Dahl v. C. R. Bard, Inc.
Filing
181
MEMORANDUM OPINION AND ORDER The 41 MOTION by C. R. Bard, Inc. for Partial Summary Judgment Against Dianne Dahl is GRANTED in part and DENIED in part; the 43 MOTION by C. R. Bard, Inc. for Partial Summary Judgment on Plaintiffs Punitive Damages C laims is DENIED; the 156 MOTION by Dianne D. Dahl to Strike is DENIED as moot. The following specific causation Motions: 45 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By John Miklos, M.D.; 47 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony by Jerry G. Blaivas, M.D.; 49 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions and Testimony of Dr. Bruce A. Rosenzweig; 51 MOTION by C. R. Bard, Inc. to Exclude or Limi t Certain Opinions and Testimony of Donald R. Ostergard, M.D; 53 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony By Lennox Hoyte, M.D.; 55 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Sean Franci s, M.D.; 58 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of David F. Feigal, Jr., M.D., M.P.H.; 59 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of Nathan Guerette, M.D. on the Adequacy of Defendants' Warnings and Standard of Care Issues; 60 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of John G. Heller, M.D.; 63 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions an d Testimony of Dr. Maureen Reitman; 64 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of Peter Rosenblatt, M.D.; 65 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of Donna-Bea Till man, Ph.D., M/P.A., FRAPS; 66 MOTION AND BRIEF IN SUPPORT by Dianne D. Dahl to Exclude Opinions and Testimony of Marta Villaraga, Ph.D.; 67 MOTION by Dianne D. Dahl to Exclude Opinions and Testimony of Christine T. Wood, Ph.D.; 70 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By Anthony Brennan, Ph.D.; 72 MOTION by Dianne D. Dahl to Exclude Opinions and Testimony of Michael Kennelly, M.D.; 73 MOTION by Dianne D. Dahl to Exclude the Testimony of Carol Glo wacki, M.D.; 75 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony of Julia Babensee, Ph.D.; 77 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions and Testimony by Ahmed El-Ghannam Ph.D.; 79 MOTION by Dia nne D. Dahl to Exclude the Testimony of Joseph Maccarone, M.D.; 81 MOTION by C. R. Bard, Inc. to Exclude The Opinions And Testimony Of Bernd Klosterhalfen, M.D.; 83 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Tatiana V. Sa nses, M.D.; 85 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Colleen Fitzgerald, M.D.; 89 MOTION by C. R. Bard, Inc. to Exclude, or in the Alternative Limit, The Opinions and Testimony of Kimberly H. Allison, M. D.; 91 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Abraham Morse, M.D.; 93 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Daniel S. Elliott, M.D.; 95 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Keith Reeves, M.D.; 145 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of Robert D. Tucker, Ph.D., M.D.; 146 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Tes timony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Laura Bigby; 147 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Scott B ritton; 148 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Roger Darois; 149 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certa in Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Michele Davis; 150 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate W itness Expert Scott Robirds; 151 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Mary Mayo; 152 MOTION with Brief in Support by Dianne D. Dah l to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert John Knorpp; 153 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Reta ined Corporate Witness Expert John Deford; 154 MOTION with Brief in Support by Dianne D. Dahl to Exclude Certain Opinions and Testimony of C.R. Bard, Inc.'s Non-Retained Corporate Witness Expert Adam Silver; 155 SUPPLEMENTAL MOTION by Dianne D. Dahl to Exclude Certain General Opinions and Testimony of Stephanie Molden, M.D., Pursuant to PTO's 161, 163, 165 and 167 and Brief in Support; and 178 MOTION by Dianne D. Dahl to Exclude Certain Opinions and Testimony of James M. Anderson , Ph.D., M.D., and Brief in Support, to the extent that the parties seek relief that is consistent with this Memorandum Opinion & Order, are GRANTED in part. In all other respects, the parties' motions are RESERVED in part. Signed by Judge Joseph R. Goodwin on 3/21/2017. (cc: counsel of record; any unrepresented party) (kp)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
DIANNE D. DAHL,
Plaintiff,
v.
Civil Action No. 2:12-cv-6944
C. R. BARD, INC.,
Defendant.
MEMORANDUM OPINION AND ORDER
Pending before the court are all remaining pretrial motions. All are ripe for
adjudication.
I.
Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel
on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat
pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven
MDLs, there are more than 58,000 cases currently pending, approximately 7,000 of
which are in the Bard MDL, MDL 2187. In an effort to efficiently and effectively
manage this MDL, I decided to conduct pretrial discovery and motions practice on an
individualized basis so that once a case is trial-ready (that is, after the court has ruled
on all Daubert motions and summary judgment motions, among other things), it can
then be promptly transferred or remanded to the appropriate district for trial. To this
end, I ordered the plaintiffs and defendant to each select 50 cases, which would then
become part of a “wave” of cases to be prepared for trial and, if necessary, remanded.
