United States District Court, S.D. West Virginia, Charleston Division
December 6, 2016
PENNY HAVANICK, Plaintiff,
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 Summary Judgment [ECF No.
72]. As set forth below, Bard's Motion for Summary
Judgment is GRANTED IN PART with respect to the
plaintiff's 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 plaintiff's design defect and 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.
Havanick's case was selected as a Wave 2 case by the
plaintiffs. PTO # 118, No. 2:12-md-2187 [ECF No. 841].
Havanick was surgically implanted with the Align Urethral
Support System (the “Align”) by Dr. Kenneth Blau
at Danbury Hospital in Danbury, Connecticut. Am. Short Form
Compl. ¶¶ 9-13 [ECF No. 237]. As a result of
complications allegedly caused by the Align, Ms. Havanick
brings the following claims against Bard: strict liability
for design defect, manufacturing defect, and failure to warn;
negligence; breaches of express and implied warranties; and
punitive damages. Id. at ¶ 14. In the instant
Motion, Bard moves for partial summary judgment on a number
of different grounds. See Mem. Supp. Mot. Summ. J.
(“Mem. in Supp.”) [ECF No. 73].
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 Ms. Havanick
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. Havanick received the implantation
surgery for the Align in Connecticut. Thus, the choice-of-law
principles of Connecticut guide this court's
parties agree, as does this court, that these principles
compel application of Connecticut law. Connecticut typically
follows the lex loci deliciti doctrine, which states
“that the substantive rights and obligations arising
out of a tort controversy are determined by the law of the
place of injury.” O'Connor v.
O'Connor, 519 A.2d 13, 15 (Conn. 1986). Connecticut
courts have held that in situations where the lex loci
deliciti doctrine would produce irrational results,
courts should also consider the choice-of-law principles
found in the Restatement (Second) of Conflict of Laws.
Id. at 21-22 (“It is therefore our conclusion
that we too should incorporate the guidelines of the
Restatement as the governing principles for those cases in
which application of the doctrine of lex loci would
produce an arbitrary, irrational result.”). Under the
Restatement (Second) analysis, “[i]n an action for a
personal injury, the local law of the state where the injury
occurred determines the rights and liabilities of the
parties, unless, with respect to the particular issue, some
other state has a more significant relationship.”
Restatement (Second) of Conflict of Laws § 146 (1971).
Here, the alleged wrong occurred in Connecticut, and
Connecticut has the most significant relationship to the
claims. Thus, under either analytical framework, I apply
Connecticut's substantive law to the claims in this case.
Connecticut Product Liability Act
initial matter, Bard argues that Ms. Havanick's several
claims should instead be treated as one single claim governed
by the Connecticut Product Liability Act (the
“CPLA”). See Conn. Gen. Stat. Ann. §
52-572; see also Winslow v. Lewis-Shepard, Inc., 562
A.2d 517, 521 (Conn. 1989) (“The legislature clearly
intended to make our products liability act an exclusive
remedy for claims falling within its scope.”). The
plaintiff does not contest that the CPLA governs her claims.
Accordingly, each of the plaintiff's theories of recovery
in this case will be deemed part of a single claim under the
argues that it is entitled to partial summary judgment in
this case because the plaintiff's claims lack evidentiary
support. The plaintiff has agreed not to pursue manufacturing
defect claims. Response 1 [ECF No. 134]. Accordingly,
Bard's Motion for Summary Judgment on the plaintiff's
claims for manufacturing defect is GRANTED. Below, I apply
the summary judgment standard to each remaining claim.
has adopted the doctrine of strict liability for defective
products set forth in section 402A of the Restatement
(Second) of Torts (“Restatement”). See
Vitanza v. Upjohn Co., 778 A.2d 829, 835 (Conn. 2001).
