defect claim because “a product is not reasonably safe under

22

Wisconsin law if it is ‘in a condition not contemplated by the ultimate consumer.’”

23

Doc. 12101 at 2 (quoting Green, 245 Wis. 2d at 825-26); see Doc. 12100 at 3. But Green

24

was effectively overruled by the adoption of § 895.047, and the consumer contemplation

25

test is now only one factor in determining whether the Bard filter was unsafe. The statute

26

adopts § 2 of the Restatement, and, under § 2, “consumer expectations do not constitute

27

an independent standard for judging the defectiveness of product designs” because they

28

do not take into account “whether an alternative design would provide greater overall

Analysis.

-5-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 6 of 8

1

safety.” See Restatement (Third) § 2, cmt. g; see also WIS JI-CIVIL § 3260.1 (noting

2

that § 895.047(1)(a) introduced the “reasonable alternative design” test for design defect

3

cases “apparently discarding the consumer contemplation test”). Thus, the Court cannot

4

exclude the IFU and SIR guidelines on the basis urged by Plaintiff – that they are not

5

relevant to consumer expectations.4

6

Plaintiffs further argue that the IFU and SIR guidelines are no longer needed to

7

support a learned intermediary defense because the failure to warn claims have been

8

dismissed. Docs. 12100 at 1-2, 12101 at 2. Those claims have been dismissed, but the

9

IFU and SIR guidelines are also relevant to the design defect claim. As noted above, the

10

jury must consider not only whether there was a reasonable alternative design, but also

11

whether Bard’s failure to adopt that design rendered the filter “not reasonably safe.” Wis.

12

Stat. § 895.047(1)(a). The SIR guidelines – created by the Society of Interventional

13

Radiologists to inform the medical community regarding acceptable rates of risk in IVC

14

filters – are relevant to the jury’s determination of whether Bard’s filter was reasonably

15

safe. Bard’s IFU, including what it tells physicians about risks of the Bard filters and

16

how to mitigate them, is also relevant in determining whether the filter was reasonably

17

safe. Nothing in § 895.047 precludes Defendants from arguing to the jury that the

18

warnings provided with the Bard filter disclosed the risks of complications, that the

19

medical community was aware of those risks and found them to be acceptable, and that

20

the omission of an alternative design therefore did not render the filter “not reasonably

21

safe.”5

22
4

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25
26
27
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Plaintiffs note in their trial brief that comment g to § 2(b) provides that consumer
expectations, while not dispositive, still play a role in determining defectiveness.
Doc. 12400 at 10-11. A Wisconsin district court has expressed doubt whether this “is an
accurate statement of the law in Wisconsin.” In re Zimmer, 218 F. Supp. 3d at 723. The
Court need not decide this issue for purposes of the MILs because consumer expectations
are, at most, only one factor to be considered in the ultimate determination of whether the
omission of a proposed alternative design renders a product not reasonably safe. See id.;
§ 895.047(1)(a).
5

Defendants note that a comment to the Restatement provides that the instructions
and warnings accompanying a product may be considered in determining whether a
product is defective. Docs. 12384 at 2, 12385 at 2 (citing § 2, cmt. f). Based on this and
other comments to the Restatement, Defendants propose jury instructions setting forth a
-6-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 7 of 8

1

The IFU and SIR guidelines also are relevant to Plaintiffs’ negligence and punitive

2

damages claim. In deciding whether Defendants acted reasonably for purposes of the

3

negligence claim, the jury may consider rates of risk accepted within the medical

4

community (the SIR guidelines) and what Defendants told physicians about those risks in

5

the IFU.

6

To recover punitive damages under Wisconsin law, Plaintiffs must show that

7

Defendants “acted maliciously” or in an “intentional disregard of the rights” of Plaintiffs.

8

Wis. Stat. 895.043(3); see Strenke v. Hogner, 694 N.W.2d 296, 304-05 (Wis. 2005). The

9

jury may consider Defendants’ “attitude and conduct” and “the degree of [Defendants’]

10

awareness of the hazard and of its excessiveness.” Doc. 12438 at 38-39; see WIS JI-

11

CIVIL § 1707.2. Warnings provided in the IFU are relevant to Defendants’ attitude and

12

conduct toward patients who receive Bard filter implants, and whether Defendants acted

13

with malice or an intentional disregard for patient safety. The SIR guidelines are relevant

14

to Defendants’ awareness of filter complication rates and the extent of harm posed by

15

filter complications, and can also inform the jury of risk levels found acceptable by

16

interventional radiologists – a relevant fact for deciding whether Defendants’ acted with a

17

disregard for patient safety.

18

Plaintiffs contend that the IFU should be excluded under Rule 403. Docs. 12100

19

at 3. But evidence regarding the IFU will not unfairly prejudice Plaintiffs or confuse the

20

jury.

21

otherwise defend against the dismissed failure to warn claims, and the Court will properly

22

instruct the jury on the claims at issue and the law that applies to them.

Defendants will not be permitted to assert a learned intermediary defense or

23

Plaintiffs contend that any probative value of the SIR guidelines is substantially

24

outweighed by the dangers described in Rule 403 because no expert has testified that the

25

SIR guidelines set forth “acceptable” complication rates. Doc. 12101 at 2-4. But the

26
27
28

host of factors the jury may consider in deciding whether the Bard filter is defective.
Doc. 12438 at 46-48. Plaintiff objects to the proposed instructions, arguing that the
comments to the Restatement have not been incorporated into Wisconsin product liability
law. Id.; Doc. 12400 at 11 (trial brief). The Court need not decide this issue in order to
resolve the MILs.
-7-

Case 2:15-md-02641-DGC Document 12507 Filed 09/04/18 Page 8 of 8

1

Court will require an appropriate foundation before admitting the SIR guidelines, and

2

Plaintiffs’ challenge to their veracity will go to their weight, not their admissibility.

3
4
5

IT IS ORDERED that Plaintiffs’ MILs Nos. 4 and 5 (Docs. 12100, 12101) are
denied.
Dated this 4th day of September, 2018.

6
7
8
9
10
11
12
13
14
15
16
17
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20
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22
23
24
25
26
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28

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Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 1 of 9

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9
10
11
12
13

IN RE: Bard IVC Filters Products Liability
Litigation,
___________________________________
Lisa Hyde and Mark E. Hyde, a married
couple,
Plaintiffs,

14
15
16
17
18

No. MDL 15-02641-PHX-DGC

No. CV-16-00893-PHX-DGC
ORDER

v.
C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,
Defendants.

19
20
21

The case brought by Plaintiffs Lisa and Mark Hyde is set for a bellwether trial

22

later this month. The parties have filed motions in limine (“MILs”) in advance of trial.

23

The Court previously ruled on Plaintiffs’ MILs 4 and 5. Doc. 12507. This order will rule

24

on the remaining MILs except Defendants’ MIL 5.1

25
26
27
28

1

Defendants have withdrawn MIL 2, which sought to exclude marketing
materials. Docs. 12089, 12496. Defendants’ MIL 5 seeks to exclude opinion testimony
of Dr. Kandarpa. Doc. 12092. The parties agreed at today’s final pretrial conference that
the Court should review the deposition designations for Dr. Kandarpa and make rulings
on a question-by-question basis. The Court will issue a separate order addressing
Defendants’ objections to Dr. Kandarpa’s testimony.

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 2 of 9

1

I.

Background.

2

Plaintiff Lisa Hyde received a Bard IVC filter implant in 2011. In 2014, she

3

learned that the filter had tilted, perforated the IVC wall, and fractured. The filter and

4

fractured limbs were removed three months later.2

5

Mrs. Hyde and her husband assert various claims. Doc. 364; Doc. 1, Case No.

6

CV-16-00893.

7

Defendants on several claims. Doc. 12007. Plaintiffs continue to assert claims for strict

8

liability design defect (Count III), negligent design (Count IV), negligence per se

9

(Count IX), loss of consortium (Count XV), and punitive damages. Id. at 19.

10

II.

Applying Wisconsin law, the Court granted summary judgment to

Plaintiffs’ Motions in Limine.

11

A.

12

In the Booker case, the Court denied a motion in limine to exclude evidence of the

13

FDA’s 510(k) clearance process and lack of enforcement action against Bard. Doc. 9881.

