Metal-on-metal hip implant lawyers at Pintas & Mullins Law Firm report that more than 11,000 consumers recently asked the FDA to re-classify all high risk implants, such as those made by Stryker and DePuy. The reclassification would require the manufacturers to prove that these medical devices were safe and effective before they can be put on the market.
The letter, sent by the Consumer’s Union, urged the federal agency to subject these implants to a premarket approval process (PMA), which is a scientific and regulatory review. It is the most rigorous type of device marketing application required by the agency, and is based on adequate legitimate scientific evidence that the device is effective and safe.
About two months ago, in February 2013, the FDA proposed this very action, although it has not yet made a final decision. The Consumer Union letter was written in attempt to persuade the agency to adopt the proposal in whole. All U.S. residents may comment on FDA proposals. Comments are due for this action by May 28, 2013, and a link to which may be found here.
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Hundreds of thousands of patients have been seriously injured by these metal- on-metal implants; among the most common include early device failure, metallosis, and other internal injuries. Metallosis occurs in many patients because the implants are made from a metallic blend that generates high levels of metal ions. These small metal particles can release into the body when corroded, often causing metallosis and premature device failure. Symptoms of this condition include swelling or pain around the implant site, loosening of the device, changes in walking ability, and sounds coming from the implant. The condition can cause severe bone and tissue damage, and may render patients permanently disabled. If the metallosis goes untreated for a long period of time it may lead to severe cognitive and cardiac damage and even death.
Traditionally, hip and knee implants were made from plastic, and lasted about 15 years before wearing out. The monetary and physical costs of replacement surgeries are extensive, and metal-on-metal implants were designed to be longer lasting. Due to authoritarian mishaps, hip implant manufacturers were only required to demonstrate that the products were similar in design to hip implants already on the market before being approved by the FDA. Since these metal-on-metal devices were indeed similar to other plastic implants, the agency did not require and safety testing before it released the devices onto U.S. markets.
The result of this is dangerous, even catastrophic in certain patients. Thousands of patients have filed lawsuits against the various manufacturers responsible for these injuries, which include Stryker, DePuy, Biomet, and Zimmer. The specific products subject to lawsuits include the DePuy ASR and Pinnacle, Biomet M2A Magnum, Zimmer Durom, and Stryker Rejuvenate.
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Recently, in March 2013, a jury ordered Johnson & Johnson (the parent company of DePuy) to pay $8.3 million to a patient implanted with the ASR XL hip implant. The man, Loren “Bill” Kransky, accused the company of knowingly marketing a defective implant, which was later recalled. After being implanted in 2007, Kransky experienced premature failure and was forced to undergo a painful revision surgery. He testified that, as a result of the defective device, he had to live in constant pain, was unable to walk, and suffered from metal poisoning.
This was the first of nearly 11,000 similar cases involving the ASR and Pinnacle hip implants. Johnson & Johnson has already set aside about $2 billion to cover the costs of this litigation. The medical giant knew about the implant’s problems since about 2008, and in January 2013, the company conducted an internal study and found that the ASR products may fail in nearly 40% of patients. To date, about one in eight of these patients needed theirs replaced within five years.
If you or a loved one was injured by a Stryker, Biomet, DePuy, or Zimmer all-metal implant device, you may be entitled to significant compensation. Metal-on-metal hip implant lawyers at Pintas & Mullins Law Firm can ensure you will receive the best representation and largest settlement possible for any medical bills, lost wages, or pain and suffering you may have experienced due to the defective design of these products.