DePuy ASR Trial Update: Parker Waichman LLP Comments on Bloomberg Report Detailing How Johnson & Johnson Failed Its Own Safety Test

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According to a report in Bloomberg News, witnesses in the DePuy ASR trial have testified that Johnson & Johnson failed its own safety test designed to assess whether the metal-on-metal hip implant releases unsafe levels of metal ions. Consultant George Samaras said that instead of changing the design of the hip replacement, J&J changed the test in order to pass the device.

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“This witness’ testimony is further evidence demonstrating that Johnson & Johnson failed to take proper precautions in designing and marketing the DePuy ASR,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is weighing-in on a Bloomberg report detailing how Johnson & Johnson failed its own safety test when designing the DePuy ASR hip implant. According to Bloomberg, during the DePuy ASR bellwether trial that began last week, a witness said that the company chose to change the protocol rather than redesign the hip implant. J&J recalled 93,000 units of its ASR implant in 2010 after data showed that the device failed in 13 percent of patients within five years.

http://www.businessweek.com/news/2013-01-28/j-and-j-failed-its-own-safety-test-in-hip-design-witness-testifies

The case that has gone to trial is In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al., BC456086, Los Angeles Superior Court. The lawsuit is the first of approximately 10,000 cases alleging that the DePuy ASR hip implant is defective and causes injuries including metallosis, soft tissue reaction, pain and the need for early revision surgery. Most of the cases are pending in the U.S. District for the Northern District of Ohio as part of the In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (MDL 2197).

According to Bloomberg, a consultant named George Samaras testified for Plaintiff Loren Kransky, a retired corrections officer who had his DePuy ASR hip implant replaced last year. Samaras told jurors that the DePuy ASR hip cup failed the safety test set up by Johnson & Johnson’s DePuy unit, citing an internal document showing that the ASR produced 16 times more chromium and cobalt debris compared to another product manufactured by the company. By these standards, Samaras said, the device should have failed, but it passed because the company changed the protocol. He stated “That’s not what good engineers do. You are playing games with what the requirements for the device are.”

The DePuy ASR, like other metal-on-metal hip implant, was approved through the 510(k), a process that approved devices without clinical safety tests so long as it is similar enough to a previous device. Samaras said that when the ASR cup failed the internal test, the company decided to compare it to another previous (predecessor) device to make the implant appear safer. “They changed the test,” Samaras stated. “They didn’t do what they were supposed to do, which is change the design.”

“This witness’ testimony is further evidence demonstrating that Johnson & Johnson failed to take proper precautions in designing and marketing the DePuy ASR,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “Because of their actions, thousands of people have been injured by these devices.”

Samaras is not the only expert testifying against Johnson & Johnson. Before his testimony, an epidemiologist at Dartmouth Medical School named John Baron said that the ASR XL failed at a rate of 22 percent after five years and 44 percent after seven years, based on the Australian national registry data.

Recently, the U.S. Food and Drug Administration (FDA) proposed stricter regulations for approving metal-on-metal hips. The agency proposed that, instead of going through the 510(k) process, hip makers should be required to show that their implants are safe and effective before selling them. The FDA has also issued new guidelines, recommending that patients under regular physical examinations, diagnostic imaging and metal ion testing as needed.

Parker Waichman LLP offers free legal advice to people implanted with the DePuy ASR hip and implant and other metal-on-metal hip replacements. The firm has filed a number of lawsuits on behalf of metal hip recipients who allege injuries from the device. On August 24th, for instance, the firm filed a lawsuit in the U.S. District Court for the Northern District of Ohio, Western Division (Case No. 1-12-dp-23381) on behalf of a Florida resident who says the DePuy ASR caused pain and other complications. Among other things, the suit alleges that DePuy and parent company Johnson and Johnson knew about the defects of the device but continued to sell it nonetheless.

Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Gary Falkowitz
Parker Waichman LLP
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