The plaintiff in the 1st pelvic mesh lawsuit to go to trial against Boston Scientific (NYSE:BSX) won a new trial yesterday when a Massachusetts appeals court overturned a 2014 verdict dismissing the case.
Diane Albright alleged that the Pinnacle mesh implanted to treat her pelvic organ prolapse was improperly designed and caused her injuries after it was implanted in 2010. In July 2014, a jury in the Middlesex County Superior Court in Woburn, Mass., found that the device was properly designed and that the medical device company gave adequate warning about risks.
Albright appealed, arguing that Judge Diane Kottmyer improperly kept the jury from hearing about a warning on the material safety data sheet for the polypropylene Boston Scientific used in the mesh that it was not suitable for permanent implantation. The appeal also argued that Kotmyer should not have excluded a pair of letters from the FDA ordering the company to launch a post-market surveillance study of the Pinnacle device and later agreeing to suspend the trial after Boston Scientific said it planned to shelve the implant, according to court documents.
Yesterday the Massachusetts Appeals Court agreed, remanding the case for reconsideration in light of its judgment that the jury should have been allowed to see the MSDS warning and the FDA letters.
“We conclude that the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that [Boston Scientific Corp.], which had received the MSDS well before 2009, had notice or knowledge of the content of the caution,” Justice Gary Katzmann wrote. “When considered solely for the purpose of demonstrating notice or the extent of BSC’s knowledge, the caution was not hearsay.
“We conclude that, in the unique context of this lengthy trial, 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. Such a limited use, to show bias or to rebut the witness’s opinion testimony, would be reasonable cross-examination,” Katzmann wrote.
“We add that the judge would have been well within her discretion to exclude all reference to the 510(k) clearance because of its potential to mislead the jury and confuse the issues. However, having permitted BSC to invoke the 510(k) clearance, it was error to preclude Albright from using the later-in-time (2012) letters in cross-examination of BSC experts or employees, who had addressed the FDA clearance, to rebut BSC’s claim that its product was, in essence, ‘cleared’ as a safe device,” he wrote.