# COHEN v. JOHNSON & JOHNSON

> District Court, W.D. Pennsylvania · October 5, 2022

URL: https://www.frixlaw.com/law-library/cases/10418163

## Case

- **Court:** District Court, W.D. Pennsylvania
- **Decided:** October 5, 2022
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
RANDI COHEN AND JAMES COHEN, )
)
Plaintiffs, ) 2:20-cv-00057
)
v. ) Judge Mark R. Hornak
)
JOHNSON & JOHNSON, )
)
Defendant. )
)

OPINION
Mark R. Hornak, Chief United States District Judge
Plaintiffs Randi and James Cohen (collectively “Plaintiffs”) filed this personal injury,
products liability civil action against Defendants’ Ethicon Inc. and Johnson & Johnson
(collectively “Defendants”)1 alleging a variety of injuries and complications arising from the
implantation of Defendants’ Gynemesh pelvic mesh device.
On October 31, 2011, Ms. Randi Cohen, a Pennsylvania resident, underwent surgery at a
UPMC hospital in Pittsburgh to implant the pelvic mesh in order to treat her pelvic organ prolapse.
(ECF No. 28-1, at 5.) After the surgery, Ms. Cohen alleges that she experienced pain and
discomfort, resulting in the eventual surgical removal of the pelvic mesh in June of 2013. (Id. at
6.) Ms. Cohen alleges that she experienced and continues to experience ongoing discomfort and

1 The claims were originally brought against Ethicon, Inc. and Ethicon, LLC. (ECF No. 1.) However, after
the case was transferred to this Court and the pending Motion was filed, the parties filed a stipulation noting that
Ethicon LLC was dismissed in the MDL and that Johnson & Johnson “should be listed as a named defendant.” (ECF
No. 47.) The Court approved the Stipulation, removed Ethicon LLC as a Defendant, and added Johnson & Johnson as
a Defendant on February 5, 2020. (ECF No. 48.) The Court nonetheless refers to “Defendants” in the context of the
matters considered here.
pain today as a result of the implantation of the pelvic mesh. (Id.; ECF No. 32.) This action was
part of the Multi-District Litigation (“MDL”) in the United States District Court for the Southern
District of West Virginia, In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation,
MDL No. 2327. (See ECF No. 38.) This case was transferred to this Court on January 14, 2020
after the completion of discovery under the auspices of the MDL court. (Id.; ECF No. 43.)

Plaintiffs’ First Amended Master Long Form Complaint brought eighteen (18) claims
against Defendants: Negligence (Count I), Strict Liability – Manufacturing Defect (Count II),
Strict Liability – Failure to Warn (Count III), Strict Liability – Defective Product (Count IV), Strict
Liability – Design Defect (Count V), Common Law Fraud (Count VI), Fraudulent Concealment
(Count VII), Constructive Fraud (Count VIII), Negligent Misrepresentation (Count IX), Negligent
Infliction of Emotional Distress (“NIED”) (Count X), Breach of Express Warranty (Count XI),
Breach of Implied Warranty (Count XII), Violation of Consumer Protection Laws (Count XIII),
Gross Negligence (XIV), Unjust Enrichment (Count XV), Loss of Consortium (Count XVI),

Punitive Damages (Count XVII) and Discovery Rule and Tolling (Count XVIII). (See ECF No.
39-1.)
Defendants moved for partial summary judgment on Plaintiffs’ claims at Counts I–XVIII.
(ECF Nos. 28, 29.) Plaintiffs filed a response in which they conceded that several claims should
be dismissed, specifically those at Counts II, XI, XII, XIV, and XV. (ECF Nos. 31, 32.) The Court
held a telephonic oral argument on April 16, 2020, at which Plaintiffs then withdrew their claims
at Counts IV, XVII and XVIII. (ECF No. 60.) At the oral argument Defendants also indicated that

they were not moving for summary judgment as to the claim at Count I, to the extent it rests on a
design defect theory, nor as to the loss of consortium claim at Count XVI.
Thus, pending before the Court for decision was Defendants’ Motion for Summary
Judgment as to Counts I (Negligence – Failure to Warn), III (Strict Liability – Failure to Warn), V
(Strict Liability – Design Defect), VI (Common Law Fraud), VII (Fraudulent Concealment), VIII
(Constructive Fraud), IX (Negligent Misrepresentation), X (NIED), and XIII (Violation of
Consumer Protection Laws). Thereafter, this action was stayed for nine (9) months in light of a
proceeding at our Court of Appeals which may have resolved certain claims central to this action.

(See ECF Nos. 61–65.) Thereafter, that stay was lifted, and supplemental briefing was authorized
and received (ECF Nos 64–67.)
For the reasons explained below, the Court GRANTS in part and DENIES in part
Defendants’ Motion. Summary judgment is granted in favor of the Defendants and against the
Plaintiffs as to the claims at Counts I (failure to warn only), II, IV, VI, VII, VIII, IX, XI, XII, XIII,
XIV and XV. The Defendants’ Motion for Summary Judgment is denied as to the claims at Counts
III, V, and X, and this action will proceed as to those three claims, and as noted below, the claims

at Count I (as to the claim for negligence – design defect) and XVI.
I. BACKGROUND
As stated above, Plaintiffs’ current action was part of an MDL against Defendants relating
to the advertising, design, manufacturing, selling, and use of Defendants’ pelvic mesh device. The
relevant facts are as follows. On October 31, 2011, Ms. Cohen, in order to treat her pelvic organ
prolapse, underwent surgery to implant Defendants’ Gynemesh product, a pelvic mesh medical
device. (ECF Nos. 29, 32.) The surgery occurred at Magee Womens’ Hospital of UPMC in
Pittsburgh and was performed by Dr. Halina Zyczynski. (Id.) Following the procedure, Ms. Cohen
suffered a series of complications and injuries that she alleges were “directly attributable to the
Gynemesh PS.” (ECF No. 32, at 2.) Further, Ms. Cohen alleges that Defendants knew about the
alleged complications caused by its Gynemesh product and disregarded such when it developed
and marketed the product. (Id. at 2–3.)

On September 5, 2013, Plaintiffs filed the instant action with Ms. Randi Cohen bringing
seventeen (17) claims against Defendants. (ECF No. 1.) Ms. Cohen’s husband and co-Plaintiff
James Cohen also brought a claim for loss of consortium against Defendants. (Id.) The parties
agree that Pennsylvania substantive law applies in this case. (ECF Nos. 29, 32); see also Belanger
v. Ethicon, Inc., No. 13-12036, 2014 WL 346717, at *7 (S.D.W. Va. Jan. 30, 2014) (holding that
cases arising out of the larger MDL should apply the law of “the place where the plaintiff was
implanted with the product”).
On December 19, 2019, this case was transferred from the MDL to this Court by Order of

the MDL Judge, Judge Joseph R. Goodwin. (ECF No. 38.) Judge Goodwin identified this case as
“ready to be transferred to the appropriate jurisdiction” because “the time to conduct discovery is
complete . . . and the parties have had time to file dispositive and Daubert motions, response and
replies.” (ECF No. 38, at 1.) On January 14, 2020, this case was docketed before this Court and
this Court ordered the parties to confer and file a Joint Status Report (“JSR”) detailing a plan of
suggested action. (ECF No. 44.) The parties provided such on February 5, 2020. (ECF No. 49.) In
the JSR, the parties suggested that this Court establish a scheduling order after the present pending
Motion for Partial Summary Judgment has been ruled upon by the Court. (Id.) After receiving
additional papers from the parties, the Court held a telephonic oral argument on the pending

Motion. (ECF No. 60.)
At the oral argument, Plaintiffs did not contest Defendants’ Motion for Summary Judgment
as to the following Counts: (1) Count II (Strict Liability – Manufacturing Defect); (2) Count IV
(Strict Liability – Defective Product); (3) Count XI (Breach of Express Warranty); (4) Count XII
(Breach of Implied Warranty); (5) Count XIV (Gross Negligence); and (6) Count XV (Unjust
Enrichment). (Id.) Accordingly, the Court will GRANT summary judgment in favor of the
Defendants as to those Counts. In addition, at oral argument the parties agreed that Counts XVII

and XVIII (Punitive Damages and Discovery Rule and Tolling) were not cognizable as
independent legal claims under Pennsylvania law and the Court dismissed those Counts without
prejudice. (Id.)
Thus, remaining at issue in Defendants’ pending Motion are the following claims: Count I
(Negligence – Failure to Warn)2, Count III (Strict Liability – Failure to Warn), Count V (Strict
Liability – Defective Design), Count VI (Common Law Fraud), Count VII (Fraudulent
Concealment), Count VIII (Constructive Fraud), Count IX (Negligent Misrepresentation), Count

