Patient alleges Edwards Lifesciences transcatheter heart valve was defective

By Noddy A. Fernandez | Nov 23, 2018

SAN FRANCISCO – A San Francisco woman alleges her surgery failed because of a defective medical device.

Nancy Romney filed a complaint on Nov. 7 in the San Francisco Superior Court against Edwards Lifesciences LLC, Edwards Lifesciences Corp., Edwards Lifesciences (U.S.) Inc. and Does 1-50 alleging strict liability, negligence in manufacturing and failure to warn.

According to the complaint, on March 23, 2017, Romney underwent surgery for the purpose of implanting a transcatheter heart valve using defendants' manufactured medical device.  She alleges her surgery was unsuccessful due to the alleged defects of the device and she needed further invasive surgery.

The plaintiff alleges the defendants failed to follow good manufacturing requirements and failed to manufacture them consistent with the pre-market approval application.

The plaintiff requests a trial by jury and seeks judgment for economic and non-economic damages, declaratory judgment, disgorgement of profits, award of attorneys' fees, costs, prejudgment interest, and such other and further relief as the court may deem just and proper. She is represented by C. Brooks Cutter and Margot P. Cutter of Cutter Law PC in Sacramento.

San Francisco Superior Court case number CGC18571182

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Cutter Law, PC. San Francisco Superior Court

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