# SCHRECENGOST v. COLOPLAST CORPORATION

> District Court, W.D. Pennsylvania · December 2, 2019

URL: https://www.frixlaw.com/law-library/cases/10415200

## Case

- **Court:** District Court, W.D. Pennsylvania
- **Decided:** December 2, 2019
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

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## How later opinions describe it (automated extraction)

- holding that a warning to call a doctor if complications arose was not an adequate warning because it did not tell the user to stop taking the drug
- noting that a party opposing summary judgment “must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue”

## Opinion text

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
DEBORAH SCHRECENGOST and ) Case No. 3:17-cv-220
ROGER SCHRECENGOST, )
)
Plaintiffs, ) JUDGE KIM R. GIBSON
)
v. )
)
COLOPLAST CORPORATION and )
COLOPLAST MANUFACTURING US, )
LLC, )
)
Defendants. )
MEMORANDUM OPINION
I. Introduction
This case arises from Plaintiff Deborah Schrecengost’s alleged injuries resulting from
complications from a surgery to treat her stress urinary incontinence (“SUI”) with Defendants’
Aris Transobturator Sling System (“Aris”), a prescription-only surgical mesh implant. Pending
before the Court are Defendants’ Motion to Exclude Opinions and Testimony of Dr. Grant
Campbell (ECF No. 61), Motion to Strike Plaintiffs’ Proposed Sur-Reply and to Exclude from Trial
the Untimely Expert Opinions of Dr. Michael Margolis (ECF No. 93), and Motion for Summary
Judgment. (ECF No. 63.) The Motions are fully briefed (ECF Nos. 62, 64, 70, 73, 79, 80, 92, 94, 98-
1, 102) and ripe for disposition. For the reasons that follow, the Court DENIES Defendants’
Motions.
II. Jurisdiction and Venue
This Court has subject-matter jurisdiction because the parties are diverse and the amount
in controversy exceeds $75,000. 28 U.S.C. § 1332. Venue is proper because the case was

transferred to the Western District of Pennsylvania, where a substantial part of the events giving
rise to Plaintiff's claims occurred. 28 U.S.C. § 1391(b)(2), § 1404(a).
III. Factual Background
The following facts are undisputed unless otherwise noted.'
A. Mrs. Schrecengost’s Surgery
On November 3, 2008, Dr. Jeffrey David performed pelvic reconstructive surgery on Mrs.
Schrecengost at Armstrong County Memorial Hospital in Kittanning, Pennsylvania, during
which he implanted Coloplast’s Aris to treat her SUI. (ECF No. 81] 1.) Aris is an FDA-cleared,
prescription-only surgical mesh implant indicated for pelvic reconstructive surgery, including
the procedure Dr. David performed on Mrs. Schrecengost. (Id. [ 2.) The Aris is the only surgical
mesh implant Dr. David has ever used to treat female SUI and he still uses it to surgically treat
SUI. (Id. {{ 3-4.) Because the Aris implant surgery is an elective surgery, not an emergency
surgery, Dr. David stated that he would mention any extraordinary risks to his patients. (Id. New
Matter { 6.)
Defendants assert, and Plaintiffs deny, that prior to performing her November 3, 2008
surgery, Dr. David consulted with Mrs. Schrecengost three times regarding the potential risks of

' The Court derives these facts from a combination of Defendants’ Concise Statement of Undisputed
Material Facts in Support of Their Motion for Summary Judgment (ECF No. 65), Plaintiffs’ Response to
Defendants’ Concise Statement of Facts in Support of Their Opposition to Defendants’ Motion for
Summary Judgment (ECF No. 72-2), Defendants’ Reply to Plaintiffs’ Response to Defendants’ Concise
Statement of Material Facts in Further Support of Their Motion for Summary Judgment and Response to
Plaintiffs’ Concise Statement of Facts (ECF No. 81), Plaintiffs’ Supplemental Statement of Material Facts
Regarding Dr. Michael Thomas Margolis’s Expert Report and His Examination of Deborah Schrecengost
(ECF No. 104), Defendants’ Response to Plaintiffs’ Supplemental Statement of Material Facts Regarding Dr.
Margolis (ECF No. 109). When referring to the New Matter Plaintiffs raise in response, the Court will refer
to it as (ECF No. 81 New Matter) with the appropriate reference.
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using the Aris to treat her SUI, specifically warning her about dyspareunia, which is painful
sexual intercourse, and chronic pelvic pain. (Id. { 6.) Defendants assert that Dr. David had no
recollection of reading or referring to the Aris Instructions for Use (“IFU”) prior to performing
Mrs. Schrecengost’s 2008 surgery; Plaintiffs respond that Dr. David reviewed the Aris IFU prior
to Mrs. Schrecengost’s surgery and relied on the directions and warnings that came with the Aris.
(Id. 7.) Dr. David testified that he relies in part on the warnings he receives from Defendants
with their devices and that the warnings should list any complication with the frequency or
severity that has some impact on the risk and benefit discussion that doctors have with their
patients. (Id. New Matter 11 11-12.) Defendants assert that Mrs. Schrecengost gave her informed
consent to proceed with the 2008 surgery. (Id. J 8.) Plaintiffs state that although Mrs.
Schrecengost signed the consent form, Dr. David did not warn her of the risk that the Aris mesh
could degrade over time. (Id.)
On August 23, 2016, Dr. Michael Bonidie performed a resection of Mrs. Schrecengost’s
Aris at University of Pittsburgh Medical Center because she was experiencing pain. (Id. 9-
10.) Defendants assert that Dr. Bonidie found no evidence that Mrs. Schrecengost’s Aris had
become infected or exposed, or that it had eroded, extruded, or degraded. (Id. { 11.)
B. Medical Risks of the Aris
Plaintiffs assert that Defendants had paid consultants who expressed concerns about
safety issues associated with the Aris and that Defendants failed to include significant risks in its
IFU related its products, including injury in the form of life-long, late infections. (Id. New Matter
{1 7-8.) Plaintiffs assert that Coloplast significantly downplayed the risks that it listed in its IFU
and that the IFUs did not include sufficient information to advise physicians on the permanence,
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frequency, or severity of the complications that can arise from the use of its devices. (Id. New
Matter JJ 9-10.)
Plaintiffs assert that Defendants’ internal company documents and company witnesses
confirm that Defendants knew of the risks and complications associated with the Aris yet
continued to market and sell the device. (Id. New Matter J 14.) At a 2008 Women’s Health
Advisory Board Meeting, several doctors warned Defendants about the use of heavier weight
mesh, like the kind used in the Aris, and its relationship to increased erosion rates. (Id. New
Matter { 21.) Dr. Bruce Rosenzweig testified to the potential dangers of the heavy-weight, small

pore polypropylene mesh Defendants used in the Aris, calling the devices “unreasonably
dangerous.” (Id. New Matter { 20.) Plaintiffs assert that the effects of chemical and biological
degradation of the mesh in a woman’s tissues can lead to a greater foreign body reaction,
enhanced inflammatory response, and excessive scarring, which can lead to severe complications
in patients, like Mrs. Schrecengost’s complications. (Id. New Matter JJ 4-5.)
Additionally, Plaintiffs assert that Defendants knew that lighter weight mesh alternatives
existed prior to November 2008. (Id. New Matter { 17.) Plaintiffs assert that Defendants had an
opportunity to purchase “gold standard” mini-sling intellectual property that had the potential
to reduce or eliminate adverse risks to patients, but that they failed to implement these alternative
designs. (Id. New Matter { 15.) Plaintiffs assert that the Ultrapro, a similar medical device, is an
example of a safer alternative design for use in the treatment of SUI in women. (Id. New Matter
q 18.)

