MILLS v. ATRIUM MEDICAL CORPORATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

LATIESE MILLS,

Plaintiff,

v.

ETHICON, INC.; JOHNSON & Civ. No. 17-12624 (KM) (JBC)

JOHNSON; C.R. BARD INC.; DAVOL,

INC.; ATRIUM MEDICAL OPINION

CORPORATION; MAQUET

CARDIOVASCULAR, LLC; GETINGE

AB; COVIDIEN, INC.; COVIDIEN LLC;

COVIDIEN PLC; COVIDIEN AG;

SOFRADIM PRODUCTIONS; and

JOHN DOE CORPORATIONS 1-100,

Defendants.

KEVIN MCNULTY, U.S.D.J.:

Plaintiff Latiese Mills commenced this personal injury action against

defendants Atrium Medical Corporation (“Atrium”) and Maquet Cardiovascular,

LLC (“Maquet”). Now Before the Court is the motion of Atrium and Maquet for

summary judgment. For the reasons expressed below, Atrium and Maquet’s

motion for summary judgment is GRANTED in part and DENIED in part.

BACKGROUND

A. Facts1

In April 2012, Mills underwent surgery wherein her bowel was

improperly attached to her vagina. (Def. St. ¶ 2; Pl. Resp. ¶ 2.) Thereafter, Mills

1 Certain citations to record are abbreviated as follows:

“DE” = Docket entry number in this case

“Compl.” = Mills’s Amended Complaint (DE 43)

“Def. Mot.” = Atrium and Maquet’s Memorandum of Law in Support of their

Motion for Summary Judgment (DE 102-1)

underwent corrective surgery involving a midline incision. (Id.) A year after

Mills’s operation, “her incision was tender, the bottom of her incision bled, and

it sometimes had a foul odor.” (Def. St. ¶ 3; Pl. Resp. ¶ 3.) “A hernia later

developed along Plaintiff’s incision and, [o]n March [27,] 2013, Plaintiff

underwent hernia repair surgery by Dr. Alan Schuricht with ProLite [mesh]

placed at the hernia site to complete the repair.” (Def. St. ¶ 4; Pl. Resp. ¶ 4.)

ProLite is a polypropylene surgical mesh used in hernia repair. (Pl. St. ¶ 27;

Def. Resp. ¶ 27.) “The subject ProLite mesh was manufactured by Atrium at

Hudson on April 2, 2012, implanted in Plaintiff on March 27, 2013 and

explanted on March 31, 2017.” (Pl. St. ¶ 39; Def. Resp. ¶ 39.)

Mills’s surgical site became infected and, on July 3, 2013, Dr. Schuricht

performed surgery to debride the infection. (Def. St. ¶ 10; Pl. Resp. ¶ 10.) “The

debridement surgery removed infected abdominal wall tissue and a small

portion of ProLite, measuring 1 x 1.5 centimeters of the original 3 x 6 inches.”

(Def. St. ¶ 12; Pl. Resp. ¶ 12.) Plaintiff alleges that she sustained “seroma,

“Def. St.” = Atrium and Maquet’s Statement of Undisputed Facts (DE 102-2)

“Power Decl.” = Declaration of Caroline Power in Support of Atrium and

Maquet’s Motion for Summary Judgment (DE 102-3)

“Pl. Op.” = Mills’s Memorandum in Opposition to Atrium and Maquet’s Motion

for Summary Judgment (DE 104)

“Pl. Resp.” = Mills’s Response to Atrium and Maquet’s Statement of Material

Facts (DE 104-1 pp. 1–9)

“Pl. St.” = Mills’s Statement of Additional Material Facts (DE 104-1 pp. 9–20)

“Benak Decl.” = Declaration of James D. Benak in Support of Mills’s Opposition

to Atrium and Maquet’s Motion for Summary Judgment (DE 104-2)

“Def. Reply” = Atrium and Maquet’s Reply Brief in Support of Motion for

Summary Judgment (DE 106)

“Def. Resp.” = Atrium and Maquet’s Response to Mills’s Statement of Additional

Material Facts (DE 107)

“Pl. Surreply” = Mills’s Surreply in Opposition to Atrium and Maquet’s Motion

for Summary Judgment (DE 109-2)

infection, additional surgery, scar formation, pain, and hernia recurrence”

because of the ProLite mesh. (See Def. St. ¶ 6; Pl. Resp. ¶ 6.)

On February 4, 2014, Mills filed a malpractice action in Pennsylvania

state court claiming that her 2012 surgeries caused her 2013 hernia surgery

and subsequent issues, ongoing abdominal pain and infection, and other

damages. (Def. St. ¶ 15; Pl. Resp. ¶ 15; see Power Decl. Ex. 5.) In her

malpractice action, Mills alleged: “The hernia developed as a consequence of

damage to the muscles and fascia in the abdomen as a consequence of the

[2012] open laparotomy procedure and erosion of these tissues as a

consequence of infection and irritation by contaminants as a result of the

colovaginal fistula.” (Def. St. ¶ 16; Pl. Resp. ¶ 16.) On November 23, 2015, in

relation to the malpractice action, Mills executed a settlement agreement

releasing:

“all [] person . . . whether or not named herein . . . from any and all

causes of action, claims and demands of whatsoever kind on

account of all known and unknown injuries, losses and damages

allegedly sustained by Latiese M. Mills as a result of any conduct

and/or action of [named healthcare providers], at any time,

including but not limited to any claim arising out of or in any way

connected with [Ms. Mills’s 2012 abdominal surgeries]. . . . It is

expressly understood and agreed that this release and settlement

is intended to cover and does cover not only all now known

injuries, losses and damages, but any further injuries, losses and

damages which arise from, or are related to, any claim which

Latiese M. Mills ever had, now has, or may have [regarding her

2012 abdominal surgeries].

(Def. St. ¶ 17; Pl. Resp. ¶ 17.)

B. Procedural History

On November 30, 2017, Mills filed a complaint in New Jersey state court

alleging the following claims: (1) negligence; (2) strict products liability –

defective design; (3) strict products liability – failure to warn; (4) breach of an

express warranty; (5) breach of an implied warranty for a particular purpose;

and (6) breach of an implied warranty of merchantability. On December 5,

2017, defendant Covidien Inc. removed the action to this Court, invoking

diversity jurisdiction, 28 U.S.C. § 1332(a). (DE 1). On December 15, 2017, Mills

voluntarily dismissed the following defendants: Ethicon, Inc.; Johnson &

Johnson; C.R. Bard Inc.; Davol, Inc.; Covidien, Inc.; Covidien LLC; Covidien

PLC; Covidien AG; Sofradim Productions; and John Doe Corporations 1-100.

(DE 2).

On January 15, 2019, the remaining defendants, Atrium, Maquet, and

Getinge AB, filed motions to dismiss. (DE 25, 26.) Atrium and Maquet sought

dismissal of the complaint pursuant to Federal Rule 12(b)(6) on the grounds

that the complaint failed to meet pleading standards for statement of a claim.

They also contended that applicable Pennsylvania substantive law does not

recognize strict liability or warranty claims in medical device products liability

cases. Getinge AB, the Swedish corporate parent of Atrium and Maquet,

contended that service was defective and that it was not subject to personal

jurisdiction in New Jersey.

