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, March 5, 2015

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.


UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye
(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.
Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.
Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.
The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.
The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.
Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.
Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.
Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."
Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.
Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.
Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)

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