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Mrs. Schrecengost testified that if she had been informed of the true risks associated with
the Aris, such as permanent vaginal pain, permanent pelvic pain, and permanent dyspareunia,
she would not have consented to the Aris implantation surgery. (Id. New Matter { 13.)
C. Mrs. Schrecengost’s Post-Resection Medical Examinations
On February 7, 2019, Dr. Grant Campbell, M.D., an obstetrician and gynecologist,
performed a medical exam on Mrs. Schrecengost. (ECF No. 66-13 at 1.) He issued a report on
February 28, 2019, opining that the Aris caused Mrs. Schrecengost’s pelvic injuries. (ECF No. 66-
12 at 5.) Dr. Campbell reached his conclusion by performing a differential diagnosis, which
involved looking at Mrs. Schrecengost’s symptoms and ruling out possible alternative causes of
her symptoms to determine the cause. (See id.)
In late August 2019, Mrs. Schrecengost reported to Plaintiffs’ counsel that her symptoms
had increased in severity since her February 2019 visit with Dr. Campbell, reporting a recent onset
of heavy vaginal bleeding and increased pain.? (ECF No. 104 { 1.) Dr. Michael Margolis, M.D., a
board certified urogynecologist, performed an independent medical exam of Mrs. Schrecengost
on September 3, 2019. (Id. [ 2.) At mediation on September 18, 2019, Plaintiffs’ counsel advised
defense counsel that Mrs. Schrecengost had a change in condition with worsening symptoms and
that Mrs. Schrecengost had been examined by a potential new expert who was going to issue a
report after reviewing Mrs. Schrecengost’s medical records. (Id. J 4.) Plaintiffs’ counsel also
offered Defendants the opportunity to perform their own medical examination of Mrs.
Schrecengost. (Id.)

2 Defendants deny most of Plaintiffs’ statements regarding Dr. Margolis. (See ECF No. 109.)
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On October 2, 2019, Dr. Margolis issued an expert report detailing his physical
examination of Mrs. Schrecengost and discussing his opinions that the Aris sling contributed to
her injuries. (Id. [ 5.) In his report, Dr. Margolis noted injuries attributable to the Aris sling which
were developing but not yet present during Dr. Campbell’s examination eight months earlier.
(Id. J 7.) On October 16, 2019, Plaintiffs disclosed Dr. Margolis as an expert. (Id. 1 6.) Since the
disclosure, Mrs. Schrecengost has seen, or is scheduled to be seen by, doctors on multiple dates
throughout October and November of 2019 regarding her pelvic pain. (Id. J 18.)
IV. Procedural Background
On August 31, 2017, Plaintiffs filed the Complaint (ECF No. 1), in the United States District
Court for the Eastern District of Pennsylvania. On November 20, 2017, that court transferred the

case to this Court (ECF No. 12), and the Defendants filed their Answer on December 4, 2017 (ECF
No. 14). On June 14, 2019, the parties stipulated to a dismissal with prejudice of nine counts in
the Complaint, and three further counts on October 28, 2019, leaving only the claims for Strict
Liability - Defective Design (Count I); Strict Liability - Failure to Warn (Count II); Negligence
(Count III); and Loss of Consortium (Count XIV). (See ECF Nos. 59, 60, 96, 97.)
Defendants moved to exclude the opinions and testimony of Dr. Grant Campbell on June
21, 2019, and moved for summary judgment that same day. (ECF Nos. 61, 63.) Plaintiffs
responded in opposition to both motions on July 22, 2019 (ECF Nos, 69, 72), to which Defendants
replied on July 31, 2019. (ECF No. 79, 81.) Plaintiffs filed a Sur-Reply on October 22, 2019 (ECF
No. 92), which Defendants moved to strike on October 24, 2019 (ECF No. 93). Plaintiffs responded
in opposition to the Motion to Strike on October 30, 2019 (ECF No. 98), to which Defendants
replied on November 6, 2019. (ECF No. 102.)
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V. Legal Standards
A. Expert Opinion
Under the Federal Rules of Evidence, a trial judge acts as a “gatekeeper” to ensure that
“any and all expert testimony or evidence is not only relevant, but also reliable.” Pineda v. Ford
Motor Co., 520 F.3d 237, 244 (3d Cir. 2008) (quoting Kannankeril v. Terminex Int'l, Inc., 128 F.3d 802,
806 (3d Cir. 1997)). Therefore, when a party seeks to admit expert testimony, the Court must
make a preliminary determination that the proffered expert meets the requirements of Rule 702.
Magistrini v. One Hour Martinizing Dry Cleaning, 68 F. App’x 356, 356 (3d Cir. 2003) (citing Daubert

v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592 (1993)). Rule 702 allows a qualified expert to testify
in the form of an opinion if:
(a) the expert’s scientific, technical, or other specialized knowledge will help the
trier of fact to understand the evidence or to determine a fact in issue; (b) the
testimony is based on sufficient facts or data; (c) the testimony is the product of
reliable principles and methods; and (d) the expert has reliably applied the
principles and methods to the facts of the case.
Fed. R. Evid. 702(a).
The Third Circuit has interpreted Rule 702 as having three major requirements. Pineda,
520 F.3d at 244. First, the proffered witness must be qualified as an expert. Id. Second, the expert
must testify about matters requiring scientific, technical, or specialized knowledge and base his

or her opinions on reliable processes and techniques. Id. Third, the expert's testimony must assist
the trier of fact. Id. The party offering the expert must prove each of these requirements by a
preponderance of the evidence. Mahmood v. Narciso, 549 F. App’x 99, 102 (3d Cir. 2013) (citing In

re TMI Litig., 193 F.3d 613, 663 (3d Cir. 1999)).

