Ana Martinez and her husband Jose sued Marlborough, Mass.-based Boston Scientific in August 2012 in the Bay State’s Middlesex County Superior Court. After a 16-day trial, the jury found June 15 that Boston was not negligent in the design of its Pinnacle and Obtryx pelvic mesh products and did not fail to warn patients of the risks associated with the meshes, according to court documents.
The jury also found that the Pinnacle and Obtryx devices were not defectively designed and that the company did not fail to adequately warn the plaintiff’s implanting physician of their risks, according to the documents.
Boston Scientific’s pelvic mesh products drew worldwide scrutiny last month after being covered in a 60 Minutes episode airing claims that the company knowingly purchased inauthentic Chinese plastic materials to make them.
The report claimed that Boston Scientific won FDA clearance for and used “Marlex” branded polypropylene, made by a subsidiary of Chevron Philips, for its meshes, but in 2004 was warned by Chevron Philips that the branded polypropylene should not be used for permanent implantation.
In January 2016, a purported class-action racketeering lawsuit accused Boston Scientific of illegally smuggling counterfeit resin made in China to make pelvic mesh. Shortly after filing, however, a federal judge booted the lawsuit on claims that the FDA has jurisdiction over the case.
In April 2016, a federal probe into the counterfeit resin allegiations reportedly convened a grand jury in West Virginia.
The same firm that filed the the racketeering suit later asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.
Boston Scientific said the 60 Minutes report contained “completely false claims,” asserting that the resin it uses in its transvaginal mesh products “matches a formulation from the original U.S. produced resin.”
“We believe that this story was irresponsible and misleading. We provided the show with a statement and are disappointed that our perspective, and those of medical societies and the healthcare community, were not fully reflected in the broadcast,” the company said at the time.
“Our mesh products contribute to only 1% percent of annual sales to our company. Continuing to provide these mesh products is not about profits. It is about doing what is right for patients. Without these products, women would be left with few treatment options for these debilitating and often embarrassing conditions. Across Boston Scientific, our employees work diligently to bring forward important medical devices that help people around the world to live longer, healthier lives. We remain steadfast in our commitment to patients,” Boston Scientific said.
Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.
You can hear her story and more when you register for DeviceTalks Boston, October 8-10.
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