Photo of Michelle Yeary

Today’s case originated in the pelvic mesh MDL pending in the Southern District of West Virginia.  Approximately one year ago, the matter was transferred to plaintiff’s home jurisdiction in Florida.  Accompanying the case upon transfer was defendant’s motion for partial summary judgment on four of plaintiff’s claims.  Plaintiff abandoned three of those claims (strict liability manufacturing defect, breach of express warranty, and breach of implied warranty), leaving only plaintiff’s failure to warn claim to be decided by Swintelski v. American Medical Systems, Inc., — F.Supp.3d —, 2021 WL 687202 (S.D. Fla. Feb. 22, 2021).

The facts of the case are straightforward.  Plaintiff underwent surgery during which her surgeon implanted defendant’s pelvic mesh product.  She alleges she suffered adverse health effects thereafter.  Id.  at *1.  At the core of the matter, however, is the testimony of her implanting surgeon – the learned intermediary.  The implanter testified that he had independent knowledge of the risks of implanting pelvic mesh at the time he performed the surgery on plaintiff.  Id. at *2, *4.  Even more important to the outcome of the issue was the doctor’s testimony 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.  Id.

According to the decision, plaintiff made three primary arguments.  First, a manufacturer’s failure to provide an adequate warning prevents the doctor from being considered a learned intermediary at all, meaning that the defendant would have to warn the plaintiff directly.  Second, if her implanter had been provided a more detailed warning he would have conveyed that information to plaintiff and she would have refused to undergo surgery.  Third, the jury should weigh the credibility of the implanter’s testimony.  Id. at *3.

As to plaintiff’s first argument, she offered no law in support, and in fact, the opinion cites numerous cases holding just the opposite.  Id. at *4.  Plaintiff’s second argument was the most substantive.

Under Florida’s learned intermediary rule, “it is plaintiff’s burden to establish the causation element by showing that adequate warning would have altered the treating physician’s decision to prescribe the device at issue.”  Id. at *3 (citation omitted).  In this case, plaintiff did not dispute that the implanter would have made the same decision.  The implanter testified that if he had more information at the time of the surgery, he would have passed it on to plaintiff.  Plaintiff relied on that testimony to argue that she then would have changed her decision to undergo the procedure.  Id. at *4.  But that is a different question and not the standard under the learned intermediary rule in Florida.  The relevant issue is whether the implanting surgeon would have altered his decision, not whether the surgeon might have said or done something that would have caused a patient to act differently.  In this case, the undisputed evidence was that the surgeon would not have changed the prescription decision.  Id. at *5.  This is an excellent ruling, since it keeps the plaintiff’s interested testimony out of the causal equation.

Finally, arguing that summary judgment was precluded because the jury need test the credibility of the surgeon’s testimony was likewise an unsupported proposition.  It was plaintiff’s burden to establish proximate cause and under Florida law, a court can decide causation where the evidence is undisputed.  Id.