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Rule 702 has “a liberal policy of admissibility.” Pineda, 520 F.3d at 243 (citing Kannankeril,
128 F.3d at 806). Exclusion of expert testimony is the exception rather than the rule because
“vigorous cross-examination, presentation of contrary evidence, and careful instruction on the
burden of proof are the traditional and appropriate means of attacking shaky but admissible
evidence.” Fed. R. Evid. 702 advisory committee’s note to 2000 amendment (citing Daubert, 509
USS. at 595),
B. Summary Judgment
This Court will grant summary judgment “if the movant shows 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); Melrose, Inc. v. Pittsburgh, 613 F.3d 380, 387 (3d Cir. 2010) (quoting Ruehl v. Viacom,
Inc., 500 F.3d 375, 380 n.6 (3d Cir. 2007)); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).
There is a genuine issue of fact “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); see
also McGreevy v. Stroup, 413 F.3d 359, 363 (3d Cir. 2005). Material facts are those that affect the
outcome of the trial under governing law. Anderson, 477 U.S. at 248. The Court's role is “not to
weigh the evidence or to determine the truth of the matter, but only to determine if the evidence
of record is such that a reasonable jury could return a verdict for the nonmoving party.” Am.
Eagle Outfitters v. Lyle & Scott Ltd., 584 F.3d 575, 581 (3d Cir. 2009). In deciding a summary
judgment motion, this Court “’must view the facts in the light most favorable to the nonmoving
party and draw all inferences in that party's favor.” Farrell v. Planters Lifesavers Co., 206 F.3d 271,
278 (3d Cir. 2000) (quoting Armbruster v. Unisys Corp., 32 F.3d 768, 777 (3d Cir. 1994)).

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The moving party bears the initial responsibility of stating the basis for its motion and
identifying those portions of the record that demonstrate the absence of a genuine issue of
material fact. Celotex, 477 U.S. at 323. If the moving party meets this burden, the party opposing
summary judgment “may not rest upon the mere allegations or denials” of the pleading, but
“must set forth specific facts showing that there is a genuine issue for trial.” Saldana v. Kmart
Corp., 260 F.3d 228, 232 (3d Cir. 2001) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
USS. 574, 587 n.11 (1986)). “For an issue to be genuine, the nonmovant needs to supply more than

a scintilla of evidence in support of its position—there must be sufficient evidence (not mere
allegations) for a reasonable jury to find for the nonmovant.” Coolspring Stone Supply v. Am. States
Life Ins. Co., 10 F.3d 144, 148 (3d Cir. 1993); see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594
(3d Cir. 2005) (noting that a party opposing summary judgment “must present more than just
bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue”).
VI. Discussion
A. The Court Denies Defendants’ Motion to Exclude Opinions and Testimony of
Dr. Grant Campbell
1. The Parties’ Arguments
Defendants first argue that the Court should exclude Dr. Campbell’s testimony because
he lacks a reliable foundation and methodology to support any opinion he offers about the cause
of Mrs. Schrecengost’s alleged injuries.3 (ECF No. 62 at 9-10.) Defendants assert that because Dr.

3 It is within the discretion of a district court to determine whether a Daubert hearing is necessary to
determine if a proffered expert's testimony satisfies Rule 702. See Padillas v. Stork-Gamco, Inc., 186 F.3d 412,
417-18 (3d Cir. 1999). Here, the Court finds that it is unnecessary to hold a hearing on the admissibility of
Plaintiffs’ proffered expert testimony. The parties did not request a Daubert hearing and the Court is
satisfied that the briefing on the expert testimony in this case is sufficient to decide the Motion.
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Campbell did not review any of Mrs. Schrecengost’s medical history predating the implantation
of her Aris, his opinion about the causes of her current alleged injuries is unreliable. (Id. at 10-
11.) After Dr. Campbell saw Mrs. Schrecengost’s medical records at his deposition, he testified
that he could no longer opine with medical certainty that the Aris had caused some of her
complaints. (Id. at 14.) Defendants contend that there is no possible way that Dr. Campbell could
have reliably concluded that Mrs. Schrecengost’s Aris implant was the sole or primary cause of
all of her alleged injuries because Dr. Campbell did not review her medical history either before
he wrote his report or when Defendants deposed him.‘ (Id. at 15.)
Defendants next argue that the Court should exclude Dr. Campbell from testifying
because his report does not satisfy the requirements of Rule 26(a) because it fails to list his
qualifications or publications, include the necessary list of his prior case testimony, or provide his
rate of compensation. (Id. at 17.) Defendants assert that Dr. Campbell should not be able to file
an amended or supplemental report because the deadline for expert disclosures has already
passed. (Id. at 16.)
Plaintiffs assert that Dr. Campbell’s opinion is reliable because he reviewed all of the
records provided to him, including Mrs. Schrecengost’s medical records, as his report indicates.
(ECF No. 70 at 4-6.) Plaintiffs contend that Dr. Campbell considered the contents of each of the
records when performing his differential diagnosis and argue that whether he could recall certain

4 Defendants also assert that this Court should preclude Dr. Campbell from offering opinions that he has
testified that he will not offer or can no longer reliably offer. (ECF No. 62 at 15.) Plaintiffs state that Dr.
Campbell will not offer opinions inconsistent with his prior testimony and will not offer opinions on
subjects for which he is not an expert. (ECF No. 70 at 12.) Because experts may supplement or amend their
reports up to 30 days before trial under Rule 26, the Court holds that this request is premature and denies
it without prejudice.
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records at his deposition is not relevant to the reliability of his opinion. (Id. at 5-6.) Specifically,
that Dr. Campbell was aware of Mrs. Schrecengost’s prior history of dyspareunia from the 1990s
and that he determined that those complaints were resolved before her Aris implant surgery. (Id.
at 8.) He also ruled out her history of endometriosis, pelvic relaxation, and vaginal lacerations as
possible causes of her current dyspareunia. (Id. at 10-12.) Plaintiffs assert that because the record
shows that Dr. Campbell relied on these records in preparing his expert report, his opinions and
testimony are reliable and admissible. (Id. at 2.)
Plaintiffs next argue that whether an expert may file a supplemental report is not a proper
subject for a Daubert motion because it does not speak to the relevancy or reliability of Dr.
Campbell’s opinion. (Id. at 13.) Under Rule 26, Dr. Campbell has until 30 days before trial to
supplement his expert disclosures. (Id.) Plaintiffs further argue that any errors or omissions in
his expert disclosure were harmless, have already been cured, and do not warrant exclusion of
Dr. Campbell’s report because Defendants now possess Dr. Campbell’s testimonial history and
fee schedule and that this information was not withheld in bad faith. (Id. at 14-16.)
2. The Court Holds that Dr. Campbell’s Expert Opinion Is Reliable
The parties contest only the reliability of Dr. Campbell's differential diagnosis opinion.
Defendants do not challenge the differential diagnosis methodology, but instead argue that Dr.
Campbell did not reliably apply the differential diagnosis methodology to the facts of the case.
For a differential diagnosis to be reliable, the expert must “rule out alternative causes” by pointing
to a plausible alternative cause and explaining why that alternate cause was not the sole cause.
In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 759 n.27 (3d Cir. 1994). An expert need not rely on the

