After previously securing a pelvic mesh trial win, Boston Scientific will now have to face a new trial based on the results of a recent Massachusetts Appeals Court ruling.

The appeals court decided that the trial judge withheld important evidence about what Boston Scientific knew about its pelvic mesh dangers from the trial.

The original pelvic mesh trial verdict was decided in July 2014 when a Massachusetts jury issued a verdict favoring Boston Scientific Corp.

This lawsuit was the first of its kind that involved product liability allegations over the company’s Pinnacle Pelvic Floor Repair Kit. Essentially, the jury ruled that the device was not defectively designed.

Plaintiff Diane A. alleged in her lawsuit that the device caused her to develop severe pain as well as other physical side effects.

She claims that before her surgery, she and her physicians were unaware that the pelvic mesh was allegedly defectively designed.

Pelvic Mesh Trial Verdict Overturned

The appeals court ruled that the pelvic mesh trial judge improperly excluded pertinent information that detailed a warning that appeared on the material safety data sheet (MSDS) on the polypropylene material that the device was made out of.

“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,” the appeals court ruled.

“Exclusion of the MSDS caution substantially affected [the plaintiff’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,” the ruling stated.

The appeals court ruled that the omitted information pointing to Boston Scientific’s ability to foresee the problem and stated that “no other evidence before the jury served a similar function.”

The MSDS caution that was omitted read, “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.”

Diane initially had the pelvic mesh implant and when she had surgery to treat a cystocele, more commonly known as bladder prolapse.

In the opening arguments of her pelvic mesh trial, Diane’s attorneys told the jury that the Pinnacle device was too large and too heavy to be implanted and is made with plastic materials that make it nearly impossible to remove in the event that there are complications.

Thousands of lawsuits have been filed against Boston Scientific and other companies such as C. R. Bard Inc., and Ethicon, a division of Johnson & Johnson.

In response, in April 2014, the FDA issued to proposed orders that would reclassify pelvic mesh as a high-risk device and would require manufacturers of pelvic mesh to apply for premarket approval.

The Pelvic Mesh Lawsuit is Case No. MICV2012-00909, in the Superior Court of the Commonwealth of Massachusetts, County of Middlesex.