Opinion
CASE NO. 20-60410-CIV-CANNON/Hunt
2021-02-22
Sharon SWINTELSKI and Arthur Swintelski, Plaintiffs, v. AMERICAN MEDICAL SYSTEMS, INC., Defendant.
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.
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. 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 .
For ease of reference, the Court refers to Sharon Swintelski as the Plaintiff in this action.
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]. 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].
Slings are medical devices made from materials that are implanted in patients to alleviate multiple medical conditions, including stress urinary incontinence [ECF No. 36-2 (Dr. Kahn Dep. at 11:1-11:5; 19:1-19:17)].
To expedite resolution of pre-trial filings in the MDL, Judge Goodwin instructed all plaintiffs who wished to assert such claims against AMS to file a short form complaint that adopted relevant allegations and claims for relief from the First Amended Master Long Form Complaint. See In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation , Master File Number: 2:12-MD-02325, ECF No. 288 (Judge Goodwin's Pre-Trial Order #17); ECF No. 288-1 (First Amended Master Long Form Complaint and Jury Demand).
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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 to a medical professional, who serves as a so-called "learned intermediary" in this context, rather than the patient. See Felix v. Hoffmann–LaRoche, Inc. , 540 So.2d 102, 104 (Fla. 1989). A learned intermediary is defined as an individual " ‘who has knowledge of the danger and whose position vis-a-vis the manufacturer and consumer, confers a duty to convey the requisite warnings to the consumer.’ " Aubin v. Union Carbide Corp. , 177 So. 3d 489, 514 (Fla. 2015) (quoting Union Carbide Corp. v. Kavanaugh , 879 So. 2d 42, 44 (Fla. Dist. Ct. App. 2004) ).
Where a medical device manufacturer raises the learned intermediary defense to contest a failure to warn claim, it is plaintiff's burden to establish the causation element by showing that adequate warnings would have altered the treating physician's decision to prescribe the device at issue. See Eghnayem , 873 F.3d at 1321 ("[T]o satisfy the causation element [of a failure to warn claim], a plaintiff must show that her treating physician would not have used the product had adequate warnings been provided."); Pringle v. Johnson & Johnson , No. 13-81022-CIV, 2020 WL 4501834, at *4 (S.D. Fla. Jan. 30, 2020) ("[I]n a failure to warn case against a manufacturer of a prescription drug or medical device involving a learned intermediary, Florida courts continue to require the plaintiff to prove as part of her case that the physician would have acted differently if an adequate warning had been given."); Thomas v. Hoffman-LaRoche, Inc. , 949 F.2d 806, 814 (5th Cir. 1992) ("The burden remains on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff."). Furthermore, while proximate cause is an issue of fact normally reserved for the jury, Florida law does permit a court to decide questions of proximate case as a matter of law when the evidence is undisputed. See Faulk v. Parrish , 58 So. 2d 523, 526 (Fla. 1952) ; G. Ferlita & Sons, Inc. v. Beck , 143 Fla. 509, 197 So. 340, 342 (1940) ; Hoffmann-La Roche Inc. , 27 So. 3d at 77. Accordingly, a Plaintiff cannot establish the requisite causation element of a failure to warn claim where the undisputed record evidence shows that the treating physician's prescribing decision would not have been altered by the undisclosed risk.
C. Application
On this record, even when viewed in the light most favorable to Plaintiff, AMS is entitled to judgment as a matter of law on Count IV because any inadequacy in AMS's warnings was not the proximate cause of Plaintiff's alleged injury. For purposes of this Motion, the Court assumes that AMS's warning was inadequate, focusing only on the question of proximate cause under the learned intermediary doctrine.
Dr. Kahn testified that he read AMS's instructions for use of the SPARC Mesh Sling [ECF No. 36-2 (Dr. Kahn Dep. at 43:24-44:3)], and that he was aware of the FDA's 2011 public health notice concerning polypropylene mesh implants [ECF No. 36-2 (Dr. Kahn Dep. at 42:12-43:4)]. During his deposition, Dr. Kahn also testified that, knowing what he knows today (referring to the purportedly undisclosed risk information concerning the SPARC Mesh Sling), he still believes that (1) his decision to implant the SPARC Mesh Sling into Ms. Swintelski was the "right thing to do" notwithstanding the "difficulty" he experienced "dealing with her" [ECF No. 36-2 (Dr. Kahn Dep. at 68:23-69:12) (testifying that implanting Ms. Swintelski with the SPARC Mesh Sling was the "right thing to do" even though she was a "difficult subject" with "a lot going on")]; (2) the SPARC Mesh Sling was a "good product" [ECF No. 26-2 (Dr. Khan Dep. at 59:23-60:1)]; (3) the transvaginal mesh operation is a "great operation" that he continues to perform with only occasional minor complications [ECF No. 36-2 (Dr. Kahn Dep. at 69:9-69:14; 59:9-59:13)]; (4) he "absolutely" agrees that a body of evidence supports the use of the SPARC Mesh Sling and himself has gone public expressing the safety of the product and lamenting the risk that litigation will lead companies to stop making the product [ECF No. 36-2 (Dr. Kahn Dep. at 58:5-58:13; 59:14-59:18)]; and (5) he "absolutely" would recommend polypropylene mesh slings to "every female member" of his family [ECF No. 36-2 (Dr. Kahn Dep. at 58:14-58:19)].
