Pinnacle Pelvic Floor Repair kit
A decision by a Massachusetts Appeals Court means a mesh-injured woman from Ohio will win a new trial against Boston Scientific over her Pinnacle Pelvic Floor Repair Kit pelvic mesh implant she claims caused her injuries.
Yesterday, the court overturned the 2014 verdict against Diane Albright.
The jury in her 2014 trial in Massachusetts had concluded her Pinnacle pelvic mesh was not defective and the warnings to her doctor were adequate.
Fidelma Fitzpatrick, Motley Rice
Lawyers for Albright immediately filed an appeal.
Judge Diane M. Kottmyer
The judge withheld from jurors the Material Safety Data Sheet (MSDS), that is a document that gives detailed information about a chemical, its properties, safety, and environmental hazards. It is designed to keep workers who handle such materials safe and is required by OSHA, the Occupational Safety and Health Administration.
It has been one of the most compelling pieces of evidence plaintiffs' attorneys have shown at trial for several different types of mesh, all made of the polymer, polypropylene.
The MSDS said that devices made from polypropylene resin are "not suitable for permanent implantation." Pinnacle, made from polypropylene, is a permanently implanted pelvic mesh.
Judge Kottmyer also did not let jurors see two letters from the Food and Drug Administration (FDA) that ordered post approval surveillance of Pinnacle. Instead, Boston Scientific took Pinnacle off the market in a voluntary recall in May 2011, three years after it was launched.
While the jury knew that the produce was cleared, the Plaintiffs were not allowed to present evidence about what was wrong with that 510(k) application process, a process that clears mesh for sale and not based on safety. That left the jury with the impression that the product was “legal” even though the Plaintiff vigorously argued that the product was not safe and was not effective.
According to court documents printed in MassDevice:
“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 weot.