Section 402A provides:
(1) One who sells any product in a defective condition
unreasonably dangerous to the user or consumer or to his
property is subject to liability for physical harm thereby
caused to the ultimate user or consumer, or to his property,
(a) the seller is engaged in the business of selling such a
(b) it is expected to and does reach the user or consumer
without substantial change in the condition in which it is
(2) The rule stated in Subsection (1) applies although
(a) the seller has exercised all possible care in the
preparation and sale of his product, and
(b) the user or consumer has not bought the product from or
entered into any contractual relation with the seller.
§ 402A. “A product may be defective due to a flaw
in the manufacturing process, a design defect or because of
inadequate warnings or instructions.” Vitanza,
778 A.2d at 835.
has adopted comment k to Section 420A of the Restatement
(Second) of Torts. Vitanza, 778 A.2d at 837. Comment
k exempts certain products from strict liability because they
are “unavoidably unsafe.” The interpretation and
treatment of this exemption varies. Connecticut courts
consider comment k as a defense against strict liability to
manufacturers of medical device companies. Hurley v.
Heart Physicians, P.C., 898 A.2d 777, 784 (Conn. 2006)
(“[W]e can see no principled reason to distinguish
between a prescription implantable medical device like a
pacemaker and a prescription drug.”). “[C]omment
k provides a defense against strict liability to
manufacturers of ‘unavoidably unsafe' products so
long as the product is (1) properly manufactured and (2)
proper warnings are given.” Moss v. Wyeth,
Inc., 872 F.Supp.2d 162, 167 (D. Conn. 2012).
correctly asserts that it is the plaintiff's burden to
prove by a preponderance of the evidence that if adequate
warnings or instructions had been provided, the claimant
would not have suffered harm. Conn. Gen. Stat. Ann. §
52-572q(c). Bard, however, misconstrues the implications of
this burden at the summary judgment stage. Bard summarily
asserts that proper warnings were given with each Align
product. However, Bard does not affirmatively show that the
plaintiff will be unable to meet her burden. Rather, the
plaintiff offers information that her implanting physician
thought could be relevant in his decision to use Bard's
product. Dr. Kenneth Blau Dep. 92:22-93:17 [ECF No. 134-2].
presents no other argument on design defect. Thus, Bard has
failed to meet its burden under the summary judgment standard
of showing the absence of a genuine dispute as to any
material fact. See Fed. R. Civ. P. 56(a);
Adickes v. S.H. Kress & Co., 398 U.S. 144, 157
(1970), superseded on other grounds by Celotex Corp. v.
Catrett, 477 U.S. 317 (1986). Therefore, Bard's
Motion on the plaintiff's claim based on a design defect
theory is DENIED.
Failure to Warn
regards to failure to warn claims, the CPLA provides:
(a) A product seller may be subject to liability for harm
caused to a claimant who proves by a fair preponderance of
the evidence that the product was defective in that adequate
warnings or instructions were not provided.
(b) In determining whether instructions or warnings were
required and, if required, whether they were adequate, the
trier of fact may consider: (1) The likelihood that the
product would cause the harm suffered by the claimant; (2)
the ability of the product seller to anticipate at the time
of manufacture that the expected product user would be aware
of the product risk, and the nature of the potential harm;
and (3) the technological feasibility and cost of warnings
(c) In claims based on this section, the claimant shall prove
by a fair preponderance of the evidence that if adequate
warnings or instructions had been provided, the claimant
would not have suffered the harm.
(d) A product seller may not be considered to have provided
adequate warnings or instructions unless they were devised to
communicate with the person best able to take or recommend
precautions against the potential harm.
Gen. Stat. Ann. § 52-572q.
Connecticut, like most jurisdictions, follows the learned
intermediary doctrine. Montagnon v. Pfizer, Inc.,
584 F.Supp.2d 459, 462 (D. Conn. 2008) (citing
Vitanza, 778 A.2d at 839). The learned intermediary
doctrine precludes recovery under a failure to warn theory
unless the injured party can “show that the warnings
were inadequate as” given to the physician.
Id; see also Johannsen v. Zimmer, Inc., No.