X (Negligent Infliction of Emotional Distress), and Count XIII (Violation of Consumer Protection
Laws).
On March 29, 2021, the Court stayed this action pending final disposition of another similar
case arising from the Eastern District of Pennsylvania, Ebert v. C. R. Bard, Inc., 459 F. Supp. 3d
637 (E.D. Pa. 2020), which, on appeal, was poised to address the question of whether the
Pennsylvania Supreme Court would extend comment k to section 402A of the Restatement

2 At oral argument, Defendants confirmed that they are not moving to dismiss Plaintiffs’ negligent design
defect claims.
(Second) Torts to cases involving medical devices,3 a central issue, inter alia, in this action. (ECF
No. 61.) However, on November 10, 2021, apparently due to a settlement, the Third Circuit granted
the appellant’s unopposed motion to dismiss the appeal in Ebert, and as a result, discontinued its
certification to the Pennsylvania Supreme Court. (ECF No. 64.) Accordingly, and after receiving
a Joint Status Report from the parties requesting that this Court lift the stay and rule on the pending
Motion, this Court lifted the stay in this case and ordered additional briefing from the parties on

any updated and applicable case law relating to the pending Motion. (ECF No. 65.) The parties
then provided such briefing. (See ECF Nos. 66, 67.)
The matter is now ripe for disposition.
II. LEGAL STANDARD
Under Federal Rule of Civil Procedure 56, summary judgment is proper “if the movant
shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment
as a matter of law.” Fed. R. Civ. P. 56(a). On summary judgment, it is not the court's role to weigh

the disputed evidence and decide which is more probative, or to make credibility
determinations. Boyle v. Cnty. of Allegheny, 139 F.3d 386, 393 (3d Cir. 1998). Instead, the court
must consider the evidence and all reasonable inferences which may be drawn from it in the light
most favorable to the non-moving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 587 (1986) (citing United States v. Diebold, Inc., 369 U.S. 654, 655 (1962)). If a conflict
arises between the evidence presented by the parties, the court must accept as true the allegations

3 In that case, the Third Circuit had requested that the Supreme Court of Pennsylvania accept by certification
the questions at issue in Ebert, which involved open questions of Pennsylvania tort law, including whether comment
k was applicable to medical devices. (See Ebert v. C. R. Bard, Inc., Appeal No. 20-2139, Doc No. 50.) As a result,
this Court further continued the stay in this case. (ECF No. 62.)
of the non-moving party, and “all justifiable inferences are to be drawn in his favor.” Anderson v.
Liberty Lobby, 477 U.S. 242, 255 (1986).
When a party with the burden of proof fails to produce sufficient evidence to prove their

claim, summary judgment may be granted. Saldana v. K-Mart Corp., 260 F.3d 228, 232 (3d Cir.
2001). And when the non-moving party bears the burden of proof on an issue, it may not merely
rely on the allegations in its pleadings to survive summary judgment but must set forth sufficient
facts showing that there is a genuine issue for trial. Id.
III. DISCUSSION
Count I of the Amended Complaint alleges that Defendants were negligent in the
“manufacturing, design, warning, instruction, training, selling, marketing, and distribution” of its
Gynemesh product. (ECF No. 39-1, at 24–26.) Count III alleges that Defendants “failed to properly
and adequately warn and instruct the Plaintiffs and their health care providers” about the safest
and most effective methods of implantation and the risks and benefits of the products. (Id. at 28–

30.) Count V alleges that Defendants’ Gynemesh product was “not reasonably safe for its intended
use and was defective” in design. (Id. at 31–32.) Counts VI–VIII allege that Defendants made false
and/or fraudulent representations about the product to the medical and health community that the
Gynemesh product was tested and found to be safe and effective. (Id. at 33–44.) Plaintiffs allege
that Defendants either fraudulently concealed and intentionally or recklessly omitted pertinent
information about risks associated with the Gynemesh product from their representations to
healthcare providers and to Plaintiffs and breached their duty to disclose to Plaintiffs and to
physicians the alleged defective nature of the product. (Id.)
Counts IX–X allege that Defendants were negligent in making allegedly false
representations to the medical community and to Plaintiffs by failing to exercise ordinary care in
making representations with respect to the “manufacture, sale, testing quality assurance, quality
control, and distribution” of the Gynemesh product. (Id. at 44–46.) Finally, Count XIII alleges that
Plaintiffs bought and used the Gynemesh product for personal use and suffered “ascertainable
losses” as a result of Defendants’ violation of the state consumer protection laws. (Id. at 50–54.)

Plaintiffs further allege that but for the Defendants “deceptive conduct,” they would not have
purchased the Gynemesh product, and that Defendants deceptive and fraudulent representations
made in “marketing and promotional materials” violated the consumer protection laws of
Pennsylvania. (Id.)
Defendants’ Motion seeks summary judgment on all of these Counts. (ECF Nos. 28, 29.)
The Court will address each in turn.

A. Strict Liability Claims

First, Defendants argue that Plaintiffs’ remaining strict liability claims at Count III (Failure
to Warn) and Count V (Defective Design) are barred under Pennsylvania law because
“Pennsylvania courts, applying comment k of the Restatement (Second) of Torts § 402A, do not
recognize strict liability claims in cases involving prescription drugs and medical devices.” (ECF
No. 29, at 4.) Conversely, Plaintiffs argue that “the Pennsylvania Supreme Court has not extended
or applied comment k of § 402A to bar strict liability claims against medical device manufacturers
and Defendants cite no Pennsylvania Supreme Court cases which apply comment k to immunize
medical device manufacturers from strict liability design defect claims.” (ECF No. 32, at 5.)
The Court concludes that these strict liability claims are cognizable under Pennsylvania
law and in this case, so Defendants are not entitled to summary judgment on Plaintiffs’ strict
liability claims. Accordingly, the Summary Judgment Motion as to Counts III and V is DENIED.

Here’s why.
i. Applicability of comment k
The central dispute between the parties is whether Pennsylvania strict liability law has
extended comment k of the Restatement (Second) of Torts § 402A, which precludes the application
of strict liability to certain products, to cover prescription medical devices. In Hahn v. Richter, 673

A.2d 888, 889–90 (Pa. 1996), the Pennsylvania Supreme Court adopted comment k in the context
of prescription drugs and concluded that strict liability could not be applied to prescription drugs
where adequate warnings of the drugs’ potential risks had been provided.
Although the Pennsylvania Supreme Court has not extended comment k to cover medical
devices, following Hahn, several courts (including the Pennsylvania Superior Court) have
categorically barred strict liability claims from proceeding as to prescription medical devices, in
reliance on comment k.4 See e.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006)
(“We find no reason why [Hahn’s rationale] may not be applied to medical devices.”); see also

Wilson v. Synthes USA Prods., LLC, 116 F. Supp. 3d 463, 466 (E.D. Pa. 2015) (collecting cases
finding that plaintiffs may not assert strict liability claims against device manufacturers); Mills v.
Ethicon, Inc., 406 F. Supp. 3d 363, 378 (D.N.J. 2019) (“Federal courts, faced with the same issue

4 Since the Pennsylvania Supreme Court has not spoken on this issue, this Court must predict how the
Pennsylvania Supreme Court would decide it. See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 45–46 (3d Cir. 2009)
(“In the absence of a controlling decision by the Pennsylvania Supreme Court, a federal court applying that state's
substantive law must predict how Pennsylvania's highest court would decide [the] case.”)
of Pennsylvania law, have unanimously held that comment k applies to medical devices, barring
strict liability design defect and failure-to-warn claims”); Kohn v. Ethicon, Inc., No. 19-40004,
2020 WL 733126 (E.D. Pa. Feb. 13, 2020) (agreeing that this area of Pennsylvania law is unsettled
and predicting that the Pennsylvania Supreme Court would find that strict liability claims against
medical device manufacturers are not cognizable); Atkinson v. Ethicon, Inc., No. 13-697, 2019 WL
3037304, at *5 (W.D. Pa. July 11, 2019) (“As to strict liability, there is a split among federal

district courts applying Pennsylvania law as to whether strict liability is an available cause of action
against the manufacturer of a medical device; yet, even under the most permissive interpretation,
such claims exist only with respect to manufacturing defects in medical devices and not with
respect to other theories of strict liability.”); Eneida Lopez v. Ethicon, No. CV 20-2694, 2020 WL
5569770, at *5 (E.D. Pa. Sept. 17, 2020) (“[T]his Court predicts that the Supreme Court of
Pennsylvania would apply its holding in Hahn to medical devices . . .”); McGrain v. C.R. Bard,
Inc., 551 F. Supp. 3d 529, 537 (E.D. Pa. 2021) (“[T]his Court predicts that the Pennsylvania
Supreme Court would extend its reasoning in Hahn to preclude strict liability manufacturing defect
claims against medical device manufacturers.”); Mikula v. C.R. Bard, Inc., No. 2:21-CV-01307-

