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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Tuesday, June 3, 2014

Billion: That is $2.5 billion !!! Settlement is not justice for harmed patients!

Warsaw firm to settle thousands of implant lawsuits
Paul Wyche | The Journal Gazette  Published: May 31, 2014 3:00 a.m.

DePuy Orthopaedics, a unit of Johnson & Johnson, has waived its “walk-away rights,” which means the Warsaw company agrees to pay more than $2.5 billion to settle thousands of hip implant lawsuits, court documents show.

Officials at the medical device company have decided that enough plaintiffs exist to proceed with the settlement, according to paperwork filed last week with the U.S. District Court for the Northern District of Ohio in Toledo.

“While Settlement Program enrollment forms are still being processed, most (eligible) patients have opted into the program,” court documents stated.

“The company is, therefore, moving forward before the June 1 decision deadline provided for in the Agreement. The exact timing and amount of compensation will depend on a number of factors and circumstances specific to each claim,” the documents continued.

“However, eligible patients with allowed claims can expect payment now that there is certainty the program is moving forward,” the court papers said.

In November, the parent company agreed to pay plaintiffs who received the DePuy-made ASR hip implants.

The settlement gives money to patients based on several factors, including age, extent of injuries and whether they had to replace the defective implant. That agreement set the base rate at $250,000 per patient.

The DePuy ASR recall was announced in August 2010 after post-market data indicated that 12 percent to 13 percent of recipients required revision surgery within five years, according to Bernstein Liebhard, a New York law firm offering free legal evaluations to patients.

Attorneys with Bernstein Liebhard said that by the time the recall was announced, nearly 100,000 people worldwide had received the devices. Evidence revealed during DePuy ASR lawsuit trials indicated that the implant’s actual failure rate may be closer to 5 percent.

Other circumstances could entitle plaintiffs to a supplemental award if, for example, they required multiple revision surgeries, or if they experience “certain extraordinary injuries” in the future, attorneys said.

“DePuy remains committed to the well-being of ASR patients, as demonstrated by the worldwide voluntary recall and the global Broadspire program providing support for recall-related care,” said Mindy Tinsley, a DePuy spokeswoman, in an email Friday.

Broadspire is an independent, third-party claims processor available to patients not eligible for the U.S. Settlement Program, DePuy said.

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