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

Filing 169

MEMORANDUM OPINION AND ORDER The 46 NOTICE OF MOTION AND MOTION by C. R. Bard, Inc. for Partial Summary Judgment Regarding Plaintiff Bessie Bowling is GRANTED in part and DENIED in part; and the 48 MOTION by C. R. Bard, Inc. for Partial Summary Judgment on Plaintiffs Punitive Damages Claims is DENIED. The following specific causation Motions: 50 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By John Miklos, M.D., 52 MOTION by C. R. Bard, Inc. to Exclude o r Limit Certain Opinions and Testimony by Jerry G. Blaivas, M.D., 54 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions and Testimony of Dr. Bruce A. Rosenzweig., 56 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Donald R. Ostergard, M.D., 58 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony By Lennox Hoyte, M.D., 60 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Sean Francis, M.D., 64 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Exclude Opinions and Testimony of David F. Feigal, Jr., M.D., M.P.H., 65 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Exclude Opinions and Testimony of John G. Heller, M.D., 66 MOTION AND BRIEF IN SUP PORT by Bessie Bowling to Exclude Opinions and Testimony of Donna-Bea Tillman, Ph.D., M/P.A., FRAPS, 67 MOTION by Bessie Bowling to Exclude Opinions and Testimony of Christine T. Wood, Ph.D., 69 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Ex clude Opinions and Testimony of Peter Rosenblatt, M.D., 70 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Exclude Opinions and Testimony of Maureen T.F. Reitman, SC.D., 71 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Exclude Opinions and Te stimony of Marta Villaraga, Ph.D., 72 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By Anthony Brennan, Ph.D., 74 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony by Garth Wilkes, Ph.D. , 76 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions and Testimony by Ahmed El-Ghannam Ph.D., 78 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony of Julia Babensee, Ph.D., 80 MOTION AND BRIEF IN SUPP ORT by Bessie Bowling to Exclude Opinions and Testimony of Dr. Michael Kennelly, 81 MOTION AND BRIEF IN SUPPORT by Bessie Bowling to Exclude the Opinions and Testimony of Nathan Guerette, M.D., on the Adequacy of Defendants' Warnings and Stand ard of Care Issues, 82 MOTION by Bessie Bowling to Exclude the Testimony of Joseph Maccarone, M.D., 84 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Bernd Klosterhalfen, M.D., 86 MOTION by Bessie Bowling to Exclude the Tes timony of Carol Glowacki, M.D., 88 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Colleen Fitzgerald, M.D., 92 MOTION by C. R. Bard, Inc. to Exclude, or in the Alternative Limit, The Opinions and Testimony of Kim berly H. Allison, M.D., 94 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Keith Reeves, M.D., 96 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Abraham Morse, M.D., 98 MOTION by C. R. Bard, Inc. to Limit th e Opinions and Testimony of Daniel S. Elliott, M.D., 136 MEMORANDUM OF LAW IN SUPPORT of DAUBERT MOTION by Bessie Bowling to Preclude the Testimony of Kathryn Arendt, MD., on the Adequacy of Defendants' Warnings and Standard of Care Issues, [1 37] MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Laura Bigby and Brief in Support, 138 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Scott Britton and Brief in Support, 139 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Roger Darois and Brief in Support, 140 M OTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Michele Davis and Brief in Support, 141 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc .'s Non-Retained Corporate Expert John Deford and Brief in Support, 142 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert John Knorpp and Brief in Support, 143 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Mary Mayo and Brief in Support, 144 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s N on-Retained Corporate Expert Scott Robirds and Brief in Support, 145 MOTION by Bessie Bowling to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Adam Silver and Brief in Support, and 146 MOTION AND MEMORANDUM OF LAW in Support of the Motion by Bessie Bowling to Exclude the Opinions and Testimony of Sharon Mount, M.D. 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

BESSIE BOWLING,
Plaintiff,
v.

Civil Action No. 2:13-cv-9105

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. Bowling’s case was selected
as a Wave 1 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).