MJH, 2021 WL 5989130 (W.D. Pa. Dec. 17, 2021).
However, primarily relying on two post-Hahn cases, other courts have declined to
categorically exclude strict liability claims involving prescription medical devices. See, e.g.,
Patchcoski v. W.L. Gore & Assocs., Inc., No. CV 3:19-1556, 2020 WL 4335016, at *10 (M.D. Pa.
July 28, 2020) (predicting that the Pennsylvania Supreme Court would not
extend Hahn and comment k to all prescription medical device manufacturers); Schrecengost v.
Coloplast Corp., 425 F. Supp. 3d 448 (W.D. Pa. 2019), motion to certify appeal denied, No. 3:17-
CV-220, 2019 WL 7499923, at *8–10 (W.D. Pa. Dec. 19, 2019) (predicting that the Pennsylvania
Supreme Court would hold that strict liability claims against medical device manufacturers are
cognizable); Moultrie v. Coloplast, No. 18-231, 2020 WL 1249354 (W.D. Pa. Mar. 16, 2020)
(determining that “extending comment k to medical devices is a matter that should be addressed
by the Pennsylvania General Assembly or the Pennsylvania Supreme Court” and allowing the
strict liability claims to proceed).

Courts that have declined to extend comment k to medical devices mostly rely on the
Pennsylvania Supreme Court decisions in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014)
and Lance v. Wyeth, 624 Pa. 231, 261 n.21 (2014). See Schrecengost v. Coloplast Corp., 425 F.
Supp. 3d 448, 463–66 (W.D. Pa. 2019); Ebert v. C.R. Bard, Inc., 459 F. Supp. 3d 637, 651–52
(E.D. Pa. 2020). For the reasons explained below, this Court is similarly persuaded that Tincher
and Lance are “persuasive and an indication of how [the Pennsylvania Supreme Court] would rule
on this issue.” Schrecengost, 425 F. Supp. 3d at 463.

In Tincher, the Pennsylvania Supreme Court expressed skepticism of wholesale bars on
the availability of the strict liability doctrine in products liability cases. The Tincher court reiterated
that “[n]o product is expressly exempt and, as a result, the presumption is that strict liability may
be available with respect to any product, provided that the evidence is sufficient to prove a defect.”
Tincher, 628 Pa. at 386. While the court cited Hahn as standing for the premise that a manufacturer
is immune from strict liability defective design claims, “upon sale of prescription drugs without
adequate warning,” and did not specifically overrule or limit that principle, Tincher’s general

caution against making categorical exemptions for strict liability indicates to this Court that the
Pennsylvania Supreme Court would be skeptical of extending Hahn’s holding to medical devices
as a categorical matter.5
Further, in Lance, the Pennsylvania Supreme Court expressed skepticism about Hahn’s

reach in a footnote, stating that “it is our perspective that [the Hahn court] applied a rather one-
dimensional analysis in its adoption of a blanket approach to comment k in the first instance. For
example, the terse opinion in Hahn does not mention, let alone evaluate, the reasons why many
other jurisdictions had interpreted comment k to require a case-by-case assessment concerning the
availability of its protections. Compare, e.g., Hahn, 543 Pa. at 560–63, 673 A.2d at 889–91, with
Toner, 732 P.2d at 304–09. We emphasize that we are not revisiting Hahn; rather, our point is only
that the truncated analysis in the Hahn line offers a poor foundation for extrapolation.” 624 Pa.
231, 261, 85 A.3d 434, 452 n.21 (2014). In this Court’s estimation, this assessment by the
Pennsylvania Supreme Court significantly undermines the strength and persuasive value of the
analysis and applicability of Hahn, though it does not explicitly overrule Hahn’s ultimate holding

as to prescription drugs.
Reading Lance and Tincher together, this Court is persuaded that comment k likely would
not be applied by the Pennsylvania Supreme Court to categorically bar the applicability of strict
liability principles as to all medical devices. And even if the Pennsylvania Supreme Court were to
extend comment k to cover medical devices in some fashion, this Court concludes that it would
not do so using the same more modest analysis utilized by the same court in Hahn and by the

5 See Tincher v. Omega Flex, Inc., 628 Pa. 296, 390, 104 A.3d 328, 384 (2014) (“Our decision is limited to
the context of a ‘design defect’ claim by the facts of this matter, albeit the foundational principles upon which we
touch may ultimately have broader implications by analogy.”)
Pennsylvania Superior Court in Creazzo.6 Instead this Court concludes that the Pennsylvania
Supreme Court likely would conclude that strict liability claims are cognizable against medical
device manufacturers, and that the extension of comment k to bar strict liability claims may only
apply as to certain medical devices and only when as evaluated on a case-by-case basis and only
after consideration of the full and developed factual record. Ebert, 459 F. Supp. 3d at 652–53.

Based on a review of the record here, the Court determines that it does not establish that
comment k should be extended to the Gynemesh product in this case. Comment k of the
Restatement (Second) of Torts § 402A excludes “unavoidably unsafe products” from strict liability
claims. These products are described as “some products which, in the present state of human

6 Some other courts, including some within this District, place greater weight on Creazzo upon determining
that in the “absence of controlling Third Circuit or Pennsylvania Supreme Court precedent,” courts are to “give serious
consideration to the decisions of the intermediate appellate courts in ascertaining and applying state law.” Mikula v.
C.R. Bard, Inc., No. 2:21-CV-01307-MJH, 2021 WL 5989130, at *5 (W.D. Pa. Dec. 17, 2021) (citing Robinson v.
Jiffy Executive Limousine Co., 4 F.3d 237, 242 (3d Cir. 1993)). However, this Court concludes, as have other courts,
that Creazzo is less than persuasive and should be given less consideration in predicting the direction that the
Pennsylvania Supreme Court would take on this issue. See Schrecengost. 425 F. Supp. 3d at 465.

First, Creazzo was not based on a comprehensive review of policy considerations in deciding that comment
k should be extended to medical devices. Rather the Superior Court simply stated that because it found “no reason
why the same rationale [in Hahn] applicable to prescription drugs may not be applied to medical devices,” the lower
court made no reversible error in applying comment k to the medical device at issue in that case. Creazzo v. Medtronic,
Inc., 903 A.2d 24, 31 (Pa. Super. 2006). Second, the Pennsylvania Supreme Court has not cited, endorsed or adopted
the holding in Creazzo with respect to medical devices and strict liability. Thus, there is reason to doubt the persuasive
value of Creazzo and when considered in conjunction with Lance and Tincher, these observations as to the reasoning
and treatment (or lack thereof) of Creazzo is “other persuasive data” that the Pennsylvania Supreme Court would
decide this issue of the applicability of comment k to medical devices differently than did the court in Creazzo. See
West v. Am. Tel. & Tel. Co., 311 U.S. 223, 237 (1940) (“Where an intermediate appellate state court rests its considered
judgment upon the rule of law which it announces, that is a datum for ascertaining state law which is not to be
disregarded by a federal court unless it is convinced by other persuasive data that the highest court of the state would
decide otherwise.”) (emphasis added); see also, Taransky v. Sec'y of U.S. Dep't of Health & Hum. Servs., 760 F.3d
307, 316 (3d Cir. 2014) (“[W]e may consider the decisions of state intermediate appellate courts, which, ‘[a]lthough
not dispositive, ... should be accorded significant weight in the absence of an indication that the highest state court
would rule otherwise.’” (emphasis added) (internal citations omitted).
knowledge, are quite incapable of being made safe for their intended and ordinary use.”
Restatement (Second) of Torts, § 402A cmt. k.
Such products are considered not to be unreasonably dangerous or defective even when

they have an unavoidable, high degree of risk because the protection they provide is so beneficial
that use of the product is “fully justified.” Id. (using the example of the rabies vaccine which often
causes “serious and damaging consequences” when injected, however, is considered not
unreasonably dangerous because it protects against a disease that “invariably leads to a dreadful
death”). Such products are “especially common in the field of drugs . . . and vaccine[s]” however,
the comment states that other products “which . . . cannot legally be sold except to physicians, or
under the prescription of a physician” or that are “new and experimental . . . [such that], 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” may fall within the purview of the comment. Id.

