By Dietrich Knauth J.D.
The Eleventh Circuit Court of Appeals denied Boston Scientific Corp.’s (BSC) appeal over a $6 million jury verdict related to an allegedly defective transvaginal mesh implant, finding that BSC was not prejudiced by the lower court’s handling of the case, including its exclusion of evidence related to FDA approval for the device (Eghnayem v. Boston Scientific Corp., October 19, 2017, Marcus, S.).
Florida district court juries awarded four plaintiffs more than $6 million in damages each for injuries allegedly caused by BSC’s Pinnacle® Pelvic Floor Repair Kit, a transvaginal mesh medical device used to remedy pelvic organ prolapse in female patients. The plaintiffs’ injuries included incontinence, pain and bleeding during intercourse, pelvic pain and pressure, and multiple surgeries to correct the problems and remove the device.
BSC argued on appeal that it was prejudiced by court rulings on the evidence presented to the jury, and by the consolidation of four separate lawsuits. BSC also claimed that it was entitled to judgment as a matter of law based on Florida’s four-year statute of limitations for product liability claims and on the alleged lack of evidence in support of design defect and failure to warn claims. The appellate court ruled against BSC on all of its arguments.
The lower court properly excluded evidence relating to the implants’ FDA approval, according to the decision, because the specific approval at issue did not examine the safety of the device and might have confused the jury. The Pinnacle device was approved for sale through the FDA’s 510(k) "substantial equivalence" process, which allows for the sale of medical devices that are similar to other, older products that have not gone through full premarket approval. Because the 501(k) process actually exempts devices from rigorous safety review, evidence on the product’s FDA approval would not have helped a jury decide whether the products were safe or adequately tested, and might have confused or misled the jury instead, the circuit court found. The Eleventh Circuit noted that the Fourth Circuit has similarly ruled that 510(k) evidence may be excluded in cases over allegedly defective medical devices.
The appellate court also ruled that the plaintiffs had presented enough evidence on design defect and failure to warn claims, finding that BSC’s warnings about its product did not indicate that the device would be difficult or impossible to remove without also removing healthy tissue. In addition, the four-year statute of limitations did not apply, according to the decision, because the plaintiffs presented evidence that they initially believed that subsequent medical issues were related to complications from surgery, rather than the result of a defectively designed implant.
The case is No. 16-11818.
Attorneys: Jane Kreusler-Walsh (Kreusler-Walsh Compiani & Vargas, PA) for Amal Eghnayem. Daniel B. Rogers (Shook Hardy & Bacon, LLP) for Boston Scientific Corp.
Companies: Boston Scientific Corp.
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