On August 27, 2019, I granted the motion to dismiss. (DE 38.) I

dismissed, with prejudice, Mills’s claims of strict liability for defective design

(second count); strict liability for failure to warn (third count); breach of the

implied warranty of fitness for a particular purpose (fifth count); and breach of

the warranty of merchantability (sixth count). I dismissed, without prejudice,

Mills’s claims of negligence and breach of express warranty (first and fourth

counts). I also concluded that Mills’s service on Getinge AB was deficient.

On November 8, 2019, Mills filed an amended complaint naming only

Atrium and Maquet (as well as John Doe Corporations 1-100) as defendants.

(DE 43.) The amended complaint asserts two claims: negligence (first count)

and breach of express warranty (second count).

On August 12, 2022, Atrium and Maquet filed a motion for summary

judgment and a motion to exclude the opinions and testimony of Mills’s expert

Dr. Paul J. Cohen. (DE 102, 103.) On March 1, 2023, the motion for summary

judgment was stayed pending decision on the motion in limine to exclude Dr.

Cohen’s evidence. (DE 112.) On March 28, 2023, Judge Clark issued an

opinion and order denying defendants’ motion to exclude. (DE 113.)

Accordingly, Judge Clark reinstated the pending motion for summary judgment

(DE 124), which is fully briefed and ripe for decision. (See DE 102, 104, 106,

107, 109, 129.)

LEGAL STANDARD

Summary judgment is appropriate where “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). A fact is material if it “might

affect the outcome of the suit under the governing law” and a dispute about a

material fact is genuine “if the evidence is such that a reasonable jury could

return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477

U.S. 242, 248 (1986). Disputes over irrelevant or unnecessary facts will not

preclude the Court from granting a motion for summary judgment. See id.

A party moving for summary judgment has the initial burden of showing

the basis for its motion and must demonstrate that there is an absence of a

genuine issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323

(1986). “A party asserting that a fact [is not] genuinely disputed must support

the assertion by . . . citing to particular parts of materials in the record,

including depositions, documents . . ., affidavits or declarations, stipulations

(including those made for purposes of the motion only), admissions,

interrogatory answers, or other materials.” Fed. R. Civ. P. 56(c)(1)(A). After the

moving party adequately supports its motion, the burden shifts to the

nonmoving party to “go beyond the pleadings and by her own affidavits, or by

the depositions, answers to interrogatories, and admissions on file, designate

specific facts showing that there is a genuine issue for trial.” Celotex, 477 U.S.

at 324 (internal quotation marks omitted).

“[W]ith respect to an issue on which the nonmoving party bears the

burden of proof . . . the burden on the moving party may be discharged by

‘showing’ — that is, pointing out to the district court — that there is an

absence of evidence to support the nonmoving party’s case.” Id. at 325. Once

the moving party has met that threshold burden, the non-moving party “must

do more than simply show that there is some metaphysical doubt as to

material facts.” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S.

574, 586 (1986). The opposing party must present actual evidence that creates

a genuine issue as to a material fact for trial. Anderson, 477 U.S. at 248.

Unsupported allegations, subjective beliefs, or argument alone cannot

forestall summary judgment. See Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871,

888 (1988) (nonmoving party may not successfully oppose summary judgment

motion by simply replacing “conclusory allegations of the complaint or answer

with conclusory allegations of an affidavit.”); see also Brewer v. Quaker State

Oil Ref. Corp., 72 F.3d 326, 330 (3d Cir. 1995) (“[T]he nonmoving party creates

a genuine issue of material fact if it provides sufficient evidence to allow a

reasonable jury to find for him at trial.”). Thus, if the nonmoving party fails “to

make a showing sufficient to establish the existence of an element essential to

that party’s case, and on which that party will bear the burden of proof at trial

. . . there can be ‘no genuine issue of material fact,’ since a complete failure of

proof concerning an essential element of the nonmoving party’s case

necessarily renders all other facts immaterial.” Katz v. Aetna Cas. & Sur. Co.,

972 F.2d 53, 55, n.5 (3d Cir. 1992) (quoting Celotex, 477 U.S. at 322-23).

“In considering a motion for summary judgment, a district court may not

make credibility determinations or engage in any weighing of the evidence;

instead, the nonmoving party’s evidence ‘is to be believed and all justifiable

inferences are to be drawn in his favor.’” Marino v. Indus. Crating Co., 358 F. 3d

241, 247 (3d Cir. 2004) (quoting Anderson, 477 U.S. at 255)). In that respect,

the Court’s role in deciding a motion for summary judgment is simply “to

determine whether there is a genuine issue for trial.” Anderson, 477 U.S. at

249. Ultimately, there is “no genuine issue as to any material fact” if a party

“fails to make a showing sufficient to establish the existence of an element

essential to that party’s case.” Celotex, 477 U.S. at 322.

DISCUSSION

A. Mills’s 2015 Settlement

Defendants assert that summary judgment should be granted in their

favor because Mills’s claims are barred by a release agreement she signed in

November 2015 in a separate malpractice action. (Def. Br. p. 19.)

In April 2012, Mills underwent surgery involving the bowel and vagina.

(Def. St. ¶ 2; Pl. Resp. ¶ 2.) A hernia developed, and in March 2013, Mills

underwent further surgery, which included implantation of ProLite mesh. (Def.

St. ¶¶ 3–4; Pl. Resp. ¶¶ 3–4.) On February 4, 2014, Mills filed a malpractice

action, wherein she claimed that “her 2012 surgeries caused her 2013 hernia

surgery and subsequent issues, ongoing abdominal pain and infection, and

other damages.” (Def. St. ¶ 15; Pl. Resp. ¶ 15.)

On November 23, 2015, Plaintiff executed a settlement agreement in the

malpractice action. Atrium and Maquet, although they were not parties to the

malpractice action, argue that the settlement agreement unambiguously

releases them from all of Mills’s claims in the current action. (Def. Mot. p. 19.)

Plaintiff responds that the subject matter of the malpractice action is not

sufficiently related to the later infection, which she alleges was caused by

ProLite mesh. (Pl. Op. p. 19.) That ProLite mesh, Mills explains, was inserted as

part of the 2013 hernia surgery, which occurred after the initial 2012 surgery

that was at issue in the malpractice action. (Id. p. 20.)

“In Pennsylvania, it is well settled that the effect of a release is to be

determined by the ordinary meaning of its language. The enforceability of

settlement agreements is governed by principles of contract law. Courts will

enforce a settlement agreement if all its material terms have been agreed upon

by the parties.” Pennsbury Vill. Assocs., LLC v. Aaron McIntyre, 11 A.3d 906,

914 (Pa. 2011) (internal citations and quotation marks omitted). “A settlement

agreement will not be set aside absent a clear showing of fraud, duress, or

mutual mistake.” Id.

Additionally, “[a] long line of Pennsylvania cases has held that a release

covers only those matters which may be fairly said to have been within the

contemplation of the parties when the release was given.” Bowman v. Sunoco,

Inc., 65 A.3d 901, 909 (Pa. 2013) (quoting Restifo v. McDonald, 230 A.2d 199,

201 (Pa. 1967)). The Court should “interpret a release so as to discharge only

those rights intended to be relinquished. The intent of the parties must be

sought from a reading of the entire instrument, as well as from the

surrounding conditions and circumstances.” Vaughn v. Didizian, 648 A.2d 38,

40 (Pa. Super. Ct. 1994); see also Fortney v. Callenberger, 801 A.2d 594, 597

(Pa. Super. Ct. 2002) (“[R]eleases are strictly construed so as not to bar the

enforcement of a claim that had not accrued at the date of the execution of the

release.”). Furthermore, “[w]aivers which release liability for actions not

accrued at the time of the release are generally only invalid if they involve

future actions entirely different than ones contemplated by the parties at the

time of the release.” Bowman, 65 A.3d at 909.

