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

Filing 200

MEMORANDUM OPINION AND ORDER The 39 MOTION by C. R. Bard, Inc. for Partial Summary Judgment Against Kimberly Bromeland is GRANTED in part and DENIED in part; and the 41 MOTION by C. R. Bard, Inc. for Partial Summary Judgment on Plaintiffs Puniti ve Damages Claims is DENIED. The following specific causation Motions: 43 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Sean Francis, M.D., 45 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By J ohn 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 Limit 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 George Kemp, M.D., 57 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Dr. David W. Feigal, Jr., M.D. and Brief in Support., 59 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Maureen T. Reitman, Sc.D. for General and Specific Expert Causation Opinions and Brief in Support., 60 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Marta Villarraga, Ph. D. for Both General and Specific Causation Opinions and Brief in Support., 61 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of John G. Heller, M.D. and Brief in Support., 62 MOTION by Gerald Bromeland, Kimber ly K. Bromeland to Exclude Opinions and Testimony of Donna-Bea Tillman, Ph.D., M/P.A., FRAPS and Brief in Support., 63 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Christine T. Wood, Ph.D., 64 MOTION by C . R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony By Anthony Brennan, Ph.D.., 66 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony by Garth Wilkes, Ph.D., 68 MOTION by C. R. Bard, Inc. to Exclude Or Li mit Certain Opinions and Testimony by Ahmed El-Ghannam Ph.D.., 71 MOTION by C. R. Bard, Inc. to Exclude Or Limit Certain Opinions And Testimony of Julia Babensee, Ph.D.., 73 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude the Opinion s and Testimony of Nathan Guerette, M.D. on the Adequacy of Defendants' Warnings and Standard of Care Issue and Brief in Support., 74 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Peter Rosenblatt, M.D. and Brief in Support., 75 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Bernd Klosterhalfen, M.D., 78 DAUBERT MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions of Dr. Michael Kennelly and Brief in Suppor t., 79 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude the Testimony of Joseph Maccarone, M.D., 81 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude the Testimony of Carol Glowacki, M.D., 83 MOTION by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Colleen Fitzgerald, M.D., 87 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Keith Reeves, M.D., 89 MOTION by C. R. Bard, Inc. to Exclude, or in the Alternative Limit, the Opin ions and Testimony of Kimberly H. Allison, M.D., 91 MOTION by C. R. Bard, Inc. to Limit The Opinions and Testimony of Daniel S. Elliott, M.D., 93 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Abraham Morse, M.D., 103 MOTION by Gerald Bromeland, Kimberly K. Bromeland to Exclude the Testimony of Tanaz Ferzandi, M.D., 149 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retain ed Corporate Expert Laura Bigby, 150 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Scott Britton, 151 MOTION with Brief i n Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Roger Darois, 152 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exc lude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Michelle Davis, 153 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.&# 039;s Non-Retained Corporate Expert John Knorpp, 154 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert John Deford, 155 MOTIO N with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Adam Silver, 156 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bro meland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Mary Mayo, 157 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard , Inc.'s Non-Retained Corporate Expert Scott Robirds, 158 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Matthew Clark, 159 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of C. R. Bard, Inc.'s Non-Retained Corporate Expert Michael Vardy, 160 MOTION with Brief in Support by Gerald Bromeland, K imberly K. Bromeland to Exclude Certain Opinions and Testimony of Douglas Van Drie, M.D., 161 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Opinions and Testimony of Thomas Guidice, M.D., 162 MOTION with Brief in Support by Gerald Bromeland, Kimberly K. Bromeland to Exclude Certain Opinions and Testimony of Robert Tucker, Ph.D., M.D., 163 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Alan Garely, M.D., 165 MOTION with Brief in Supp ort by Gerald Bromeland, Kimberly K. Bromeland to Exclude the Opinions and Testimony of Sharon Mount, M.D., 166 MOTION with Memorandum in Support by C. R. Bard, Inc. to Exclude or Limit Certain Opinions and Testimony of Brian Raybon, M.D., and [197 ] MOTION by Gerald Bromeland, Kimberly K. Bromeland 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

KIMBERLY K. BROMELAND, et al.,
Plaintiffs,
v.

Civil Action No. 2:13-cv-7011

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. Bromeland’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).

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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, Minnesota. 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.”).
The parties agree, as does the court, that these principles compel application
of Minnesota law to the plaintiffs’ 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 fivefactor 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
Minnesota, 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 Minnesota
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

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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.”).
Having considered both factors in Minnesota’s choice-of-law test, I find that
Minnesota law governs the plaintiffs’ substantive claims in 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

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).

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III.

Discussion
a. Bard’s Motion for Summary Judgment [ECF No. 39]

For reasons appearing to the court, Bard’s Motion for Summary Judgment
[ECF No. 39] is GRANTED in part as to the following claims: manufacturing defect,
breach of implied warranty, the Minnesota Uniform Deceptive Trade Practices Act
claims, the Minnesota Consumer Fraud and False Statement in Advertising claims,
and negligent inspection, marketing, packging, selling, testing, and training. The
plaintiff did not respond to Bard’s arguments on these claims or produce any evidence
in support thereof.
After considering the parties’ proffered arguments and evidence, I FIND that
genuine disputes of material fact exist regarding the plaintiffs’ 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. 41]
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.
41] is DENIED.

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c. Specific Causation Daubert Motions [ECF Nos. 43, 45, 47, 49, 51, 53, 55,
57, 59, 60, 61, 62, 63, 64, 66, 68, 71, 73, 74, 75, 78, 79, 81, 83, 87, 89, 91,
93, 103, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161,
162, 163, 165, 166, 197]
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
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

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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 forty-seven 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
case are RESERVED for trial.
IV.

Conclusion
The court ORDERS that:
•

Bard’s Motion for Summary Judgment [ECF No. 39] is GRANTED in
part and DENIED in part;

•

Bard’s Motion for Partial Summary Judgment [ECF No. 41] is
DENIED; and

•

The specific causation Motions [ECF Nos. 43, 45, 47, 49, 51, 53, 55,
57, 59, 60, 61, 62, 63, 64, 66, 68, 71, 73, 74, 75, 78, 79, 81, 83, 87, 89,
91, 93, 103, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160,
161, 162, 163, 165, 166, 197], to the extent that the parties seek relief

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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