Critically, Ms. Swintelski does not dispute that Dr. Kahn, knowing what he knows today, would have persisted in his decision to prescribe and use the SPARC Mesh Sling in her operation [ECF No. 36 p. 3]; [ECF No. 92 (transcript of motions hearing pp. 26:9-27:11)]. Rather, Ms. Swintelski relies on Dr. Kahn's testimony that he would have communicated additional risk information to his patients about the product had he received such additional information [ECF No. 36-2 (Dr. Kahn Dep. at 22:10-22:18) ("Q. [I]f that information had been made available to you back in 2012, certainly, you would have relayed that to your patients at that time....? A. Yes, I think that goes without saying. The more information the doctor has to pass on to a patient, the more likely he is to pass it on.")]. That change in communication practices, Ms. Swintelski says, is sufficient to defeat application of the learned intermediary doctrine because she would have refused to undergo the procedure if Dr. Kahn had communicated to her the additional risk information that AMS purportedly failed to provide [ECF No. 36 p. 6; ECF No. 92 (transcript of motions hearing pp. 26:22-27:11)].
After weighing applicable Eleventh Circuit and Florida law, the Court grants summary judgment on Plaintiff's failure-to-warn claim.
To begin, contrary to Ms. Swintelski's suggestion, AMS's purported failure to provide a sufficiently detailed warning to Dr. Kahn does not preclude him from being considered a so-called "learned intermediary." Ms. Swintelski points to no controlling authority in the Eleventh Circuit suggesting that an experienced and highly trained physician like Dr. Khan automatically loses learned intermediary status because a manufacturer provides allegedly insufficient warnings about a product. To the contrary, the Eleventh Circuit has affirmed the grant of summary judgment and a motion to dismiss even in the face of similar claims. See Dietz v. Smithkline Beecham Corp. , 598 F.3d 812, 816 (11th Cir. 2010) ; Tutwiler v. Sandoz, Inc. , 726 F. App'x 753, 756-57 (11th Cir. 2018). Further, there is no dispute that Dr. Kahn is a Board-certified surgeon who has performed hundreds of transvaginal mesh operations and undergone extensive training [ECF No. 36-2 (Dr. Kahn Dep. at 22:10-22:18; 24:25-29:16; 43:24-44:2; 52:2-53:1; 59:9-59:13; 65:25-66:6)].
Second, under applicable Eleventh Circuit authorities, the critical inquiry is not whether Dr. Kahn would have communicated more information to his patient who then perhaps would have altered her decision to undergo the surgery. Instead, the relevant question is whether the additional risk information would have impacted the implanting physician's decision to implant the product at issue. See Hubbard v. Bayer HealthCare Pharm. Inc. , 983 F.3d 1223, 1236 (11th Cir. 2020) ; Eghnayem , 873 F.3d at 1321 ; Dietz , 598 F.3d at 816 ; Pringle , 2020 WL 4501834, at *4 ; Hoffmann-La Roche Inc. , 27 So. 3d at 77. On that score, Ms. Swintelski's claim fails as a matter of law. She argues that another expert witness, Dr. Bruce Rosenzweig, will testify about various known yet undisclosed risks from the SPARC product [ECF No. 36 p. 3 (referring to Dr. Bruce Rosenzweig)]. But what matters is whether the implanting physician would have altered his decision to implant the product had he been equipped with more detailed warnings. And here, Ms. Swintelski does not dispute that Dr. Khan still would have prescribed and used the SPARC Mesh Sling in her operation even if he had been in possession of more detailed warnings about elevated risks. Nor is it sufficient to argue, as Ms. Swintelski does, that a factfinder is required to test Dr. Khan's credibility [ECF No. 36 p. 5]; it is Plaintiff's burden under Florida law to prove proximate cause in this context, and Florida law permits a court to decide questions of proximate cause where the evidence is undisputed. See Faulk , 58 So. 2d at 526 (citing G. Ferlita & Sons, Inc. , 197 So. at 342 (Fla. 1940) ); Hoffmann-La Roche Inc. , 27 So. 3d at 77. For these reasons, the causal chain is severed, and summary judgment is warranted on Count IV.
CONCLUSION
Accordingly, it is hereby ORDERED AND ADJUDGED as follows:
1. The Defendant's Motion for Partial Summary Judgment [ECF No. 34] is GRANTED.
2. Summary Judgment is entered in favor of Defendant American Medical Systems, Inc., as to the Plaintiff's claims for strict liability manufacturing defect (Count III), strict liability failure to warn (Count IV), breach of express warranty (Count VI) and breach of implied warranty (Count VII).
3. Final Judgment on these counts shall be entered by separate order.
DONE AND ORDERED in Fort Pierce, Florida, this 22nd day of February 2021.