DePuy Engineer: ASR Recalled Over Safety Concerns

dupuy-enginneer-saftey-concernsAn engineer with Johnson & Johnson’s DePuy Orthopaedics unit just testified that the recall of its ASR metal-on-metal hip implant devices was implemented over safety, not clinical, concerns; this just days after the president of DePuy testified otherwise. The trial is the first of some 10,000 cases against the device maker.

Engineer Graham Isaac testified during the trial of Loren Kransky, who is suing over the recalled ASR hip implant, said Parker Waichman LLP. According to the national law firm, Isaac said that the recall was based on safety concerns. The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

“Considering all the evidence that has been presented so far, this testimony does not come as a surprise.” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “We receive inquiries on a daily basis from concerned and injured patients who have received the DePuy ASR as well as other metal-on-metal hip replacements.  Their concern is very real and at this point justified.”  The firm advises hip replacement patients to speak with their surgeons if they experience symptoms such as:

  • Pain
  • Swelling
  • Difficulty walking, or a change in the ability to walk
  • Popping, creaking, or other sounds emanating from the area of the implant
  • Metallosis, high levels of metal ions
  • Early failure, the need for revision surgery

DePuy Orthopaedics and parent company, Johnson & Johnson, issued a worldwide recall of 93,000 ASR hip implants in 2010. At that time, Johnson & Johnson stated that the metal-on-metal hip implants failed in 12 percent of patients within five years. According to Parker Waichman LLP, Isaac confirmed that the failure of these devices was a safety issue when Kransky’s attorneys questioned him.

Isaac’s testimony conflicts with prior testimony given by DePuy executive, Andrew Ekdahl, who insisted that the recall was issued because the device “did not meet the clinical needs for the product.”

An internal DePuy analysis in 2011 showed that the devices failed at a rate of 37 percent in 4.5 years. Last year, the Australian national joint registry data suggested that the failure rate was 44 percent in seven years.

Kransky’s lawsuit, like thousands of other similar cases pending in the litigation, alleges that the DePuy ASR generated a toxic amount of chromium and cobalt ions. This buildup of metal debris allegedly caused complications such as blackened tissue and early revision surgery. Yesterday during the trial, Isaac also acknowledged during his testimony that DePuy did not disclose information about the release of metal ions in ASR patients.

Meanwhile, in an unprecedented move, the U.S. Food and Drug Administration (FDA) recently advised that metal ion testing be conducted for all-metal hip replacement patients experiencing symptoms such as pain, swelling, or difficulty walking. In issuing these new guidelines, the agency also recommended diagnostic imaging and regular physical examinations.

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