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First Bellwether Trial in Multidistrict Litigation for DePuy Orthopaedics Inc.’s All-Metal Hip Implant to Commence on September 9 in Ohio’s Northern District, Reports Parker Waichman LLP
Date:8/30/2013

omplication rate is a concern as well.”

The DePuy ASR and other metal-on-metal hip implants were approved without clinical testing for safety or efficacy due to the 510(k) approval route, which exempts devices from clinical testing as long as the manufacturers show that their product is similar to a previously approved device. The U.S. Food and Drug Administration (FDA) reported on Jan. 18, 2013, that it was attempting to change the 510(k) approval process; the agency has proposed that all-metal hip replacements go through premarket approval, which would require device makers to prove that their products are safe and effective.

The FDA, in that report, also advises people implanted with a metal hip to immediately speak with their doctors if they experience any of the following symptoms:

  •     Early failure, revision surgery
  •     Metallosis, high levels of metal ions in the bloodstream
  •     Difficulty walking, or a change in their ability to walk
  •     Swelling
  •     Pain

Johnson & Johnson, which owns DePuy as a subsidiary, recalled 93,000 ASR hips in 2010, citing a failure rate of 12 percent in five years, according to a March 8, 2013, Bloomberg report. In Australia, failure rates have exceeded 40 percent in seven years.

Parker Waichman LLP continues to offer free legal consultations to victims of DePuy ASR and other metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associat
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