COHEN v. JOHNSON & JOHNSON

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