14

Plaintiffs state that they are neither re-urging nor seeking reconsideration of that order,

15

but instead seek to exclude evidence beyond the scope of the order. Doc. 12095 at 1 n.1.

16

Plaintiffs assert that the FDA evidence admitted in the Booker and Jones bellwether trials

17

created an impression that the FDA made safety and efficacy determinations by implying

18

that Bard “worked hand-in-hand with the FDA” and “conducted a design process with the

19

FDA.” Id. at 2. Plaintiffs seek to exclude evidence regarding (1) Bard’s post-market

20

surveillance communications with the FDA, (2) the FDA’s reclassification of IVC filters

21

from class III to class II devices, and (3) “gratuitously offered” testimony about FDA

22

communications unrelated to the 510(k) process. Id. at 2-4.

MIL 1 – FDA Evidence.

23

Bard’s post-market surveillance communications with the FDA are relevant to the

24

question of whether Bard acted reasonably for purposes of the negligent design claim,

25

particularly since Plaintiffs claim that the G2 line of filters constituted an ongoing design

26

and iteration of the original G2 filter. See Stevens v. Stryker Corp., No. 12-CV-63-BBC,

27
28

2

The parties dispute whether Mrs. Hyde’s filter was a G2X or an Eclipse. The
Court has concluded that the issue should be presented to the jury. Doc. 12157.
-2-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 3 of 9

1

2013 WL 4758948, at *4 (W.D. Wis. Sept. 4, 2013) (noting that the reasonableness of the

2

manufacturer’s conduct is informed by FDA regulations). Post-market communications

3

are also relevant to Plaintiff’s punitive damages claim that Bard acted maliciously and

4

with intentional disregard for the rights of others. See Wis. Stat. § 895.043(3) (to recover

5

punitive damages the plaintiffs must show that the defendants “acted maliciously” or in

6

an “intentional disregard of the rights” of the plaintiffs). Additionally, Plaintiffs have

7

stated that their punitive damages case will be based in part on Bard’s failure to take post-

8

sale remedial actions. See Doc. 12400 at 17-19. Bard’s post-market surveillance of its

9

products, and its and communications with the FDEA about that surveillance, are directly

10

relevant to this issue. Finally, evidence regarding Bard’s post-market communications

11

with the FDA and the agency’s lack of enforcement action with respect to Bard filters are

12

relevant to Plaintiffs’ claim that Bard failed to disclose relevant evidence to and misled

13

the FDA. See Docs. 11011 at 4, 10323 at 2-3.

14

Plaintiffs seek exclusion of the FDA’s 1996 reclassification memo because it does

15

not directly relate to the 510(k) process or any Bard retrievable filter. Doc. 12095 at 3;

16

see Doc. 12095-8. But as Defendants note, the memo explains why IVC filters are

17

subject to 510(k) review instead of the premarket approval process, and tends to rebut

18

Plaintiffs’ argument that Bard strategically chose the easier path of clearance instead of

19

approval. Doc. 12381 at 3 & n.3. Plaintiffs claim that the memo “sends the message that

20

[the] FDA deemed Bard’s devices safe and effective.” Doc. 12095 at 4. But Plaintiffs

21

have ample evidence to contest any such implication. See Doc. 10323 at 3. The Court

22

cannot conclude that admission of the reclassification memo will unfairly prejudice

23

Plaintiffs.

24

Similarly, the probative value of testimony from Bard witnesses that they regularly

25

communicated and shared information with the FDA, and that they personally believe

26

Bard filters are safe and effective, is not outweighed by the danger of unfair prejudice.

27

Doc. 12095 at 4. Plaintiffs can make appropriate objections is they feel that gratuitous

28

and irrelevant comments are being made during testimony.

-3-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 4 of 9

1

Consistent with the Court’s earlier ruling, Defendants will be precluded from

2

presenting evidence or argument that the FDA “approved” Bard retrievable filters for

3

market, or that clearance of the devices under 510(k) review constitutes a finding by the

4

FDA that the filters are “safe and effective.” Doc. 9881 at 6. But Defendants will not be

5

precluded from presenting evidence of the FDA’s 510(k) clearance process and lack of

6

enforcement action against Bard. See id. at 3-6. The motion in limine (Doc. 12095) is

7

denied.

8

B.

9

Plaintiffs seek to exclude evidence and argument regarding a 2008 report issued

10

by the U.S. Department of Health and Human Services titled “The Surgeon General’s

11

Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism” (the “Call to

12

Action report”). Doc. 12097; see Doc. 12382-1. Plaintiffs contend that the report is

13

irrelevant and confusing, and any probative value is substantially outweighed by the

14

danger of unfair prejudice. Doc. 12097 at 1-3. Plaintiffs further contend that the report

15

constitutes inadmissible hearsay.

16

admissible under the public records hearsay exception, is relevant, not prejudicial, and

17

will not confuse the jury. Doc. 12382. The Court agrees with Defendants.

MIL 2 – Surgeon General’s Call to Action.

Id. at 3-4.

Defendants argue that the report is

18

The Call to Action report is relevant to the design defect and negligence claims.

19

With respect to the design defect claim, the jury must consider not only whether there

20

was a reasonable alternative design for the Bard filter, but also whether Bard’s failure to

21

adopt that design rendered the filter “not reasonably safe.” Wis. Stat. § 895.047(1)(a).

22

The jury thus will be required to make a reasonableness determination with respect to the

23

filter’s safety.

24

required to decide whether Defendants acted reasonably in designing and releasing the

25

filter. In making this determination, the jury may employ a risk-benefit analysis. See

26

Meyer v. Val Lo Will Farms, Inc., 111 N.W.2d 500, 503 (Wis. 1961) (explaining that

27

negligence claims require a risk-benefit analysis); Green v. Smith & Nephew AHP, Inc.,

28

629 N.W.2d 727, 751 (Wis. 2001) (same); see also Restatement (Third) of Torts, § 2 cmt.

Similarly, in deciding Plaintiff’s negligence claim, the jury will be

-4-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 5 of 9

1

d (1998) (noting that “[s]ubsection (b) adopts a reasonableness (‘risk-utility balancing’)

2

test as the standard for judging the defectiveness of product design”).3

3

The Call to Action report is relevant to the risk-benefit analysis because it explains

4

the benefits of IVC filters. It notes that deep vein thrombosis and pulmonary emboli are

5

major public health problems, contributing to at least 100,000 deaths per year.

6

Doc. 12382-1 at 8. The report calls for actions to reduce the risk of these diseases, and

7

notes that IVC filters are one option for the prevention of pulmonary emboli.

8

at 26-28. The report plainly is probative of whether the benefits of Bard filters, when

9

weighed against their risks, render Bard’s actions unreasonable or the filter “not

10

reasonably safe.” See Doc. 10258 at 8 (denying motion to exclude evidence that IVC

11

filters are “lifesaving” devices because the benefits of IVC filters are relevant to a risk-

12

utility analysis).

Id.

13

The record does not support Plaintiffs’ assertion that Defendants argued during the

14

first two bellwether trials that “Bard acted at the direction of the Surgeon General” and

15

“the Surgeon General considers Bard’s IVC filters necessary” to treat pulmonary emboli.

16

Doc. 12097 at 2. If Plaintiffs believe that Defendants are improperly implying the

17

imprimatur of the Surgeon General, they may object at trial. See id. But the Court

18

cannot conclude that admission of the Call to Action report will confuse the jury or

19

unfairly prejudice Plaintiffs.

20

Nor can the Court conclude that the report constitutes inadmissible hearsay. The

21

report falls within the public records hearsay exception. Fed. R. Evid. 803(8). Plaintiffs’

22

citation of Philip Morris USA, Inc. v. Pollari, 228 So. 3d 115, 123 (Fla. Dist. Ct. App.

