The Potential for a DePuy Pinnacle Recall

The Potential for a DePuy Pinnacle Recall

DePuy Manufacturing started in the medical device manufacturing industry with a synthetic splint in the late 1800s and has grown into a billion dollar company over the last century. Things have got even better for DePuy over the last decade (since it was purchased by Johnson & Johnson), as it now earns roughly $5 billion in revenue a year. Unfortunately, the company has seen a particularly rough patch over the last few months, highlighted by a recall of the ASR hip replacement system, which was deemed too prone to failure to remain on the market. Now, DePuy is bracing itself for a wave of litigation regarding the product.

The DePuy ASR was approved for sale to the public by the U.S. Food and Drug Administration (FDA) through a controversial method called the 510(k) process. Through the 510(k) process, the FDA allows a medical device to be sold on the open market without pre-market testing as long as it is "substantially similar" to an already-approved device. This system is criticized as not taking the proper measures to ensure the safety of product recipients.

The ASR was approved without pre-market testing based upon its similarity to the DePuy Pinnacle hip replacement system. Now there are serious concerns with the viability of that earlier product for multiple reasons. The FDA has reported over 500 complaints with the Pinnacle system, mostly that the product is prematurely loosening within a few years of being implanted in patients. There is an additional risk with the Pinnacle system that was first highlighted by a New York Times report last year. Metal-on-metal hip replacement systems like the Pinnacle may carry the risk of causing metal toxicity in the patient.

The issue with metal-on-metal hip replacement systems is that the metal components constantly rubbing against each other cause metal particles to flake off and either embed themselves in the soft tissue surrounding the device or enter the bloodstream. Once a significant enough level of the foreign substance builds up in the patient, then she may suffer from metal toxicity. The symptoms of metal toxicity can vary depending on the sufferer, but typically there are feelings of disorientation and unexplained depression.

There has yet to be a DePuy Pinnacle recall, but if you have suffered some harm from your Pinnacle device, you could have a claim against DePuy. The attorneys at the Rottenstein Law Group have spent a total of over 25 years representing the rights of victims who have suffered from the negligence of big corporations like DePuy.

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