A federal court recently granted defendant’s motion for partial summary judgment in a case that originated in the pelvic mesh MDL pending in the Southern District of West Virginia and was then transferred to plaintiff’s home jurisdiction in Florida.  Swintelski v. American Medical Systems, Inc., NO. 20-60410-CIV-CANNON/Hunt, 2021 WL 687202 (S.D. Fla. Feb. 22, 2021),  reconsideration denied, No. 20-60410-CIV, 2021 WL 1902233 (S.D. Fla. Apr. 21, 2021).  The motion addressed plaintiff’s failure to warn claim.

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). 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).  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. 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  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  record evidence shows that the treating physician’s prescribing decision would not have been altered by the undisclosed risk.

Here, the motion highlighted that the implanter testified that he had independent knowledge of the risks of implanting pelvic mesh at the time he performed the surgery on plaintiff, and that had he been provided with the more detailed warning suggested by plaintiff, he still would have made the same decision to implant the mesh.

“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.”  Rather, plaintiff relied 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. 2021 WL 687202, at *4.  And this is a typical plaintiff tactic when a prescriber/implanter testifies he or she would not have changed the key decision, the doctor’s own decision.  Plaintiffs argue that hypothetically if the doctor had different warnings, and if the doctor had passed on additional information, the plaintiff would not have undergone the surgery.  But that is an entirely different question and not the relevant standard under the learned intermediary rule.  The court confirmed that the critical inquiry is not whether the doctor 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; Hoffmann-La Roche Inc., 27 So. 3d at 77.

Defendant’s motion granted.