United States District Court, S.D. West Virginia, Charleston Division
December 6, 2016
KATIE RODENKIRCH-KLEINDL, et al., Plaintiffs,
C. R. BARD, INC., Defendant.
MEMORANDUM OPINION AND ORDER (DEFENDANT'S MOTION
FOR SUMMARY JUDGMENT)
R. GOODWIN UNITED STATES DISTRICT JUDGE
before the court is defendant C. R. Bard's
(“Bard”) Motion for Partial Summary Judgment [ECF
No. 44]. As set forth below, Bard's Motion for Summary
Judgment is GRANTED IN PART with respect to
the plaintiffs' claims for manufacturing defect, breach
of implied warranty, breach of express warranty, and
negligent inspection, packaging, marketing, and selling.
Bard's Motion for Summary Judgment is DENIED IN
PART with respect to the plaintiffs' strict
liability and negligent failure to warn claims.
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 8, 000 of
which are in the Bard MDL, MDL 2187. In an effort to
efficiently and effectively manage this massive 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. 2:12-md-2187
[ECF No. 729]. This selection process was completed twice,
creating two waves of 100 cases, Wave 1 and Wave 2. Ms.
Rodenkirch-Kleindl's case was selected as a Wave 1 case
by the plaintiffs. PTO # 118, No. 2:12-md-2187 [ECF No. 841].
Rodenkirch-Kleindl was surgically implanted with the Align
Urethral Support System (the “Align”) by Dr.
Kenneth Ostermann at the Beaver Dam Community Hospital in
Beaver Dam, Wisconsin. Am. Short Form Compl. 4 [ECF No. 28].
As a result of complications allegedly caused by the Align,
the plaintiffs bring the following claims against Bard:
strict liability for design defect, manufacturing defect, and
failure to warn; negligence; breaches of express and implied
warranties; loss of consortium; and punitive
damages. Id. at 5. In the instant motion,
Bard moves for partial summary judgment on the grounds that
the plaintiffs' claims are without evidentiary support.
Bard's Mem. Supp. Mot. Summ. J. 1 (“Mem. in
Supp.”) [ECF No. 45].
obtain summary judgment, the moving party must show that
there is no genuine dispute as to any material fact and that
the moving party is entitled to judgment as a matter of law.
Fed. R. Civ. P. 56(a). In considering a motion for
summary judgment, the court will not “weigh the
evidence and determine the truth of the matter.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249
(1986). Instead, the court will draw any permissible
inference from the underlying facts in the light most
favorable to the nonmoving party. Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574, 587-88 (1986).
the court will view all underlying facts and inferences in
the light most favorable to the nonmoving party, the
nonmoving party nonetheless must offer some “concrete
evidence from which a reasonable juror could return a verdict
in his [or her] favor.” Anderson, 477 U.S. at
256. Summary judgment is appropriate when the nonmoving party
has the burden of proof on an essential element of his or her
case and does not make, after adequate time for discovery, a
showing sufficient to establish that element. Celotex
Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). The
nonmoving party must satisfy this burden of proof by offering
more than a mere “scintilla of evidence” in
support of his or her position. Anderson, 477 U.S.
at 252. Likewise, conclusory allegations or unsupported
speculation, without more, are insufficient to preclude the
granting of a summary judgment motion. See Dash v.
Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone
v. Liberty Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir.
Choice of Law
28 U.S.C. § 1407, this court has authority to rule on
pretrial motions in MDL cases such as this. The choice of law
for these pretrial motions depends on whether they involve
federal or state law. “When analyzing questions of
federal law, the transferee court should apply the law of the
circuit in which it is located. When considering questions of
state law, however, the transferee court must apply the state
law that would have applied to the individual cases had they
not been transferred for consolidation.” In re
Temporomandibular Joint (TMJ) Implants Prods. Liab.
Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal
citations omitted). In cases based on diversity jurisdiction,
the choice-of-law rules to be used are those of the states
where the actions were originally filed. See In re Air
Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576
(5th Cir. 1996) (“Where a transferee court presides
over several diversity actions consolidated under the
multidistrict rules, the choice of law rules of each
jurisdiction in which the transferred actions were originally
filed must be applied.”); 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,
plaintiff files her claim directly into the MDL in the
Southern District of West Virginia, however, as the
plaintiffs did in this case, I consult the choice-of-law
rules of the state in which the plaintiff was implanted with
the product. See Sanchez v. Boston Scientific Corp.,
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.”). Ms. Rodenkirch-Kleindl received the
implantation surgery for the Align in Wisconsin. Thus, the
choice-of-law principles of Wisconsin guide this court's
that these principles compel application of Wisconsin law.
For tort claims, Wisconsin's choice of law methodology
“begins with a presumption that the law of the forum
applies unless ‘nonforum contacts are of the greater
significance.'” Assembly Component Sys., Inc.
v. Platinum Equity, L.L.C., No. 09-CV-778, 2010 WL
2719978, at *6 (E.D. Wis. July 7, 2010) (quoting Glaeske
v. Shaw, 661 N.W.2d 420, 427 (Wis. App. 2003)). The
methodology then “ends with an analysis of five
‘choice influencing factors': predictability of
results, maintenance of interstate and international order,
simplification of the judicial task, advancement of the
forum's governmental interests, and application of the
better rule of law.” Id. Here, given the
presumption in favor of the law of the forum, and that there
is no indication that any of the five factors would weigh
against applying Wisconsin law, I find that the tort claims
are governed by Wisconsin law.
argues that it is entitled to partial summary judgment
because the plaintiffs lack evidentiary support on the
following claims: failure to warn on both theories of
negligence and strict liability, breach of express warranty,
manufacturing defect on both theories of negligence and
strict liability, breach of implied warranty, and negligent
inspection, marketing, packaging and selling. The plaintiffs
have agreed not to pursue claims for manufacturing defect,
breach of express warranty, and breach of implied warranty.
See Response 11 [ECF No. 109]. Accordingly,
Bard's Motion on the plaintiffs' claims for
manufacturing defect, under theories of strict liability and
negligence, breach of express warranty, and breach of implied
warranty are GRANTED. Below, I apply the
summary judgment standard to each remaining claim.
Failure to Warn
Wisconsin law, a manufacturer is strictly liable for design
defect if the claimant establishes all of the following by a
preponderance of the evidence:
(a) That the product is defective because it contains a
manufacturing defect, is defective in design, or is defective
because of inadequate instructions or warnings. . . . [;] (b)
[t]hat the defective condition rendered the product
unreasonably dangerous to persons or property[;] (c) [t]hat
the defective condition existed at the time the product left
the control of the manufacturer[;] (d) [t]hat the product
reached the user or consumer without substantial change in
the condition in which it was sold[; and] (e) [t]hat the
defective condition was a cause of the claimant's
Wis. Stat. § 895.047.
product is defective for want of adequate instructions or
warnings “only if the foreseeable risks of harm posed
by the product could have been reduced or avoided by the
provision of reasonable instructions or warnings by the
manufacturer and the omission of the instructions or warnings
renders the product not reasonably safe.” Wis.Stat.
§ 895.047(1)(a). A plaintiff suing in strict liability
must also prove that the inadequate instructions or warnings
were “a cause” of the plaintiff's damages.
asks the court to employ the learned intermediary doctrine in
considering the plaintiffs' failure to warn claims. The
learned intermediary doctrine allows a manufacturer “to
fulfill its duty to warn about the known dangers arising from
use of its products and avoid liability for failure to warn
by adequately warning the physician, ” thus relieving
manufacturers of prescription drugs and medical devices of
the duty to warn the patients directly about the
product's dangerous propensities. Forst v. SmithKline
Beecham Corp., 602 F.Supp.2d 960, 968 (E.D. Wis. 2009).