Manufacturers of such “unavoidably unsafe products” are “not to be held to strict liability
for unfortunate consequences attending their use, merely because [the manufacturer] has
undertaken to supply the public with an apparently useful and desirable product, attended with a
known but apparently reasonable risk.” Id.
The record before the Court does not demonstrate that the Gynemesh product should be
classified as such an “unavoidably unsafe product.” The product is not generally implanted to

prevent a life-threatening condition, and the record does not reveal that such was the purpose of
its implantation for Ms. Cohen. (ECF No. 32, at 6.) Nor is there any evidence that it is incapable
of being made safe for its intended use. (Id.) To the contrary, Plaintiffs have presented expert
reports which demonstrate that the product could have been more safely designed. (Id.) Further,
though Gynemesh is a prescription-only medical device, the Court declines to categorically bar
the application of strict liability to claims arising from its use simply because the medical device
requires a prescription, absent any other showing that the product carries an “unavoidable high
degree of risk” but is “new or experimental” and “apparently useful and desirable” such that the
risk is justifiable. See Schrecengost, 425 F. Supp. 3d at 465–66 (declining to categorically bar strict
liability claims against a prescription-only surgical mesh product and deferring to the “general rule

in Pennsylvania that no product is immune from strict liability.”). Thus, based on the record here,
the Court concludes that the strict liability claims in this case are cognizable as related to the
medical device at issue.
Accordingly, the Court must next examine whether Plaintiffs’ strict liability claims are
sufficiently supported so as to survive summary judgment. The Court determines that Defendants
are not entitled to summary judgment on Plaintiffs’ strict liability claims because there are genuine
issues of material fact that would prevent the entry of judgment as a matter of law in favor of the

Defendants.
ii. Strict Liability, on the Merits
Under Pennsylvania law, manufacturers may be held strictly liable for “any product in a
defective condition unreasonably dangerous to the user or consumer” if “(a) the seller is engaged
in the business of selling such a product, and (b) it is expected to and does reach the user or

consumer without substantial change in the condition in which it is sold.” Webb v. Zern, 422 Pa.
424, 427 (1966) (citing and adopting the Restatement (Second) of Torts 402A). The manufacturer
will be held liable for injury even if “the seller has exercised all possible care” in preparing the
product and even if “the user or consumer has not bought the product from or entered into any
contractual relation with the seller.” Id. In other words, strict liability, unlike negligence, is
“product-oriented,” not “conduct-oriented.” Harford Mut. Ins. Co. v. Moorhead, 396 Pa. Super.
234, 251 (1990). And, “[t]here are three different types of defective conditions that can give rise
to a strict liability claim: design defect, manufacturing defect, and failure-to-warn defect.” Phillips
v. A-Best Prod. Co., 542 Pa. 124, 131, 665 A.2d 1167, 1170 (1995).

Here, Plaintiffs allege strict liability only under the design defect and failure to warn
theories. The Court will address each in turn.
iii. Strict Liability, Design Defect

Under § 402A, adopted as Pennsylvania law, to make out a strict liability claim “a plaintiff
must establish that the product was defective, that the defect was a proximate cause of the plaintiff's
injuries, and that the defect causing the injury existed at the time the product left the seller's hands.”
Davis v. Berwind Corp., 547 Pa. 260, 267 (1997). With respect to causation, a plaintiff must prove
that the defective product “was a substantial factor in causing the injury.” Spino v. John S. Tilley
Ladder Co., 548 Pa. 286, 293 (1997). Under a design defect theory, a plaintiff “may prove
defective condition by showing either that (1) the danger is unknowable and unacceptable to the
average or ordinary consumer, or that (2) a reasonable person would conclude that the probability
and seriousness of harm caused by the product outweigh the burden or costs of taking precautions.”
Tincher v. Omega Flex, Inc., 628 Pa. 296, 309 (2014).

Plaintiffs have demonstrated that there is a genuine issue of material fact as to whether
there was a defect in the product and whether the defect was the proximate cause of Ms. Cohen’s
injuries. Plaintiffs produced expert reports from Drs. Veronikis, Guelcher and Karlovsky which
state that there were safer, alternative designs for the product, that the design used and marketed
was defective, and that the risks of such products as designed were not disclosed to customers and
physicians. (ECF Nos. 31, 32.) Further, Plaintiffs have advanced an expert witness who will testify
that the defects in the design were the direct cause of Ms. Cohen’s injuries. (Id.) There is enough
admissible evidence presented in the current record to conclude, taking all reasonable inferences
in favor of Plaintiffs, that there is an issue of fact as to whether there was a defect in the product
and whether such a defect was a substantial factor in causing Ms. Cohen’s injuries.

Accordingly, the Court DENIES Defendants Motion for summary judgment of Plaintiffs
claim at Count V and that claim will proceed.
iv. Strict Liability, Failure to Warn

Under a failure to warn theory, a “dangerous product can be considered ‘defective’ for
strict liability purposes if it is distributed without sufficient warnings to notify the ultimate user of
the dangers inherent in the product.” Davis, 547 Pa. 260 at 267. A plaintiff must also still
demonstrate that the product was defective and that the defect, and failure to warn about the defect,
was the proximate cause of the plaintiff’s injuries. Id. Further, the “determination of whether a
warning is adequate and whether a product is ‘defective’ due to inadequate warnings are questions
of law.” Id. However “where fact questions exist ... the question of adequacy is one for the jury.”
Rowland v. Novartis Pharms. Corp., 34 F. Supp. 3d 556, 572 (W.D. Pa. 2014) (citing In re Avandia
Mktg., Sales Practices and Prods. Liab. Litig., 817 F. Supp. 2d 535, 545–46 (E.D. Pa. 2011)).

Typically, in cases regarding prescription drugs, the adequacy of warnings requires medical expert
testimony and as a result the question of adequacy is “ordinarily a question for the jury.” Id.
Here, the Court determines that there is a genuine issue of material fact as to whether the
product was defective, and whether the warnings were adequate. Plaintiffs have presented expert
testimony that can establish that the warnings at the time of Ms. Cohen’s surgery did not properly
warn of all the known risks associated with the Gynemesh product such that there remain factual
issues as to whether the warnings were adequate. Plaintiffs also present expert testimony that
supports the conclusion that the warnings were inadequate and were the proximate cause of Ms.
Cohen’s injuries, i.e., the inadequate warnings were a substantial factor in causing her injuries. See
Schrecengost, 425 F. Supp. 3d at 462–63, 467 (providing that under negligent failure to warn

claims proximate cause requires showing that had the defendant issued a proper warning, that
warning would have altered the physician’s treatment, but under strict liability failure to warn
claims proximate cause only requires a showing that the lack of warnings was “a substantial factor”
in bringing about plaintiffs injuries); see also id., (allowing the strict liability failure to warn claims
to proceed because Plaintiffs could “show that had [plaintiff] known about these additional risks,
she would not have agreed to the surgery”).7
Accordingly, the Court determines that Defendants are not entitled to summary judgment

on Plaintiffs’ strict liability failure to warn claim and the Motion is DENIED as to Count III.

