Massachusetts Appeals Court Returns Transvaginal Mesh Case to Court for ReconsiderationSep 21, 2016
More than two years, a jury in a Boston Scientific transvaginal mesh trial found in favor of the manufacturer. The plaintiff appealed the verdict, and the Massachusetts Appeals Court has recently agreed with the plaintiff, and the case will be reheard.
The woman had the Boston Scientific transvaginal mesh device implanted in 2010 to treat a cystocele, a form of pelvic organ prolapse. The woman alleged that the device caused her severe pain and other serious complications, Lawyers and Settlements reports. She claimed that neither she nor her doctors were warned before surgery about the device's allegedly defective design.
An expert witness for the plaintiff was not allowed to testify. Boston Scientific petitioned the judge to bar the witness on grounds that the witness's expert opinion had been barred in similar litigation against a Boston Scientific competitor.
In the two years since the trial, information has surfaced about the dangers of transvaginal mesh devices, including the Food and Drug Administration (FDA) decision to re-classify transvaginal mesh medical devices from class II-the moderate risk category-to class III, the high-risk category. The FDA also issued an order that requires transvaginal mesh device manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
During opening arguments in the 2014 trial, the plaintiff's attorney explained to the jury that the Pinnacle Pelvic Floor Repair Kit was too large and too heavy to be implanted safely and, further, the device was nearly impossible to remove in the event of complications, according to Lawyers and Settlements.
In the appeal, the woman's attorney's argued that the trial judge, Diane Kottmyer, improperly kept the jury from hearing about a warning that the polypropylene material Boston Scientific used in its mesh was not suitable for permanent implantation. The attorneys further argued that Kottmyer should not have excluded a two letters from the FDA ordering Boston Scientific to launch a post-market surveillance study of the Pinnacle device.
The Massachusetts Appeals Court agreed with these arguments and remanded the case for reconsideration because the jury should have been allowed to see the Material Safety Data Sheet warning and the FDA letters.
The MSDS provides basic information on a material or chemical product. Justice Gary Katzmann wrote that the MSDS warning was "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." The warning reads: "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."
In trials involving Boston Scientific transvaginal mesh devices, a jury awarded $18.5 million to four plaintiffs in November 2014. In October 2014, a jury awarded $26.7 million against Boston Scientific over the Pinnacle transvaginal mesh device. A $73.4 million award was made in September 2014 to plaintiffs in a lawsuit over Boston Scientific's Obtryx device, Lawyers and Settlements reports.