Under the above principles, Atrium and Maquet’s reliance on Buttermore

v. Aliquippa Hospital, 561 A.2d 733 (Pa. 1989) and Slater v. Saint Vincent

Health Ctr., No. 896 WDA 2016, 2017 WL 1041384 (Pa. Super. Ct. Mar. 17,

2017), is misplaced. (See Def. Mot. pp. 20–22.)

In Buttermore, the plaintiff suffered injuries in a car accident and was

taken by ambulance to a hospital. 561 A.2d at 734. The plaintiff signed an

agreement with the insurer of the other driver in the accident. The agreement

with the insurance company released “any and all other persons, associations

and/or corporations, whether known or unknown . . . present and future

claims, . . . for or because of any matter or thing done, omitted or suffered to be

done, on account of or arising from damage to property, bodily injury or death

resulting or to result from [the car accident at issue].” Id. Thereafter, the

plaintiff filed a separate lawsuit against the hospital where he received

treatment for his accident-related injuries. Id. at 734–35. The plaintiff asserted

that his claims against the hospital should not be barred because it was not

his intent when signing the release agreement to release the hospital from

liability. Id. at 735. That reasoning was found insufficient, and the court

determined that his claims were barred by the language of the release

agreement. Id.

In Slater, the plaintiff executed an agreement releasing “named and

unnamed individuals and entities from any and all actions, causes of action,

claims or demands . . . for any known or unknown injuries, losses or damages

[they] sustained that were related in any way” to the claim at issue. 2017 WL

1041384, at *13 (internal quotation marks omitted). Thereafter, the plaintiff

filed another lawsuit, wherein the defendants raised the release as a bar. The

trial court determined that, because the claims in the second lawsuit were

related to the released claims in the first lawsuit, and because the plaintiff had

expressly asserted the current claims in the prior action, those claims were

barred under the release agreement. See id. *7, *13 n.3.

Buttermore and Slater have a common, determinative factor. There, the

claims in the plaintiffs’ later-filed actions were (a) apparent to the plaintiffs at

the time they executed their release agreements and (b) closely related to the

claims that they had released. Pennsylvania courts have declined to enforce a

release agreement, however, when those factors were not present—i.e., when

the new claims were not apparent at the time of the release and were

sufficiently distinct from the old claims. In that connection, subsequent

intervening acts of negligence have been found particularly significant.

In Vaughn, for example, the plaintiff executed a general release of liability

for all claims resulting from an automobile accident. 648 A.2d at 39. About

seven months later, the plaintiff underwent surgery for those injuries. Id. The

plaintiff then filed a malpractice lawsuit alleging that the doctor negligently

performed the surgery. Id. at 40. The court held that the release did not bar the

plaintiff’s claims against the doctor because the doctor’s negligent treatment of

her injuries, which had not occurred or accrued at the time of the release,

could not have been contemplated by the parties. Id. at 41. As one court has

described the situation in Vaughn, “the claim alleged to have been waived was

a step removed from the actual release at issue.” Sauer Inc. v. Honeywell Bldg.

Sols. SES Corp., 742 F. Supp. 2d 709, 718 (W.D. Pa. 2010).

Similarly, in Youngren v. Presque Isle Orthopedic Group, Inc., the plaintiff

was involved in a car accident and underwent low lumbar surgery to address

her injuries. 876 F. Supp. 76, 77 (W.D. Pa. 1995). Thereafter, the plaintiff

executed a general release form releasing the driver and “all other persons”

from all liability related to the accident. Id. A few years later, the plaintiff was

involved in a second car accident and sought medical treatment. Id. at 78.

During her consultation, she discovered that the doctor who had performed her

low lumber surgery following the first accident had done so on the wrong side

of her spine, and she filed a malpractice lawsuit against that doctor. Id. The

court determined that the plaintiff’s claim did not arise from the accident

covered by the release but rather from a separate tort: the injury caused by the

doctor when he performed the low lumbar surgery on the wrong side of her

spine. Id. at 79. The court also determined, separately and in the alternative,

that a jury could conclude that the claim at issue did not accrue until years

later when plaintiff discovered the doctor’s negligence. Id. at 80.

In this case, Mills executed an agreement in November 2015 releasing

“any claim arising out of or in any way connected with” her 2012 abdominal

surgeries and “any claim which [Mills] ever had, now has, or may have”

regarding those 2012 surgeries. (Def. St. ¶ 17; Pl. Resp. ¶ 17.) Now it is true

that Mills underwent her hernia repair surgery in March 2013, prior to

executing the release agreement. However, there is no indication in the release

agreement or the surrounding circumstances of the prior lawsuit that the

parties contemplated that the settled dispute concerning Mills’s 2012 surgery

would encompass a claim of negligence against the manufacturer of a mesh

product used in a separate hernia surgery almost a year later.2 As in Youngren,

2 Dr. Schuricht’s deposition testimony also indicates that he did not believe that

Mills’s 2013 hernia repair surgery was a continuation of her 2012 surgery:

Mills’s injury resulting from the ProLite mesh is separate from her 2012

abdominal surgery and is, therefore, not covered by the language of the release

agreement.3

Summary judgment is denied on this ground.

B. Statute of Limitations

Negligence Claims

Defendants move for summary judgment on Mills’s negligence claims,

asserting that they are barred by the applicable statute of limitations. (Def. Br.

p. 14.)

Pennsylvania has a two-year statute of limitations for suits alleging

personal injury. 42 Pa. Const. Stat. Ann. § 5524. Generally, “a cause of action

accrues, and thus the applicable limitations period begins to run, when an

injury is inflicted.” Wilson v. El-Daief, 964 A.2d 354, 361 (Pa. 2009).

The running of the limitations period may be delayed, however, under

Pennsylvania’s “discovery rule.” The discovery rule, similar to that of New

Jersey, provides that the limitations period does not begin to run “until the

plaintiff discovers, or reasonably should discover, that she has been injured

Q. Do you mean to say that your surgery was a continuation of the

previous surgery?

A [by Dr. Schuricht]. No. . . .

Q. . . . [I]f there was malpractice that was committed in the first surgery,

that certainly would not be attributable to you in the second surgery,

would it? . . .

A. Are you asking me am I responsible for a complication in an operation

I was not at?

Q. Correct.

A. I would hope not.

(Benak Decl. Ex. 22, Dr. Schuricht Dep. Tr. 102:19–103:12.)

3 In the alternative, there is an argument that Mills’s claims against Atrium and

Maquet had not accrued at the time she executed the release agreement. The accrual

of Mills’s claims will be addressed below in connection with the statute of limitations.

See Section III.B.1.

and that her injury has been caused by another party’s conduct.” Id. at 361–

62. Reasonable diligence is an objective inquiry, but one which includes to

some degree “the difference[s] between persons and their capacity to meet

certain situations and the circumstances confronting them at the time in

question.” Fine, 870 A.2d at 858 (quoting Crouse v. Cyclops Indus., 745 A.2d

606, 611 (Pa. 2000)). Thus, “reasonable diligence is not an absolute standard,

but is what is expected from a party who has been given reason to inform

[her]self4 of the facts upon which [her] right to recovery is premised.” Id.