23

2017), does not help their position. Pollari found that Surgeon General reports satisfy

24

Federal Rule of Evidence 803(8)(A)(iii) as records of factual findings from authorized

25
26
27
28

3

Plaintiffs contend that the Call to Action report has no relevance because
Wisconsin law employs a “consumer contemplation” test for design defect claims, not a
risk-benefit analysis. Doc. 12097 at 4 (citing Green, 629 N.W.2d at 752). As explained
in the Court’s order denying Plaintiffs’ MILs 4 and 5, this contention is incorrect.
Doc. 12507. In addition, the risk-benefit analysis is relevant to Plaintiffs’ negligence
claim, as noted above. Green, 629 N.W.2d at 751; Meyer, 111 N.W.2d at 503.
-5-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 6 of 9

1

investigations, but excluded the reports because Florida law did not follow the federal

2

rule. Id. Other cases have admitted Surgeon General reports under Rule 803(8). See

3

Boerner v. Brown & Williamson Tobacco Co., 394 F.3d 594, 600 (8th Cir. 2005) (finding

4

Surgeon General reports “properly admitted under the public records exception,

5

inasmuch as they were prepared pursuant to a legal obligation”). The motion in limine

6

(Doc. 12097) is denied.

7

C.

8

Plaintiffs seek to exclude evidence and argument that Mrs. Hyde’s falls in

9

November 2012 and May 2013 caused or contributed to the Bard filter’s failures.

10

Doc. 12099. Defendants state that they will not argue or suggest that the falls contributed

11

to the filter’s failures or otherwise impacted Mrs. Hyde’s filter-related complications.

12

Doc. 12383 at 2. The motion in limine is granted in this regard.4

13

III.

MIL 3 – November 2012 and May 2013 Falling Incidents.

Defendants’ Motions.

14

A.

15

Defendants seek to exclude evidence of deaths caused by cephalad migration of

16

Recovery filters. Doc. 12088. Plaintiffs contend that such evidence is relevant because

17

excluding the deaths associated with the predicate Recovery filter that led to the G2’s

18

design would unduly prejudice Plaintiffs in proving the design defect claim. Doc. 12392

19

at 2. But this case does not involve a Recovery filter. Mrs. Hyde received a filter that

20

was either a G2X or Eclipse, two or three generations after the Recovery filter. See

21

Doc. 12157. She was implanted with the filter in early 2011, more than five years after

22

cephalad migration deaths stopped when the Recovery was taken off the market in 2005.

23

The cephalad migration deaths from the Recovery in 2004 and 2005 do not show that

24

G2X or Eclipse filters – which did not cause cephalad migration deaths (see Doc. 10920)

25

– had design defects when they left Defendants’ control several years later. Nor do the

MIL 1 – Recovery Filter Cephalad Migration Deaths.

26
27
28

4

Defendants state that they intend to introduce evidence of the falls only to rebut
the injuries and damages Mrs. Hyde alleges she suffered as a result of her IVC filter. Id.
Plaintiffs have not sought to preclude Defendants from using the evidence for this
purpose.
-6-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 7 of 9

1

cephalad migration deaths, which were eliminated by design changes to the G2, shed

2

light on Defendants’ state of mind when designing and marketing the G2X and Eclipse.

3

The Court will exclude evidence of Recovery filter cephalad migrations deaths

4

under Rule 403, for the reasons it excluded the same evidence in the Jones trial.

5

Docs. 10819, 10920, 11041.5 The motion in limine (Doc. 12088) is granted.6

6

B.

7

To prove that the Bard filter is defective in design, Plaintiffs must show that the

8

foreseeable risks of harm could have been reduced or avoided by a reasonable alternative

9

design. Wis. Stat. § 895.047(1)(a). Defendants seek to exclude evidence that Bard’s

10

Simon Nitinol filter (“SNF”) is a reasonable alternative design because, unlike the G2X

11

and Eclipse, the SNF is a non-retrievable, permanent filter. Defendants cite no rule of

12

evidence that would make this evidence inadmissible. See Doc. 12090.

MIL 3 – Simon Nitinol Filter as a Reasonable Alternative Design.

13

Presumably, Defendants are suggesting that the evidence is irrelevant because a

14

permanent filter cannot be a reasonable alternative to a filter that is both permanent and

15

retrievable. But relevancy is a relatively low standard – evidence having “any” tendency

16

to make a fact in dispute more probable (Fed. R. Evid. 401) – and it is the jury’s task to

17

decide whether a proposed alternative is “reasonable.” Defendants can make a Rule 50

18

motion if they think the evidence would not support a jury verdict on this issue, but the

19

Court cannot conclude that Plaintiffs should be precluded from presenting evidence and

20

argument to support their theory. The motion in limine (Doc. 12090) is denied.

21

C.

22

Defendants seek to exclude testimony from Dr. Muehrcke that he “personally felt

23

betrayed” because Bard had not told physicians about information contained in Bard’s

MIL 4 – Personal Opinions of Dr. Muehrcke.

24
25
26
27
28

5

See In re Bard IVC Filters Prods. Liab. Litig., No. CV-16-00782-PHX-DGC,
2018 WL 2124146 (May 8, 2018), 2018 WL 1993767 (Apr. 27, 2018), and 2018 WL
1876896, at *2-4 (Apr. 18, 2018).
6

Nothing in this ruling precludes Plaintiffs from presenting “crucial” evidence
that Defendants were able to modify their filter design quickly – within nine months of
Recovery reaching the market – as part of Plaintiffs’ claim that alternative designs were
possible. Doc. 12392 at 6-7 & n. 6.
-7-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 8 of 9

1

internal documents, and that he has a “moral and ethical issue” with how Bard addressed

2

adverse events. Doc. 12091 at 2; see Doc. 12091-1 at 3 (testimony in Jones trial).

3

“Personal views on corporate ethics and morality are not appropriate expert opinions.”

4

In re Baycol Prods. Liab. Litig., 532 F. Supp. 2d 1029, 1053 (D. Minn. 2007); see In re

5

Trasylol Prods. Liab. Litig., No. 08-MD-1928, 2010 WL 1489793, at *9 (S.D. Fla.

6

Feb. 24, 2010) (finding opinions on Bard’s responsibilities inadmissible under Rule 702

7

because they were based on the doctor’s subjective beliefs rather than any objective

8

standard or specialized knowledge); In re Rezulin Prods. Liab. Litig., 309 F. Supp.

9

2d 531, 542-43 (S.D.N.Y. 2004) (“The opinions of plaintiffs’ witnesses, however

10

distinguished these individuals may be as physicians and scientists, concerning the ethical

11

obligations of pharmaceutical companies and whether the defendants’ conduct was

12

ethical are inadmissible[.]”). Dr. Muehrcke will be permitted to explain, if asked at trial,

13

why he does not use Bard’s filters based on his personal experience using the filters and

14

his review of Bard internal documents. But he is precluded from testifying about his

15

personal feelings of betrayal and his moral and ethical issues with Bard’s conduct.

16

Dr. Muehrcke’s personal feelings are not relevant. See Ollier v. Sweetwater Union High

17

Sch. Dist., 768 F.3d 843, 861 (9th Cir. 2014) (noting that “personal opinion testimony is

18

inadmissible as a matter of law under Rule 702”); see also Doc. 9433 at 17 (holding that

19

no expert, on either side, will be permitted to opine on ethics). The motion in limine

20

(Doc. 12091) is granted.

21

D.

22

Defendants seek to exclude evidence and argument about informed consent.

MIL 6 – Informed Consent.

23

Doc. 12093.

24

provide the medical community with additional information about its IVC filters so that

25

physicians could obtain informed consent from patients. See id. at 2-3. Defendants argue

26

that the opinions are irrelevant now that the failure to warn claims have been dismissed.

27

Id. at 2-4. The Court does not agree.

28

Plaintiffs’ medical experts have offered opinions that Bard needed to

In opposing Plaintiffs’ motion in limine to exclude evidence of the Bard filter’s

-8-

Case 2:15-md-02641-DGC Document 12533 Filed 09/07/18 Page 9 of 9

1

instructions for use (“IFU”), Defendants argued that warnings provided in the IFU about

2

filter complication risks are relevant to the jury’s determination of whether Bard acted

3

reasonably in designing the filter and whether the filter is “not reasonably safe” under

4

Wisconsin product liability law. Doc. 12384 at 2 (citing Wis. Stat. § 895.047(1)(a);

5

Restatement (Third) of Torts, § 2 cmts. d, f). Defendants similarly argued that certain

6

guidelines published by the Society of Interventional Radiologists (“SIR”) are relevant in

7

evaluating what is “not reasonably safe” because they inform treating physicians about

8

acceptable rates of risk in IVC filters. Doc. 12385 at 2-3. The Court agreed, and held

9

that Defendants are not precluded from arguing to the jury that the warnings provided

10

with the Bard filter disclosed the risks of complications, that the medical community was

11

aware of those risks and found them to be acceptable, and that the omission of

12

an alternative design therefore did not render the filter “not reasonably safe.” Doc. 12507

13

at 6. The Court also found that the IFU and SIR guidelines are relevant to the punitive

14

damages claim because they reflect Bard’s attitude toward patient safety and awareness

15

of filter complication rates. Id. at 7.

