Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, August 15, 2013

Failed Surgical Mesh producer C.R. Bard guilty.



By Jef Feeley & Phil Milford - Aug 15, 2013 2:51 PM CT
            C.R. Bard Inc. (BCR) should pay $250,000 to a woman who sued saying she suffered injuries from the company’s vaginal-mesh implant, a jury found.
The first federal-court trial of more than 5,000 claims over the devices now moves to the punitive-damages phase in Charleston, West Virginia.
Jurors deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable today for injuries that Donna Cisson blamed on its Avaulta line of devices.
Patients claim the implants cause organ damage and make sexual intercourse painful when they erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP)-formerly American Medical Systems- and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through incisions, degrade and shrink over time.
Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. U.S. District Judge Joseph Goodwin ruled earlier that plaintiffs couldn’t mention that Bard had withdrawn the products.
Scott Lowry, a Bard spokesman, wasn’t immediately available at his New Jersey office to comment on the verdict.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
To contact the reporters on this story: Jef Feeley in federal court in Charleston, West Virginia, at jfeeley@bloomberg.net; Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

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