“[T]he determination concerning the plaintiff’s awareness of the injury

and its cause is fact intensive, and therefore, ordinarily is a question for a jury

to decide.” Wilson, 964 A.2d at 362 (citing Fine, 870 A.2d at 858). However,

“courts may resolve the matter at the summary judgment stage where

reasonable minds could not differ on the subject.” Id.; see also Fine, 870 A.2d

at 858–59; Adams v. Zimmer US, Inc., 943 F.3d 159, 167–68 (3d Cir. 2019)

(reversing and remanding the district court’s grant of summary judgment on

statute of limitations grounds because factual disputes remained concerning

application of Pennsylvania’s discovery rule, which needed to be resolved by the

jury). “It is the party that asserts application of the discovery rule that bears

the burden of proving that reasonable diligence was exercised.” Nicolaou v.

Martin, 195 A.3d 880, 893 (Pa. 2018).

Mills filed this second action on November 30, 2017. As relevant here,

she asserted negligence against the manufacturer of the ProLite mesh that had

been used in her hernia repair surgery on March 27, 2013. Under the general

rule, Mills’s claims would be barred by the statute of limitations because the

injury-causing event occurred outside the two-year limitations period (i.e.,

before November 30, 2015). However, Mills relies on the discovery rule,

asserting that her discovery of her 2013 injury was reasonably delayed under

4 As the plaintiff is female, I have attempted where practicable to substitute

gendered pronouns to clarify the application of quoted legal standards to her case.

the circumstances. Atrium and Maquet assert that the discovery rule does not

save Mills’s claims for three reasons, discussed below.

First, Atrium and Maquet argue that the statute of limitations began to

run on Mills’s claim in July 2013, when Dr. Schuricht performed surgery to

debride Mills’s infected surgical site. (Def. Br. p. 18; see Pl. Resp. ¶ 10.) Atrium

and Maquet rely on Mill’s deposition testimony, wherein she was asked “Did

you believe [in July 2013] that the mesh was causing your injuries?” to which

she responded, “Yes.” (Def. Br. p. 17 (quoting Power Decl. Ex. 1, Mills Dep. Tr.

176:23-177:1); see also Pl. Resp. ¶ 11.) Atrium and Maquet cite three cases for

the proposition that “[i]n cases involving surgical mesh and Pennsylvania’s

discovery rule, courts have held claims accrue at the latest when the plaintiff

undergoes a subsequent surgery to address mesh-related complications”:

Kennedy v. Ethicon, Inc., No. 20-cv-185, 2020 WL 4050459 (E.D. Pa. July 20,

2020); Soutner v. Covidien, LP, No. 17-cv-2178, 2019 WL 3801438 (M.D. Pa.

Aug. 13, 2019); Hartey v. Ethicon, Inc., No. 04-cv-5111, 2006 WL 724554 (E.D.

Pa. Mar. 20, 2006).

Mills responds that she “was not made aware that the cause of her

injuries could be the ProLite mesh until Spring 2017” when she “saw an

advertisement on television regarding defective mesh.” (Pl. Op. p. 18; Benak

Decl. Ex. 37, Mills Aff. ¶ 8.) Mills explains in her affidavit that “[n]o treating

physician has told me that the mesh device implanted in me was faulty or non-

sterile or linked [to] my symptoms” and she “was not aware before [March or

April 2017] that any of [her] symptoms could be a result of faulty mesh from the

manufacturer rather than just [her] body’s reaction to the mesh surgery.”

(Benak Decl. Ex. 37, Mills Aff. ¶¶ 7–8 (emphasis added).) Mills asserts that “her

doctor assured her that the mesh was not causing her problem.” (Pl. Surreply

p. 5.) In support, she cites her own deposition testimony describing her

doctor’s advice in connection with the July 2013 debridement surgery:

Q. Before you had this debridement surgery, did you talk to Dr.

Schuricht about the surgery?

A [Mills]. Yes.

Q. What did you talk about?

A. I was asking him why the drains kept falling out and why I kept

being in so much pain. And he told me he wanted to do a

debridement surgery to wash out the area. And I told him -- I

asked did he think it was coming from the mesh; and if it was,

could he just take the mesh out.

Q. And what was his response to that question?

A. No, he didn’t want to take the mesh out. He wanted to do the

debridement and wash around the surgical site and area where the

mesh was at.

Q. Did you believe at that point in time that the mesh was causing

your injuries?

A. Yes.

Q. When did you first start thinking that the mesh was the cause

of your injuries?

A. When the drains kept falling out. When I kept having so much

pain. And that’s it.

(Benak Decl. Ex. 36, Mills Dep. Tr. 176:5–177:7.)

The record might (or might not) support the conclusion that the July

2013 debridement surgery addressed infection complications that were in fact

caused by the ProLite mesh. Contrary to Atrium and Maquet’s position,

however, undergoing corrective surgery does not necessarily place a plaintiff on

notice for statute of limitations purposes. Rather, the court must consider the

facts and circumstances of the plaintiff’s situation, and it cannot do so in a

vacuum. See Nicolaou, 195 A.3d at 894. Patients are of course aware of their

symptoms, but they are often ill-equipped to assess the medical causes of

them, and must therefore rely on medical advice. See Adams, 943 F.3d at 165

(citing Nicolaou, 195 A.3d at 893). Accordingly, a court considering the

applicability of the discovery rule must take into account what the patient was

being told by her doctors.

For example, in Nicolaou, the plaintiff suffered from symptoms that she

suspected were caused by Lyme disease. Id. at 883. However, the plaintiff’s

doctors told her that she did not have Lyme disease and instead diagnosed her

with and treated her for multiple sclerosis. Id. at 883–84. During that

treatment, the plaintiff’s symptoms continued. Id. When the plaintiff was finally

diagnosed with and treated for Lyme disease, her symptoms began to improve.

Id. at 885. The plaintiff filed a medical malpractice action against the

healthcare providers who failed to diagnose and treat her Lyme disease. Id. at

882. Without the benefit of the discovery rule, the plaintiff’s claims would have

been time barred. However, when considering all of the circumstances of the

plaintiff’s case, including that her prior doctors advised her that she did not

have and failed to treat her for Lyme disease, the court held that it was for the

jury to decide whether it was reasonable for the plaintiff to not have suspected

that she had Lyme disease at an earlier date. Id. at 894–95.

Mills testified that she believed or suspected in July 2013 that her mesh

was the cause of her injuries. When she raised the issue with her doctor,

however, he informed her that debridement surgery and washing of the site,

not removal of the mesh, was called for. Dr. Schuricht, who performed the

debridement, testified that “the infection could not have originated with

Plaintiff’s ProLite mesh because, if it had, more of the mesh would have

required removal.”5 (Def. St. ¶ 13; Pl. Resp. ¶ 13.) Mills also stated that no

treating physician had informed her that her mesh device was causing her

injuries and she believed that her injuries were simply the result of her body

not reacting well to the surgery. (Mills Aff. ¶¶ 7–8.) As the Third Circuit has

recognized, “a lay person is only charged with the knowledge communicated to

him or her by the medical professionals who provided treatment and

diagnosis.” Adams, 943 F.3d at 165 (quoting Nicolaou, 195 A.3d at 893). To

“discover” that her infection resulted from the mesh, Mills would have needed,

in effect, to override her physician’s opinion with her own. Applying a summary

5 Mills’s July 2013 debridement surgery removed only “a small portion of ProLite,

measuring 1 x 1.5 centimeters of the original 3 x 6 inches.” (Def. St. ¶ 12; Pl. Resp. ¶

12.) Whether that fact rebuts causation may present an issue on the merits.

judgment standard, I cannot say that the state of her knowledge does not

present a factual issue.

