A Massachusetts appeals court revived a pelvic mesh product liability case against Boston Scientific Corp. (BSC) because the trial court had wrongly excluded three pieces of evidence to rebut the company’s claims that the FDA had “cleared” its Pinnacle pelvic floor repair kit for sale.
A state court jury returned a defense verdict in favor of the company in 2014 in the first product liability lawsuit involving the its pelvic mesh products to go to trial.
Plaintiff Diane Albright of Ohio filed suit in 2012 the Massachusetts Superior Court against BSC, which is based in Massachusetts, seeking damages for injuries after the Pinnacle device was surgically implanted to treat her pelvic organ prolapse (POP) condition.
“The repeated reference to the FDA’s clearance aided BSC’s defense, and handicapped Albright’s case, on the central product safety issue in the case,” the appeals court said. The case is Diane Albright v. Boston Scientific Corporation (PDF), No. 15-P-633 (Sept. 13, 2016).
Trial judge Diane M. Kottmyer erroneously excluded key evidence:
- A medical application caution in the 2004 material safety data sheet provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device. It states, “Do not use this [polypropylene] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” The appeals court ruled, ” the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.”
- A letter from the FDA ordering BSC to conduct a “postmarket surveillance” study of the Pinnacle device to address concerns as to the safety and efficacy of the device in treating POP.
- A second letter from the FDA, agreeing to a request from BSC to suspend its postmarket surveillance study because the company planned to stop the manufacture and marketing of the Pinnacle device.
“Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial,” the appeal court ruled.
The same documents have been allowed into other trials, including one in Delaware that landed a $100 million verdict last year. Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.
Some 39,000 pelvic mesh cases have been consolidated in MDL 2327 before US District Judge Joseph R. Goodwin in the Southern District of West Virginia. There are six other MDLS, making it the largest ongoing medical device litigation in the country. The Judicial Panel on Multidistrict litigation lists 75,000 cases in dockets involving different manufacturers.
A surgeon inserted the Pinnacle device into Albright in 2010. Within six months, she experienced pain and discomfort when urinating and other “hardto-describe” pain in her pelvic area. Two other doctors examined her and concluded that Albright was suffering from painful bladder syndrome and other complications due to the erosion and degradation of the mesh in her body.