If the court applied the learned intermediary doctrine in
this case, as Bard urges me to do, Bard's liability on
this claim would depend on whether it adequately warned the
implanting physician about the risks associated with the
Align product. Whether it directly warned the plaintiff would
Wisconsin Supreme Court has not had the opportunity to decide
whether to adopt the learned intermediary rule, see
Forst, 602 F.Supp.2d at 968, and federal courts applying
Wisconsin law are split on the issue. Several federal courts
have used the rule without mentioning that the state supreme
court has not yet expressly adopted it. See, e.g.,
Menges v. Depuy Motech, Inc., 61 F.Supp.2d 817, 830
(N.D. Ind. 1999) (applying Wisconsin law); Lukaszewicz v.
Ortho Pharm. Corp., 510 F.Supp. 961, 963,
amended, 532 F.Supp. 211 (E.D. Wis. 1981)
(recognizing that the learned intermediary rule is a
“general rule [of] the courts of this country”).
More recent decisions by federal courts, however, reach the
opposite conclusion and decline to apply the learned
intermediary doctrine under Wisconsin law. See Maynard v.
Abbott Labs., No. 12-C-0939, 2013 WL 695817, at *5 (E.D.
Wis. Feb. 26, 2013) (“Wisconsin does not apply the
learned intermediary doctrine . . . .”);
Forst, 602 F.Supp.2d at 968 (declining to adopt the
learned intermediary rule “without some indication that
the state's highest court would apply the doctrine if
given the opportunity to do so” (quotation marks
omitted)); Peters v. AstraZeneca, LP, 417 F.Supp.2d
1051, 1054 (W.D. Wis. 2006) (same).
not resolve this issue here. Regardless of whether Bard's
duty to warn extended to the implanting physician or to the
plaintiffs directly, the plaintiffs have presented evidence
demonstrating genuine disputes of material fact with regard
to whether an inadequate warning caused her injuries, as is
required for both negligent and strict liability failure to
warn claims under Wisconsin products liability law.
See Wis. Stat. § 895.047(1)(e) (requiring a
plaintiff to prove that “the defective condition was a
cause” of her injuries). Likewise, genuine disputes of
material fact exist with regard to whether Bard's warning
was adequate. Therefore, Bard's Motion for Summary
Judgment on the plaintiffs' strict liability and
negligent failure to warn claims is DENIED.
Wisconsin law, a negligence 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).
contends that the plaintiffs' claims for negligent
inspection, packaging, marketing, and selling of the Align
fail for lack of evidence. The plaintiffs, in response, argue
that there is ample evidence that demonstrate Bard breached a
duty to the plaintiffs and that there was resulting harm from
this breach. The plaintiffs state that Bard was negligent in
failing to include adequate warnings, failing to include
appropriate instructions for use, exaggerating the benefits
of the Align, and marketing and selling the Align without
adequate testing. However, apart from reciting allegations
that form the plaintiff's failure to warn and design
defect claims, the plaintiffs do not offer any support that
Bard breached a legal duty that caused the plaintiff's
injuries in their “inspection, marketing, labeling,
packaging, or selling” of the Align. Accordingly,
Bard's Motion on these points is
reasons discussed above, it is ORDERED that
Bard's Motion [ECF No. 44] is GRANTED IN
PART with respect to the plaintiffs' claims for
negligent inspection, packaging, marketing, and selling,
manufacturing defect, breach of implied warranty, and breach
of express warranty. Bard's Motion is DENIED IN
PART with respect to the plaintiffs' strict
liability and negligent failure to warn claims.
Court DIRECTS the Clerk to send a copy of
this Order to counsel of record and any unrepresented party.
 Bard also filed a Motion for Partial
Summary Judgment on Punitive Damages Claims [ECF No. 46].
That motion is addressed in a separate order.