Schrecengost v. Coloplast Corp.

• Decision Date: 02 December 2019
• Docket Number: Case No. 3:17-cv-220
• Citation: 425 F.Supp.3d 448
• Parties: Deborah SCHRECENGOST and Roger Schrecengost, Plaintiffs, v. COLOPLAST CORPORATION and Coloplast Manufacturing US, LLC, Defendants.
• Court: U.S. District Court — Western District of Pennsylvania

425 F.Supp.3d 448

Deborah SCHRECENGOST and Roger Schrecengost, Plaintiffs,

v.COLOPLAST CORPORATION and Coloplast Manufacturing US, LLC, Defendants.

Case No. 3:17-cv-220

United States District Court, W.D. Pennsylvania.

Signed December 2, 2019

Lee Balefsky, Christopher A. Gomez, Kila B. Baldwin, Lorraine Donnelly, Philip M. Pasquarello, Tracie L. Palmer, Kline & Specter, P.C., Philadelphia, PA, for Plaintiffs.

Gregory A. Ruehlmann, Robert K. Woo, Atlanta, GA, Donald F Zimmer, San Francisco, CA, Geoffrey M. Drake, Atlanta, GA, Lana K. Varney, Lisa H. Shub, King & Spalding LLP, Austin, TX, Wendy West Feinstein, Morgan, Lewis & Bockius LLP, Matthew H. Sepp, Pittsburgh, PA, for Defendants.

MEMORANDUM OPINION

KIM R. GIBSON, UNITED STATES DISTRICT JUDGE

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.¹

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 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 ¶¶ 11–12.) Defendants assert that Mrs. Schrecengost gave her informed consent to proceed with the 2008 surgery. (Id. ¶ 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 ¶¶ 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, frequency, or severity of the complications that can arise from the use of its devices. (Id. New Matter ¶¶ 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 ¶ 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 ¶¶ 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 ¶ 18.)

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.² (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. ¶ 4.) Plaintiffs' counsel also offered Defendants the opportunity to perform their own medical examination of Mrs. Schrecengost. (Id. )

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. ¶ 7.) On October 16, 2019, Plaintiffs disclosed Dr. Margolis as an expert. (Id. ¶ 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. ¶ 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 Defe...