Wednesday, September 14, 2016

Boston Scientific Pelvic Mesh Trial Win Overturned - Law360

 Boston Scientific Pelvic Mesh Trial Win Overturned

Law360, Boston (September 13, 2016, 5:28 PM EDT) -- The Massachusetts Appeals Court ruled Tuesday that a new trial must be held for a woman who said Boston Scientific's surgical mesh was defective, because a judge kept critical evidence about what the company knew about the product's dangers out of the trial.

In July 2014, a Massachusetts jury returned a verdict in favor of Boston Scientific Corp. in the first product liability lawsuit involving the company’s pelvic mesh products to go to trial. The jury found BSC's Pinnacle Pelvic Floor Repair Kit was not defectively designed. Plaintiff Diane Albright had said that Pinnacle caused severe pain and other physical side effects. Albright claims neither she nor her physicians were warned before surgery about the Pinnacle kit's allegedly defective design.

The trial judge improperly excluded information about a warning that appeared on the material safety data sheet for the polypropylene that BSC made the device out of, the appeals court said.

“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,” it said.

“Exclusion of the MSDS caution substantially affected Albright's rights as, without this key piece of evidence, the jury did not have a complete picture of the information bearing on the safety of the Pinnacle device that BSC either knew of or, in the exercise of reasonable care, should have known about,” it said.

That goes to the heart of BSC's ability to foresee the problem, and “no other evidence before the jury served a similar function,” the panel said.

The caution in question said, "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.”

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