See Pretrial Order (“PTO”) # 102, No. 2:10-md-2187 [ECF No. 729]. This selection
process was completed twice, creating two waves of 100 cases, Wave 1 and Wave 2.
Thereafter, I entered orders on subsequent waves. Ms. Dahl’s case was selected as a
Wave 2 case by the plaintiffs. PTO # 118, No. 2:10-md-2187 [ECF No. 841].
II.
Legal Standards
a. Summary Judgment
To obtain summary judgment, “the movant must show that there is no genuine
dispute as to any material fact and that the movant is entitled to judgment as a
matter of law.” Fed. R. Civ. P. 56(a). In turn, to avoid summary judgment, the
nonmovant must offer some “concrete evidence from which a reasonable juror could
return a verdict” in his or her favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
256 (1986).
b. Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in
MDL cases. To determine the applicable state law for a dispositive motion, the court
generally refers to the choice-of-law rules of the jurisdiction where the plaintiff first
filed her claim. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576
(5th Cir. 1996); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th Cir.
1981); In re Digitek Prods. Liab. Litig., MDL No. 2:08-md-01968, 2010 WL 2102330,
at *7 (S.D. W. Va. May 25, 2010).
2
This case was originally filed in the United States District Court for the
District of Minnesota. Therefore, I use Minnesota’s choice-of-law rules to determine
which state’s law to apply to this case. The parties agree, as does the court, that these
principles compel application of Wisconsin law to the plaintiff’s claims. Minnesota
focuses on two factors in resolving choice-of-law issues: (1) the maintenance of
interstate order and (2) the advancement of the forum state’s interest. See In re
Baycol Prods. Litig., 218 F.R.D. 197, 207 (D. Minn. 2003) (stating that only two factors
in Minnesota’s usual five-factor test apply to the resolution of choice-of-law issues
arising under tort law) (citing Nodak Mut. Ins. Co. v. Am. Family Mut. Ins. Co., 604
N.W.2d 91, 94–96 (Minn. 2000)). With respect to the first factor, the court should look
to the state with “the most significant contacts with the facts relevant to the
litigation.” Id. Here, that state is Wisconsin, where the plaintiff resides and
underwent implantation surgery. The second factor, which requires the court to
consider “the state law in which the plaintiff lives and in which the injury occurred,”
also weighs in favor of applying Wisconsin law. See, e.g., In re Baycol, 218 F.R.D. at
207 (“[A]s the injury occurred in the state of plaintiff’s residence, the substantive law
of the state of plaintiff’s residence should be applied to their claims.”); Foster v. St.
Jude Med., Inc., 229 F.R.D. 599, 605 (D. Minn. 2005) (“[P]roper consideration of
Minnesota’s choice-of-law factors reveals that the law of the state where the [d]evice
was implanted would apply to Plaintiffs’ [products liability] claims.”). Accordingly,
Wisconsin substantive law governs this case.
c. Daubert Motions – Specific Causation
3
Expert testimony is admissible if the expert is qualified and if his or her expert
testimony is reliable and relevant. Fed. R. Evid. 702; see also Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579 (1993). An expert may be qualified to offer expert
testimony based on his or her “knowledge, skill, experience, training, or education.”
Fed. R. Evid. 702.
In the context of specific causation expert opinions, the Fourth Circuit has held
that “a reliable differential diagnosis provides a valid foundation for an expert
opinion.” Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262–63 (4th Cir. 1999). “A
differential diagnosis that fails to take serious account of other potential causes may
be so lacking that it cannot provide a reliable basis for an opinion on causation.” Id.
at 265. However, an expert’s causation opinions will not be excluded “because he or
she has failed to rule out every possible alternative cause of a plaintiff's illness.” Id.
At bottom, the court has broad discretion to determine whether expert testimony
should be admitted or excluded. Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 200
(4th Cir. 2001).
III.
Discussion
a. Bard’s Motion for Summary Judgment [ECF No. 41]
Bard’s Motion for Summary Judgment [ECF No. 41] is GRANTED in part as
to the following conceded claims: manufacturing defect.
For reasons appearing to the court, Bard’s Motion for Summary Judgment
[ECF No. 41] is also GRANTED in part as to the following claims: negligent
inspection, marketing, packaging, and selling. Under Wisconsin law, a negligence
4
action requires the proof of four elements: “(1) A duty of care on the part of the
defendant; (2) a breach of that duty; (3) a causal connection between the conduct and
the injury; and (4) an actual loss or damage as a result of the injury.” Rockweit v.
Senecal, 541 N.W.2d 742, 747 (Wis. 1995). “The duty of any person is the obligation
of due care to refrain from any act which will cause foreseeable harm to others even
though the nature of that harm and the identity of the harmed person or harmed
interest is unknown at the time of the act.” Id. After it is shown that a duty of care
was owed, “the plaintiff is simply required to prove that the defendant failed to
exercise ordinary care and the act or omission complained of was the cause, in the
legal sense, of the plaintiff’s injury.” Greiten v. LaDow, 235 N.W.2d 677, 685 (Wis.