16

If Defendants are permitted to present evidence about Bard’s warnings to doctors

17

as part of their defense, then Plaintiffs are permitted to present evidence about what

18

warnings Bard did not give. See Doc. 12508 at 4. In this regard, Plaintiffs’ experts are

19

not precluded from explaining to the jury that they have an obligation to obtain informed

20

consent from patients and, in order to fulfill this obligation, they need manufacturers to

21

provide honest and complete information about the risks and benefits associated with the

22

medical device. The Court cannot conclude that evidence regarding informed consent is

23

irrelevant. The motion in limine (Doc. 12093) is denied.

24

Dated this 7th day of September, 2018.

25
26
27
28

-9-

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 1 of 6

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9
10
11
12
13

IN RE: Bard IVC Filters Products
Liability Litigation,

No. MDL 15-02641-PHX DGC

__________________________________
Debra and James Tinlin, a married couple,

No. CV-16-00263-PHX-DGC

Plaintiffs,

14
15

v.

16

C. R. Bard, Inc., a New Jersey
corporation; and Bard Peripheral
Vascular, Inc., an Arizona corporation,

17
18

ORDER

Defendants.

19
20
21
22

Plaintiffs move to exclude certain opinions of Dr. Morris and evidence that

23

Ms. Tinlin’s medical care was an intervening cause of injury. Docs. 15077, 16576. The

24

motions are fully briefed. Docs. 15661, 16032, 16890. The parties request oral argument,

25

but it will not aid the Court’s decision. See Fed. R. Civ. P. 78(b); LRCiv 7.2(f). For reasons

26

stated below, the Court will grant the motion to exclude Dr. Morris’s opinions and grant in

27

part and deny in part the motion in limine regarding medical care as an intervening cause

28

of injury.

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 2 of 6

1

I.

2

Background.
On May 7, 2005, Dr. Riebe implanted a Bard Recovery filter in Plaintiff Debra

3

Tinlin’s inferior vena cava (“IVC”).

4

implantation, including one taken by Dr. Haller on April 15, 2008.

Ms. Tinlin had multiple chest scans after the

5

Ms. Tinlin experienced cardiac tamponade on June 10, 2013. A chest scan showed

6

evidence of two fractured Recovery struts in the right ventricle of her heart. Dr. Roitstein

7

performed emergency surgery to drain a large pericardial effusion. The procedure – a

8

subxiphoid pericardial window – involved removing a small piece of the heart sac and

9

inserting a drainage tube through the incision.

10

On July 31, 2013, Dr. Kress removed a fractured strut through open heart surgery.

11

A subsequent chest scan revealed multiple fractured struts in the pulmonary arteries. These

12

struts and the filter have not been removed.

13

II.

Motion to Exclude Dr. Morris’s Opinions About Drs. Roitstein and Kress.

14

In his case-specific report, Dr. Morris opines that an interventional radiologist could

15

have drained Ms. Tinlin’s pericardial effusion through percutaneous placement of a

16

drainage tube. Doc. 15081-2 at 18, ¶ 6. He claims that this procedure “likely would have

17

been performed more expeditiously, with less morbidity and risk than [Dr. Roitstein’s]

18

surgical procedure, using moderate sedation rather than general anesthesia.” Id.

19

Dr. Morris further opines that the fractured strut Dr. Kress removed potentially

20

could have been retrieved percutaneously by an interventional radiologist, which “might

21

have precluded open heart surgery, with all of its attendant risks and morbidity, including

22

tracheomalacia and epigastric ventral hernia.” Id. at 18-19, ¶ 7. Dr. Morris notes that a

23

chest scan taken two days before the surgery revealed no strut in the heart. Id. He opines

24

that the failure to perform a chest scan immediately before surgery is significant because

25

“it was possible that neither arm fragment was still located in the heart, and therefore, open

26

heart surgery would have been contraindicated.” Id. at 19, ¶ 7.

27

Plaintiffs have filed a motion to exclude these opinions, arguing that Dr. Morris is

28

not qualified to opine on the standard of care for cardiothoracic surgeons and his opinions

-2-

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 3 of 6

1

are unreliable and would be unhelpful and confusing to the jury. Doc. 15081-1 at 3-4.

2

Defendants make clear that they are not offering Dr. Morris to opine on the standard of

3

care for the surgeries performed by Drs. Roitstein and Kress, or any related breach.

4

Doc. 15661 at 6, 11. Defendants assert that they are merely “exercising [their] right under

5

Wisconsin law to present expert testimony that may ‘weaken’ Plaintiffs’ claim of

6

injuries[.]” Id. at 11 (citations omitted).

7

Under Wisconsin law, “when a tortfeasor causes an injury to another person who

8

then undergoes unnecessary medical treatment of those injuries despite having exercised

9

ordinary care in selecting her doctor, the tortfeasor is responsible for all of that person’s

10

damages arising from any mistaken or unnecessary surgery.” Hanson v. Am. Family Mut.

11

Ins., 716 N.W.2d 866, 871 (Wis. 2006) (citing Butzow v. Wausau Mem’l Hosp., 187

12

N.W.2d 349, 351-52 (Wis. 1971)). The rule was first announced in Selleck v. City of

13

Janesville, 75 N.W. 975, 976 (Wis. 1898):

14
15
16
17
18
19

The plaintiff is not held responsible for the errors or mistakes of a physician
or surgeon in treating an injury received by a defect[,] providing she
exercises ordinary care in procuring the services of such physician. Where
one is injured by the negligence of another, . . . if her damages have not been
increased by her own subsequent want of ordinary care she will be entitled
to recover in consequence of the wrong done, and the full extent of damage,
although the physician that she employed omitted to employ the remedies
most approved in similar cases, and by reason thereof the damage to the
injured party was not diminished as much as it otherwise should have been.

20
21

The Selleck rule remains good law in Wisconsin. See Fouse v. Persons, 259 N.W.2d 92,

22

95 (Wis. 1977) (“The rule for awarding damages for injuries aggravated by subsequent

23

mistaken medical treatment was established in Selleck . . . and has been followed since.”);

24

Paddock v. United States, No. 16-CV-947, 2018 WL 3696618, at *3 (E.D. Wis. Aug. 3,

25

2018) (discussing the “long-standing principle set forth in Selleck”); see also Wis Civil-JI

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1710 (citing Selleck to support the jury instruction for aggravation of injury because of

27

medical negligence).

28

-3-

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 4 of 6

1

Defendants do not dispute that the surgeries performed by Drs. Roitstein and Kress

2

were undertaken to treat injuries Ms. Tinlin sustained from the Recovery arm fragment in

3

her heart. See Docs. 15081-2 at 6-7, 16952 at 5. Nor do Defendants present any evidence

4

or argument that Ms. Tinlin was negligent in selecting the doctors to perform the surgeries.

5

Thus, even if the surgeries were unnecessary as Dr. Morris suggests, Plaintiffs still can

6

recover resulting damages under the Selleck rule if Defendants are found liable at trial.

7

As a result, Defendants have not shown that Dr. Morris’s opinions about the

8

treatment provided by Drs. Roitstein and Kress are relevant to any issue in the case. The

9

opinions would be unhelpful and confusing to the jury. The Court will grant the motion to

10

exclude the opinions. See Fed. Rs. Evid. 401-03.1

11

III.

Motion in Limine No. 1: Medical Care as an Intervening Cause of Injury.

12

Plaintiffs argue that under the Selleck rule, Defendants should be precluded from

13

offering Dr. Morris’s opinions that an interventional radiologist could have drained

14

Ms. Tinlin’s pericardial effusion and retrieved the Recovery arm fragment from her heart

15

through percutaneous procedures less intrusive than heart surgeries. Doc. 16576 at 1-2 &

16

n.1 (citing Doc. 15661 at 2). The Court agrees for reasons stated above, and will grant the

17

motion in limine in this regard.

18

Plaintiffs argue more broadly that Defendants should be precluded from offering

19

any evidence that Ms. Tinlin’s medical care was an intervening cause of her injury. Id.