The three cases cited by Atrium and Maquet are not to the contrary,

because those plaintiffs did not receive incorrect or unclear information from

their doctors. In Kennedy, the plaintiff’s doctor informed her that her injuries

were related to her implanted mesh device and, during one medical visit, the

plaintiff viewed through a camera that her injuries were caused by the mesh

device. 2020 WL 4050459, at *13. In Soutner, the plaintiff suffered severe

inflammation at the site of his mesh device implant and ultimately had the

mesh removed, along with his vas deferens. 2019 WL 3801438, at *2. And, in

Hartey, following surgery, the plaintiff was advised that she had “massive scar

tissue” and learned that the scarring was “secondary to the use of Mersilene

mesh.” 2006 WL 724554, at *3. As of the date they received such unequivocal

advice from their physicians, those plaintiffs indisputably were on reasonable

notice that their mesh devices caused their injuries, and those courts so ruled.

Not so in Mills’s case.

Second, Atrium and Maquet rely on the “sham affidavit” doctrine. (See

Def. Reply pp. 1–4.) According to Atrium and Maquet, Mills is attempting to

contradict her deposition testimony that she believed in July 2013 that her

mesh was causing her injuries by submitting an affidavit stating that she did

not know that her mesh was causing her injuries until Spring 2017. (Compare

Benak Decl. Ex. 36, Mills Dep. Tr. 176:5–177:7, with Ex. 37, Mills Aff. ¶ 8.)

Their reliance on the “sham affidavit” doctrine is misplaced. A sham affidavit is

“a contradictory affidavit that indicates only that the affiant cannot maintain a

consistent story or is willing to offer a statement solely for the purpose of

defeating summary judgment.” Jiminez v. All American Rathskeller, Inc., 503

F.3d 247, 253 (3d Cir. 2007). For the reasons expressed above, in the context

of the medical advice Mills was receiving, the inconsistencies between the two

statements may provide fodder for cross-examination, but are not so

contradictory as to suggest bad faith. I decline to apply the sham affidavit

doctrine.

Third, Atrium and Maquet assert that, even if Mills was not aware of the

cause of her injuries in July 2013, she was surely aware of them when she filed

her malpractice lawsuit on February 4, 2014. (Def. Br. p. 18.) Defendants

acknowledge, however, that Mills filed her malpractice action to recover

damages she sustained during her 2012 surgery; the malpractice complaint

does not mention ProLite mesh or name any of the defendants in this action.

(See id.) There is nothing in the malpractice complaint or release to indicate

that Mills then knew that the ProLite mesh was causing her injuries. Therefore,

I decline to hold that the statute of limitations began to run on the date that

Mills filed her malpractice complaint in February 2014.

* * *

There exists a genuine dispute of material fact regarding the date on

which Mills knew or should have known that her injuries were caused by

Atrium and Maquet’s alleged negligence. See Adams, 943 F.3d at 163, 167. For

the above reasons, Atrium and Maquet’s motion for summary judgment on

Mills’s negligence claims based on the statute of limitations is denied.

Breach of Express Warranty Claim

Defendants also move for summary judgment on Mills’s breach of

express warranty claim, claiming it is barred by the statute of limitations.

According to Atrium and Maquet, Mills’s express warranty claim accrued as

soon as she underwent her hernia repair surgery in March 2013 because an

express warranty claim accrues “when tender of delivery is made.” (Def. Br. pp.

13–14.) Additionally, Atrium and Maquet assert that they never made any

express warranty to Mills, let alone a warranty extending to future

performance. (Id. p. 14.)

Mills responds that, because Atrium and Maquet warranted “the future

performance of the goods,” her cause of action did not accrue until she

discovered, or should have discovered, the breach. (Pl. Op. p. 24.) Mills asserts

that the discovery rule applies to her breach of warranty claim because her

mesh was designed as a permanent implant. (Id. p. 25.)

In Pennsylvania, the statute of limitations for a breach of warranty is

four years. 13 Pa. Cons. Stat. Ann. § 2725(a). “In cases involving the

implantation of a medical device, a breach of warranty cause of action accrues

on the date the device is implanted.” Drumheller v. Johnson & Johnson, No. 20-

cv-6535, 2021 WL 1853407, *13 (E.D. Pa. May 10, 2021); Goodling v. Johnson

& Johnson, No. 21-cv-82, 2022 WL 414285, at *11 (M.D. Pa. Feb. 10, 2022).

The Pennsylvania statute contains an exception “where a warranty explicitly

covers future performance of the goods, in which case a cause of action

accrues when the breach is or should have been discovered.” White v. Hon Co.,

520 F. App’x 93, 94 (3d Cir. 2013) (citing 13 Pa. Cons. Stat. Ann. §§ 2725(a),

(b)). The “future performance” exception reads as follows:

A breach of warranty occurs when tender of delivery is made,

except that where a warranty explicitly extends to future

performance of the goods and discovery of the breach must await

the time of such performance the cause of action accrues when the

breach is or should have been discovered.

13 Pa. Cons. Stat. Ann. § 2725(b). “Except for explicit warranties of future

performance, the statute expressly rejects a discovery rule similar to the one

that has been developed for personal injury actions.” O’Brien v. Eli Lilly & Co.,

668 F.2d 704, 711 (3d Cir. 1981).

The focus of the exception “is not on what is promised, but on the

duration of the promise—i.e., the period to which the promise extends.”

Nationwide Ins. Co. v. Gen. Motors Corp./Chevrolet Motor Div., 625 A.2d 1172,

1176 (Pa. 1993) (citation omitted). A defendant’s express warranty that a

medical device is a “permanent” implant may establish that the warranty

extends to future performance. See Goodling, 2022 WL 414285, at *12;

McLaughlin v. Bayer Essure, Inc., No. 14-cv-7316, 2019 WL 1382710, at *8

(E.D. Pa. Mar. 27, 2019). However, because a warranty extension is “an

exception to the general rule,” it must be “strictly construed.” Zawadzki v.

Ethicon, Inc., No. 92-cv-6453, 1994 WL 77350, at *3 (E.D. Pa. Mar. 11, 1994).

Thus, “a bare statement of how a good will perform after delivery does not

constitute an explicit extension forward,” particularly where it “fails to state

clearly and unambiguously a period of time during which the warrant[y] will be

in force.” Id. at *5 (citing Nationwide, 625 A.2d at 1176 and Patton v. Mack

Trucks, Inc., 519 A.2d 959, 964 (Pa. Super. Ct. 1986) (additional citation

omitted)).

Here, Mills’s mesh device was implanted in March 2013. Therefore, the

statute of limitations on Mills’s breach of express warranty claim expired in

March 2017, before the filing of this action—unless the future-performance

exception applies. In order for that exception to apply, Atrium and Maquet

must have made an explicit warranty of future performance. Mills asserts that

they did because “this mesh was designed as a permanent implant.” (Pl. Op. p.

