The litigation has been centralized into the U.S. District Court for the Northern District of Texas, Dallas Division, before Judge Sidney A. Fitzwater. The first lawsuit is scheduled to begin in September 2014.
Although litigation involving the DePuy ASR hip implant has received more attention than the Pinnacle hip implant, both products are very similar — when the FDA approved the ASR, DePuy avoided conducting safety studies because they claimed it was “substantially equivalent” to the Pinnacle.
Both the ASR and the Pinnacle are metal-on-metal hip implants that have been linked to similar side effects. The metal parts can grind together, shed toxic particles of chromium and cobalt, and cause debilitating side effects that may require revision surgery.
The first lawsuit involving the Pinnacle was filed on June 16, 2010, two months before DePuy recalled the ASR. Of the 500,000 Americans who are implanted with a metal-on-metal hip implant, an estimated 150,000 people have the Pinnacle implant.
Johnson & Johnson, which owns DePuy Orthopaedics, alleges that the failure rate of the Pinnacle is similar to other metal-on-metal hip implants. They have not issued a recall of the Pinnacle implant, and they have refused to pay for revision surgeries.
It is unclear exactly how many Pinnacle hip implants have failed, because the U.S. Food and Drug Administration (FDA) does not track the performance of medical implants. The manufacturer also has not disclosed how many products have been sold, which makes it difficult to estimate what percentage have failed. There are also plastic and ceramic designs, in addition to the metal-on-metal implants.
All of the lawsuits allege that the manufacturer did not adequately warn about the serious risks associated with the implant, including:
- Metallosis (metal poisoning)
- Shedding particles of cobalt and chromium
- Chronic pain
- Tissue damage
- Bone loss
- Dislocation of the hip joint
- Revision surgery
- And more
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