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www.fdanews.com/articles/178434-ruling-against-plaintiff-vacated-in-boston-scientific-pelvic-mesh-lawsuit

Ruling Against Plaintiff Vacated in Boston Scientific Pelvic Mesh Lawsuit

September 15, 2016

A Massachusetts appeals court vacated the dismissal of a woman’s lawsuit against Boston Scientific over injuries from a mesh implant.

The plaintiff, Diane Albright, alleged that the pelvic mesh implanted to treat her pelvic organ prolapse was improperly designed and caused her injuries after it was implanted in 2010.

The initial ruling in 2014 was the device was found to be properly designed and that the medical device company gave adequate warning about risks.

Albright appealed the ruling, claiming that Judge Diane Kottmyer kept the jury from hearing about a warning on the material safety data sheet for the polypropylene Boston Scientific used in the mesh. The MSDS said the material was not suitable for permanent implantation.

The appeals court said that the 510(k) process is not relevant to state tort law.

The case was remanded to the lower court. The decision is available here: www.fdanews.com/09-15-16-AlbrightvBostonScientific.pdf. — Cynthia Jessup

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