Issues have been swarming the DePuy Pinnacle hip replacement system resulting in a number of lawsuits. More people who experience symptoms of metallosis and hip pain, or have loosening devices are seeking legal consultation and compensation. An all metal hip replacement research has been coordinated by a group because of these rising issues.
The loophole in the approval process of these malfunctioning devices was seen as a major cause why numerous lawsuits are happening. Through its 510(k) approval process, the U.S. Food and Drug Administration allowed the DePuy Pinnacle system to be marketed publicly. The sale and distribution of a medical device can go without subjecting to necessary clinical trials as long as the manufacturer can show the FDA that the device is 'substantially equivalent' to the safety level of a similar device already approved on the market. The approval of the Pinnacle system in DePuy's case was based on the similarity of other hip replacement system currently on the market. The Pinnacle system is now being condemned due to the inherent risks attached to it.
Around 500 complaints were thrown against the Pinnacle system as reported by the FDA. A report published in 2010 has focused on the serious risk of metal toxicity while most of these complaints zeroed in on the device loosening prematurely. Contrasting the typical hip replacement system that uses a synthetic plastic liner inside the socket component of the synthetic joint, the Pinnacle systems are metal-on-metal devices that increase the risk of metal toxicity due to the friction of their metal components causing release of metal particles into the bloodstream. With the buildup of these metallic particles, patients may suffer symptoms of metallosis, which include disorientation and feelings of general malaise.
Back in the late 1800s when DePuy was formed as a splint manufacturing company, its founders could never have imagined that it would become the industry leader it is today. Johnson & Johnson has purchased the company in 1998 and the investment has now paid dividends. Now, it has been bringing $5 billion in annual sales revenue from its medical devices. The company has suffered some setbacks in the recent months. The company has been facing complaints with their ASR hip system resulting to litigations and a recall. Now, the company is facing another challenge as a lot of people are filing for a DePuy Pinnacle lawsuit.