Carroll v. Boston Scientific Corporation

Filing 109

MEMORANDUM OPINION AND ORDER (Motions in Limine) The court GRANTS in part and RESERVES in part the defendant's 102 Initial Motions in Limine, GRANTS the plaintiff's 103 Motion in Limine No. 1 - Evidence Relating to the United States Food and Drug Administration, and RESERVES the plaintiff's 104 Motion in Limine No. 2. Signed by Judge Joseph R. Goodwin on 5/24/2016. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
CHERYL CARROLL,
Plaintiff,
v.

CIVIL ACTION NO. 2:13-cv-11601

BOSTON SCIENTIFIC CORPORATION,
Defendant.
MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are the defendant’s Initial Motions in Limine [ECF
No. 102] and the plaintiff’s Motions in Limine [ECF Nos. 103 and 104].
This case resides in one of seven MDLs assigned to the court by the Judicial
Panel on Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical
mesh to treat pelvic organ prolapse and stress urinary incontinence (“SUI”). In the
seven MDLs, there are more than 75,000 cases currently pending, approximately
19,000 of which are in the Boston Scientific Corporation (“BSC”) MDL, MDL No. 2326.
In this MDL, the court’s tasks include “resolv[ing] pretrial issues in a timely
and expeditious manner” and “resolv[ing] important evidentiary disputes.” Barbara
J. Rothstein & Catherine R. Borden, Fed. Judicial Ctr., Managing Multidistrict

Litigation in Products Liability Cases 3 (2011).
From time to time, the court seeks the assistance of the parties in completing

these tasks by asking the parties to focus on discrete, important, or more relevant
matters. The court expected the parties to focus their motions in limine on matters
possessing prejudice so potent it would be hard to dissipate with a curative
instruction. Pretrial Order No. 142, at 1. Nevertheless, in some instances, the parties
fret over matters both minimal and curable.
Other concerns also arise. Several of the requests concern evidence that may
be presented. The court advised it would not offer advisory admissibility opinions, so
the court declines to grant or deny requests of this sort. Pretrial Order No. 142, at 1.
And some of the requests address expansive categories of evidence without concern
for context. The court is concerned with content and context, and where neither is
presented, the court concludes the matter will not be considered until trial.
To be frank, the parties practically ignored Pretrial Order No. 142 on more
than one front. Now bound by bureaucratic requirements, the court must rule on
evidentiary matters it advised the parties to avoid.
I.

The Defendant’s Initial Motions in Limine
The defendant’ filed a single Initial Motions in Limine [ECF No. 102], which

includes arguments relating to nine distinct—yet not all unfamiliar—categories of
evidence and arguments it seeks to exclude.
a. Motion to Preclude Evidence or Argument Regarding Fraud on the FDA
or Alleged Misbranding
The plaintiff has stated she will neither introduce evidence of nor present
arguments about fraud on the FDA or alleged misbranding. Accordingly, the court
GRANTS the defendant’s Motion on this point.
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b. Motion to Preclude Evidence or Argument Regarding
Procurement of Polypropylene Resin Sourced in China

BSC’s

BSC asks the court to prohibit the plaintiff from presenting evidence related
to a plot to procure polypropylene resin from China. BSC baldly asserts the device at
issue here did not include resin procured from China. BSC further claims any
probative value the evidence has is outweighed by the prejudice that would result
from its presentation. But this evidence, the plaintiff retorts, informs her substantive
and punitive damages claims.
The court agrees that this evidence is potentially relevant to the plaintiff’s
substantive and punitive damages claims. However, any discussion of an alleged
resin smuggling operation requires quite a digression from the issues central to this
case. Time spent on explaining the intricacies of the smuggling scheme may detract
from this case, transforming it from an individual-who-was-injured-by-a-product case
into a corporate-cabals-and-international-intrigue case. For now, the scales seem
close to even, counseling against exclusion. See Fed. R. Evid. 403 (noting exclusion is
warranted if probative value is “substantially outweighed” by other considerations).
Despite the court’s current assessment, an evidentiary ruling on this matter
depends on the specific content introduced and the context in which it is introduced.
So the court would be remiss at this time to weigh the overall substantive value
against the overall prejudice related to this evidence in an effort to craft a blanket
admissibility ruling. The court will wait to see the content and context before ruling
on this matter. The court RESERVES judgment on this issue until trial.