20

at 2. But Plaintiffs identify no specific evidence other than Dr. Morris’s opinions discussed

21

above.

22

Defendants make clear that they intend to present evidence that Dr. Riebe’s decision

23

to implant a Recovery in Ms. Tinlin after measuring her IVC diameter at larger than 28

24

mm constitutes negligence that was an intervening cause of her injuries. Doc. 16890 at 3-4.

25

Defendants also intend to present evidence that the April 15, 2008 chest scan showed

26
27
28

1

Given this ruling, the Court need not determine whether the opinions are reliable
under Rule 702 and Daubert. Nor must the Court decide whether Dr. Morris is qualified
to opine on the standard of care for cardiothoracic surgeons given Defendants’ avowal that
no such opinion will be offered at trial. See Doc. 15661 at 6, 11.
-4-

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 5 of 6

1

foreign metallic bodies in Ms. Tinlin’s heart, and Dr. Haller’s failure to identify this

2

abnormality prevented Ms. Tinlin’s treating physicians from properly evaluating her

3

condition before the Recovery arm fragments became symptomatic and caused her injury

4

five years later. Id. at 4. Defendants argue that the Selleck rule does not apply because the

5

negligence of Drs. Riebe and Haller preceded Ms. Tinlin’s injuries – her cardiac tamponade

6

and pericardial effusion procedure, the open heart surgery to remove a fractured strut, and

7

subsequent medical complications. Id.2

8

Defendants also raise this issue in the parties’ proposed final pretrial order, asserting

9

that the jury is entitled to consider the negligence of both Dr. Riebe and Dr. Haller, and to

10

allocate a percentage of fault to each of them because their negligence was a cause of

11

Ms. Tinlin’s injuries. Doc. 16952 at 18 (citing Connar v. W. Shore Equip. of Milwaukee,

12

Inc., 227 N.W.2d 660, 662 (Wis. 1975) (explaining that “when apportioning negligence, a

13

jury must have the opportunity to consider the negligence of all parties to the transaction”)).

14

In response, Plaintiffs reference their motion in limine and contend that under the Selleck

15

rule, Defendants are liable for the full amount of damages caused by the aggravation of

16

Ms. Tinlin’s injuries. Id. at 19; see also Doc. 16950 at 45. But Plaintiffs fail to address

17

Defendants’ argument that the Selleck rule does not apply because the alleged negligence

18

of Drs. Riebe and Haller preceded, rather than aggravated, Ms. Tinlin’s injuries.

19

Plaintiffs have not shown that evidence regarding the medical care provided by

20

Drs. Riebe and Haller should be excluded. The Court will deny the motion in limine in

21

this respect.3

22
23
24
25
26

2

27

3

28

Defendants contend that an asymptomatic filter complication is not an injury. Id.

Plaintiffs contend that a directed verdict is proper on this issue because Defendants
lack the requisite expert opinion that the alleged negligence of Drs. Riebe and Haller was
a cause of Ms. Tinlin’s injuries. Doc. 16952 at 19. Plaintiff will be free to raise this
argument at the appropriate time during trial. See Fed. R. Civ. P. 50.
-5-

Case 2:15-md-02641-DGC Document 17285 Filed 04/23/19 Page 6 of 6

1

IT IS ORDERED:

2

1.

Plaintiffs’ motion to exclude certain opinions of Dr. Morris (Doc. 15077) is

3

granted.

Dr. Morris is precluded from opining that the surgeries performed by

4

Drs. Roitstein and Kress were unnecessary. See Doc. 15081-2 at 18-19, ¶¶ 6-7.

5

2.

Plaintiffs’ motion in limine regarding medical care as an intervening cause

6

of injury (Doc. 16576) is granted in part and in denied part. The motion is granted

7

regarding the medical care provided by Drs. Roitstein and Kress and denied with respect

8

to the care provided by Drs. Riebe and Haller.

9

Dated this 23rd day of April, 2019.

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-6-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 1 of 13

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WO

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5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9
10
11
12
13

IN RE: Bard IVC Filters Products Liability
Litigation,

No. MDL 15-02641-PHX DGC

___________________________________
Debra and James Tinlin, a married couple,

No. CV-16-00263-PHX-DGC

Plaintiffs,

14
15

v.

16

C. R. Bard, Inc., a New Jersey corporation;
and Bard Peripheral Vascular, Inc., an
Arizona corporation,

17
18

ORDER

Defendants.

19
20
21

The parties have filed motions in limine (“MIL”) in advance of the Tinlin

22

bellwether trial. The Court previously ruled on Plaintiffs’ MIL 1. Doc. 17285. This

23

order will rule on the remaining motions.

24

I.

Plaintiffs’ MILs.

25

A.

MIL 2 – Ms. Tinlin’s IVC Size.

26

The diameter of Ms. Tinlin’s inferior vena cava (“IVC”) measured between 28 and

27

29 mm when she received her Recovery filter. Plaintiffs seek to preclude Defendants

28

from using this evidence to show that Dr. Riebe’s decision to implant a Recovery filter

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 2 of 13

1

constitutes negligence that was a cause of Ms. Tinlin’s injuries. Doc. 16578 at 1-2.

2

Plaintiffs contend that the evidence is irrelevant and unfairly prejudicial because

3

Dr. Riebe is not a defendant in the case and no medical malpractice claim is asserted

4

against him. Id. at 2-3.

5

Wisconsin law has “established without a doubt that, when apportioning

6

negligence, a jury must have the opportunity to consider the negligence of all parties to

7

the transaction, whether or not they be parties to the lawsuit and whether or not they can

8

be liable to the plaintiff or to the other tortfeasors.” Connar v. W. Shore Equip. of

9

Milwaukee, Inc., 227 N.W.2d 660, 662 (Wis. 1975); see Heldt v. Nicholson Mfg. Co., 240

10

N.W.2d 154, 157 (Wis. 1976) (trial court did not err in including the plaintiff’s employer

11

in the verdict where the record was replete with evidence of its negligence); Hauboldt v.

12

Union Carbide Corp., 467 N.W.2d 508, 515 (Wis. 1991) (“We have held that in an action

13

for negligence, the jury must be given the opportunity to consider the possible negligence

14

of all persons, whether parties or not, who might have contributed to the total

15

negligence.”) (citing Connar); York v. Nat’l Cont'l Ins., 463 N.W.2d 364, 367 (Wis. Ct.

16

App. 1990) (“If there is evidence of conduct that, if believed by the jury, would constitute

17

negligence on the part of an actor, then that actor should be included in the special

18

verdict.”). The fact that Dr. Riebe is not a party to this case and cannot be found liable

19

does not preclude Defendants from presenting evidence that he was negligent in selecting

20

a Recovery filter for Ms. Tinlin and that this was a cause of her injuries.

21

Ms. Tinlin’s IVC size also is relevant to the failure to warn claims.

22

Recovery’s instructions for use (“IFU”) cautioned that “[i]f the IVC diameter exceeds

23

28 mm, the filter must not be inserted into the IVC.” Doc. 16893-1 at 2. Plaintiff claims

24

that Dr. Riebe would have read an IFU that contained an adequate warning and may have

25

changed his decision to use a Recovery for Ms. Tinlin. See Doc. 16893 at 4. Existing

26

warnings in the IFU clearly are relevant.

The

27

In his Tinlin report, Dr. Morris opines that a Recovery filter should not be placed

28

in an IVC larger than 28 mm because this can lead to tilt and migration. Doc. 15081-2

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Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 3 of 13

1

at 16-17, ¶ 1. He further opines that Dr. Riebe’s decision to implant a Recovery in

2

Ms. Tinlin fell below the standard of care. Id. Based on Dr. Morris’s recent deposition

3

testimony, Plaintiffs contend that he can only speculate that the IVC size and Dr. Riebe’s

4

decision to implant a Recovery caused Ms. Tinlin’s injuries. Doc. 16748 at 2-3.

5

Plaintiff has the burden of proof as to her claimed injuries, and her “medical

6

testimony in meeting such burden cannot be based on mere possibilities.” Hernke v. N.