same information for each differential diagnosis for it to be reliable because “there will be some
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cases in which a physician can offer a reliable differential diagnosis without ever examining the
patient, looking at medical records, taking a medical history, and performing laboratory tests.”
Id. at 762. Moreover, a court should not exclude a medical expert’s causation conclusion solely
because he has failed to rule out every possible alternative cause of a plaintiff's injuries. Heller v.
Shaw Indus., Inc., 167 F.3d 146, 156 (3d Cir. 1999).
Here, the Court holds that Dr. Campbell reliably performed a differential diagnosis when
forming his expert opinion. Dr. Campbell’s expert report indicates that he reviewed Mrs.
Schrecengost’s pre-implant surgical history when forming his opinion. His report and testimony
show that he ruled out Mrs. Schrecengost’s history of endometriosis, pelvic relaxation, and
vaginal lacerations as possible causes of her current dyspareunia. The record establishes that Dr.
Campbell performed the differential diagnosis appropriately in reaching his conclusion that the
Aris was the cause of Mrs. Schrecengost’s recent dyspareunia. Defendants’ concerns with Dr.
Campbell's opinion are matters of weight, not admissibility. Whether Dr. Campbell’s conclusion
is credible is a matter for the trier of fact when Dr. Campbell is subject to cross-examination. See
In re TMI Litig., 193 F.3d at 665.
Accordingly, Plaintiffs have satisfied the burden under Rule 702 and Defendants’ Motion

to Exclude Dr. Campbell’s opinion and testimony is denied.5

5 The Court also holds that Dr. Campbell’s report contains no errors under Rule 26 that would require
exclusion of his testimony at trial. Defendants have obtained all the information required by the rule within
the appropriate timelines. The Court also holds that under Rule 26, Dr. Campbell may file a supplemental
or amended expert report 30 days before trial. See Fed. R. Civ. P. 26(a)(3)(B).
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B. The Court Denies Defendants’ Motion to Strike Sur-Reply and Exclude
Testimony of Dr. Michael Margolis
Defendants argue that the Court should strike Plaintiffs’ Sur-Reply because it fails to
satisfy the basic requirements for sur-replies.© (ECF No. 94 at 2.) Defendants contend that
Plaintiffs do not have a good faith justification for failing to abide by the deadlines and
procedures of the Court’s scheduling order and Federal Rules. (Id.) Defendants assert that
Plaintiffs’ late disclosure of Dr. Margolis would prejudice them because he opined that the Aris
caused new injuries and there would be no feasible way to correct the prejudice without
scrapping the trial schedule. (ECF No. 102 at 4.)
Plaintiffs respond that because of Mrs. Schrecengost’s recent change in medical condition,
Plaintiffs were within their right to have an expert such as Dr. Margolis perform an additional
medical examination and opine as to the cause of Mrs. Schrecengost’s recent change in condition.
(ECF No. 98-1 at 7.) Defendants have failed to articulate any extreme prejudice that would
necessitate striking Dr. Margolis’s expert report and Plaintiffs’ Sur-Reply. (/d.) Plaintiffs assert
that Dr. Margolis’s opinions do not change Plaintiffs’ theory of liability in this case. (Id. at 7-8.)
Moreover, to cure any minimal prejudice that might exist, Plaintiffs offer Dr. Margolis for
deposition and would allow Defendants to conduct their own medical examination of Mrs.
Schrecengost. (Id. at 8.)

6 The Court notes with disapproval the combative tone Defendants take towards Plaintiffs, their counsel,
and counsel’s law firm in their briefs. (See ECF Nos. 94, 102, 109.) For example, Defendants attack the
integrity and reputation of Plaintiffs’ law firm by accusing it of “gamesmanship” and “expert shopping”
across the federal court system. Use of such language goes beyond mere advocacy and is not behavior the
Court encourages nor finds persuasive. The Court reminds defense counsel that the Pennsylvania Code of
Civility requires that all lawyers practicing in Pennsylvania speak and write in a civil and respectful
manner in all communications with the court, and treat all participants in the legal process in a civil,
professional, and courteous manner at all times. See 204 Pa. Code § 99.3(1)-{2).
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The decision to strike briefing, including sur-replies, is within the sole discretion of the
district court. Venuto v. Carella, Byrne, Bain, Gilfillan, Cecchi & Stewart, P.C., 11 F.3d 385, 388 (3d
Cir. 1993). The Court denies Defendants’ motion to strike Plaintiffs’ Sur-Reply because the Sur-
Reply raises important issues about Mrs. Schrecengost’s injuries not known to Plaintiffs at the
time Plaintiffs filed their opposition to Defendants’ Motion for Summary Judgment.’ In personal
injury cases such as this one, a plaintiff is not limited to recovering only the alleged damages at
the date of the filing of the case, but rather can recover present and future damages resulting from
her injuries attributable to the defendant. See, e.g., Denby v. N. Side Carpet Cleaning Co., 390 A.2d
252, 256 (Pa. Super. Ct. 1978). Plaintiffs are not raising new theories of liability in the Sur-Reply.
Whether the Court should exclude the expert disclosure contained in the Sur-Reply is a separate
issue.
A party who fails to disclose a witness or expert report as either Rule 26 or court order
requires may not use that information at trial unless the failure to disclose was substantially
justified or is harmless. Fed. R. Civ. P. 37(c)(1). The imposition of such sanctions for abuse of
discovery under Rule 37 is a matter within the discretion of the trial court. Newman v. GHS
Osteopathic, Inc., Parkview Hosp. Div., 60 F.3d 153, 156 (3d Cir. 1995).
The exclusion of evidence or testimony is an “extreme” sanction, not normally to be
imposed absent a showing of “willful deception” or “flagrant disregard” of a court order.
Konstantopoulos v. Westvaco Corp., 112 F.3d 710, 719 (3d Cir. 1997). In deciding whether to exclude

