January 25, 2013 — A woman from Rochester, NY who filed a lawsuit after she was injured by a defective metal hip implant has been selected as one of two “bellwether trials” in federal court.
The jury’s decision in her case could help decide more than 7,000 other hip implant lawsuits pending in a centralized federal Multi-District Litigation (MDL) in the U.S. District Court for the Northern District of Ohio, before Judge David Katz. Recent documents unsealed last week in state court trials in California have linked the hip implant to a 37% five-year failure rate.
The plaintiff, Ann McCracken, was implanted with the DePuy ASR XL Acetabular System in 2009, one year before the implant was recalled. Before the recall, DePuy marketed the ASR as a longer-lasting hip implant, ideal for younger and more active patients. McCracken, a 57 year-old single mother who owns the Good Sign Co., has required multiple revision surgeries to correct complications of the ASR, including two surgeries in 2011 to address hip dislocations. After her third surgery, she suffered permanently decreased range of motion in her hip, and she may require additional corrective surgeries.
McCracken initially filed her lawsuit in U.S. District Court in Rochester, alleging that DePuy knew the device was defective, but waited to issue a recall. McCracken’s lawsuit is scheduled for trial on July 8, 2013.
Nationwide, more than 10,000 lawsuits are pending against Johnson & Johnson and its subsidiary company DePuy Orthopedics. According to evidence from state court trials in California, DePuy officials were informed about “extreme” levels of metal ions in ASR patients as early as 2008 — one year before McCracken was implanted with the ASR, and two years before the company issued a recall.
According to court documents, the ASR was approved by the U.S. Food and Drug Administration (FDA) under the 510(k) approval process. This allows manufacturers to bypass the rigorous pre-market approval process so long as their new device is “substantially equivalent” to an existing device. Unfortunately, the FDA has recently warned that metal-on-metal hip implants have unique risks in addition to the normal risks associated with implants made out of plastic or ceramic.
The problem with metal-on-metal hip implants is that the metal “ball and socket” grind together when the patient walks. Over time, tiny particles of cobalt and chromium debris can accumulate in the soft tissues in the hip. This may lead to severe inflammation and damage to soft tissue and bone. Another risk is that metal can seep into a patient’s bloodstream and cause metallosis (metal poisoning).
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