Pinnacle pelvic floor kit brochure recalled by the fdaMesh News Desk, November 13, 2014 ~A nine-person jury in the defective product trial of a pelvic mesh product made by Boston Scientific decided this evening the four women should receive over $6 million each for the injuries they suffered! 

The nine-person jury entered into deliberations 2 pm today (Thursday, November 13) and delivered their verdict about four hours later.

They decided the Pinnacle Pelvic Mesh Repair Kit was defectively designed and that its instructions to physicians were also defective, that the company was negligent and failed to warn patients about the dangers of the Pinnacle.

The award represents compensatory damages. The jury declined awarding punitive damages, designed to send a message to the company.

The women suffer permanent damages including chronic pelvic pain and infection, nerve damage and mesh migration.  They face further surgeries to have the Pinnacle removed. It is intended to be a permanent implant.

Plaintiffs Margarita Dortes, Maria Nunez, Juana Betancourt and Amal Eghnayem will receive between $6.5 and $6.7 million.

The decision against Boston Scientific was the first for a bellwether case. The company faces nearly 15,000 consolidated defective product cases filed in federal court in West Virginia.  A bellwether case tests legal theories to determine the relative value  in hopes of reaching a settlement.

The company said in its last quarterly SEC report that internationally it is facing 23,000 product liability actions over its pelvic mesh products in the U.S., Canada and the UK.

Federal courthouse Miami

Federal courthouse Miami

Closing arguments Thursday afternoon,  Shelly Hutson (Clark, Love Hutson), one attorney for the four women, reminded jurors their case showed Boston Scientific was the last mesh manufacturer to have a pelvic mesh kit on the market. the mandate was to rush it to market without any testing to first prove its safety.

Hildy Sastre (Shook Hardy) said the warning to physicians were adequate and some of the plaintiffs suffered preexisting conditions that led to the pain and complications they suffer today. “There is no such thing as a risk-free surgery,” said Sastre reports Reuters.

The last case of Salazar v. Boston Scientific resulted in a $73.5 million verdict for Ms. Salazar in September, which has since been reduced by half.

At this writing, there is another trial being heard against Boston Scientific in Charleston, West Virginia. The Obtryx, midurethral sling has been called defective in its design in that product liability case. In that consolidated proceeding, four women claim it too was defective in the design and in its instructions to doctors for use.

Boston Scientific used polypropylene mesh known as Marlex to make its pelvic mesh implants to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The Pinnacle Pelvic Floor Mesh Kit was the largest among all mesh kits ever made among all manufacturers to treat POP. It was voluntarily recalled from the market by Boston Scientific in 2011.