3:00-cv-2270(DJS), 2005 WL 756509, at *8 (D. Conn. Mar. 31,
2005) (“A plaintiff must show, by a preponderance of
the evidence, that adequate warnings were not provided and
that if such warnings had been provided, the harm would have
argues that the plaintiff cannot establish the necessary
element of proximate cause for her failure to warn theory
under the learned intermediary doctrine and the CPLA. Bard
states that Dr. Blau, Ms. Havanick's implanting
physician, testified in his deposition that even if Bard had
provided all of the information that the plaintiff contends
that Dr. Blau should have received, he still would have
implanted Ms. Havanick with the Align. The plaintiff,
conversely, contends that Dr. Blau testified multiple times
in the same deposition that had he known such information,
his decision to use the Align would have been affected. A
review of this deposition, however, demonstrates that both
parties mischaracterize Dr. Blau's testimony. Dr. Blau
stated that if he possessed certain information the plaintiff
claims that implanting physicians should have received and if
that information was relevant and accurate, he may have
viewed using the Align differently. Dr. Kenneth Blau Dep.
92:22-93:17 [ECF No. 134-2]. Thus, the plaintiff has
demonstrated that there is a genuine dispute over whether Dr.
Blau would have implanted the plaintiff with the Align had he
been as fully informed as the plaintiff has suggested.
as seen above, there exists a genuine dispute about whether
Bard's warnings were adequate. Thus, several genuine
disputes of material fact exist regarding the plaintiff's
claim based on a failure to warn theory. Therefore,
Bard's Motion on the part of the plaintiff's claim
based on a failure to warn theory is DENIED.
further moves for summary judgment regarding the
plaintiff's claims for negligent inspection, marketing,
labeling, packaging, and selling of the Align. According to
Bard, the plaintiff's claim based on these negligence
theories must fail because the plaintiff does not allege any
type of breach of duty or allege how such a breach would have
caused the alleged damage that is subject to the
plaintiff's claim. In response, Ms. Havanick argues that
Bard misconstrues the nature of the plaintiff's
negligence argument, and that her allegations regarding the
inspection, marketing, labeling, packaging, and selling of
the Align comprise part of her general negligence claim,
rather than distinct theories of recovery. The plaintiff
asserts that Bard failed to adequately study or test its mesh
products, including the Align, to determine their safety. The
plaintiff then states that this is “merely a sample of
the copious evidence” that the plaintiff can put forth
to support this claim, but does not actually provide any
further evidence. Response at 12.
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
plaintiff's other negligence allegations posit that Bard
was “negligent . . . in designing, manufacturing,
marketing, labeling, packaging, and selling” the Align.
Id. at ¶ 64. Thus, the plaintiff's concerns
that Bard is misconstruing the plaintiff's negligence
claim are 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 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 GRANTED.
Express and Implied Warranties
have held that ‘because the CPLA is silent as to the
elements of a cause of action for breach of warranty, '
plaintiffs may rely on the Connecticut Uniform Commercial
Code, Title 42a of the Connecticut General Statutes.”
Kuzmech v. Werner Ladder Co., No.
3:10-cv-266, 2012 WL 6093898, at *12 (D. Conn. Dec. 7, 2012)
(citing Walters v. Howmedica Osteonics Corp., 676
F.Supp.2d 44, 55 (D. Conn. 2009)). Express warranties are
(a) Any affirmation of fact or promise made by the seller to
the buyer which relates to the goods and becomes part of the
basis of the bargain creates an express warranty that the
goods shall conform to the affirmation or promise. (b) Any
description of the goods which is made part of the basis of
the bargain creates an express warranty that the goods shall
conform to the description. (c) Any sample or model which is
made part of the basis of the bargain creates an express
warranty that the whole of the goods shall conform to the
sample or model.
Gen. Stat. Ann. § 42a-2-313 (West).
