DePuy Orthopaedics faces the start 6,000 trials concerning its Pinnacle metal-on-metal hip-implants.
If you remember, the Johnson & Johnson subsidiary recalled its ASR systems in 2010, after the FDA revealed high levels of revision surgery and reactions to metal ions. However, the company did not recall its similar Pinnacle systems and, instead, phased them out instead of retesting the product per the FDA’s request. Now, even after a $2.5 billion settlement in 2013 for ASR products, DePuy has to face legal action for its Pinnacle implants.
All claims have been consolidated into the U.S. District Court in Texas, with Herlihy-Paoli v. DePuy Orthopaedics Inc., 12- cv-3590 beginning in the first week of September. According to court documents, the plaintiff experienced severe pain in both of her hip joints not long after surgery. A blood test revealed levels of chromium and cobalt 85-percent higher than normal. After a resulting infection, the plaintiff had the system removed. During the trial’s proceedings, she claimed she was not made aware of the Pinnacle’s associated risks.
Johnson & Johnson since counteracted by stating the infection didn’t result from the product but, rather, the position of the plaintiff’s hips.
All plaintiffs are seeking compensatory and punitive damages.
As the first trial starts, a Bloomberg article revealed that Johnson & Johnson knew as early as 2001 that Pinnacle products were defective. A consultant found the metal-on-metal implant generated debris and warned the company about it.
Later, internal documents show officials were aware of a 15-percent failure rate after five years. However, a 2007 brochure states that the 99.9 percent of the products were in use after five years.
It has since been found that all metal-on-metal hip implants from DePuy, Stryker, and other manufacturers experienced fretting or corroding near the joints, caused swelling and walking problems for patients, and resulted in adverse reactions once metal ions entered the blood stream. In response to the latter, patients developed a skin rash, cardiomyopathy, sensory or psychological changes, renal function impairment, or thyroid dysfunction, and a significant percentage required revision surgery to remove the joint. The FDA has estimated that 93,000 people received these products, which have been commercially available since 2005.