25.)

“Any affirmation of fact or promise made by the seller to the buyer which

relates to the goods and becomes part of the basis of the bargain creates an

express warranty that the goods shall conform to the affirmation or promise.”

13 Pa. Cons. Stat. Ann. § 2313(a). A promise is the “basis of the bargain if the

plaintiff can prove ‘that she read, heard, saw or knew of the advertisement

containing the affirmation of facts or promise.’” Gross v. Stryker Corp., 858 F.

Supp. 2d 466, 501 (W.D. Pa. 2012) (quoting Parkinson v. Guidant Corp., 315 F.

Supp. 2d 741, 752 (W.D. Pa. 2004)).

Thus, Pennsylvania law requires explicitness in the making of an express

warranty: “Absent a demonstration that a promise or affirmative statement was

made, how or by whom the promise was made, or what was in fact promised, a

claim for breach of express warranty is not sufficiently pled.” Gross, 858 F.

Supp. 2d at 501–02. As I stated in my motion to dismiss opinion, “[a] plaintiff

bringing an express warranty claim is saying that she bought the product

based on a statement or promise by the defendant that turned out to be

untrue. It is not too much to expect the plaintiff to identify that statement or

promise.” (DE 38 p. 34.) Fact discovery is now complete, and no such explicit

statement or promise has emerged from the evidence.

In Drumheller, the plaintiff alleged that the defendant warranted, among

other things, that the plaintiff’s pelvic mesh product “will permanently cure or

alleviate” her medical condition and “would not need to be partially removed.”

2021 WL 1853407, at *14. The court nevertheless determined that the plaintiff

failed to allege an express warranty because she did not “provide the specific

warranties on which she allegedly relied” and did not “allege the specific

materials containing these warranties, nor [did] she allege how she became

aware of these materials.” Id. at *15. Courts have also found that a warranty

that a suture will provide “lasting strength” or a warranty that a hip implant

“would not fail” did not qualify as extended warranties under Pennsylvania law.

See Zawadski, 1994 WL 77350, at *5; Horsmon v. Zimmer Holdings, Inc., No.

11-cv-1050, 2012 WL 423434, at *3–*5 (W.D. Pa. Feb. 8, 2012).

Like the plaintiff in Drumheller, Mills fails to point to any specific

warranty or statement on which she relied that stated any particular duration,

let alone permanence. (See Pl. St. ¶¶ 5–9, 16, 35–37, 49–53, 57.) The testimony

and other documents to which Mills cites do not contain any representation

made by defendants to Dr. Schuricht or any representation “that the ProLite

mesh used in [Plaintiff’s] surgery was intended to be permanent.” (See Pl. St. ¶

53; Benak Decl. Ex. 22, Dr. Schuricht Dep. Tr. 16:14-20:19; Ex. 31, Atrium’s

mesh device Instructions for Use (hereinafter, “IFU”); Ex. 27 p. 6,

LyondellBasell Product Stewardship Bulletin (stating that the polypropylene

used in the ProLite mesh “may not be used in . . . applications involving

permanent implantation into the body”).) Because Mills fails to identify an

explicit warranty of future performance made by Atrium or Maquet, plaintiff’s

breach of express warranty claim is barred by the statute of limitations.

Therefore, summary judgment is granted in favor of Atrium and Maquet

on the breach of express warranty claim (Count Two).

C. Merits of the Remaining Claims

The negligence claim encompasses two alternative theories.

Defendants’ motion for summary judgment is denied as to the claim of

failure to warn, but granted as to the claim of defective design.

Negligent Failure-to-Warn Claim

Defendant moves for summary judgment on Mills’s negligent failure-to-

warn claim for lack of evidence of causation. (Def. Br. p. 9.)

Under Pennsylvania law, to maintain a negligence claim, a plaintiff must

show (1) that the defendant had a duty “to conform to a certain standard of

conduct”; (2) that the defendant breached the duty; (3) that such breach

caused the injury in question; and (4) actual loss or damage. Phillips v. Cricket

Lighters, 841 A.2d 1000, 1008 (Pa. 2003). “[A] cause of action for negligence

must fail unless defendant’s conduct is shown to have been the . . . cause of

plaintiff[’]s injury.” Kester v. Zimmer Holdings, Inc., No. 10-cv-523, 2010 WL

2696467, at *6 (W.D. Pa. June 16, 2010) (quoting Long v. Krueger, Inc., 686 F.

Supp. 514, 517 (E.D. Pa. 1988)). “[A]bsent such identification, there can be no

allegations of duty, breach of duty or legal causation, and hence there can be

no liability.” Id. (citing Cummins v. Firestone Tire & Rubber Co., 495 A.2d 963,

967–68 (Pa. Super. Ct. 1985)).

To establish proximate causation, a plaintiff asserting a failure-to-warn

claim must demonstrate that the “user of the product would have avoided the

risk had he been advised of it by the seller.” Jeter v. Brown & Williamson

Tobacco Corp., 113 F. App’x 465, 467–68 (3d Cir. 2004). The “evidence must be

such as to support a reasonable inference, rather than a guess,” that an

adequate warning would have prevented the injury. Staymates v. ITT Holub

Indus., 527 A.2d 140, 147 (Pa. Super. Ct. 1987). For a negligent failure-to-warn

claim, 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., 671 A.2d 1151, 1155 (Pa. Super. Ct. 1996) (quoting

Mazur v. Merck & Co. Inc., 742 F. Supp. 239, 262 (E.D. Pa. 1990)). “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 Pracs. & Prod. Liab. Litig., 639 F. App’x 874, 878 (3d Cir. 2016) (quoting

Lineberger v. Wyeth, 894 A.2d 141, 150 (Pa. Super. Ct. 2006); Demmler, 671

A.2d at 1156).

Under the learned intermediary doctrine, “a manufacturer will be held

liable only where it fails to exercise reasonable care to inform a physician of the

facts which make the drug likely to be dangerous.” Gurley v. Janssen Pharms.,

Inc., 113 A.3d 283, 292–93 (Pa. Super. Ct. 2015) (quoting Cochran v. Wyeth,

Inc., 3 A.3d 673, 676 (Pa. Super. Ct. 2010)). Forearmed with adequate

warnings from the manufacturer, the physician then takes on the

responsibility to warn the patient. “[T]he determination of whether a warning is

adequate is initially a question of law.” Ebert v. C.R. Bard, Inc., 459 F. Supp. 3d

637, 647 (E.D. Pa. 2020). “For a warning to be adequate as a matter of law . . .

it must: (1) accurately and unambiguously convey the scope and nature of the

risk, and (2) state the risk with sufficient specificity.” Schrecengost v. Coloplast

Corp., 425 F. Supp. 3d 448, 462 (W.D. Pa. 2019). “[W]here fact questions exist

(e.g., regarding the sufficiency of the warning for a particular risk identified in

the label and whether the warning was diluted by marketing representations),

the question of adequacy is one for the jury.” In re Avandia Mktg., Sales

Practices & Prods. Liab. Litig., 817 F. Supp. 2d 535, 545–46 (E.D. Pa. 2011).