7 Moreover, the Court would have granted Plaintiffs leave to file their Sur-Reply had they filed the
appropriate motion. However, Plaintiffs are instructed to follow this Court’s practices and procedures for
all future _ filings. See Practices and Procedures of Judge Kim R. Gibson at 2,
https://www.pawd.uscourts.gov/sites/pawd/files/JG-Practices-Procedures.pdf (“([R]eply briefs and sur-
replies are not to be filed without leave of Court.”)
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an untimely witness, courts consider: (1) the actual prejudice or surprise of the party against
whom the proffered witnesses would testify, (2) the ability of that party to cure the prejudice, (3)
the extent to which waiver of the rule against calling unlisted witnesses would disrupt the orderly
and efficient trial of the case or other cases in the court, (4) bad faith or willfulness in failing to
comply with the district court's order, and (5) the importance of the proffered witness’s
testimony. Id.
Here, the Court holds that the disclosure of Dr. Margolis’s report does not prejudice
Defendants and that the timing of Plaintiffs’ disclosure is substantially justified. Mrs.
Schrecengost’s change in medical condition justified a new medical examination. Plaintiffs timely
notified Defendants of the examination and put Defendants on notice that Plaintiffs might retain
a new expert to testify to the extent of Mrs. Schrecengost’s worsened condition. The record
establishes that Plaintiffs retained Dr. Margolis out of necessity—not to ambush Defendants.
Defendants have not shown that Plaintiffs’ explanation for the late disclosure is unjustified.
Defendants have also failed to show how Plaintiffs’ late disclosure of Dr. Margolis will
prejudice them or disrupt the trial schedule. Defendants have sufficient time to depose Dr.
Margolis before trial and Plaintiffs have stated their willingness to arrange such a deposition.
Defendants also have sufficient time to move to exclude his testimony if they believe they have
grounds to do so. Defendants have not shown that this disclosure was made in bad faith or that
they had no notice of Dr. Margolis’s examination of Mrs. Schrecengost before the disclosure was
made in the Sur-Reply.
Accordingly, the Court will not strike Plaintiffs’ Sur-Reply or the opinions and testimony
of Dr. Margolis.
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C. The Court Denies Defendants’ Motion for Summary Judgment
Defendants have moved for summary judgment on all of Plaintiffs claims, which are: (1)
negligent design defect, (2) negligent failure to warn, (3) strict liability — defective design, (4) strict
liability — failure to warn, and (5) loss of consortium. The Court will address each in turn.
1, Plaintiffs Can Establish that Defendants Negligently Designed the
Aris
Defendants argue that Plaintiffs’ negligent design claim fails for lack of evidence of
causation and existence of an alternative design. Defendants argue that Plaintiffs lack the
specific-causation evidence necessary to sustain their negligent design claim because Dr.
Campbell’s opinions are unreliable and the Court should exclude them. (ECF No. 80 at 2.)
Moreover, Plaintiffs have no evidence of any feasible safer alternative design, which is an
essential element of Plaintiffs’ claim. (Id.) Defendants contend that Dr. Rosenzweig’s proffered
safer alternatives are actually entirely different products because they are not polypropylene
surgical mesh implants indicated and cleared to treat SUI. (Id. at 3.) Specifically, the Ultrapro is
not a safer alternative because it is not indicated for surgical treatment of SUI and Defendants
therefore could not have practically adopted it. (Id. at 4.)
Plaintiffs respond by stating that they can establish all the required elements of their claim.
Plaintiffs assert that they have shown that there is a question of fact that the Aris proximately
caused Mrs. Schrecengost’s injuries. (ECF No. 73 at 8.) Plaintiffs argue that Dr. Rosenzweig
testified that the Aris is capable of producing significant injuries and that Dr. Campbell testified
that the Aris specifically caused Mrs. Schrecengost’s injuries. (Id. at 8-9.) Dr. Margolis’s

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testimony would also establish that the Aris caused Mrs. Schrecengost’s injuries. (ECF No. 92 at
3.)
Plaintiffs assert that showing the existence of a safer alternative design is not an element
for a negligent design defect claim under Pennsylvania law, but that the alternative designs can
show that other designs existed to establish Defendants’ negligence. (ECF No. 73 at 10.) Plaintiffs
assert that Defendants could have used an absorbable mesh to minimize the risks associated with
nonabsorbable mesh slings like the Aris. (Id. at 11.) Plaintiffs argue that Defendants knew prior
to Mrs. Schrecengost’s Aris surgery that additional alternative designs existed, including lighter
weight mesh alternatives, such as the Ultrapro. (Id. at 11-12.) Additionally, several doctors
warned Defendants in 2008 about the relationship between using heavier weight mesh and
increased erosion rates. (Id. at 12.)
To establish a negligent design claim in Pennsylvania, a plaintiff must demonstrate that
the defendant breached its duty of care in designing the product, and that the breach caused her
injuries. Phillips v. Cricket Lighters, 841 A.2d 1000, 1008 (Pa. 2003). 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. Tincher v. Omega Flex, Inc., 104 A.3d 328, 398 (Pa. 2014); Lance

v. Wyeth, 85 A.3d 434, 458 n.36 (Pa. 2014). To establish proximate cause, plaintiffs must introduce
expert testimony to show that: (1) the product at issue is capable of causing the alleged injury
(general causation), and (2) the product did in fact cause the plaintiffs alleged injury (specific
causation). Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 525 (W.D. Pa. 2003) (applying
Pennsylvania law).

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Here, the Court holds that Plaintiffs have introduced sufficient evidence for a jury to
conclude that Defendants breached their duty of care owed to Mrs. Schrecengost by negligently
designing a defective product. Plaintiffs can show that Defendants were aware of medical risks
of injury from the Aris because of the heavier weight mesh the Aris used. Moreover, Plaintiffs

can show that Defendants were aware that other types of lighter mesh were on the market and
would have reduced the risks of injury by using these alternatives. Plaintiffs can show that
alternative devices that can treat SUI without using the heavier weight mesh that the Aris used
existed, such as the Ultrapro. Dr. Rosenzweig explained that alternative, lighter weight, large-
pore mesh designs, such as Ultrapro, would have decreased the medical risks associated with
smaller-pore, heavier weight polypropylene mesh. Plaintiffs need not present an alternative
design that is identical in every respect to Defendants’ product, but instead Plaintiffs can use the
designs to show that there were feasible alternative ways to more safely treat SUI and that
Defendants were negligent for failing to use those methods and designs.
Additionally, the Court holds that Plaintiffs could convince a reasonable jury that the Aris
proximately caused Mrs. Schrecengost’s injuries. Dr. Rosenzweig determined that the Aris could

cause significant injuries because its mesh can degrade over time and can lead to complications
in patients. He found that these complications include chronic and debilitating pelvic pain,
chronic dyspareunia, rejection of the mesh, sexual dysfunction, and the need for additional
surgeries. Moreover, the Court finds that Dr. Campbell and Dr. Margolis each provide sufficient
and independent expert testimony to establish that the Aris specifically caused Mrs.
Schrecengost’s injuries. Dr. Campbell testified that Mrs. Schrecengost’s dyspareunia was caused
by the Aris and ruled out other possible causes of her pelvic pain for his differential diagnosis.
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Dr. Margolis found in his examination that Mrs. Schrecengost is suffering from several
complications that defects in the Aris caused.
Accordingly, the Court holds that Plaintiffs can satisfy their burden of proof for their
negligent design defect claim.
2. Plaintiffs Can Establish that Defendants Negligently Failed to Warn
Dr. David of All of the Aris’s Medical Risks
Defendants argue that Plaintiffs’ claim for negligent failure to warn fails because they
have no evidence that Mrs. Schrecengost’s alleged injuries were proximately caused by any defect
in the warnings included with the Aris when Dr. David treated her SUI. (ECF No. 64 at 18.)
Moreover, the learned-intermediary doctrine bars Plaintiffs’ claim because Dr. David testified
that he did not recall reviewing the Aris IFU prior to Mrs. Schrecengost’s surgery and because
Dr. David was independently aware of the risks of the injuries that Mrs. Schrecengost alleges that
she suffered as a result of the Aris. (Id. at 18-19.) Defendants assert that Dr. David would not
have changed his behavior when treating Mrs. Schrecengost because he still uses the Aris to treat
SUI. (Id. at 19.)
Plaintiffs assert that Defendants failed to include, or downplayed, significant risks in their
IFU for the Aris. (ECF No. 73 at 15.) Dr. Rosenzweig found that Defendants’ IFUs did not include
sufficient information to advise physicians on the permanence, frequency, and severity of the
complications that could arise from the use of its devices. (Id.) Plaintiffs assert that Defendants

were aware of these risks because Defendants’ paid consultants expressed concerns about safety
issues associated with the Aris to them. (Id.) Plaintiffs argue they can establish causation because
Dr. David testified that he read and relied on the IFUs in counseling his patients regarding risks

