Separate product liability suits have been filed in the U.S. District Court for the Eastern
District of Pennsylvania by two patients that ignored a 2010 recall notice, but began experiencing problems years later.
Kevin Riedel, of Airville, Pa., and Joye Schuchart, of New Freedom, Pa., claim that their devices felt fine at the time of the recall and did not think the notice applied to them. However, in late 2013 or early 2014, they both say they experienced pain and discomfort from the hip replacement device.
Both plaintiffs seeks compensatory and punitive damages in excess of $75,000 from DePuy Orthopedics, a manufacturer that created and marketed the ASR XL Acetabular System, and its parent company, Johnson & Johnson. The suit alleges that the company was aware of device defects before they were implanted into the plaintiffs.
According to the suit, Riedel received his hip replacement in January 2010, and Schuchart had hers implanted in November 2007. Both suits say that the DePuy knew that reports of problems with the device rose between 2006 and 2009 in the European and Australian markets.
The complaints say that Johnson & Johnson brought the ASR to market in 2005 after receiving approval from the Food and Drug Administration. According to the claims, the company bypassed the more strict guidelines by using a more mainstream approval process. According to the court documents, the company told the FDA that its product was similar enough to other devices on the market to warrant the easier process.
If the ASR had gone through the more rigorous testing, the suit says, it would have been revealed that the device's design created a large amount of metal debris that damaged patients' muscles and tendons, and high levels of metal in the wearers' blood.
The ASR devices' high failure rate was a result of premature wear and loosening of the prothesis, the complaints say.
The suits says that the defendants issued a warning to U.S. surgeons in March 2010 of the ASR's failure rate, followed six months later by a product recall. They followed up with their doctor shortly after receiving the letters of recall and decided to keep their devices implanted since neither of them were experiencing any pain or discomfort.
At the end of 2013, Schuchart began to feel pain and difficulty with her hip. Further tests revealed she had elevated levels of chromium and cobalt in her blood. She received revision surgery in March 2014 to correct the problem, but she still holds DePuy and Johnson & Johnson negligent and in breach of warranty for marketing a product they allegedly knew to be defective.
Riedel also felt discomfort in his hip in March 2014. He has not yet undergone the revision surgery and holds the defendants responsible for his need for further medical attention.
Both plaintiffs are represented by Jaime Jackson of Atlee Hall, LLP in Lancaster, Pa.
The federal case IDs are 2:14-cv-04954-TJS and 2:14-cv-04956-JCJ.