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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Monday, May 18, 2015

Criminal behavior, but no jail time. Lives lost, PREVENTABLE harm. Follow the money.





Published : Friday, May 15, 2015 | 2:50 PM  (FiDA highlight)
Several hundred women that were represented by a Los Angeles-based attorney were a part of a $119 million settlement against a Massachusetts-based medical company over claims that its vaginal mesh product did not work and caused serious injuries.
“Most of the claims assert that the device manufacturer failed to properly test the pelvic mesh implant, ignored warnings, or that the device implanted into human tissue did not work and sometimes caused very serious problems,” said Los Angeles lawyer Dana Taschner, representing hundreds of women in the national medical device litigation involving several device
manufacturers.
Surgical mesh products were implanted in women in an effort to treat pelvic organ prolapse, stress urinary incontinence, and following hysterectomies.
Medical Device Company Boston Scientific agreed to settle thousands of lawsuits involving a vaginal mesh product, including the claims of an area woman claiming injury from the company’s transvaginal mesh medical device. Boston Scientific is paying $119 million to resolve almost 3,000 cases around the country, Taschner said.
“The trial that settled this week is one of thousands of transvaginal mesh lawsuits in federal and state courts across the country alleging product flaws” he said.
Boston Scientific claimed no admission of wrongdoing in the settlements, and insists their mesh medical device is not faulty or to blame for alleged problems.
Payments in the settlement are to be paid into a settlement escrow by the device manufacturer by October 1, 2015. Boston Scientific has reportedly set aside close to $1billion to cover costs, liabilities, legal expenses, and settlement associated with continuing transvaginal mesh and bladder sling claims.
Two other recent cases involving Boston Scientific resulted in significant and expensive defeats for the company.  In Miami, Florida, a federal jury returned a verdict of $26.7 million after plaintiffs argued that the company’s Pinnacle mesh device design was faulty and caused serious problems.
In another case in West Virginia, the jury returned a verdict of $18.5 million after the plaintiff sued Boston Scientific for injuries the plaintiff claims are a result of the medical device.
In addition to Boston Scientific, several other medical device companies are defending lawsuits for alleged transvaginal mesh problems.
“Boston Scientific is still exposed to claims from thousands of women claiming injury from the medical devices” said Taschner.
As of February, more than 25,000 product liability cases or claims regarding the mesh products had been made against the company, according to Boston Scientific filings.
Boston Scientific spokesperson Kelly Leadem said in an e-mail Tuesday that when it comes to those other cases and claims, the company will continue to look at all of its options.
“If there are opportunities to settle cases at reasonable terms in the future, then we will consider settling,” said Leadem in the e-mail. “Otherwise, we will continue to contest these claims

vigorously.”


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