Boston Scientific ($BSX) is facing a setback in the first case to go to trial over its vaginal mesh products after the plaintiff won an appeal in a Massachusetts court.
The Woburn, MA-based Middlesex County Superior Court overturned an earlier verdict which dismissed the case against Boston Scientific. Back in July 2014, a jury found that the company’s Pinnacle mesh implant was properly designed and that Boston Scientific had warned plaintiff Diane Albright about its risks.
Unsurprisingly, Albright was not pleased with the verdict and appealed the court’s decision. Albright argued that Judge Diane Kottmyer excluded key evidence from the jury and didn’t tell them about a safety warning for the device, according to court documents seen by MassDevice.
In particular, Kottmyer didn’t tell the jury about a warning on the material safety data sheet for the polypropylene used in the mesh, which is unsuitable for permanent implantation, MassDevice reports. Kottmyer also left out two letters from the FDA ordering Boston Scientific to launch a post-market surveillance study of Pinnacle and regulators’ later decision to suspend the trial after the company said that it would pull its implant from the market.
The Massachusetts Appeals Court agreed with Albright and sent back the case for further consideration. The material warning on the device is “relevant, material evidence for the limited purpose of showing that (Boston Scientific), which has received the (warning) well before 2009, had notice or knowledge of the caution,” Judge Gary Katzmann of Middlesex County Superior Court wrote in the opinion, as quoted by MassDevice.
The judge should have also allowed Albright to use the letters so her representation could cross-examine the company’s witnesses about the device’s safety, Katzmann wrote. Kottmyer made a good point of excluding the regulatory evidence concerning Pinnacle’s approval “because of its potential to mislead the jury and confuse the issues.”
But “it was error to preclude Albright from using the later-in-time letters in cross-examination of Boston Scientific experts or employees,” Katzmann wrote, especially after the judge allowed the company to use evidence about the device’s approval to bolster its case.