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c. Motion to Preclude Evidence or Argument Concerning BSC’s Decisions
to Discontinue Selling Certain Mesh Products or Any Suggestion that
its Products Were Recalled or Withdrawn
BSC asks the court to exclude evidence about its decisions to discontinue mesh
products and product withdrawals or recalls. Decisions to discontinue, withdraw, or
recall a product are likely subsequent remedial measures. These kinds of measures
are not admissible to prove negligence, culpability, or product defects. Fed. R. Evid.
407. Accordingly, the court GRANTS the defendant’s Motion on this point. 1
d. Motion to Preclude Evidence or Argument that BSC Owed or Breached
a Duty to Warn Plaintiff Directly
BSC asks the court to prohibit the plaintiff from arguing BSC had or breached
a duty to warn the plaintiff about the risks associated with the devices at issue
because the learned intermediary doctrine renders these arguments irrelevant. This
doctrine focuses, in this context, on BSC’s duty to warn physicians. E.g., 63A Am. Jur.
2d Prods. Liab. § 1097 (2016). Any evidence that BSC owed or breached a duty to
warn the plaintiff directly is therefore irrelevant and subject to exclusion. Fed. R.
Evid. 402 (“Irrelevant evidence is not admissible.”). The court GRANTS the
defendant’s Motion on this point. Some clarification is necessary though—this ruling
only relates to evidence that BSC owed or breached a duty to the plaintiff and does
not address the admissibility of warnings that were or should have been provided to

The plaintiff responds that, in other trials, BSC has implied that certain mesh products are still in
use, making this evidence relevant. But the court will not base its ruling here on BSC’s conduct in
other trials. That said, this issue may be revisited at trial if this evidence becomes admissible for
another purpose. See Fed. R. Evid. 407 (“[T]he court may admit this evidence for another purpose,
such as impeachment or—if disputed—providing ownership, control, or the feasibility of precautionary
measures.”).
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physicians.
e. Motion to Preclude Evidence or Argument that Pelvic Mesh Can Cause
Complications Not Experienced by Plaintiff
BSC asks the court to exclude evidence of and to prohibit argument about
medical complications allegedly caused by devices manufactured by BSC but not
experienced by the plaintiff. In general, other injuries are irrelevant because this case
is about the plaintiff’s injuries alone. E.g., Tyree v. Boston Sci. Corp., No. 2:12-cv8633, 2014 WL 5445769, at *6 (S.D. W. Va. Oct. 22, 2014). But in the rare case, other
complications and injuries may be relevant. This depends on content and context. So
the court RESERVES judgment on this issue until trial. However, the court advises
the parties to be mindful of the rule of relevancy and the prejudice that could be
caused by such evidence when deciding what evidence they plan to present.
f. Motion to Preclude Evidence or Argument Concerning Lawsuits Against
Other Manufacturers of Pelvic Mesh Devices
BSC asks the court to exclude evidence of and to prohibit argument about
lawsuits against other manufacturers of pelvic mesh. Here—as in the other MDLs
involving other mesh manufacturers—evidence of other lawsuits against other
manufacturers is inadmissible. E.g., Tyree, 2014 WL 5445769, at *7. Evidence of this
variety is inadmissible under Rule 403 because its prejudicial effect outweighs its
probative value. E.g., id. (“Even assuming evidence about lawsuits brought against
other manufacturers has some relevance to the present case, the relevance is dwarfed
by the risk of unfair prejudice posed by requiring BSC to attest for lawsuits in which
it was not involved.”). The court GRANTS the defendant’s Motion on this point.