7

Ins. Co. of N.Y., 122 N.W.2d 395, 399 (Wis. 1963). But in challenging Plaintiff’s claim,

8

Defendants are “not required to confine [themselves] to reasonable medical

9

probabilities.” Id. Rather, Defendants “may attempt to weaken the claim of injuries with

10

medical proof which is couched in terms of possibilities.” Id.; see Felde v. Kohnke, 184

11

N.W.2d 433, 441 (Wis. 1971) (“It is clear that a contrary opinion to that presented by an

12

opposing party may be presented in terms of possibilities[.]”); Roy v. St. Lukes Med. Ctr.,

13

741 N.W.2d 256, 264 (Wis. Ct. App. 2007) (explaining that “a defense expert is allowed

14

to produce evidence of possibilities”).

15

Plaintiff will claim that the filter’s defective design caused her injuries, and

16

Defendants can respond with Dr. Morris’s testimony that her injuries possibly were

17

caused by placement of the filter in an IVC that exceeded 28 mm. Plaintiffs will be free

18

to argue that this is a mere possibility and Dr. Morris’s opinions are nothing more than

19

speculation and conjecture. See id. at 3-5. But the fact that Dr. Morris could not

20

“affirmatively state” the cause of Ms. Tinlin’s injuries is no basis for excluding his

21

opinions under Wisconsin law. Doc. 16748 at 3; see Hernke, 122 N.W.2d at 399; Roy,

22

741 N.W.2d at 264. The motion in limine (Doc. 16578) is denied.1

23
1

24
25
26
27
28

Defendants contend that the jury may apportion fault to Dr. Riebe based solely
on evidence that he breached the standard of care and therefore was negligent.
Docs. 16946 at 8-9, 16893 at 4. This is not correct. To apportion fault to physicians in
this case, Defendants must “prove that [they] were causally negligent.” Hegarty v.
Beauchaine, 727 N.W.2d 857, 901 (Wis. Ct. App. 2006) (emphasis added). This requires
a showing not only of negligence, but also that the negligence was a substantial factor in
producing Ms. Tinlin’s injuries. See Fandrey v. Am. Family Mut. Ins., 680 N.W.2d 345,
353 (Wis. 2004); Burton v. Am. Cyanamid, No. 07-CV-0303, 2019 WL 325318, at *2
(E.D. Wis. Jan. 25, 2019); Wis JI-Civil 1023 (medical negligence standard); see also
Hegarty, 727 N.W.2d at 903 (rejecting the argument that the jury should have been
allowed to apportion fault to other physicians where the defendants failed to show that
-3-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 4 of 13

1

B.

2

Plaintiffs seek to exclude evidence concerning certain medical conditions that they

3

MIL 3 – Unrelated Medical Conditions.

claim are unrelated to the injuries caused by the Recovery filter:









4
5
6
7
8
9

Graves’ disease
Surgical resection of the thyroid gland
Hypothyroidism
Sjogren’s syndrome
Hypertension
Uterine and rectal prolapse
Fibromyalgia and rheumatoid arthritis
Pernicious anemia

10

Doc. 16577 at 1-2. Plaintiffs contend that these conditions are not relevant to any issue in

11

the case and would only mislead the jury, confuse the issues, and waste time. Id. at 3.

12

Defendants counter that the conditions carry symptoms that overlap with some of

13

Ms. Tinlin’s claimed injuries – future cardiac complications, shortness of breath, back

14

pain, and a weakened trachea. Doc. 16938 at 3. Defendants cite various medical articles

15

purportedly showing the causal connections (id. at 2-5), but it is not clear that the

16

documents will be admissible at trial. Nor do Defendants identify any expert medical

17

testimony they will offer on the issue.

18

Under Wisconsin law, however, Defendants may cross-examine Plaintiffs’ experts

19

as to whether it is possible that Ms. Tinlin’s medical conditions are related to her claimed

20

injuries. See Hernke, 122 N.W.2d at 399. The Court cannot conclude that Ms. Tinlin’s

21

medical conditions are irrelevant or otherwise inadmissible.

22

(Doc. 16577) is denied.2

The motion in limine

23
24
25
26
27
28

“the alleged negligence caused [the patient’s] injuries”) (emphasis in original).
2

Defendants assert that the Recovery filter protected Ms. Tinlin when she needed
to stop anticoagulation treatment for various medical procedures between 2005 and 2015,
including procedures for uterine and rectal prolapse. Doc. 16938 at 3. Defendants agree
that they need not divulge the specific reasons that Ms. Tinlin temporarily stopped taking
anticoagulants as long as they can offer evidence that she needed to do so multiple times
over the years for conditions unrelated to this case. Id. at 3-4. The parties should confer
and agree on how evidence that Ms. Tinlin stopped anticoagulation from time to time will
be presented during trial.
-4-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 5 of 13

1

C.

2

Plaintiffs anticipate that Defendants will attempt to use a chart they created from

3

their internal TrackWise database regarding reporting rates of IVC filter complications.

4

Doc. 16579 at 2. Plaintiffs contend that the chart is an untrustworthy hearsay document

5

that fails the requirements of the business records exception provided by Rule 803(6). Id.

6

at 2-3. Plaintiffs further contend that the chart is inadmissible under Rule 403 because

7

any probative value it may have is substantially outweighed by the danger of unfair

8

prejudice. Id. at 3-4.

MIL 4 – Rates of Filter Complications.

9

Defendants assert that they have been fully candid in explaining what the

10

internally calculated reporting rates represent, and Plaintiffs will be free to challenge the

11

accuracy of the rates through evidence of their own and cross-examination of

12

Defendants’ witnesses. Doc. 16896 at 2-4. Defendants note that the chart was admitted

13

in the Booker trial over Plaintiffs’ hearsay and Rule 403 objections. Id. at 2; see

14

Doc. 16896-1 at 13-16.

15

The Court will not predetermine whether Defendants will be able to lay adequate

16

foundation for admission of the chart in the Tinlin trial, or whether the chart should be

17

precluded under Rule 403. The motion in limine (Doc. 16579) is denied.3

18

D.

19

Plaintiffs seek to preclude Defendants from using a chart comparing the sales of

20

the permanent Simon Nitinol filter (“SNF”) with those of retrievable filters between 2002

21

and 2016. Doc. 16580 at 1-2. Plaintiffs contend that the chart is not relevant because

22

Ms. Tinlin received her filter in 2005. Id. at 2.

MIL 5 – Retrievable Filter Sales Versus SNF Sales.

23

Plaintiffs will present evidence that the SNF is a reasonable alternative design to

24

the Recovery filter. The Court concludes that Defendants should be allowed to present

25

evidence of diminished SNF sales to show that the medical community viewed

26
27
28

3

Defendants were precluded in the Hyde trial from using reporting rates to claim
that Bard filters are “99.9% effective.” See Doc. 16579-2. Defendants do not state that
they will attempt to make the same claim in this case, but if they decide to do so, they
should first raise the issue with the Court outside the presence of the jury.
-5-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 6 of 13

1

retrievable filters – including the Recovery – as offering benefits over permanent-only

2

filters. The fact that the chart includes sales after Ms. Tinlin received her filter can be

3

pointed out to the jury and goes to the weight of the evidence, not its admissibility.

4

Plaintiffs have not shown that admission of the rates chart would mislead the jury or

5

result in unfair prejudice. The motion in limine (Doc. 16580) is denied.

6

E.

7

Plaintiffs contend that evidence regarding social security disability benefits Ms.

8

Tinlin applied for or received is barred by Wisconsin’s collateral source rule. Doc. 16581

9

at 1-2. “[T]he collateral source rule states that benefits an injured person receives from

10

sources that have nothing to do with the tortfeasor may not be used to reduce the

11

tortfeasor’s liability to the injured person.” Leitinger v. DBart, Inc., 736 N.W.2d 1, 7

12

(Wis. 2007). The rule “generally precludes introduction of evidence regarding benefits a

13

plaintiff obtained from sources collateral to the tortfeasor.” Id. at 9.

MIL 6 - Social Security Benefits.

14

Plaintiffs seek to exclude a June 8, 2005 letter Dr. Stanko wrote in support of

15

Ms. Tinlin’s application for permanent disability, a phone message regarding a request

16

for the letter, and Dr. Stanko’s deposition testimony about the letter. Doc. 16581 at 2; see

17

Doc. 16583. Defendants make clear, however, that they will not offer evidence of

18

Ms. Tinlin’s disability to show that she received benefits from a collateral source as

19

compensation for her claimed injuries or to offset any potential damages award.