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If a plaintiff files her claim directly into the MDL in the Southern District of
West Virginia, as the plaintiff did here, I consult the choice-of-law rules of the state
in which the implantation surgery took place—in this case, Tennessee. See Sanchez

v. Bos. Sci. Corp., No. 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17,
2014) (“For cases that originate elsewhere and are directly filed into the MDL, I will
follow the better-reasoned authority that applies the choice-of-law rules of the
originating jurisdiction, which in our case is the state in which the plaintiff was
implanted with the product.”).
Tennessee law employs “the most significant relationship test” to determine
which state’s substantive law to apply in a tort action. Hataway v. McKinley, 830
S.W.2d 53, 59 (Tenn. 1992). Under this test, the court must evaluate the contacts of
each interested state and determine which state “has the most significant contacts”
with the lawsuit. Id. In doing so, the court balances four factors: “(a) the place where
the injury occurred, (b) the place where the conduct causing the injury occurred, (c)
the domicile, residence, nationality, place of incorporation and place of business of the
parties, [and] (d) the place where the relationship, if any, between the parties is
centered.” Id. Here, the plaintiff is a resident of Tennessee, Ms. Bowling was
implanted with the product at issue in Tennessee, and her alleged injuries occurred
in Tennessee. Accordingly, I will apply Tennessee’s substantive law to this case.
c. Daubert Motions – Specific Causation
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

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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. 46]

Bard’s Motion for Summary Judgment [ECF No. 46] is GRANTED in part as
to the following conceded claims: manufacturing defect.
For the following reasons, Bard’s Motion for Summary Judgment [ECF No. 39]
is also GRANTED in part as to the following claims: negligent inspection, marketing,
labeling, packaging, and selling. “In order to establish a prima facie claim of
negligence, basically defined as the failure to exercise reasonable care, a plaintiff
must establish the following essential elements: ‘(1) a duty of care owed by defendant

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to plaintiff; (2) conduct below the applicable standard of care that amounts to a breach
of that duty; (3) an injury or loss; (4) cause in fact; and (5) proximate, or legal, cause.’”

Giggers v. Memphis Hous. Auth., 277 S.W.3d 359, 364 (Tenn. 2009) (quoting McCall
v. Wilder, 913 S.W.2d 150, 153 (Tenn.1995)).
Bard contends that the plaintiff’s claims for negligent inspection, packaging,
marketing, and selling of the product fail for lack of evidence. The plaintiff argues
that Bard misconstrues the nature of their negligence argument, and that her
allegations regarding the inspection, marketing, labeling, packaging, and selling of
the product comprise part of her general negligence claim, rather than distinct
theories of recovery. In short, the plaintiff asserts that Bard failed to adequately study
or test its mesh products to determine if the products were adequately safe.
A review of the plaintiff ’s Count I in the Master Complaint, Master Compl. ¶¶
62–67, No. 2:10-md-2187 [ECF No. 199], reveals that the plaintiff asserted three
distinct negligence theories under “Count I.” The bulk of the Count I allegations make
claims for negligent failure to warn and negligent design defect. The other negligence
allegations posit that Bard was “negligent . . . in designing, manufacturing,
marketing, labeling, packaging, and selling” the product. Id. at ¶ 64. Thus, the
plaintiff ’s concern that Bard is misconstruing the plaintiff ’s negligence claim is
meritless; Bard simply chose to address the plaintiff ’s different theories of negligence
separately. However, apart from reciting allegations that form the plaintiff ’s failure
to warn and design defect claims, the plaintiff does not offer sufficient support to
create a genuine dispute that Bard breached a legal duty that caused the plaintiff ’s

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injuries in its inspection, marketing, labeling, packaging, or selling of the product.
Accordingly, Bard’s Motion on these points is GRANTED.
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. 48]
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.
48] is DENIED.
c. Specific Causation Daubert Motions [ECF Nos. 50, 52, 54, 56, 58, 60, 64,
65, 66, 67, 69, 70, 71, 72, 74, 76, 78, 80, 81, 82, 84, 86, 88, 92, 94, 96, 98,
136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146]
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

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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
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-eight separate

Daubert motions. Thus, I have considered principles of good judicial efficiency and
proper management of judicial resources, and I now determine that substantive

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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
case are RESERVED for trial.
IV.

Conclusion
The court ORDERS that:
•

Bard’s Motion for Summary Judgment [ECF No. 46] is GRANTED in
part and DENIED in part;

•

Bard’s Motion for Partial Summary Judgment [ECF No. 48] is
DENIED; and

•

The specific causation Motions [ECF Nos. 50, 52, 54, 56, 58, 60, 64,
65, 66, 67, 69, 70, 71, 72, 74, 76, 78, 80, 81, 82, 84, 86, 88, 92, 94, 96,
98, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146], 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.

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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March 21, 2017