“The adequacy of a warning is determined based on what the manufacturer

knew, or should have known, about a given risk at the time the patient was

prescribed the medical device, and whether the label warned of that risk.” Ebert

v. C.R. Bard, Inc., 459 F. Supp. 3d 637, 647 (E.D. Pa. 2020).

Defendants argue that summary judgment is appropriate because Dr.

Schuricht testified during his deposition that “he was aware of the risks of

hernia repair and ProLite, including risk of the conditions Plaintiff alleges she

sustained because of ProLite—seroma, infection, additional surgery, scar

formation, pain, and hernia recurrence.” (Def. St. ¶ 6; Pl. Resp. ¶ 6.)

Defendants also rely on Dr. Schuricht’s deposition testimony that the ProLite

label “adequately warned [him] of the adverse reactions and complications that

were possible with” ProLite and that “a different warning would not have

impacted his treatment decisions.” (Def. Br. p. 11–12; see Def. St. ¶¶ 7–8; Pl.

Resp. ¶¶ 7–8.)

However, Dr. Schuricht also testified that, “[h]ad there been a risk the

mesh was not sterile, he would not have used it.” (Pl. Op. p. 6; see Pl. St. ¶¶ 5–

6; Def. Resp. ¶¶ 5–6.)6 Mills argues that “Dr. Schuricht assumed that the

Atrium mesh he implanted in [her] was sterile” based on the IFU, which states:

“Atrium Polypropylene Monofilament Surgical Mesh is a sterile, non-

absorbable, knitted polypropylene monofilament mesh material for tissue

reinforcement. . . . Atrium Mesh is contraindicated where tissue may be

contaminated or infected . . . . Complications that may occur with the use of

any surgical mesh include, but are not limited to, inflammation, infection or

mechanical disruption of the tissue and/or mesh material, possible adhesions

when placed in direct contact with the viscera (intestines).” (See Benak Decl.

Ex. 31.)

Additionally, Mills asserts that Dr. Schuricht did not know about an

October 11, 2012, warning letter from the Food and Drug Administration

6 Less pertinent is Mills’s citation of Dr. Schuricht’s tautological deposition

testimony that he should have been warned about matters he should have been

warned about:

Q. [I]f there is additional risk that has not been described to you in these IFUs,

or additional risk that you were not aware of them, based on knowledge within

the medical community, would you like to know that before you decide to use

this mesh? . . .

A [by Dr. Schuricht]. Certainly if there are issues that should be known, I would

like to know about them.

(Benak Decl. Ex. 22, Dr. Schuricht Dep. Tr. 107:16–108:5; see Pl. St. ¶ 7; Def. Resp. ¶

7.)

(“FDA”) to Atrium (the “Warning Letter”), which states that, during an

inspection of Atrium, FDA investigators noted violations, including “not

adequately validat[ing] your current Ethylene Oxide (ETO) sterilization process

that is used to sterilize all thirty nine (39) of your medica[l] devices.” (Benak

Decl. Ex. 3.; see Pl. St. ¶ 8; Def. Resp. ¶ 8; Ex. 22 Dr. Schuricht Dep. Tr.

110:1–10.).) After reviewing the Warning Letter and Atrium’s “FDA Sterilization

Response Quality Plan” (see Benak Decl. Exs. 3 and 4), Dr. Schuricht testified

that, had he been aware of those documents, “it would have raised a level of

concern,” although assurances from the manufacturer and FDA, if given, might

have allayed that concern:

A [by Dr. Schuricht]. [B]ut I was not aware of this

contemporaneous with Ms. Mills’ surgery in March of 2013.

Q. Yeah, I know, and . . . now that you’ve seen it, would that have

impacted your decision to use the product? . . .

A. You know, it would have raised a level of concern, but if I had

the reassurances from the manufacturer and the FDA that the

products that were currently out were safe and posed no risk to

the patient, I would be happy and fine and comfortable to continue

to use the product.

Q. Okay. Did you ever seek assurances from the manufacturer or

the FDA in case? . . .

A. Personally, no.

(Benak Decl. Ex. 22, Dr. Schuricht Dep. Tr. 121:1–22.) According to Mills, “Dr.

Schuricht’s assumption that the mesh was sterile as represented by the

manufacturer, renders his opinion at best unreliable and at worst

meaningless.” (Pl. Op. pp. 6–7.)

After review of the record, a genuine dispute remains regarding whether

Dr. Schuricht would have altered his treatment decisions if he had received

additional warnings that the mesh used during Mills’s 2013 hernia repair

surgery may not have been sterile. Mills cites, for example, FDA warnings

about Atrium’s sterile procedures, of which Dr. Schuricht was not aware.

Although Dr. Schuricht testified that Mills’s ProLite label “had adequate

warnings and a different warning would not have impacted his treatment

decisions,” he also testified that, if he had known about the Warning Letter and

Atrium’s “FDA Sterilization Response Quality Plan,” “it would have raised a

level of concern,” even if hypothetical additional advice might have relieved that

concern. (See Def. St. ¶ 8; Pl. Resp. ¶ 8; Benak Decl. Ex. 22, Dr. Schuricht

Dep. Tr. 121:1–22.)

Therefore, because there are issues of fact that bear on whether the

warning provided to Dr. Schuricht was adequate and whether a different

warning would have altered Dr. Schuricht’s decision, I will deny defendants’

motion for summary judgment on Mills’s negligent failure-to-warn claim.

Negligent Design Claim

Defendant moves for summary judgment on Mills’s negligent design

claim for lack of evidence of a safer alternative design. (Def. Br. p. 12.) As to

this alternative negligence theory, Defendants’ motion is granted.

To establish a negligent design claim under Pennsylvania law, “a plaintiff

must demonstrate that the defendant breached its duty of care in designing the

product, and that the breach caused her injuries.” Schrecengost v. Coloplast

Corp., 425 F. Supp. 3d 448, 461 (W.D. Pa. 2019) (citing Phillips v. Cricket

Lighters, 841 A.2d 1000, 1008 (Pa. 2003)). Specifically, the plaintiff must show

that the defendant “failed to exercise reasonable care in the adoption of a safe

design.” McGrain v. C.R. Bard, Inc., 551 F. Supp. 3d 529, 541 (E.D. Pa. 2021).

“To establish a breach of a duty of care, plaintiffs may, but are not

required to, present evidence of a safer alternative design that the defendant

could have adopted.” Schrecengost v. Coloplast Corp., 425 F. Supp. 3d 448, 461

(W.D. Pa. 2019) (citing Tincher v. Omega Flex, Inc., 104 A.3d 328, 398 (Pa.

2014); Lance v. Wyeth, 85 A.3d 434, 458 n.36 (Pa. 2014)). In the extreme case

where a plaintiff “proceed[s] under the theory that the product was too

dangerous to market, then by definition no alternative design is necessary.”