1975).
Bard contends that the plaintiff’s claims for negligent inspection, packaging,
marketing, and selling of the Align fail for lack of evidence. The plaintiff, in response,
argues that there is ample evidence that demonstrates Bard breached a duty to the
plaintiffs and that there was resulting harm from this breach. The plaintiff states
that Bard was negligent in failing to include adequate warnings, failing to include
appropriate instructions for use, exaggerating the benefits of the product, and
marketing and selling the product without adequate testing. However, apart from
reciting allegations that form the plaintiff ’s failure to warn and design defect claims,
the plaintiff does not offer any support that Bard breached a legal duty that caused
the plaintiff ’s injuries in its “inspection, marketing, labeling, packaging, or selling” of
the Align. Accordingly, Bard’s Motion on these points is GRANTED.
5
After considering the parties’ proffered arguments and evidence, I FIND that
genuine disputes of material fact exist regarding the plaintiff ’s remaining claims.
Accordingly, to the extent Bard’s Motion challenges any other claims, the Motion is
DENIED.
b. Bard’s Motion for Partial Summary Judgment [ECF No. 43]
The question of whether a plaintiff is entitled to punitive damages often
involves an interlocking web of factual determinations respecting the defendant’s
conduct. The evidentiary record is frequently muddled enough on the point that
genuine issues of material fact remain. That is the case here. Consequently, Bard is
not, at least at this stage of the case, entitled to judgment as a matter of law on the
punitive damages claim. Thus, the Motion for Partial Summary Judgment [ECF No.
43] is DENIED.
c. Specific Causation Daubert Motions [ECF Nos. 45, 47, 49, 51, 53, 55, 58,
59, 60, 63, 64, 65, 66, 67, 70, 72, 73, 75, 77, 79, 81, 83, 85, 89, 91, 93, 95,
145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 178]
Many of the Daubert motions filed in this MDL raise the same or similar
objections. One particular issue has been a staple in this litigation, so I find it best to
discuss it in connection with every expert. I have repeatedly excluded evidence
regarding the FDA’s section 510(k) clearance process in these MDLs, and will
continue to do so in these cases, a position that has been affirmed by the Fourth
Circuit. In re C. R. Bard, Inc., 81 F.3d 913, 921–23 (4th Cir. 2016) (upholding the
determination that the probative value of evidence related to section 510(k) was
6
substantially outweighed by its possible prejudicial impact under Rule 403). Because
the section 510(k) clearance process does not speak directly to safety and efficacy, it
is of negligible probative value. See id. at 920 (“[T]he clear weight of persuasive and
controlling authority favors a finding that the 510(k) procedure is of little or no
evidentiary value.”). Delving into complex and lengthy testimony about regulatory
compliance could inflate the perceived importance of compliance and lead jurors “to
erroneously conclude that regulatory compliance proved safety.” Id. at 922.
Accordingly, expert testimony related to the section 510(k) process, including
subsequent enforcement actions and discussion of the information the defendant did
or did not submit in its section 510(k) application, is EXCLUDED. For the same
reasons, opinions about the defendant’s compliance with or violation of the FDA’s
labeling and adverse event reporting regulations are EXCLUDED. In addition to
representing inappropriate legal conclusions, such testimony is not helpful to the jury
in determining the facts at issue in these cases and runs the risk of misleading the
jury and confusing the issues. Insofar as any Daubert motion in this case challenges
the FDA-related testimony discussed here, the motions are GRANTED.
The parties have identified more experts than can ever be called in a trial of
any reasonable length. In this case alone, the parties have filed thirty-nine separate
Daubert motions. Thus, I have considered principles of good judicial efficiency and
proper management of judicial resources, and I now determine that substantive
rulings on these motions are better suited for cases that will actually be tried on the
merits. Accordingly, all remaining Daubert challenges to expert testimony in this
7
case are RESERVED for trial.
d. The plaintiff’s Motion to Strike [ECF No. 156]
For reasons appearing to the court, the plaintiff’s Motion to Strike [ECF No.
156] is DENIED as moot.
IV.
Conclusion
The court ORDERS that:
•
Bard’s Motion for Summary Judgment [ECF No. 41] is GRANTED
in part and DENIED in part;
•
Bard’s Motion for Partial Summary Judgment [ECF No. 43] is
DENIED;
•
The specific causation Motions [ECF Nos. 45, 47, 49, 51, 53, 55, 58,
59, 60, 63, 64, 65, 66, 67, 70, 72, 73, 75, 77, 79, 81, 83, 85, 89, 91,
93, 95, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 178],
to the extent that the parties seek relief that is consistent with this
Memorandum Opinion & Order, are GRANTED in part. In all
other respects, the court ORDERS that the parties’ motions are
RESERVED in part; and
•
The plaintiff’s Motion to Strike [ECF No. 156] is DENIED as moot.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record
and any unrepresented party.
ENTER:
8
March 21, 2017
9