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Eleventh Circuit affirms $6.7 million verdict for plaintiff in transvaginal mesh product liability case against manufacturer of Pinnacle Pelvic Floor Repair Kit

On October 19, 2017, in Eghnayem v. Boston Scientific Corporation, No. 16-11818, the Eleventh Circuit Court of Appeals affirmed a $6.7 million final judgment following trial in favor of the plaintiff in a product liability case involving injuries the plaintiff allegedly suffered from the surgical implantation of from the defendant’s transvaginal mesh Pinnacle Pelvic Floor Repair Kit. The plaintiff’s lawsuit was initially filed in South District of West Virginia as part of a transvaginal mesh multidistrict litigation (“MDL”), and was subsequently consolidated with three other lawsuits for trial in the South District of Florida. Each of the plaintiffs obtained verdicts in excess of $6 million, amounting to an aggregate verdict of over $25 million. The defendant argued on appeal that the district court’s decision to consolidate the cases for trial was erroneous, a decision which like evidentiary rulings of the trial court was subject to appellate review for a “clear abuse of discretion.” See Hendrix v. Raybestos-Manhattan, Inc., 776 F.2d 1492, 1495 (11th Cir. 1985) (re consolidating actions); United States v. Brannan, 562 F.3d 1300, 1306 (11th Cir. 2009) (re evidentiary rulings). Under this standard, the Court must affirm unless the district court has made a clear error of judgment or has applied the wrong legal standard. The Eleventh Circuit rejected the defendant’s challenge to the consolidation, noting that under F. R. Civ. P. 42(a), a district court may consolidate actions that involve common question of law or fact and that decision is purely discretionary.

The defendant also claimed that the district court had abused its discretion when it excluded evidence that the device at issue had been cleared by the FDA for sale through its Section 510(k) “substantial equivalence” process. The Eleventh Circuit rejected this argument, observing that the Section 510(k) is a brief process, typically completed within 20 hours, in which the agency only considers whether the device is indeed the equivalent of a preexisting grandfathered device – regardless of how unsafe or ineffective the grandfathered device happens to be. The Eleventh Circuit concluded that successful completion of the Section 510(k) process was irrelevant to the product’s safety and was properly excluded as irrelevant under Fed. R. Evid. 402 and unduly prejudicial under Fed. R. Evid. 403. The Eleventh Circuit noted that the Fourth Circuit Court of Appeal had reached a similar conclusion regarding the Section 510(k) process. See In re C.R. Bard, Inc., MDL No. 2187, Pelvic Repair System Products Liability Litigation, 810 F.3d 913 (4th Cir. 2016).

Finally, the Eleventh Circuit Court of Appeals concluded that the district court had not erred in denying judgment as a matter of law to the defendant on the plaintiff’s design defect claims. Quoting from Force v. Ford Motor Co., 879 So. 2d 103, 106 (Fla. Dist. Ct. App. 2004), the Court noted that Florida uses the “risk-utility test”, under which a product is deemed defectively designed if the plaintiff proves that the design of the product proximately caused the plaintiff’s injuries and the defendant fails to prove that on balance, the benefits of the design outweigh the risk of danger inherent in the design.” The Court concluded that the testimony of the plaintiff’s experts provided a sufficient foundation for a reasonable jury to conclude that the design of the mesh increased both the potential for degradation and the difficulty of removal, and that it was within the jury’s province to decide whether these risks outweighed the product's benefits. See Pensacola Motor Sales Inc. v. E. Shore Toyota, LLC, 684 F.3d 1211, 1226 (11th Cir. 2012) (explaining that, in reviewing the denial of a motion for judgment as a matter of law, “we must disregard all evidence favorable to the moving party that the jury is not required to believe”).