20

Doc. 16897 at 2. Indeed, Defendants acknowledge that “an award of damages cannot be

21

limited or reduced by a collateral source payment.” Doc. 16897 at 2. Defendants instead

22

intend to use the evidence to show that Ms. Tinlin’s deep vein thrombosis with

23

pulmonary emboli was a serious condition and she was permanently disabled before her

24

Recovery filter failed. Doc. 16897 at 2-3.

25

Plaintiffs have not shown that the challenged evidence is inadmissible.

26

motion in limine (Doc. 16581) is denied.

27

///

28

///

-6-

The

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 7 of 13

1

II.

Defendants’ MILs.

2

A.

3

In each of the other bellwether cases tried in this MDL – Booker, Jones, and

4

Hyde – Defendants have moved to exclude evidence of deaths caused by Recovery filter

5

cephalad migration. Docs. 9862, 10677, 10288. The Court denied the motion in the

6

Booker case, which concerned a G2 filter, finding that the evidence concerned the device

7

that was a predicate for the G2 in Defendants’ FDA submissions and also would be

8

necessary for the jury to understand what prompted design changes in the G2.

9

Doc. 10323 at 4. The Court reached a different conclusion in the Jones and Hyde cases

10

because the G2 design eliminated cephalad migration, the cases concerned filters that

11

were two or three generations after the Recovery (G2X and Eclipse), the plaintiffs

12

received the filters more than four years after the Recovery was taken off the market, and

13

Recovery filter cephalad migration deaths – which stopped after the G2 was introduced –

14

said little if anything about the plaintiffs’ claims regarding the G2X and Eclipse. The

15

Court concluded that Recovery death evidence had only marginal relevance that was

16

substantially outweighed by the danger of unfair prejudice. Docs. 10819 at 3-5, 12533

17

at 6-7; see Docs. 10920, 11041 (orders denying motion for reconsideration in Jones).

MIL 1 – Recovery Death Evidence.

18

Defendants contend that the Court’s reasoning in Booker should not apply in this

19

case because the Court did not consider whether cephalad migration was substantially

20

similar to complications Ms. Booker’s G2 filter experienced. Doc. 16575 at 2. But this

21

case concerns the Recovery filter. Plaintiffs contend that the Recovery was defectively

22

designed, presented unusually high risks to patients, and continued to be marketed despite

23

Defendants’ knowledge of high failure rates and deaths. Plaintiff Tinlin contends that she

24

never would have received a Recovery filter if Defendants’ had disclosed these increased

25

risks to her doctor, and that Defendants’ continued marketing of this dangerous product

26

warrants punitive damages. The Recovery deaths are directly relevant to these claims.

27

To establish the strict liability design defect claim, Plaintiffs must show that the

28

Recovery’s “foreseeable risks of harm” could have been reduced by an alternative

-7-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 8 of 13

1

reasonable design, and that omission of the alternative design rendered the Recovery

2

“not reasonably safe.” Wis. Stat. § 897.047(1)(a). Plaintiffs must also show that the

3

alleged defect rendered the Recovery “unreasonably dangerous[.]”

4

Recovery filter patient deaths and Defendants’ knowledge of those deaths go directly to

5

the Recovery’s foreseeable risks of harm and whether it was unreasonably dangerous.

§ 895.047(b).

6

Defendants contend that Plaintiff Tinlin did not experience the kind of whole-filter

7

cephalad migration that resulted in the reported deaths, but Plaintiffs contend that same

8

filter defects and instability that caused cephalad migration led to the kinds of migration,

9

tilting, perforation of the IVC, and fracturing that Ms. Tinlin experienced.

10

Recovery death evidence also is relevant to Plaintiffs’ failure to warn and

11

concealment claims.

12

needed complete and accurate information from medical device manufacturers to help

13

him conduct a proper risk-benefit analysis. Doc. 15702-1 at 5. He explained that a

14

manufacturer’s concealment of true risks prevents him from conducting such an analysis.

15

Id. He further stated that he would have wanted to know that Bard had placed the

16

Recovery on hold due to significant migration problems and internally found the

17

Recovery to have unacceptable risks. Id. at 6-8, 14. This information would have been

18

important to him in understanding the Recovery’s safety and conducting a proper risk-

19

benefit analysis. Id. at 8-9, 19. The fact that patients died from Recovery migration

20

problems is probative on the causation issue – that is, whether Dr. Riebe would have

21

selected a different filter for Ms. Tinlin had he been warned about the Recovery’s true

22

risks, as Plaintiffs describe them.

Ms. Tinlin’s implanting physician, Dr. Riebe, testified that he

23

Defendants cite Cooper v. Firestone Tire & Rubber Co., 945 F.2d 1103, 1105 (9th

24

Cir. 1991), for the proposition that a showing of substantial similarity is required when a

25

plaintiff attempts to introduce evidence of other incidents of product failure as direct

26

proof of negligence or defect. Doc. 16575 at 2. But substantial similarity is not required

27

when the other incidents are used to impeach an expert’s testimony that a product is safe.

28

See Cooper, 945 F.2d at 1105. Indeed, even where other-incident evidence may have

-8-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 9 of 13

1

“some prejudicial effect, it [is] also highly probative of the credibility of the assertion of

2

[defense] experts that the [product] was generally safe.” Id. Defendants clearly will

3

assert in this case that the Recovery filter was safe and effective.

4

Defendants note that the Court expressed concern in Booker that too heavy an

5

emphasis on deaths could result in unfair prejudice that substantially outweighs the

6

probative value of the cephalad migration evidence. Id. at 3 (citing Doc. 10323 at 4).

7

The Court has the same concern in this case, but this is no basis for precluding the

8

evidence before trial. Defendants may object during trial if they believe Plaintiffs are

9

overemphasizing the cephalad migration deaths.

10

Defendants contend that admitting the death evidence to support an award of

11

punitive damages would violate due process and Wisconsin law. Id. at 4. To recover

12

punitive damages, Plaintiffs must show that Defendants “acted maliciously” or in an

13

“intentional disregard of the rights” of Plaintiffs. Wis. Stat. 895.043(3); see Strenke v.

14

Hogner, 694 N.W.2d 296, 304-05 (Wis. 2005). The jury may consider Defendants’

15

“attitude and conduct” and “the degree of [Defendants’] awareness of the hazard and of

16

its excessiveness.” Wis JI-Civil § 1707.2; see Doc. 12438 at 38-39. Evidence that Bard

17

continued to market the Recovery in the face of unusually high patient deaths is relevant

18

to Bard’s state of mind.4 Moreover, the death evidence “can help to show that the

19

conduct that harmed [Ms. Tinlin] also posed a substantial risk of harm to the general

20

public, and so was particularly reprehensible[.]” Philip Morris USA v. Williams, 549

21

U.S. 346, 355 (2007); see State Farm Mut. Auto. Ins. v. Campbell, 538 U.S. 408, 419

22

(2003) (explaining the “most important indicium of the reasonableness of a punitive

23

damages award is the degree of reprehensibility of the defendant’s conduct,” which

24

includes whether “the tortious conduct evinced an indifference to or a reckless disregard

25
26
27
28

4

The Court reached a different conclusion in Jones because cephalad migration
deaths stopped when the Recovery was taken off the market in 2005, and the deaths shed
little light on Defendants’ state of mind when marketing different filters with different
complications, years later. Doc. 10819 at 5.
-9-

Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 10 of 13

1

of the health or safety of others”) (quoting BMW of N. Am., Inc. v. Gore, 517 U.S. 559,

2

574 (1996)).

3

Defendants’ reliance on Henrikson and Kehl is misplaced. Doc. 16575 at 4. Each

4

case involved a separate act of fleeing the scene of the accident that caused the plaintiff

5

no injury.

6

(“[T]here is no evidence that Strapon’s fleeing the scene caused an injury to Henrikson or

7

aggravated any injury he received from being hit by Strapon’s car[.]”); Kehl v. Econ. Fire

8

& Cas., 433 N.W.2d 279, 281 (Wis. Ct. App. 1988) (“The collision . . . resulted from

9

negligence and was distinct from the fleeing, which was a separate volitional act.”).

10

Plaintiffs contend that the Recovery migration problems that caused Ms. Tinlin’s injuries

11

and the deaths of other patients resulted from the same flawed design. Doc. 16943 at 2.

