Thursday, December 22, 2016

Is the DePuy Pinnacle Hip Safe? Why Has a Product Recall Not Been Initiated?

December 21, 2016 - After the DePuy ASR metal-on-metal hip recall in 2010—and the settlement which encompassed thousands of injured consumers—many wonder why no similar recall for the DePuy Pinnacle hip device has been issued. The Pinnacle, manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, received FDA approval in 2000, and was actually the predecessor model of the recalled ASR. Unfortunately, many of those who received Pinnacle artificial hips now face a significantly increased risk of hip failure.

 

Dangers of Pinnacle Hip Devices

Those with a Pinnacle implant could face severe pain in the groin, thigh and hip regions, significant inflammation, dislocation of the device, and failure of the entire hip replacement system. Because the Pinnacle is a metal-on-metal hip device, there is a strong likelihood the device could experience fretting and corrosion, causing small metal ions to shear away, either burrowing deeply into the surrounding hip tissues, or finding their way to the patient’s bloodstream. When the ions reach the bloodstream, there are many adverse health issues which can occur, some of them very grave.

 

Some patients have lost their hearing and/or vision due to the buildup of cobalt and chromium in their bloodstream, while others have experienced one or more of the following: liver necrosis, respiratory issues, reproductive issues, the inability of the body to repair DNA, an increased risk of certain cancers, cardiovascular problems, neurological issues, hypothyroidism, renal failure, muscle atrophy and seizures, convulsions and tremors. This is only a partial list of the issues associated with a buildup of toxic cobalt and chromium in the bloodstream.

 

The DePuy Pinnacle and the FDA’s 510(k) Approval Process

There are many who question the safety of the FDA’s fast-track approval process, which is used for many medical devices, including artificial hips. Under the 510(k) process, the manufacturer of the metal hip must only show their device is substantially similar to a device which is already on the market. Rigorous pretrial testing and FDA inspection are bypassed under this program, meaning the safety and welfare of the public could be seriously jeopardized.

 

What About a Pinnacle Recall?

More than 37,000 Americans received a DePuy ASR before it was recalled, and since the Pinnacle has been on the market for more than 15 years, thousands of people continue to receive a hip implant which was approved without the proper clinical trials and testing. In one study, researchers looked at those who had a Pinnacle hip implanted between the years of 2003 and 2009. Of the 352 patients studied, 71 required revision surgery due to failure of the hip, or adverse reactions to cobalt and chromium ions.

 

This is considered an unusually high—and totally unacceptable—failure rate, yet the Pinnacle has not been recalled. An article in the British Medical Journal blamed poor engineering and design of the Pinnacle, and claimed DePuy exaggerated the safety and efficacy of the Pinnacle devices to health care providers. Despite these facts and the thousands of consumers who have already filed Pinnacle lawsuits, one DePuy executive stated “We stand behind the strong record of safety and effectiveness of the Pinnacle…

 

Will There Be a Pinnacle Recall?

While some believe DePuy has no choice but to issue a recall for the Pinnacle hip implants, the company seems intent on facing off with those who have filed Pinnacle lawsuits. Currently, more than 8,400 Pinnacle lawsuits are active before Judge James Edgar Kinkeade in Texas.  Earlier in 2016, a Texas jury awarded five Pinnacle plaintiffs $502 million for injuries suffered from their DePuy Pinnacle hip device. A second Texas jury ordered Johnson & Johnson and DePuy to pay more than $1 billion to six plaintiffs who claimed the defective design of the Pinnacle was responsible for their injuries. Johnson & Johnson has vowed to appeal both of these awards, however given the size of these awards, the company may decide it would be less expensive to issue a Pinnacle recall and settle the remaining cases.

 

If you or a loved one experienced problems related to a DePuy Pinnacle hip device, it could be very beneficial to speak to a knowledgeable Pinnacle hip attorney to ensure your rights are protected.
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Author: Andrew Sullo
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Andrew Sullo

Andrew SulloAndrew Sullo

Andrew Sullo is a National Trial Lawyer's Top 100 Selection for 2013-2017. He is also a member of the American Association of Justice.

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