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associated with the device. (Id. at 16.) Plaintiffs argue that although Dr. David may have been
aware of general risks that accompany any pelvic floor surgery, Defendants failed to inform him
not only of the specific risks associated with the Aris, but also the frequency, severity, and
permanency of those risks. (Id. at 17.) His general surgical knowledge was not enough to
communicate the specific risks of the Aris to Mrs. Schrecengost so that she could accurately weigh
the risks and benefits of the surgery herself. (Id.)
To establish a negligent failure to warn claim under Pennsylvania law, a plaintiff must
demonstrate that the defendant breached its duty to warn, and that the breach caused her injuries.
Taurino v. Ellen, 579 A.2d 925, 927 (Pa. Super. Ct. 1990). In the context of claims alleging a
negligent failure to warn about the risks of a medical device, the manufacturer’s duty is to
adequately warn the treating physician. Simon v. Wyeth Pharm., 989 A.2d 356, 368 (Pa. Super. Ct.
2009).
For a warning to be adequate as a matter of law under Pennsylvania law, it must: (1)
accurately and unambiguously convey the scope and nature of the risk, and (2) state the risk with
sufficient specificity. Rowland v. Novartis Pharm. Corp., 34 F. Supp. 3d 556, 572 (W.D. Pa. 2014)
(applying Pennsylvania law). A warning of a particular risk is not adequate as a matter of law,
even when that warning is accurate, if there are disputes over whether the warning was
sufficiently explicit and detailed. Id.; see e.g., Maya v. Johnson & Johnson, 97 A.3d 1203, 1215 (Pa.
Super. Ct. 2014) (holding that a warning to call a doctor if complications arose was not an
adequate warning because it did not tell the user to stop taking the drug). To determine if a
warning is adequate as a matter of law, courts look to the warning itself and what the defendant

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knew or should have known about a given risk at the time of an alleged injury. Rowland, 34 F.
Supp. 3d at 572.
To establish that a failure to warn about the risks of a medical device was a proximate
cause of an injury, a plaintiff must show that had the defendant issued a proper warning to the
prescribing physician, the warning would have altered the physician’s behavior or treatment and
the injury would have been avoided. Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155
(Pa. Super. Ct. 1996). The plaintiff must introduce evidence that shows some reasonable
likelihood that an adequate warning would have prevented the plaintiff from undergoing the

course of treatment in question. Id.
Here, the Court holds that the Aris’s warnings are not, as a matter of law, adequate and
that the adequacy of the warnings is a proper question for the jury. The parties dispute which
risks Defendants knew about the Aris and whether Defendants disclosed all these relevant risks
to Dr. David. Plaintiffs can show that Defendants were aware of medical concerns with the Aris
that were not disclosed in the IFU, such as its risk of erosion and degradation.
Additionally, Plaintiffs can show that Defendants’ failure to warn of the Aris’s risks were
the proximate cause of Mrs. Schrecengost’s injuries. Plaintiffs can show that there are risks
regarding the use of the Aris that Defendants did not disclose to treating physicians, such as Dr.
David. There is a dispute as to whether Dr. David reviewed the Aris IFU before Mrs.
Schrecengost’s surgery. Dr. David stated that he expects IFU warnings to list any potential
complications, as well as their frequency or severity, and that he would have changed his
treatment recommendations if he had known about certain risks because he would have informed
his patients of those risks. Mrs. Schrecengost testified that had she known about these other risks,
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she would have declined the surgery. Therefore, a jury could find that Mrs. Schrecengost’s
injuries could have been avoided had Defendants properly warned Dr. David of the Aris’s risks.
Accordingly, the Court holds that Plaintiffs can satisfy their burden of proof for their
negligent failure to warn claim.
3. Strict Liability Design Defect and Failure to Warn Claims Are
Cognizable in Pennsylvania
The parties contest whether Pennsylvania law recognizes strict liability claims against
medical device manufacturers like Defendants. The Pennsylvania Supreme Court has not ruled
definitively on the issue. In the absence of a decision from the Pennsylvania Supreme Court, this
Court must predict how the Pennsylvania Supreme Court would rule on this issue. See Berrier v.
Simplicity Mfg., Inc., 563 F.3d 38, 45-46 (3d Cir. 2009). A federal district court in this position
should consider “relevant state precedents, analogous decisions, considered dicta, scholarly
works, and any other reliable data tending convincingly to show how the highest court in the
state would decide the issue at hand.” Id. at 46 (quoting McKenna v. Ortho Pharm. Corp., 622 F.2d
657, 663 (3d Cir. 1980)). From the sources available, it appears that the Pennsylvania Supreme
Court would permit a cause of action against medical device manufacturers—specifically
manufacturers of surgical mesh implants—under design defect and failure to warn theories of
strict liability.
The Court finds the Pennsylvania Supreme Court's discussion of strict liability in Tincher

v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) persuasive and an indication of how that court would
rule on this issue. In Tincher, the court clarified Pennsylvania law regarding strict liability claims.
The court first explained at length that under Pennsylvania law “[n]o product is expressly exempt

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[from strict liability] 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.” Id. at 382 (citing
Restatement (Second) of Torts § 402A cmt. B (Am. Law Inst. 1975)). The Supreme Court cautioned
courts in Pennsylvania from making categorical exemptions of immunity from strict liability:
Courts, which address evidence and arguments in individual cases, are neither
positioned, nor resourced, to make the kind of policy judgments required to arrive
at ana priori decision as to which individual products, or categories and types of
products, should be exempt. Neither courts, nor the American Law Institute for
that matter, are in the business of articulating general principles tailored to anoint
special “winners” and “losers” among those who engage in the same type of
conduct. In our view, the question of “special tort-insulated status” for certain
suppliers—for example, manufacturers of innovative products with no
comparable alternative design—optimally “requires an assessment and balancing
of policies best left to the General Assembly.”
Id. at 396 (quoting Scampone v. Highland Park Care Ctr., LLC, 57 A.3d 582, 599 (Pa. 2012)). The court
clarified that where no immunity from strict liability exists under the common law, or where the
Pennsylvania General Assembly has not created immunity, “the default general rule of possible
liability operates.”® Id. (internal quotation marks omitted) (quoting Scampone, 57 A.3d at 599).
The court next addressed the Second Restatement's relation to Pennsylvania common law.
It stated that although Pennsylvania courts follow the Second Restatement, “adoption” of
Restatement principles into Pennsylvania common law requires a separate analysis. Id. at 399.
Further, it stated that the text and comments of the Second Restatement are not binding on
Pennsylvania courts, nor are they entitled to as great of weight as legislative pronouncements
would receive. Id. The court reasoned that a “principal point” of its decision is that Pennsylvania

