DePuy Pinnacle MDL Adds Another Lawsuit
Orthopaedic company DePuy is facing more legal action related to their problematic Pinnacle hip implants. The latest DePuy Pinnacle lawsuit was filed with the U.S. District Court on February 12, 2013, and has been added to others in the Depuy Pinnacle MDL in the Northern District of Texas. The plaintiff, from Mount Joy, Pennsylvania, alleges DePuy manufactured and sold a defective device, causing high levels of metal toxicity in his blood.
DePuy’s Pinnacle hip replacement device was launched in 2001. Designed to provide pain relief and a smooth range of motion, it promised to ‘meet the demands of active patients’, and was specifically marketed at younger patients who needed a longer lasting implant that could withstand an active lifestyle. DePuy claimed it would closely imitate the action of a natural hip ball-and-socket joint
The device has since been implanted in around 150,000 patients, but more than 1,300 adverse event reports have been filed with the FDA regarding failures or complications. Most of the complaints allege the implant’s metal-on-metal components have released unsafe levels of toxic metal ions, including cobalt and chromium. Plaintiffs in the DePuy Pinnacle MDL further allege that the company should have been aware of the risks, which can result in metallosis (metal poisoning), tissue death, bone erosion and the development of tumors.
Metal-on-metal hip implant complications
There are multiple complications and risks associated with metal-on-metal implants, all of which require revision surgery to correct:
DePuy, a division of Johnson & Johnson, recalled some of its hip replacement systems in 2010. Despite the increasing numbers of allegations, there has been no DePuy Pinnacle recall to date, and the device remains on the market. Though they deny any liability, Johnson & Johnson has reportedly set aside more than $2 billion to cover DePuy hip replacement lawsuit costs.
Pinnacle implant marketed despite ‘virtually no trials’
Central to the controversy is the lack of clinical testing performed on the device. The FDA granted premarket approval to DePuy based on the availability of another, older device that was considered ‘substantially equivalent’ to the Pinnacle system. Because the pre-existing device had been on the market prior to changes in the law in 1976, DePuy skirted the modern approval process for medical implants, allowing them to hit the market despite having no FDA review, and conducting virtually no clinical or non-clinical trials.
DePuy only learned of the high failure rate of the Pinnacle device after it had been on the market for five years. According to the plaintiff’s allegations in the latest DePuy Pinnacle lawsuit, this willful forfeiture of proper premarket testing resulted in loss of mobility, permanent injury and mental anguish. The plaintiff was also forced to undergo revision surgery. The court documents say the company ‘acted despicably, fraudulently, and with malice and oppression as to justify an award of punitive and exemplary damages’.
DePuy faces thousands of claims
In addition to the 3,000 DePuy Pinnacle lawsuits, the manufacturer is facing more than 6,200 cases related to their ASR implants. These have also been consolidated in federal MDL, taking place in the Northern District of Ohio. Some ASR lawsuits were settled in August 2012, resulting in payouts of $200,000 to each plaintiff.
- Metal-on-metal Hip Implants, an Overview (American Academy of Orthopaedic Surgeons). http://www.aaos.org/research/overviews/
- DePuy's hip replacement: the new big thing in product lability suits? http://blogs.wsj.com/law/2010/12/17/depuys-hip-replacement-the-new-big-thing-in-product-liability-suits/