12
13

See Henrikson v. Strapon, 758 N.W.2d 205, 215 (Wis. Ct. App. 2008)

Defendants have not shown that Recovery death evidence is inadmissible in this
case. The motion in limine (Doc. 16575) is denied.

14

B.

15

Defendants re-urge their motion to exclude the 2015 FDA warning letter.

16

Docs. 9864, 16572; see Doc. 9864-1; Ex. 1680. The Court previously found the that the

17

following topics in the letter lack probative value: Topics 1 and 2 (Recovery cone

18

retrieval system), topic 4(a) (filter cleaning process), and topics 4(b), 5, 6, 7 and 8 (Denali

19

filter). Doc. 10258 at 6-8; Booker Trial Tr. at 1890. Plaintiffs have not shown that topics

20

1, 2, 4 and 6 are relevant to any issue in this case. Plaintiffs contend that topics 7 and 8

21

show that Bard failed to properly report adverse events, and this evidence demonstrates a

22

pattern of concealment that is relevant to the failure to warn claims and punitive

23

damages. Doc. 16945 at 2. But the adverse events in topics 7 and 8 involved Bard’s

24

latest-generation filter – the Denali – which is not at issue in this case. The Court will

25

grant the motion (Doc. 16572) with respect to topics 1-2 and 4-8.

MIL 2 – FDA Warning Letter.

26

Topic 3 concerns Bard’s regulatory violations for failure to establish and maintain

27

procedures for receiving, evaluating, and reporting IVC filter complaints, and expressly

28

references the G2 and Eclipse – the filters at issue in the other bellwether trials.

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Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 11 of 13

1

Doc. 9864-1 at 5-6. The Court deferred ruling on the relevance of topic 3 until trial in

2

Booker, and took the same approach in Jones and Hyde. See Doc. 10805. The Court

3

ultimately concluded in Booker that topic 3 was relevant because much evidence had

4

been presented about the MAUDE database and adverse event reports to the FDA, the

5

data upon which Bard relied in making reports, and Bard’s root cause analysis. Topic 3

6

was relevant to rebut the implication, if not the express argument, that the FDA never

7

took action against Bard. See Booker Trial Tr. at 1888-89. The Court noted that topic 3

8

included reference to the G2, the filter at issue in Booker. Id. at 1889. The Court reached

9

similar conclusions in Jones and Hyde. See Docs. 11256, 12736.

10

Defendants contend that topic 3 should be excluded in this case because it has

11

nothing to do with the Recovery filter and is not otherwise relevant to any issue or claim.

12

Doc. 16572 at 2-4. Defendants further contend that the presentation of evidence about

13

the warning letter would waste important trial time and only confuse the jury about the

14

true issues in the case. Id. at 4.

15

Plaintiffs counter that topic 3 is relevant for the same reasons it was relevant in the

16

other bellwether trials. Doc. 16945 at 2-4. Plaintiffs assert that although topic 3 does not

17

reference the Recovery by name, it covers Bard’s processes for the entire IVC filter line,

18

including the Recovery. Id. at 3-4. Plaintiffs note that the Court previously rejected

19

Defendants’ Rule 403 objections. Id. at 4.

20

The decision on this issue will need to be made at trial once the relevancy of

21

topic 3 can be determined in light of all the facts presented. Plaintiffs shall raise the issue

22

with the Court outside the presence of the jury before seeking to admit the FDA warning

23

letter. The motion (Doc. 16572) is denied in this regard.5

24

C.

25

Defendants seek to exclude the Recovery Filter Crisis Communications Plan

26

(“CCP”) that Bard had prepared in 2004 to help manage damaging media coverage about

MIL 3 – Crisis Communications Plan.

27
28

5

If topic 3 of the letter is deemed admissible at trial, Plaintiffs shall make
appropriate redactions before offering it into evidence. See Booker Trial Tr. at 1889-90.
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Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 12 of 13

1

a Recovery migration death. Doc. 16573. Defendants contend that the CCP is irrelevant

2

for three reasons.

3

First, Plaintiffs cannot show a substantial similarity between the cephalad

4

migration death that prompted the CCP and Ms. Tinlin’s filter failures and resulting

5

injuries. Id. at 2 (citing Cooper, 945 F.2d at 1105; State Farm, 538 U.S. at 422). But as

6

explained above, cephalad migration deaths are relevant to Plaintiffs’ claims.

7

Second, the CCP was never put into action and therefore had no causal impact on

8

Plaintiffs’ claims or injuries. Id. at 2-3. Defendants’ causal connection is not the only

9

relevant issue in this case. The CCP is relevant to Defendants’ understanding of the risks

10

presented by Recovery, their response to those risks, and, potentially, their state of mind

11

for punitive damages.

12

Third, the CCP does not support Plaintiffs’ punitive damages claim because

13

retaining a public relations firm to help manage negative media coverage of product

14

failures is good corporate policy. Id. at 3. This may be a good jury argument, but it does

15

not render the CCP irrelevant. The CCP notes that, as a result of unfavorable press

16

coverage, “stock prices may plummet [and] analysts may downgrade the affected

17

company’s rating[.]” Doc. 16573-1 at 3. The CCP goes to Bard’s attitude toward

18

Recovery complications and is relevant to Plaintiffs’ claim that Bard acted with

19

intentional disregard of Plaintiff’s rights.

20

§ 1707.2. Defendants will be free to argue that the CCP was never finalized and contains

21

“template language” not specific to or approved by Bard (Doc. 16753 at 4), but this goes

22

to CCP’s evidentiary weight, not its admissibility.

23
24

See Wis. Stat. 895.043(3); Wis JI-Civil

The Court cannot conclude that the CCP is irrelevant. Nor does the Court find it
inadmissible under Rule 403. The motion in limine (Doc. 16573) is denied.

25

D.

26

Dr. Muehrcke was a consulting physician for a patient who had a Bard filter and

27

purportedly died from cardiac tamponade. He recently opined in a state-court deposition

28

that the patient’s cardiac tamponade was caused by a fractured strut that had embolized to

MIL 4 – Patient at Dr. Muehrcke’s Hospital.

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Case 2:15-md-02641-DGC Document 17401 Filed 04/26/19 Page 13 of 13

1

her heart. Doc. 16574-1 at 8. Defendants seek to preclude Plaintiffs from referencing

2

this opinion during opening statements or eliciting it during Dr. Muehrcke’s direct

3

examination because it is not included in Dr. Muehrcke’s expert reports and was not

4

offered during his deposition in this case. Doc. 16574 at 2-3 & n.2.

5

As the Court outlined in Case Management Order No. 8, expert reports under

6

Rule 26(a)(2)(B) must set forth “the testimony the witness is expected to present during

7

direct examination, together with the reasons therefor.” Doc. 519 at 3, ¶ 6 (citation

8

omitted). Plaintiffs note that Dr. Muehrcke opines in his Tinlin report that “pulmonary

9

fragments are known to cause . . . death” and “an additional strut can embolize at any

10

time to [Ms. Tinlin’s] heart causing her to suffer cardiac tamponade[.]” Doc. 16951 at 2.

11

But this says nothing about his opinion in the state-court case that one of his patients died

12

from cardiac tamponade caused by a fractured strut. Plaintiffs have not timely disclosed

13

that opinion in this case, nor have they shown that the failure to disclose is substantially

14

justified or harmless. Plaintiffs therefore are precluded from eliciting the opinion during

15

opening statements and direct examination of Dr. Muehrcke. See Fed. R. Civ. P. 37(c)(1)

16

(a party that fails to disclose information required by Rule 26(a) “is not allowed to use

17

that information . . . at a trial, unless the failure was substantially justified or harmless”);

18

see also Yeti by Molly Ltd. v. Deckers Outdoor Corp., 259 F.3d 1101, 1106 (9th Cir.

19

2001) (“Rule 37(c)(1) gives teeth to these requirements by forbidding the use at trial of

20

any information required to be disclosed by Rule 26(a) that is not properly disclosed.”).

21

The motion in limine (Doc. 16574) is granted.6

22

Dated this 26th day of April, 2019.

23
24
25
26
27
28

6

Given this ruling, the Court need not address whether the opinion should be
excluded under Rules 403 and 702. See Doc. 16574 at 3-4.
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