8 The court noted that the General Assembly has not spoken affirmatively in relation to strict liability
cause of action and strict liability claims have remained a creature of common law. Tincher, 104 A.3d at
381 n.18.
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courts should “permit the common law to develop incrementally, as we provide reasoned
explications of principles pertinent to factual circumstances of the cases that come before the
Court.” Id. at 406 (citing Scampone, 57 A.3d at 605). Consistent with the changing nature of the

common law, the court noted that its decision “may have an impact upon other foundational
issues” of strict liability law, observing that although “[o]ur decision is limited to the context of a
‘design defect’ claim by the facts . . . the foundational principles upon which we touch may
ultimately have broader implications by analogy.” Id. at 384 n.21, 409.
Although not cited in the opinion, Tincher, on its face, affects how Pennsylvania courts
apply comment k of § 402A of the Second Restatement. That comment exempts certain products
from strict liability, stating:
There are some products which, in the present state of human knowledge, are
quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs .... Such a product, properly prepared,
and accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous.
Restatement (Second) of Torts, § 402A cmt. k. The Pennsylvania Supreme Court has adopted
comment k to exempt prescription drugs from the imposition of strict liability on manufacturers
selling these drugs. Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996).
In Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006), the Superior Court noted,
after determining that no significant distinction could be drawn between the medical device
before the court and the drug in Hahn, that there was “no reason why the same rationall[e]
applicable to prescription drugs may not be applied to medical devices.” Id. at 31. Defendants

assert that Creazzo closed the door for all strict liability claims against medical device
manufacturers in Pennsylvania.
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Defendants’ reliance on Creazzo and Hahn is misplaced. First, Creazzo’s application of
Hahn to medical devices does not reflect the law in Pennsylvania. Since the Superior Court’s
decision in 2006, the Pennsylvania Supreme Court has never cited, relied on, adopted, or even
addressed Creazzo’s rationale that medical device manufacturers cannot be subject to strict
liability claims.’ Accord Wagner v. Kimberly-Clark Corp., 225 F. Supp. 3d 311, 317 (E.D. Pa. 2016).
This lack of acknowledgement by the Pennsylvania Supreme Court in cases concerning strict
liability claims against medical device manufacturers casts the Creazzo decision into doubt. See,
e.g., Beard v. Johnson & Johnson, Inc., 41 A.3d 823, 824 (Pa. 2012).
Second, the Pennsylvania Supreme Court would likely decline to adopt Creazzo’s
rationale. The Pennsylvania Supreme Court has rejected invitations to change common law
duties without presentation of a “full and balanced record covering the range of relevant policy
matters.” Lance v. Wyeth, 85 A.3d 434, 455 (Pa. 2014); see also Seebold v. Prison Health Servs., 57 A.3d
1232, 1247 (Pa. 2012). There is no indication that the parties presented a full and balanced record
of policy considerations to the court in Creazzo. In fact, the opposite was true. The court
acknowledged that the appellants, who were pro se, offered no analysis or authority for a
different interpretation of Hahn. See Creazzo, 903 A.2d at 31. Because no analysis of the relevant
policy issues concerning strict liability immunity for medical device manufacturers was squarely
placed before the Creazzo court, the Pennsylvania Supreme Court would likely not adopt its
holding without more analysis. As Tincher made clear, the principles of the Restatement must be
adopted into Pennsylvania common law and there is no dispute that the Pennsylvania Supreme

9 In fact, Creazzo has only been cited once in a footnote by the Pennsylvania Supreme Court. See Pyeritz v.
Commonwealth, 32 A.3d 687, 692 n.5 (Pa. 2011). That citation referred to the principle of spoliation of
evidence, a separate aspect of the Creazzo case from the strict liability issue. Id.
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Court has not applied comment k to shield medical device manufacturers from strict liability. See
Tincher, 104 A.3d at 399.
Third, Defendants do not justify the imposition of strict liability immunity in this case by
comparing the facts of this case to Creazzo and Hahn. The Supreme Court has instructed that
holdings of a judicial decision must be read in relation to its facts. See Lance, 85 A.3d at 453.
Defendants here do not analogize the Aris to either the drug in Hahn or the medical device in
Creazzo. Defendants assert that because the Aris is a medical device, they are immune from strict
liability claims. Defendants invite this Court to create a special tort-insulated status for medical
device manufacturers, the kind of categorical pronouncement the Tincher court instructed
Pennsylvania courts to avoid. See Tincher, 104 A.3d at 396. The Court declines to make such a
pronouncement and reserves that issue for the Pennsylvania Supreme Court and Pennsylvania
General Assembly. In the absence of a shield of strict liability immunity granted by the
Pennsylvania Supreme Court or Pennsylvania General Assembly, the Court defers to the general
rule in Pennsylvania that no product is immune from strict liability. This includes products such

as the Aris.
Fourth, even if comment k applied here, the interpretation and application of comment k
is no straightforward task for a court. The Pennsylvania Supreme Court itself has struggled with
it, stating that “comment k is not itself a model of clarity.” Lance, 85 A.3d at 451. For example, it
is unclear how courts should decide whether a product is “unavoidably unsafe” or “properly
prepared.” See, e.g., Wagner, 225 F. Supp. 3d at 317. It is also unclear whether comment k would
be a categorical shield of immunity or one for a court to assess on a case by case basis by
comparing the utility of a product to its unavoidably dangerous propensities. See id. As noted in

