Swintelski v. Am. Med. Sys., Inc.

• Decision Date: 22 February 2021
• Docket Number: CASE NO. 20-60410-CIV-CANNON/Hunt
• Citation: 521 F.Supp.3d 1215
• Court: U.S. District Court — Southern District of Florida
• Parties: Sharon SWINTELSKI and Arthur Swintelski, Plaintiffs, v. AMERICAN MEDICAL SYSTEMS, INC., Defendant.

521 F.Supp.3d 1215

Sharon SWINTELSKI and Arthur Swintelski, Plaintiffs,

v.AMERICAN MEDICAL SYSTEMS, INC., Defendant.

CASE NO. 20-60410-CIV-CANNON/Hunt

United States District Court, S.D. Florida, Fort Lauderdale Division.

Signed February 22, 2021

Jeffrey Louis Haberman, Sarah Jeanine Schultz, Schlesinger Law Offices, Fort Lauderdale, FL, for Plaintiffs.

Edward Maurice Mullins, Christina Olivos, Reed Smith LLP, Miami, FL, Barbara R. Binis, Heather A. Ritch Rocks, Pro Hac Vice, Rachel B. Weil, Pro Hac Vice, Regina M. Nelson, Pro Hac Vice, Reed Smith LLP, Philadelphia, PA, Erik W. Legg, Michael J. Farrell, Farrell White & Legg, Huntington, WV, Shana E. Russo, Pro Hac Vice, Reed Smith LLP, Princeton, NJ, for Defendant.

ORDER GRANTING DEFENDANT'S MOTION FOR PARTIAL SUMMARY JUDGMENT

AILEEN M. CANNON, UNITED STATES DISTRICT JUDGE

THIS CAUSE came before the Court upon the Motion for Partial Summary Judgment filed by Defendant American Medical System, Inc. ("Defendant" or "AMS") [ECF Nos. 34 and 35] ("Motion"). The Court has reviewed the Motion, the Opposition filed by Plaintiffs Sharon and Arthur Swintelski ("Plaintiffs" or "Ms. Swintelski") [ECF No. 36], Defendant's Reply [ECF No. 37], and the full record in this case.¹ The Court also heard oral argument on the Motion [ECF No. 91]. For the reasons set forth below, Defendant's Motion for Partial Summary Judgment [ECF No. 34] is GRANTED .

BACKGROUND

In November 2016, Ms. Swintelski filed her Short Form Complaint (the "SFC") against Defendant AMS in the Pelvic Mesh Multidistrict Litigation (the "MDL") before Judge Joseph R. Goodwin in the United States District Court for the Southern District of West Virginia. See In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation , Master File Number: 2:12-MD-02325. Ms. Swintelski sought compensatory and punitive damages on the grounds that she suffered significant adverse health effects due to the surgical implantation into her body of AMS's purportedly defective pelvic mesh product called the SPARC Mesh Sling [ECF No. 1].² The SFC adopted all of the claims for relief asserted in the MDL's First Amended Master Long Form Complaint (the "FAC") [ECF No. 1].³

The FAC alleges that the SPARC Mesh Sling was defective in numerous respects and caused significant adverse health effects in the thousands of women who were implanted with it. See MDL, First Amended Master Long Form Complaint and Jury Demand (ECF No. 288-1). In total, the FAC raises seventeen claims against AMS, including claims for negligence (Count I), strict liability design defect (Count II), strict liability manufacturing defect (Count III), strict liability failure to warn (Count IV), strict liability for distribution of a defective product (Count V), breach of express warranty (Count VI), breach of implied warranty (Count VII), and loss of consortium (Count XVI) by the spouses of harmed patients. Id. As to the failure-to-warn claim relevant here, Ms. Swintelski claims that AMS should be strictly liable because her implanting surgeon, Dr. Paul Kahn, did not receive adequate warnings from AMS as to all of the available risk information associated with the SPARC Mesh Sling [ECF No. 36 pp. 6-7].

In October 2018, following submission of extensive expert witness testimony and evidence, and while still in the context of the MDL, AMS moved for partial summary judgment on four claims adopted in Ms. Swintelski's SFC [ECF No. 34]. Thereafter in February 2020, before resolving AMS's motion, Judge Goodwin transferred thirty-nine cases from the MDL back to the venues from which they arose, including this case for any remaining proceedings [ECF No. 46].

DISCUSSION

A. Parties’ Arguments

AMS seeks summary judgment on four claims adopted in Plaintiff's SFC: (1) a claim for strict liability manufacturing defect (Count III), which alleges that AMS's SPARC Mesh Sling "deviated materially from [AMS's] design and manufacturing specifications in such a manner as to pose unreasonable risks of serious bodily harm to [Ms. Swintelski]" [Master File Number: 2:12-MD-02325, ECF No. 288-1 ¶70]; (2) a claim for strict liability failure to warn (Count IV), which alleges that AMS's SPARC Mesh Sling is "defective as described herein as a matter of law due to [its] lack of appropriate and necessary warnings" [id. , ECF No. 288-1 ¶74]; and (3) a claim for breach of express warranty (Count VI) and breach of implied warranty (Count VII) associated with the allegedly defective implantation of the SPARC Mesh Sling [id. , ECF No. 288-1 ¶¶88, 95].

