Boston Scientific loses bid to toss $19m pelvic mesh loss

Boston Scientific (NYSE:BSX) yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries.

A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed).

Boston Scientific last year asked Judge Joseph Goodwin, of the U.S. District Court for Southern West Virginia, to overturn the verdict, arguing that the plaintiffs failed to show that Obtryx is not reasonably safe because it’s within the standard of care for stress urinary incontinence. The plaintiffs also failed to link any of their injuries to specific design flaws, the company argued, and likewise didn’t prove their failure to warn claims. Boston Scientific also argued that the punitive damage awards were excessive and caused a miscarriage of justice.

Goodwin disagreed, declining to disturb the jury verdict because “there was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” according to court documents.

“[Boston Scientific] 1st argues that the plaintiffs failed to establish that the Obtryx is ‘not reasonably safe’ because it is within the standard of care for the treatment of SUI. BSC conflates the standard for medical malpractice with that used for strict liability,” Goodwin wrote. “Here, the question is whether the manufacturer used reasonable care in designing the Obtryx.

“Accordingly, despite expert testimony indicating that use of the Obtryx is within the standard of care in the medical community, a reasonable jury could balance the risks and benefits based on the significant evidence the plaintiffs produced at trial on the Obtryx’s risks,” the judge wrote. “From this evidence, a reasonable jury could conclude that the risks associated with the Obtryx are not justified by its benefits and, as a result, the product is not reasonably safe.”

On the design defect claims, Goodwin found that “a reasonable jury could conclude that the Obtryx is not reasonably safe based on evidence of the specific defects discussed above (e.g. difficulty of removal; contraction, shrinkage, and banding; degradation; scarring).”

“Because I find that the plaintiffs’ experts specifically connected at least 1 of the above defects to each plaintiff’s injuries, a reasonable jury would have no need to ‘infer the existence of a defect by circumstantial evidence,'” he wrote. “The design defects discussed above, which were specifically linked to the plaintiffs’ injuries through expert testimony, likewise could have been revealed through clinical testing of the Obtryx. Therefore, a reasonable jury could find that BSC’s failure to conduct clinical trials before marketing the Obtryx proximately caused the plaintiffs’ injuries.

“In sum, BSC knew that safety issues can arise when a product does not undergo clinical testing, failed to respond to explicit warnings from the manufacturer that polypropylene should never be used permanently in the human body, and suggested hiding negative studies to physicians considering using the Obtryx. Drawing all inferences in the light most favorable to the plaintiffs, I find that a reasonable jury could use this evidence to conclude that BSC’s conduct justified an award of punitive damages,” Goodwin wrote.

Boston Scientific alone is facing some 19,000 individual cases in the multi-district litigation over its pelvic mesh products, out of the more than 70,000 cases pending in MDLs against that company and other pelvic mesh makers including C.R. Bard (NYSE:BCR) and Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, according to the documents.