Spear v. Atrium Med. Corp., 621 F. Supp. 3d 553, 559 (E.D. Pa. 2022) (citing

Habecker v. Clark Equip. Co., 942 F.2d 210, 215 (3d Cir. 1991)). However, if a

plaintiff “argue[s] the product could have been marketed safely with better

design, they will ultimately bear the burden of proving a feasible alternative

design.” Id. “To meet this requirement, a plaintiff must do more than ‘baldly

stat[e] that there are safer alternatives’; they must provide factual support

demonstrating those alternatives exist.” Eng. v. Eisai, Inc., No. 21-cv-923, 2022

WL 780667, at *3 (M.D. Pa. Mar. 14, 2022) (quoting Salvio v. Amgen, Inc., 810

F. Supp. 2d 745, 754 (W.D. Pa. 2011)).

Here, Mills does not dispute that she must show a feasible alternative

design, and her brief confirms that she is basing her claim on the availability of

such an alternative design:

Defendant’s conduct was not just negligent, it was intentional,

willful and reckless. Knowing the raw material for its mesh

products, including ProLite, was restricted by the manufacturer for

implantation, knowing PPL tended to degrade in the body,

knowing--as it must have--the existence of PVDF and its superior

properties, it continued to sell a medical product for human

implantation made from material it knew was not just questionable

but prohibited, when another potentially superior material was

available.

(Pl. Op. p. 17 (emphasis added).) Therefore, I will consider whether Mills has

provided sufficient evidence of a feasible alternative design to survive summary

judgment.

Mills relies on the deposition testimony of her expert Dr. Guelcher

regarding the use of the material polyvinylidene fluoride (“PVDF”) as an

alternative to polypropylene, the material used for ProLite mesh. (Pl. Op. p. 15;

see Pl. St. ¶¶45-48.) Defendants respond that Dr. Guelcher did not identify

PVDF as a feasible alternative design.7 (Def. Reply p. 13; see Benak Decl. Ex.

24 Dr. Guelcher Dep. Tr. 194:2–8, 195:4–196:2.)

7 Defendants also assert, for the first time in their reply brief and without

elaboration, that “an expert report cannot be backfilled at deposition.” (Def. Reply p.

13 (citing Bedell v. Long Reef Condo. Homeowners Ass’n, 2014 WL 1715441, at *6

(D.V.I. 2014) and Ciomber v. Coop. Plus, Inc., 527 F.3d 635, 642 (7th Cir. 2008)). In

The evidence in the record shows that Dr. Guelcher identified PVDF as a

potentially better material than polypropylene for a mesh device but failed to

offer any testimony to support that the use of PVDF is feasible. During his

deposition, Dr. Guelcher acknowledged that the use of PVDF has not been fully

investigated or tested on humans; he also refused to testify that PVDF was the

“solution” without further testing:

Ciomber, the Seventh Circuit stated that later deposition testimony cannot be used to

cure a deficient expert report:

Rule 26(a)(2) does not allow parties to cure deficient expert reports by

supplementing them with later deposition testimony. The purpose of Rule

26(a)(2) is to provide notice to opposing counsel—before the deposition—

as to what the expert witness will testify, and this purpose would be

completely undermined if parties were allowed to cure deficient reports

with later deposition testimony. Allowing parties to cure a deficient report

with later depositions would further undermine a primary goal of Rule

26(a)(2): “to shorten or decrease the need for expert depositions.” After

all, the parties’ need for expert depositions would increase if they could

use deposition testimony to provide information they should have

initially included in their Rule 26(a)(2) report.

527 F.3d at 642 (internal citations omitted).

The U.S. Court of Appeals for the Third Circuit, however, does not automatically

bar consideration of such evidence. See Pritchard v. Dow Agro Scis., 263 F.R.D. 277,

282 & n.4 (W.D. Pa. 2009). When presented with a similar issue, the Third Circuit

concluded that exclusion of critical expert evidence is an “extreme” sanction. ZF

Meritor, LLC v. Eaton Corp., 696 F.3d 254, 297 (3d Cir. 2012). Prior to excluding such

evidence, the court must consider:

(1) “the prejudice or surprise in fact of the party against whom the

excluded witnesses would have testified” or the excluded evidence would

have been offered; (2) “the ability of that party to cure the prejudice”; (3)

the extent to which allowing such witnesses or evidence would “disrupt

the orderly and efficient trial of the case or of other cases in the court”;

(4) any “bad faith or willfulness in failing to comply with the court's

order”; and (5) the importance of the excluded evidence.

Id. at 298; see also Lamb v. Montgomery Township, 734 F. App’x 106, 110–11 (3d Cir.

2018). None of these factors are addressed by defendant. Therefore, I will consider the

deposition testimony of Dr. Guelcher on this basis, despite its suspect timing. I

nevertheless find it lacking.

Q. Okay. And you are not offering any opinions in this case that

there is a different hernia device that would offer less severe

potential complications, right?

A [by Dr. Guelcher]. Well, I do believe that PVDF is potentially a

better material for this device. It hasn’t been fully investigated. I

believe there are better options than polypropylene mesh because

it changes after it’s implanted, and that’s unpredictable. The

effects of it are unpredictable. . . . So it’s not a great choice.

Q. Okay. You are not testifying that PVDF would have less severe

complications in total when you can’t point to any studies or any

use in humans, right?

A: . . . I said it’s less susceptible to these problems. They should be

investigated as an alternative, but it’s not, so --

Q. You don’t know if PVDF has other problems, because you don’t

know of any testing in humans, right?

A. Well, it looks promising in the preclinical studies. In the human

studies, they haven’t been done, to my knowledge. So you would

have to look for other problems. I can’t say that it’s the solution

without the testing, but based on its material properties, I think it

offers a lot of advantages. That’s what I would say.

(Benak Decl. Ex. 24, Dr. Guelcher Dep. Tr. 205:5–206:13.)

Q: You haven’t seen any data as to how PVDF meshes perform in

people, right?

A: I can’t remember any studies off the top of my head.

Q: Okay. And so I assume you are not offering any opinion as to

how PVDF performs in people, right?

A: Well, that’s not really true either. I believe based on two things;

one, it is well known to be far less susceptible to oxidative

polypropylene; two, if the clinical study showed really no

measurable oxidative degradation, that would tell me that ‘a

potential candidate for clinical development, and making a mesh is

going to be a better material. Now, there could be other problems

that come up in clinical testing. I don’t know, but at least based on

those data, it certainly looks better opportunity, better material

selection than polypropylene, but that has to be shown in clinical

studies.

Q: Okay. So your opinion is that it is a potential material, but you

are not saying, I have looked at it and I am telling you it’s my

opinion that this is a better material to be used for hernia mesh.

A: It could be, but it hasn’t been studied in enough detail.

(Id. at 194:25–196:2.)

“Could be” won’t cut it. The question here is whether “an alternative,

feasible, safer design” would have lessened Mills’s injury. See Salvio, 810 F.

Supp. at 754 (emphasis added). Identifying PVDF as an alternative material is

not enough; Mills must provide some factual support that such an alternative

exists. See id. Mills has failed to do so. Defendants have demonstrated the

absence of evidence of feasibility of using PVDF as an alternative to

polypropylene. Mills has not responded with any evidence that her proffered

alternative design is feasible.

To turn the argument around, plaintiff is claiming that to avoid a claim

of negligent design, the manufacturer was required to employ an untested

alternative. That is not a viable, acceptable standard of care.

Because there is a failure of proof concerning whether Mills’s proffered

alternative design is feasible, which is a required element, summary judgment

is granted in favor of Atrium and Maquet on the negligent design claim.

CONCLUSION

For the reasons set forth above, Atrium and Maquet’s motion for

summary judgment is GRANTED in part and DENIED in part.

An appropriate order follows.

Dated: June 22, 2023

/s/ Kevin McNulty

___________________________________

Hon. Kevin McNulty

United States District Judge