7 Defendants also argue that Plaintiffs’ strict liability “failure to warn” claim should be dismissed because
Plaintiffs have not shown that different warnings would have altered Ms. Cohen’s physician’s decision to implant the
Gynemesh device, the same argument they make in support of their request for summary judgment on Plaintiffs’
negligent failure to warn claim. (ECF No. 29, at 11.) While the Court notes that there is no evidence in the record
demonstrating that either Ms. Cohen or her implanting physician would have changed the decision to proceed with
the implantation surgery if other, adequate warnings had been given, see Section III.D.i, infra, the Court also notes
that such a showing is not required under the strict liability failure to warn proximate cause standard. Instead, expert
testimony may be sufficient to survive summary judgment. See Moultrie, No. 18-231, 2020 WL 1249354 at *10 (W.D.
Pa. Mar. 16, 2020) (allowing the strict liability failure to warn claims to proceed because Plaintiffs offered expert
opinions where the expert “opine[d] that the [the product] is the cause of certain injuries and damages sustained by
Plaintiffs.”).
B. Learned Intermediary Doctrine
Next, Defendants argue that Plaintiffs’ claims at (1) Common Law Fraud (Count VI); (2)
Fraudulent Concealment (Count VII); (3) Constructive Fraud (Count VIII); (4) Negligent

Misrepresentation (Count IX); and (5) Violation of Consumer Protection Laws (Count XIII) are
all barred by the learned intermediary doctrine. For the reasons stated below, the Court agrees and
therefore, summary judgment on these claims is GRANTED.
i. Violation of Consumer Protection Laws (Count XIII)
Defendants argue that Plaintiffs cannot prevail under the Pennsylvania Unfair Trade
Practices and Consumer Protection Law (“UTPCPL”) because it requires proof that Plaintiffs
justifiably relied on the Defendants’ alleged misrepresentation or deceptive conduct and that such
justifiable reliance caused an ascertainable loss. (ECF No. 29, at 7.) Defendants argue that under

the learned intermediary doctrine, Defendants were only required to warn the physician, not the
patient – in this case Ms. Cohen – so Plaintiffs are unable to prove reliance or causation under the
UTPCPL. (Id. at 7–8.)
In response, Plaintiffs argue that the learned intermediary doctrine does not bar their
UTPCPL claim because Defendants failed to provide and actively concealed essential information
relating to the risks associated with Gynemesh from the implanting physicians. (ECF No. 32, at
19.) Accordingly, Plaintiffs argue, Dr. Zyczynski, Ms. Cohen’s implanting physician, could not

have been sufficiently “learned” because such information was “not disclosed by Ethicon to
physicians.” ((Id.) (citing Lance v. Wyeth, 85 A.3d 434, 457 (2014)); see also Lance, 85 A.3d at
457 (“[I]n a situation in which no warning would be sufficient, the learned intermediary doctrine
should not apply to diminish the duties of pharmaceutical companies, or to insulate them from
liability for a lack of due care.”).
The Pennsylvania UTPCPL, 73 Pa. Stat. Ann. §§ 201–1 et seq., inter alia, allows plaintiffs

to bring a private cause of action for “unfair or deceptive acts or practices” that cause a person to
suffer an “ascertainable loss” of money or property. However, “[t]o bring a private cause of action
under the [UTPCPL], a plaintiff must show that he justifiably relied on the defendant's wrongful
conduct or representation and that he suffered harm as a result of that reliance.” Yocca v. Pittsburgh
Steelers Sports, Inc., 578 Pa. 425, 438 (2004). Thus, under the UTPCPL the plaintiff must
demonstrate that she relied on the wrongful representation.

Under the learned intermediary doctrine, adopted in Pennsylvania law, prescription
medical device manufacturers have a duty to warn only the implanting physician about the
potential and possible dangers associated with the medical device. Incollingo v. Ewing, 444 Pa.
263, 282 A.2d 206, 220 (1971), abrogated on other grounds by Kaczkowski v. Bolubasz, 491 Pa.
561, 421 A.2d 1027 (1980). There is no duty to warn the recipient of the prescription medical
device, and instead the learned intermediary doctrine places the duty to warn the patient on the
prescribing physician, not the manufacturer. In re Avandia Marketing, Sales Practices & Prods.
Liab. Litig., 624 F. Supp. 2d 396, 420 (E.D. Pa. 2013). As a result, since there is no duty to warn
the direct consumer of medical devices under the learned intermediary doctrine, courts have
concluded that the consumer patient does not have a cause of action against the manufacturer under

the UTPCPL in these cases. See e.g., Kee v. Zimmer, Inc., 871 F. Supp. 2d 405, 411 (E.D. Pa.
2012) (“Under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL
against the manufacturer of prescription drugs because prescription drug manufacturers do not
have a duty to disclose information directly to consumers”); McLaughlin v. Bayer Corp., 172 F.
Supp. 3d 804, 831 (E.D. Pa. 2016) (applying Kee to manufacturers of prescription medical
devices); see also, Zafarana v. Pfizer, Inc., 724 F. Supp. 2d 545, 558 (E.D. Pa. 2010) (“Plaintiffs'
claims depend on a chain of reliance from Defendants to the prescribing physicians and the
prescribing physicians to patients. This, however, cannot be used to allow Plaintiffs to claim that
they justifiably relied on any representation made by Defendants.”)

In Lance v. Wyeth, the Pennsylvania Supreme Court suggested that “some of the
underpinnings of the [learned intermediary doctrine] principle have come into question in light of
changed practices in the prescription drug industry.” 624 Pa. 231, 270 (2014). While the
Pennsylvania Supreme Court in Lance determined that the
“learned intermediary doctrine should not apply to diminish the duties of pharmaceutical
companies, or to insulate them from liability for a lack of due care” when “no warning would be

sufficient,” the Lance court specifically stated that it “need not consider the wisdom of
modifications or exceptions to the doctrine.” Id. Thus, the Lance court did not explicitly or
implicitly overrule prior Pennsylvania precedent applying the learned intermediary doctrine to
medical device manufacturers. And courts post-Lance have continued to apply the learned
intermediary doctrine to bar recovery under the UTPCPL.8 See e.g., McLaughlin, 172 F. Supp. 3d
at 831 (“Plaintiffs argue that we should not apply the learned intermediary doctrine here because
they have alleged that Bayer withheld information from the physicians and, thus, they have
functionally alleged the physicians were not actually ‘learned.’ However, whether or not the

8 The Court also notes that the Lance court did not mention the UTPCPL, nor did it suggest that its skepticism
in assessing the learned intermediary doctrine does or should have any impact on prior cases that have barred recovery
under the UTPCPL under the doctrine.
physicians were appropriately ‘learned’ does not affect our conclusion that Plaintiffs cannot
prevail on their UTPCPL claim against Bayer because, as patients, they were required to rely on
the advice and counsel of their doctors”); Crockett v. Luitpold Pharm., Inc., No. 19-276, 2020 WL
433367, at *9 (E.D. Pa. Jan. 28, 2020) (“A plaintiff cannot satisfy the UTPCPL’s ‘justifiable
reliance’ requirement when the defendant does not sell the drug directly to the patient and does
not have a duty to warn the patient.”); Brown v. C.R. Bard, Inc., No. 5:21-CV-01552, 2022 WL

420914, at *7 (E.D. Pa. Feb. 11, 2022) (“Initially, the Court finds that the learned intermediary
doctrine precludes a claim under the UTPCPL [against the manufacturer of a prescription medical
device].”)
Based on the case law detailed above, the Court determines that Plaintiffs’ UTPCPL claim
is barred by the learned intermediary doctrine and the claim must be dismissed. Though the
Pennsylvania Supreme Court has expressed doubt about the applicability of the learned

intermediary doctrine particularly in cases where even an adequate warning to the learned
intermediary would not sufficiently protect the ultimate consumer, adoption of the doctrine with
respect to the UTPCPL has not been abrogated and here, Plaintiffs have not and cannot establish
that Ms. Cohen justifiably relied on any information provided by Defendants since there was no
duty for Defendants to provide such information to Ms. Cohen.
Accordingly, Defendants are entitled to summary judgment on Count XIII.

ii. Fraud and Misrepresentation (Counts VI-IX)
Defendants also move to dismiss all of Plaintiffs’ fraud and misrepresentation claims at
Counts VI–IX as barred by the learned intermediary doctrine. (ECF No. 29, at 7.) Defendants argue
that “[j]ustifiable reliance is an essential element of a fraud or misrepresentation claim” and
therefore, the learned intermediary doctrine breaks the chain in establishing reliance. (ECF No. 29,
at 8.) Defendants argue that under “Pennsylvania law, a plaintiff cannot assert reliance on a
manufacturer’s representations when, consistent with the learned intermediary doctrine, all of the
representations run from the manufacturer to the prescribing physician.” (Id.)

In response, Plaintiffs argue that Defendants “cannot claim that the learned intermediary
doctrine bars plaintiffs’ fraud and misrepresentation claims when it was because of Ethicon’s
deceptive acts and affirmative misrepresentations in IFUs [Instructions for Use] that Ms. Cohen
could not have been provided any warning or information regarding the frequency and severity of
[the] risks” (ECF No. 32, at 18–19.) For example, Plaintiffs cite an expert report from Dr.
Veronikis demonstrating that “numerous Ethicon corporate documents contradict[ed]” the IFUs
for Gynemesh which stated that the mesh material “remains soft and pliable” including one internal
memo which acknowledged that the Gynemesh material was “too stiff for use in vaginal tissues.”
(Id. at 18.)