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Tincher, these are policy decisions that require careful consideration more suited for a legislature.
See Tincher, 104 A.3d at 396.
The Court recognizes that other federal courts in this Circuit, including this Court, have
predicted that the Pennsylvania Supreme Court would not recognize these causes of action. See,
e.g., Wilson v. Synthes USA Prods., LLC, 116 F. Supp. 3d 463, 465-66 (E.D. Pa. 2015); Cogswell v.
Wright Med. Tech., Inc., No. 1:15-cv-295, 2015 WL 4393385, at *2 (W.D. Pa. July 16, 2015); Stout v.
Advanced Bionics, LLC, No. 2:11-cv-1061, 2013 WL 12133966, at *8 (W.D. Pa. Sept. 19, 2013); McPhee

v. DePuy Orthopedics, 989 F. Supp. 2d 451 (W.D. Pa. 2012); Kee v. Zimmer, Inc., 871 F. Supp. 2d 405,
409 (E.D. Pa. 2012); Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 750 (E.D. Pa. 2007); Parkinson v.
Guidant Corp., 315 F. Supp. 2d 741, 747 (W.D. Pa. 2004). However, these decisions were either
made before Tincher was decided in 2014 or did not interpret and apply Tincher, which the Court
interprets as an implicit recognition by the Pennsylvania Supreme Court that these strict liability
claims are cognizable against medical device manufacturers like Defendants. Defendants’
citation to these decisions does not change this Court’s analysis of the issue.
As the law stands, neither the Pennsylvania Supreme Court nor the Pennsylvania General
Assembly have created immunity from strict liability for medical device manufacturers like
Coloplast. Accordingly, since the claims are cognizable, the Court turns to evaluating whether
Plaintiffs can proceed to trial with their strict liability claims.
4, Plaintiff’s Strict Liability Claims
In Pennsylvania, a seller is strictly liable for physical harm caused by “any product in a
defective condition unreasonably dangerous to the user or consumer.” Webb v. Zern, 220 A.2d
853, 854 (Pa. 1966) (citing Restatement (Second) of Torts § 402A). Unlike a negligence claim,
-27-

which examines the conduct and fault of the defendant, strict liability claims examine the quality
of the product itself. See 578 A.2d 492, 501. Pennsylvania has recognized three types of defective
conditions that can give rise to strict liability: design defect, manufacturing defect, and failure to

warn defect. Phillips v. A-Best Prods. Co., 665 A.2d 1167, 1170 (Pa. 1995).
Here, Plaintiffs have alleged design defect and failure to warn defect strict liability claims.
The Court will address each in turn.

a. Plaintiffs Can Establish that Defendants Are Strictly Liable for
the Aris’s Design Defect
To prevail on a strict products liability claim, a plaintiff must show that: (1) the product
was in a defective condition, (2) the defect was a proximate cause of the plaintiff's injuries, and
(3) that the defect causing the injury existed at the time the product left the defendant's control.
Davis v. Berwind Corp., 690 A.2d 186, 190 (Pa. 1997). A plaintiff may prove defective condition by
showing either that: (1) the danger is unknowable and unacceptable to the average or ordinary
consumer (consumer expectations standard), 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
precautions that the defendants could take (risk-utility standard). Tincher, 104 A.3d at 335. A
defective product is a proximate cause of the plaintiff's harm if the product “was a substantial
factor in bringing about the harm inflicted upon a plaintiff.” Jones v. Montefiore Hosp., 431 A.2d
920, 923 (Pa. 1981).
Here, Plaintiffs can show that the Aris was defective under either the consumer
expectations standard or the risk-utility standard. Dr. Rosenzweig testified that the public did

not know about the danger of erosion or degradation of the Aris mesh, and Plaintiffs can show

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that this risk of injury would be unacceptable to an ordinary consumer. For example, Mrs.
Schrecengost has stated that had Dr. David told her of all of the risks of the Aris surgery, she
would not have agreed to it. Dr. Rosenzweig also testified that the probability and seriousness
of the injuries the Aris could cause outweighed Defendants’ burden to follow other safer designs
that used an absorbable, lighter pore mesh. Additionally, Plaintiffs can show that the Aris was a
proximate cause of Mrs. Schrecengost’s injuries because Dr. Campbell and Dr. Margolis have
testified that the defects of the Aris specifically caused those injuries.
Accordingly, the Court holds that Plaintiffs can satisfy their burden for their design defect
claim under a theory of strict liability.
b. Plaintiffs Can Establish that Defendants Are Strictly Liable for
Failing to Warn About the Aris’s Risks
To prevail on a strict products liability claim, a plaintiff must show that: (1) the product
was in a defective condition, (2) the defect was a proximate cause of the plaintiff's injuries, and
(3) the defect causing the injury existed at the time the product left the defendant's control. Davis,
690 A.2d at 190. A product can be considered “defective” for strict liability purposes if it is
distributed without warnings sufficient to notify the ultimate user of the dangers inherent in the
product. Id. A defective product is a proximate cause of the plaintiff's harm where the product
“was a substantial factor in bringing about the harm inflicted upon a plaintiff.” Jones, 431 A.2d at
923.
Here, for the reasons discussed previously, the Court holds that the Aris’s warnings are
not, as a matter of law, adequate. See supra Section VI.C.2. The Court also holds that a reasonable
jury could find that the lack of warnings was a substantial factor in Mrs. Schrecengost’s injuries.

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Plaintiffs can show that had Mrs. Schrecengost known about these additional risks, she would
not have agreed to the surgery.
Accordingly, the Court holds that Plaintiffs can satisfy their burden for their failure to
warn claim under a theory of strict liability.
5. Plaintiffs Can Maintain Mr. Schrecengost’s Loss of Consortium Claim
Defendants argue that because Mrs. Schrecengost’s claims fail, Mr. Schrecengost’s
derivative loss of consortium claim fails as it cannot exist as a freestanding claim. (ECF No. 64 at
20.) Plaintiffs assert that Mr. Schrecengost’s loss of consortium claim does not fail because Mrs.
Schrecengost’s claims survive summary judgment. (ECF No. 73 at 25.)
The Court holds that because Plaintiffs maintain claims other than the loss of consortium
claim, dismissal of this claim is not warranted.
VII. Conclusion
For the forgoing reasons, the Court denies Defendants’ Motion to Exclude Opinions and
Testimony of Dr. Grant Campbell, Motion to Strike Plaintiffs’ Proposed Sur-Reply and to Exclude
from Trial the Untimely Expert Opinions of Dr. Michael Margolis, and Motion for Summary
Judgment.
An appropriate order follows.

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IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
DEBORAH SCHRECENGOST and ) Case No. 3:17-cv-220
ROGER SCHRECENGOST, )
)
Plaintiffs, ) JUDGE KIM R. GIBSON
)
Vv. )
)
COLOPLAST CORPORATION and )
COLOPLAST MANUFACTURING US, )
LLC, )
)
Defendants. )
\ ORDER
AND NOW, this day of December, 2019, upon consideration of Defendants’ Motion to
Exclude Opinions and Testimony of Dr. Grant Campbell (ECF No. 61), Motion to Strike Plaintiffs’
Proposed Sur-Reply and to Exclude from Trial the Untimely Expert Opinions of Dr. Michael
Margolis (ECF No. 93), and Motion for Summary Judgment (ECF No. 63.), and for the reasons set
forth in the accompanying Memorandum Opinion, it is HEREBY ORDERED that said Motions
are DENIED.

BY THE COURT:

KIM R. GIBSON
UNITED STATES DISTRICT JUDGE

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10415200. Public record. Not legal advice.