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Was DePuy Negligent In Seeking FDA Approval For Pinnacle System? by Gregory Fraser





Article Author Biography
Was DePuy Negligent In Seeking FDA Approval For Pinnacle System? by
Article Posted: 08/18/2011
Article Views: 122
Articles Written: 48
Word Count: 511
Article Votes: 13
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Was DePuy Negligent In Seeking FDA Approval For Pinnacle System?


 
Business,Law,Health

The DePuy Pinnacle hip replacement system is allegedly unsafe and has not been tested, according to one of the many lawsuits filed against the DePuy Orthopaedics, Inc. Anna Maria Sillman, who filed her lawsuit at the United States District Court for the State of New Jersey, claimed that DePuy was able to put its pinnacle hip replacement system out in the market by inappropriately submitting it to the 510(k) approval process of the U.S. Food and Drug Administration (FDA). With the many issues surrounding hip replacement in the US, "should you consider a medical "vacation" for your hip replacement surgery"?

It has been a year since DePuy initiated a recall of its ASR hip replacement system, yet the company continues to be in "hot water", this time concerning the alleged failure of another of its medical device, the Pinnacle Acetabular Cup hip replacement system. The comparison of a new model with another lawfully marketed model for safety and effectiveness is what is required for FDA's 510(k) approval process. Sillman claims that the submission was negligent because the products already approved were apparently not subjected to clinical testing.

Sillman's lawsuit is just one of the many lawsuits filed against the Johnson & Johnson (J&J) subsidiary DePuy Orthopaedics. Last Aug. 9, Judge James E. Kinkeade of the United States District Court for the Northern District of Texas announced his intended process for organizing plaintiffs' leadership committees and requested written submissions on the organizational structure in the next 30 days during the first case management conference of the DePuy Pinnacle hip multidistrict litigation. The US Judicial Panel on Multidistrict Litigation last May ordered the consolidated litigation against DePuy and J&J being overseen by Kinkeade.

Similar to the DePuy ASR hip systems, which were recalled in August 2010, the Pinnacle Acetabular Cup is also a metal on metal hip device. The Pinnacle Acetabular Cup is also a metal on metal hip device similar to the DePuy ASR hip systems which were recalled in August 2010. Thus, individuals who underwent total hip replacement surgery and received a Pinnacle hip implant often experience Pinnacle problems akin to that of patients who received the ASR metal on metal hip systems. As the ASR, the metal on metal DePuy Pinnacle hip replacement system also increases the risk of metallosis in recipients due to constant friction of the metal components, which release metal particles into the soft tissue surrounding the device or into the bloodstream.

An opportunity is provided by the Pinnacle lawsuit for affected parties to claim compensation on damages which resulted from the defective medical device. DePuy and J&J had set aside as much as $1 billion in the past for those suffering from their defective devices.

A lot greater than a couple of individuals have registered a "DePuy Pinnacle Lawsuit" contrary to the manufacturer for their particular anguish. When you have been affected regarding this situation, verify here with regard to updates.

Related Articles - depuy pinnacle, recall, hip, replacement, implant, lawsuit, mechanism, failure, complaints, Joint, Pain,

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