Under Pennsylvania law, to establish a common law intentional misrepresentation claim a
plaintiff must show that there was “(1) a representation; (2) which is material to the transaction at
hand; (3) made falsely, with knowledge of its falsity or recklessness as to whether it is true or false;
(4) with the intent of misleading another into relying on it; (5) justifiable reliance on the
misrepresentation; and, (6) the resulting injury was proximately caused by the reliance.” Bortz v.
Noon, 556 Pa. 489, 499 (1999). Additionally, the “tort of intentional non-disclosure has the same
elements as intentional misrepresentation, except in the case of intentional non-disclosure, the

party intentionally conceals a material fact rather than making an affirmative misrepresentation.”
Id. (internal citations and quotations omitted). “Common law fraud and negligent
misrepresentation are sister claims under Pennsylvania law as the only difference between them is
the mental state the plaintiff must prove to succeed.” Blue Cross Blue Shield Ass'n v.
GlaxoSmithKline LLC, 417 F. Supp. 3d 531, 563 (E.D. Pa. 2019). Finally, in order to establish a
claim of constructive fraud, a plaintiff must demonstrate a “false statement (or omission) on which
the other party acts to his injury, without the element of dishonest intent.” Bucci v. Wachovia Bank,
N.A., 591 F. Supp. 2d 773, 784 (E.D. Pa. 2008). Further, a plaintiff must establish that there was a

“relationship between the parties that would trigger a [Defendant’s] duty.” Id.
Despite the fact that a plaintiff must show justifiable reliance by the plaintiff in order to
establish fraud and misrepresentation claims in Pennsylvania, in the context of products liability
cases like the present action, courts have determined that the learned intermediary doctrine does
not automatically bar all fraud claims. Instead, courts have allowed claims for fraud and
misrepresentation to proceed when a plaintiff can demonstrate that the defendant made fraudulent
misrepresentations or concealed information from her implanting physician. See e.g., Mikula v.

C.R. Bard, Inc., No. 2:21-CV-01307-MJH, 2021 WL 5989130, at *9 (W.D. Pa. Dec. 17, 2021)
(“[T]he learned intermediary doctrine does not, in and of itself, preclude [plaintiff’s] negligent
misrepresentation claim. Instead, [Plaintiff’s] negligent misrepresentation claim, based upon
[Defendant’s] alleged failure to adequately warn his prescribing physician, may be sufficient if
said claim satisfies the pleading requirements”); Keen v. C.R. Bard, Inc., 480 F. Supp. 3d 624, 642
(E.D. Pa. 2020) (allowing a negligent misrepresentation claim to survive summary judgment
because reliance by the doctor is sufficient to create a material dispute of fact and it is a factual
question as to whether the doctor relied on the manufacturer “to expressly disclose more accurate,
detailed information” about the product).
Accordingly, the Court determines that the learned intermediary doctrine does not
wholesale bar Plaintiffs’ fraud and misrepresentation claims at Counts VI–IX. Instead, the Court
must examine the merits of the claims.

C. Fraud and Misrepresentation, on the Merits

Defendants argue that if the Court determines that the learned intermediary doctrine does
not bar Plaintiffs’ claims of fraud and misrepresentation, they are still entitled to summary
judgment on these claims because there is no evidence in the record that Ms. Cohen read or relied
on these allegedly fraudulent statements. (ECF No. 29, at 9.)
Defendants state that Ms. Cohen specifically averred that she did not receive any written
or verbal information from the company about the product before her surgery and there is no other
evidence in the record establishing or suggesting that Ms. Cohen read or relied on any company
literature before making her decision to permit the implantation of the Gynemesh device. (Id.) In
response, Plaintiffs argue that Defendants “concealed information and provided misinformation

about risks and warnings to Ms. Cohen through her implanting physician, Dr. Zyczinski, who’s
counsel plaintiff relied upon.” (ECF No. 32, at 17.) In other words, according to Plaintiffs, Ms.
Cohen ultimately relied on these misrepresentations because her implanting physician relied on
these misrepresentations. And Plaintiffs further argue that their expert reports establish the “date,
time and place of the alleged fraud,” which creates a genuine dispute regarding a material issue of
fact as to whether there was fraud and misrepresentation which must be decided by a fact finder.
(Id. at 17–19.)
As explained above, a plaintiff can make out a claim of fraud and misrepresentation without
demonstrating justifiable reliance by the plaintiff specifically, if she can demonstrate that her
physician relied on the fraudulent statements. However, there must be concrete evidence and
specific facts in the record to establish at least that a genuine issue exists as to whether the
physician actually heard and relied on the supposedly fraudulent information and whether or not
she relayed that false information to the plaintiff patient, beyond merely alleging such in pleadings.

See Saldana, 260 F.3d at 232.
Here, the Court determines that Defendants are entitled to summary judgment because no
trier of fact could find that either Ms. Cohen or her physician relied on the alleged fraudulent
statements and/or misrepresentations of Defendants. First, as the Court noted above, Plaintiffs
cannot demonstrate that Ms. Cohen herself justifiably relied on the allegedly fraudulent or
misleading statements of Defendants because the Defendants only have a duty to provide

information to the learned intermediary, in this case, Dr. Zyczinski, Ms. Cohen’s implanting
physician. See Mikula, 2021 WL 5989130, at *9. However, the record is also devoid of any
evidence that Dr. Zyczinski herself received, read, or relied on any materials, written or oral, from
Defendants before she made her decision to perform the surgery.
Even taking all reasonable inferences in favor of Plaintiffs, the Court determines that there
is inadequate evidence in the record to create a genuine issue of material fact as to what Dr.
Zyczinski knew or didn’t know, or as to how any alleged statements or (mis)representations from

Defendants did or did not affect her decision to surgically implant the Gynemesh product. Further,
even if Plaintiffs’ experts can establish that the alleged fraud occurred at a certain time, place and
date and that the Defendants knew about and failed to disclose internal documents that
demonstrated “discrepancies between [the] risks and complications known to the Defendant,” that
evidence cannot generate an issue of fact with respect to the necessary element of reliance by Dr.
Zyczinski. (ECF No. 32, at 17.) The record does not demonstrate that Dr. Zyczinski personally did
or did not review and rely on these warnings in making her decision to proceed with Ms. Cohen’s
surgery aside from raising a speculative inference that because the proffered expert testimony
establishes that the fraud occurred around the time Ms. Cohen underwent her surgery and

Defendants “failed to communicate such to any implanting surgeons,” Ms. Cohen’s implanting
doctor therefore likely looked at and relied upon the allegedly fraudulent statements as well. (ECF
No. 32, at 18.) (emphasis in the original). Even accepting this as true, this type of inference is not
one that is reasonable and instead is speculative, and therefore is not sufficient to survive summary
judgement.9

9 The Court also notes, and Defendants argue in the alternative, that Plaintiffs negligent misrepresentation
claim also fails because it is duplicative of and subsumed by Plaintiffs’ negligent failure to warn claim. See e.g.,
McGrain v. C.R. Bard, Inc., 551 F. Supp. 3d 529, 546 (E.D. Pa. 2021) (“These allegations [of fraudulent
misrepresentation] plainly do not take Plaintiff's fraud claims beyond the scope of failure to warn of the alleged risks
of Defendants’ product. Plaintiff's argument that ‘Defendants actively concealed material facts related to the defective
nature of the IVC filter, and the dangers associated with it ... [and] misled Plaintiff and Plaintiff's physician to believe
that Defendants’ IVC filter was safe and effective for PE and DVT’ is similarly unavailing. This Court agrees with
Defendants that Plaintiff's misrepresentation claims are ‘exactly the type of dressed-up failure to warn claims’ that
other courts have rejected. Runner, 108 F. Supp. 3d at 268. Plaintiff's fraud-based claims at Counts VI and IX are,
therefore, dismissed with prejudice.”).