“that the goods shall be merchantable is implied . . .
if the seller is a merchant with respect to goods of that
kind.” Conn. Gen. Stat. Ann. § 42a-2-314 (West).
first argues that the plaintiff's claims for breach of
express and implied warranties are almost identical, and both
claims state that Bard warranted that the Align was
merchantable and reasonably fit. Bard then argues that these
warranty claims are simply re-packaged failure to warn
claims. Furthermore, in regard to a breach of express
warranty, Bard argues that the plaintiff cannot prove: (1)
that Bard made any express warranties to her and (2) that she
relied on any information from Bard in electing to use the
Align. See Blockhead, Inc. v. Plastic Forming Co.,
402 F.Supp. 1017, 1024 (D. Conn. 1975) (“In a breach of
warranty action, a plaintiff may recover only after
demonstrating that a warranty existed, that defendant
breached the warranty, and that the breach was the proximate
cause of the loss sustained); see also Criteria, II Ltd.
v. Co-Opportunity Precision Wood Prods., Inc., No.
CV000803309S, 2001 WL 1178333, at *1 (Conn. Super. Ct. Aug.
30, 2001) (“reliance . . . is a necessary element of a
cause of action to recover on a breach of express
regards to the implied warranty claim, Bard argues that there
is no evidence in this case that the Align deviated from its
ordinary purpose, to treat stress urinary incontinence, and,
therefore, there is no breach of the implied warranty of
fitness. See Hartford Cas. Ins. Co. v. PureTech Waters of
AM., LLC, No. CV116021319S, 2012 WL 1435221, at *3
(Conn. Super. Ct. Mar. 30, 2012) (“To maintain a claim
for implied warranty of fitness . . . the plaintiffs must
allege a particular purpose other than [the product's]
response, the plaintiff alleges that the plaintiff, as well
as her treating physician, were provided limited information
that amount to warranties. Thus, according to the plaintiff,
a genuine issue of material fact is raised as to whether the
plaintiff and her physician relied on representations made by
the plaintiff contends Bard made warranties to her implanting
physician and to her, the plaintiff does not specify what
these express warranties actually were. Nor does she identify
how she relied upon these alleged warranties. The plaintiff
does not respond to Bard's arguments concerning her
breach of implied warranty claim. Accordingly, for the
reasons provided, Bard's Motion on the plaintiff's
claim based on breach of warranty theories is GRANTED.
reasons discussed above, it is ORDERED that Bard's Motion
[ECF No. 72] is GRANTED IN PART with respect to the
plaintiff's claim based on theories of 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 claim based on theories of design defect and
failure to warn.
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. 74].
That motion is addressed in a separate order.
 The CPLA, in relevant part, provides
that a product liability claim under the section includes
“all actions based on the following theories: Strict
liability in tort; negligence; breach of warranty, express or
implied; breach of or failure to discharge a duty to warn or
instruct, whether negligent or innocent; misrepresentation or
nondisclosure, whether negligent or innocent.” Conn.
Gen. Stat. Ann. § 52-572m.
 Comment k provides as follows:
Unavoidably unsafe products. There are some
products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and
ordinary use. These are especially common in the field of
drugs. An outstanding example is the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very
serious and damaging consequences when it is injected. Since
the disease itself invariably leads to a dreadful death, both
the marketing and the use of the vaccine are fully justified,
notwithstanding the unavoidable high degree of risk which
they involve. Such a product, properly prepared, and
accompanied by proper directions and warning, is not
defective, nor is it unreasonably dangerous. The
same is true of many other drugs, vaccines, and the like,
many of which for this very reason cannot legally be sold
except to physicians, or under the prescription of a
physician. It is also true in particular of many new or
experimental drugs as to which, because of lack of time and
opportunity for sufficient medical experience, there can be
no assurance of safety, or perhaps even of purity of
ingredients, but such experience as there is justifies the
marketing and use of the drug notwithstanding a medically
recognizable risk. The seller of such products, again with
the qualification that they are properly prepared and
marketed, and proper warning is given, where the situation
calls for it, is not to be held to strict liability for
unfortunate consequences attending their use, merely because
he has undertaken to supply the public with an apparently
useful and desirable product, attended with a known but
apparently reasonable risk.
Restatement (Second) of Torts § 402A cmt. k