As an initial matter, Plaintiff has indicated that she does not wish to proceed on Counts III, VI, and VII, and therefore does not contest the grant of summary judgment on those three counts [ECF No. 36; see also ECF No. 92 (transcript of motions hearing p. 39:14-39:25)]. Accordingly, AMS's Motion for Partial Summary Judgment on Counts III, VI and VII is GRANTED . That leaves for disposition Count IV—Plaintiff's strict liability failure to warn claim [Master File Number: 2:12-MD-02325, ECF No. 288-1 ¶¶73-76]. AMS presents two arguments in support of summary judgment on that claim.

First, AMS asserts that Ms. Swintelski's implanting physician, Dr. Kahn, was properly advised of all the then-known risks associated with implanting pelvic mesh products in patients [ECF No. 35 pp. 1, 10; ECF No. 37 p. 3 ("Dr. Kahn had independent knowledge of all of the relevant risks associated with the SPARC....")]. Further, AMS asserts that Dr. Kahn was fully aware of those risks when he prescribed the SPARC Mesh Sling for Ms. Swintelski [ECF No. 37 p. 2 ("Dr. Kahn knew of the risks of the conditions about which Plaintiff now complains when he implanted Plaintiff with the SPARC....")].

Second, AMS argues that summary judgment is appropriate for the additional reason that Plaintiff has not shown that a more detailed warning would have changed Dr. Kahn's decision to implant the SPARC Mesh Sling into Ms. Swintelski [ECF No. 35 p. 10; ECF No. 37 pp. 2-3]. On this point, AMS relies on the so-called "learned intermediary doctrine" under Florida law, which, as set forth below, requires a plaintiff asserting a strict liability failure-to-warn claim to show that "her treating physician would not have used the product had adequate warnings been provided." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321 (11th Cir. 2017). In AMS's view, application of that doctrine precludes failure-to-warn liability here because Dr. Kahn testified unambiguously that he would have made the same decision to implant the SPARC Mesh Sling into Ms. Swintelski regardless of whether he had received the more detailed warnings that Ms. Swintelski claims AMS should have issued [ECF No. 35 (citing ECF No. 36-2 (Dr. Kahn Dep. at 59:23-60:1; 58:5-58-19; 59:9-59:18; 68:23-69:14))]. Accordingly, AMS contends, Plaintiff cannot establish the requisite causal nexus between her injuries and AMS's purported failure to warn [ECF No. 37 pp. 2-3].

In response, Ms. Swintelski asserts that the learned intermediary doctrine does not shield AMS from failure-to-warn liability because AMS failed to provide medical practitioners with all of the relevant risk information it possessed on the SPARC Mesh Sling [ECF No. 36 pp. 2-3]. That failure, Plaintiff claims, precludes Dr. Kahn from being considered a learned intermediary in the first instance [ECF No. 36 p. 3]. Moreover, Plaintiff argues that summary judgment is improper because Dr. Kahn—had he been furnished with appropriate warnings by AMS—would have conveyed the additional risk information to Plaintiff who then would have refused to undergo the surgery [ECF No. 36 p. 6 (quoting Dr. Kahn Dep. at 22:10-22:18)]. Plaintiff thus frames the question not in terms of whether Dr. Kahn would have altered his decision to prescribe the product, but rather whether he would have conveyed additional risk information to his patient who then would have opted against the surgery [ECF No. 36 pp. 6-7]. Finally, Plaintiff argues that summary judgment is not appropriate because a factfinder should be required to weigh the credibility of Dr. Khan—even if he testified "unequivocally" that he would not have changed his prescribing conduct [ECF No. 36 p. 3].

B. Applicable Legal Principles

"Under Rule 56(c), summary judgment is proper if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Celotex Corp. v. Catrett , 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ; see Fed. R. Civ. P. 56(a) ("The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law."). When evaluating whether a genuine issue of material fact exists to overcome summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment. See Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The Court, however, is not required to accept all the nonmoving party's factual characterizations and legal arguments, and the nonmoving party must adduce some concrete evidence that would permit a reasonable fact finder to enter a verdict in its favor. Id. ; see Beal v. Paramount Pictures Corp. , 20 F.3d 454, 458–59 (11th Cir. 1994).

"Under Florida law, to succeed on a failure to warn claim, a plaintiff must show that the product warning was inadequate; (2) that the inadequacy proximately caused her injury; and (3) that she in fact suffered an injury from using the product." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321 (11th Cir. 2017) (citing Hoffmann-La Roche Inc. v. Mason , 27 So. 3d 75, 77 (Fla. Dist. Ct. App. 2009) ). A medical device manufacturer may fulfill its duty to warn by providing an adequate warning concerning the device at issue...