The Court notes that even if there was enough evidence in the record to establish a genuine issue of fact with
respect to Plaintiffs’ fraud and negligent misrepresentation, they would be dismissible as subsumed by Plaintiffs’
negligent failure to warn claim since they ultimately rely on the same underlying allegations. See e.g., Goodling v.
Johnson & Johnson, No. 4:21-CV-00082, 2022 WL 414285, at *8 (M.D. Pa. Feb. 10, 2022) (“In the Amended
Complaint, [Plaintiffs] make no effort to differentiate their failure to warn and negligent misrepresentation claims,
repeating (oftentimes verbatim) the same allegations for both counts. Because the [Plaintiffs] negligent
misrepresentation claim ‘sound[s] in failure-to-warn’ and the ‘sole avenue for recovery for these types of claims is
negligent failure to warn,’ the Court dismisses this claim (Count IX) with prejudice.”); Kline v. Pfizer, Inc., No. 08-
3238, 2009 WL 32477 (E.D. Pa. Jan. 6, 2009) (“Nonetheless, a review of the fraud allegations set forth in [Plaintiff’s]
Complaint reveals that these claims are rooted in a theory of failure to warn. . . . While Kline attempts to characterize
these claims as ‘so much more than a failure to warn claim,’ these claims do, in fact, assert liability against [Defendant]
for failure to warn. The very basis of these claims is that [Defendant] knew of the dangers associated with [the
prescription drug] but fraudulently concealed this knowledge and fraudulently misrepresented that the drug was safe
by failing to warn of its dangers. Thus, the very crux of these claims rests on a failure to warn theory of liability.”)
As a result, Defendants are entitled to summary judgment on these claims. The Court
GRANTS Defendants Motion as to Counts VI–IX.
D. Negligence Claims

Defendants also move for summary judgment on two of Plaintiffs’ negligence claims:
Count I (Failure to Warn) and Count X (Negligent Infliction of Emotional Distress). With respect
to Plaintiffs’ negligent failure to warn claim, Defendants argue they are entitled to summary

judgment on the merits. Defendants also argue that Plaintiffs’ negligent infliction of emotional
distress claim should be dismissed as duplicative of and subsumed by their negligent failure to
warn claims. The Court will address each such argument in turn.
i. Failure to Warn Negligence Claim
Defendants argue that they are entitled to summary judgment on Plaintiffs’ negligent
failure to warn claim at Count I because Plaintiffs have not and cannot meet their burden in
establishing that Ms. Cohen’s implanting surgeon would have altered her decision to proceed with
the surgery, if different warnings had been given by Defendants, particularly because Plaintiffs,

did not depose Dr. Zyczinski. (ECF No. 29, at 10.) Plaintiffs argue that it is “not necessary to
produce direct testimony from a prescribing physician when the consequences of using a drug are
known to the manufacturer and are so severe that it can be presumed that the selection of the drug
should not be made.” (ECF No. 32, at 15.)
Under Pennsylvania law, a plaintiff may recover for a defendant’s failure to provide
adequate instructions and warnings about the product under a negligence theory. “In order to state
a claim for negligent failure to warn under Pennsylvania law, a plaintiff must show that (1) the
defendant manufacturer owed a duty to the plaintiff; (2) the manufacturer breached that duty; and
(3) that breach was the proximate cause of the plaintiff's injuries.” Rowland v. Novartis Pharms.
Corp., 34 F. Supp. 3d 556, 569 (W.D. Pa. 2014). Plaintiffs “must show that [the Defendant] failed
to exercise reasonable care in warning of the dangers of its prescription medical device.” Soufflas
v. Zimmer, Inc., 474 F. Supp. 2d 737, 751 (E.D. Pa. 2007). And in cases involving prescription
medical devices, “whether a warning was adequate depends on whether [the prescribing physician

as the learned intermediary] having considered the ‘the data supplied to him by the manufacturer,
other medical literature, and any other source available to him, and weighing that knowledge
against the personal medical history of his patient,’ would use his independent judgment to
prescribe a medical device.” Id. (internal quotations and citations omitted).
Further, the Third Circuit has indicated that “summary judgment is properly granted on a
failure to warn claim where the record is devoid of evidence to support the argument that a different

warning would have altered [the physician’s] prescribing methods.” In re Avandia Mktg., Sales
Practices & Prods. Liab. Litig., 639 F. A’ppx 874, 878 (3d Cir. 2016). And courts applying
Pennsylvania law have consistently held that in failure to warn cases, to establish causation, a party
must demonstrate that a different warning could have made a difference to the specific prescribing
physician in the specific case. See e.g., Pavlik v. Lane Ltd./Tobacco Exporters Int'l, 135 F.3d 876,
882–83 (3d Cir. 1998) (“Our precedents in this area of the law teach that, in a failure to warn case,
we focus our causation analysis on the additional precautions that might have been taken by the
end user had the allegedly defective warning been different. . . . This analysis requires the fact
finder at trial or a court on summary judgment to ‘consider not only what did occur, but also
what might have occurred. . . . Such a determination as to what might have happened necessarily
requires a weighing of probabilities’”) (citing the Pennsylvania Supreme Court); Lineberger v.
Wyeth, 2006 PA Super 35, ¶ 24, 894 A.2d 141, 151 (2006) (finding that summary judgment was
appropriate where Appellant’s actual doctor, in deposition testimony, stated that he would have
prescribed the drug even if the warnings had been different because “Appellant presented no
evidence that a different warning would have changed [the physician’s] decision to prescribe [the
drug] for Appellant”); Cochran v. Wyeth, Inc., 2010 PA Super 131, ¶ 14, 3 A.3d 673, 676–77

(2010) (“Assuming that a plaintiff has established both duty and a failure to warn, a plaintiff ‘must
further establish proximate causation by showing that had defendant issued a proper warning to
the learned intermediary, he would have altered his behavior and the injury would have been
avoided.’ Demmler v. SmithKline Beecham Corp., 448 Pa. Super. 425, 671 A.2d 1151, 1155 (1996)
(citation omitted).”); see also, Rowland, 34 F. Supp. 3d at 571 (“There is no basis for the Court to
conclude that Pennsylvania law, in its current state, extends a manufacturer's duty to warn beyond
the doctor who prescribed the drug to the plaintiff. The Court will therefore analyze the adequacy
of the Zometa warnings in the context of Plaintiffs' prescribing physicians only.”) (emphasis
added).

Here, there is no genuine issue of material fact as to whether Defendants alleged failure to
warn proximately caused Ms. Cohen’s injuries because there is no evidence in the record
demonstrating that any different warnings would have impacted Dr. Zyczinski’s decision to use
the Gynemesh product. In other words, no reasonable inference can be drawn from the record that
an adequate warning in this instance would have prevented the injury. Though Plaintiffs argue that
no direct testimony on this point is required, the case law, and learned intermediary doctrine as
applied under Pennsylvania law, contradict this assertion.10 See e.g., Rosci v. AcroMed, Inc., 447
Pa. Super. 403, 669 A.2d 959, 968–69 (1995) (“Thus, the information supplied by the drug
manufacturer is only one source a physician must consult, and he is expected to make an
independent medical judgment in determining whether a given drug is appropriate for a particular
patient. Under the learned intermediary doctrine, as it is applied in Pennsylvania, a manufacturer
will be held liable only where it fails to exercise reasonable care to inform the one for whose use

the product is supplied of the facts which make the product likely to be dangerous. The intended
‘user’ in a case involving a prescription drug or device is, of course, the prescribing physician”);
Demmler v. SmithKline Beecham Corp., 448 Pa. Super. 425, 434 (1996) (“[T]o create a jury
question, the evidence introduced must be of sufficient weight to establish . . . some reasonable
likelihood that an adequate warning would have prevented the plaintiff from receiving the drug . .
. Absent proof that a more thorough or more explicit warning would have prevented [Plaintiff’s]
use of [the drug], appellants cannot establish that [Defendant’s] alleged failure to warn was the
proximate cause of [Plaintiff’s] injuries”); cf., Moultrie v. Coloplast, No. 18-231, 2020 WL
1249354 at *12 (W.D. Pa. Mar. 16, 2020) (denying summary judgment where the plaintiff

submitted expert testimony that the warning was inadequate in addition to testimony from the

10 Plaintiffs state it is “well-established under Pennsylvania law that it is not necessary to produce direct
testimony from a prescribing physician when the consequences of using a drug are known to the manufacturer and are
so severe that it can be presumed that the selection of the drug should not be made.” (ECF No. 32, at 15.) However,
Plaintiffs fail to identify or cite to any Pennsylvania law to back up this assertion. And the Court has found none.
Plaintiffs do cite State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913–14 (W.Va. 2007), a case from
the West Virginia Supreme Court of Appeals that declined to adopt the learned intermediary doctrine to bar a failure
to warn claim. However, this case does not apply Pennsylvania law and, the Court notes, it has since been superseded
by a statute in West Virginia that specifically adopts the learned intermediary doctrine as a defense to claims of
inadequate warning or instructions for medical devices. See J.C. by & through Michelle C. v. Pfizer, Inc., 240 W. Va.
571, 575 n.9 (2018) (“In 2016, the Legislature enacted West Virginia Code § 55-7-30, which provides, in part, that it
is the ‘intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary
doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or medical
devices.’”)
prescribing doctor that he “was bothered by the general warnings,” “was not warned” that the harm
suffered by plaintiff could result, and that he would have presented the information to plaintiff if
he had known it at the time).