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g. Motion to Preclude Evidence or Argument Concerning Other Mesh
Lawsuits, Investigations, Claims, Verdicts, and Trials Against BSC
BSC moves to preclude evidence and arguments about other lawsuits, claims,
investigations, regulatory actions, or settlements involving any of BSC’s mesh
products. This category of evidence—like other categories focused on other cases,
other manufacturers, other injuries, and the like—is inadmissible under Rule 403.
Evidence of other proceedings against BSC will only confuse the jury, pulling its
attention away from the instant proceeding, and is highly prejudicial to the
defendant. E.g., Tyree, 2014 WL 5445769, at *7–8. Therefore, the court GRANTS the
defendant’s Motion on this point.
h. Motion to Preclude Evidence or Argument Concerning Unrelated FDA
Corporate Warning Letters and 483 Letters Pertaining to Cardiac
Devices
The plaintiff has stated she will neither introduce evidence of nor present
arguments about 2006 corporate warning letters and FDA 483 letters concerning
cardiac devices. Accordingly, the court GRANTS the defendant’s Motion.
i. Motion to Preclude Evidence or Argument Regarding BSC’s Designation
of Documents as Confidential or Any Suggestion that BSC’s Actions
Were Improper or an Attempt to Keep Certain Documents Secret
Time after time, the court has ruled that whether a document is designated as
confidential is entirely irrelevant. E.g., Tyree, 2014 WL 5445769, at *9. The court
will, as always, instruct the jury to disregard the confidentiality markings on
documents presented at trial. The court GRANTS the defendant’s Motion on this
point.

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II.

Plaintiff’s Motions in Limine
In the present case, the plaintiff filed two motions in limine [ECF Nos. 103 and

104].
a. Motion to Preclude Evidence Relating to the FDA
The plaintiff asks the court to exclude evidence related to the FDA, including
the FDA’s 510(k) process, arguing it is impermissibly irrelevant and prejudicial under
Federal Rules of Evidence 402 and 403 [ECF No. 103].
In short, the 510(k) process “does not in any way denote official approval of [a]
device.” 21 C.F.R. § 807.97. The process is not focused on whether a device is safe; it
is concerned with the devices equivalence to another device. Medtronic, Inc. v. Lohr,
518 U.S. 470, 493 (1996). Because the process does not speak to the safety or efficacy
of any product, whether BSC products were approved through this process is
irrelevant. Even if the 510(k) process were relevant, the court would exclude this
evidence under Rule 403. Any kernel of relevance is outweighed by “the very
substantial dangers of misleading the jury and confusing the issues.” In re C. R. Bard,
810 F.3d 913, 922 (4th Cir. 2016) (affirming the court’s exclusion of 510(k) evidence).
Put simply, evidence of this sort is inadmissible and, in any event, does not
survive a Rule 403 analysis. So the court GRANTS the plaintiff’s Motion on this point.
The court will not belabor the point here, it has already done so one several occasions
in this MDL and its sister MDLs. E.g., Lewis v. Johnson & Johnson, 991 F. Supp. 2d
748, 754–56 (S.D. W. Va. 2014).

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b. Motion to Preclude Certain Plaintiff-Specific Information
The plaintiff seeks to exclude evidence related to the plaintiff’s obesity,
diabetes, preexisting medical conditions, history of frequent urethral dilation of the
urethra, history of cervical dysplasia, and history of human papillomavirus, which
caused her Obtryx sling to fail [ECF No. 104]. Evidence of this variety, she claims, is
irrelevant under Rule 402 of the Federal Rules of Evidence. BSC argues this motion
lacks specificity because it asks the court to exclude a wide variety of evidence without
any factual or persuasive legal support. Additionally, BSC argues that the evidence
at issue is highly probative as to both causation and damages. While this court agrees
with BSC that information related to the plaintiff’s medical conditions is potentially
relevant to the plaintiff’s claims, the court will not make such a wide ruling
pertaining to pre-existing health or medical conditions in the abstract. Accordingly,
the court RESERVES judgment on this issue until trial.
The plaintiff also seeks to exclude any evidence that she and her husband are
currently separated, which she claims is irrelevant. BSC argues this would create a
blanket exclusion of evidence that may be necessary to rebut evidence or to impeach
testimony offered by the plaintiff. The court notes that the admissibility of evidence
of this variety is questionable because it may be substantially prejudicial. See Fed.
R. Evid. 403. However, at this time, it would be premature for the court to weigh the
probative value of this evidence against the potential prejudice arising from its
admission. An evidentiary ruling on this matter depends on the content introduced
and the context in which it is introduced. Accordingly, the court RESERVES

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judgment on this issue until trial.
III.

Conclusion

As outlined above, the court GRANTS in part and RESERVES in part the
defendant’s Initial Motions in Limine [ECF No. 102], GRANTS the plaintiff’s Motion
in Limine No. 1 [ECF No. 103], and RESERVES the plaintiff’s Motion in Limine No.
2 [ECF No. 104].
The court DIRECTS the Clerk to send a copy of this Order to counsel of record
and any unrepresented party.
ENTER:

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May 24, 2016