Here, absent facts establishing that Dr. Zyczinski, as the prescribing and implanting
physician, would have changed her ultimate decision to prescribe and implant the Gynemesh
product in this case if she had been given different warnings, summary judgment for Defendants
is appropriate because no trier of fact can properly find proximate causation in this case. While the
expert testimony presented in this case may establish a genuine issue of fact as to the adequacy of
the warnings, it does not establish a genuine issue of fact as to whether the allegedly inadequate
warnings were the proximate cause of Ms. Cohen’s injuries without evidence from her physician
that had they been different, the outcome (i.e., the decision to proceed with the surgery) might well
have been different, also.

Accordingly, the Court GRANTS Defendants’ Motion with respect to Count I, Negligent
Failure to Warn.
ii. Negligent Infliction of Emotional Distress
Defendants argue that Plaintiffs’ remaining negligence-based claim for negligent infliction
of emotional distress (“NIED”) at Count X fails because it is duplicative of, and subsumed by,
Plaintiffs’ failure to warn claims at Count I. (ECF No. 29, at 13.) Defendants argue that the

“gravamen of Plaintiffs’ negligence allegations” is that Defendants were “aware of certain dangers
associated with [the Gynemesh product] but failed to convey that information to implanting
physicians while at the same time misrepresenting the products’ safety.” (Id.) Defendants argue
that 1) this argument, that Defendants provided inaccurate or incomplete information about the
risks associated with the pelvic mesh to physicians, is essentially the same argument made in
support of Plaintiffs’ NIED claim, 2) Plaintiffs cannot recover under multiple claims for the same
failure to warn theory, and 3) therefore, the Court should summarily reject this claim.

Plaintiffs argue that each of their negligence claims are separate and distinct and should be
evaluated independently. (ECF No. 32, at 20.) Plaintiffs further argue that Ms. Cohen’s NIED
claim is “derivative of all of her negligence claims” and it is not “subsumed” solely by her
negligent failure to warn claim. (Id.) Therefore, Plaintiffs argue, the Court should not dismiss the
claim as duplicative and instead the claim should survive summary judgment because there is
enough evidence in the record to create a genuine issue of fact as to whether Defendants were
negligent and negligently inflicted emotional distress on Plaintiffs.

Under Pennsylvania law, a negligent infliction of emotional distress claim is cognizable in
four scenarios: “(1) the defendant had a contractual or fiduciary duty toward the plaintiff; (2) the
plaintiff was subjected to a physical impact; (3) the plaintiff was in a zone of danger and reasonably
feared impending physical injury; or (4) the plaintiff observed a tortious injury to a close relative.
Runner v. C.R. Bard, 108 F. Supp. 3d 261, 272 (E.D. Pa. 2015). “A plaintiff must also establish
the elements of a negligence claim, i.e., that the defendant owed a duty of care to the plaintiff, the
defendant breached that duty, the breach resulted in injury to the plaintiff, and the plaintiff suffered
an actual loss or damage.” Wilder v. United States, 230 F. Supp. 2d 648, 654 (E.D. Pa. 2002) And
“negligen[t] infliction of emotional distress is a distinct cause of action cognizable under

Pennsylvania law.” Goodling v. Johnson & Johnson, No. 4:21-CV-00082, 2022 WL 414285, at
*9 (M.D. Pa. Feb. 10, 2022) (internal quotations omitted).
In support of their NIED claim, Plaintiffs’ Amended Complaint alleges that Defendants
“carelessly and negligently manufactured, designed, developed, tested, labeled, marketed and sold
the Defendants’ Pelvic Mesh Products to Plaintiffs, carelessly and negligently concealing the
harmful effects of the Defendants’ Pelvic Mesh Products from Plaintiffs, and carelessly and
negligently misrepresented the quality, safety and efficacy of the products.” (ECF No. 39-1, at 45.)
They further allege that Defendants’ negligence directly impacted Plaintiffs “in that Plaintiffs have

sustained and will continue to sustain emotional distress, severe physical injuries and/or death,
economic loses, and other damages” as a result of their decision to purchase the Gynemesh. (Id. at
46.)11 Lastly, Plaintiffs claim that Defendants’ conduct was the direct and proximate cause of
Plaintiffs injuries. (Id.)
Thus, Plaintiffs’ claim appears to rest primarily on allegations that Defendants were
negligent in designing and providing adequate and proper warnings regarding the Gynemesh

product. Plaintiffs also concede that the NIED claim is “derivative” of all of their other negligence
claims, including the ones as to which the Defendants did not move for summary judgment,
namely, their negligent design defect claim at Count I. See Maldonado v. Walmart Store No. 2141,
No. CIV.A. 08-3458, 2011 WL 1790840, at *16 (E.D. Pa. May 10, 2011) (“In order to maintain a
claim for negligent infliction of emotional distress, there must be an underlying tort.”).
Here, the Court determines that there is undisputedly a genuine issue of material fact as to
whether Defendants were negligent in designing the Gynemesh product and whether such

11 Plaintiffs allege “severe and permanent pain, suffering, disability, impairment, loss of enjoyment of life,
loss of care, comfort, and consortium, economic loss and damages including, but not limited to medical expenses, lost
income, other damages, and/or death” under their general negligence claims at Count I and do not allege “emotional
distress” under that theory. (ECF No. 39-1, at 26.) Accordingly, contrary to Defendants’ assertion, the allegations do
not in actuality “simply recast Plaintiffs’ failure to warn claim.” (ECF No. 29, at 14.)
negligence caused Ms. Cohen’s injuries.12 There is enough evidence in the record, taking all
reasonable inferences in favor of the Plaintiffs, from which a trier of fact could find that Ms. Cohen
suffered a physical impact and emotional distress as a result of Defendants alleged negligent
behavior. For example, there is evidence in the record that Ms. Cohen suffered emotional distress
such as “situational depression/anxiety” and that she has seen a therapist resulting from such from
approximately 2011 to the present. (ECF No. 28-1.) Thus, the Court determines that there are

genuine issues of fact as to whether there was infliction of emotional harm in this case and that
since Plaintiffs’ claim is not duplicative of or subsumed by Ms. Cohen’s other negligence claims,
and that it alleges emotional distress separate from these claims, the Court will DENY Defendants’
Motion with respect to the NIED claim.
IV. CONCLUSION

For the reasons set forth above, Defendant’s Motion for Partial Summary Judgment at ECF
No. 28 is GRANTED in part and DENIED in part. The Court GRANTS Defendants’ Motion to
the extent it seeks summary judgment in Defendants’ favor as to Plaintiffs’ claims at Counts I
(Negligence – Failure to Warn), II (Strict Liability – Manufacturing Defect), IV (Strict Liability –

Defective Product), VI (Common Law Fraud), VII (Fraudulent Concealment), VIII (Constructive
Fraud), IX (Negligent Misrepresentation), XI (Breach of Express Warranty), XII (Breach of
Implied Warranty), XIII (Violation of Consumer Protection Laws), XIV (Gross Negligence) and,
XV (Unjust Enrichment).

12 Defendants do not move for summary judgment on Plaintiffs claim for negligence under a design defect
theory.
The Court DENIES Defendants’ Motion to the extent it seeks dismissal of Plaintiffs’ claims
at Counts III (Strict Liability – Failure to Warn), V (Strict Liability – Design Defect), and X
(Negligent Infliction of Emotional Distress). Accordingly, these claims may proceed along with
Plaintiffs’ claims at Counts I (Negligence – Design Defect) and XVI (Loss of Consortium).

An appropriate Order will issue.

/s/_Mark R. Hornak___________
Mark R. Hornak
Chief United States District Judge

Dated: October 5, 2022
cc: All counsel of record

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10418163. Public record. Not legal advice.