The American Association for Justice (AAJ) is urging federal health regulators not to allow manufacturers of metal-on-metal hip replacements to escape liability through product liability lawsuits by going through the FDA’s premarket approval (PMA) process years after the devices were introduced.
In 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that medical device manufacturers may not be held liable through product liability lawsuits involving devices that were approved by the FDA under the more stringent testing requirements of PMA, which is known as preemption.
Following increasing reports of problems with metal-on-metal hip replacements in recent years, the FDA has been pushing to requiring manufacturers to put their devies through PMA process. Most metal-on-metal hip designs were introduced under the FDA’s controversial 510(k) approval process, which allowed manufacturers to gain approval without conducting rigorous testing by establishing that the design of their device was a “substantial equivalent” to a previously approved design.
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Learn MoreHowever, the American Association for Justice is now warning that there may be hidden dangers in the FDA’s recent push to require metal-on-metal hip makers to put their devices through more extensive testing process, indicating that if metal-on-metal hip replacement systems are reclassified as approved through the FDA’s PMA process, it may block plaintiffs from obtaining a recovery through hip replacement lawsuits pending nationwide.
The advocacy group is urging the FDA to take steps to avoid this injustice for consumers who have suffered complications caused by metal-on-metal hip implants, including loosening of components that often results in early failure of the device and the need for risky revision surgery.
“We can envision a manufacturer seeking to gain retroactive immunity if a device is ultimately approved through a PMA, even though that would be chronologically absurd and terribly wrong,” the AAJ President Mary Alice McLarty wrote in a letter to the FDA (PDF). “Therefore we request language that makes it explicit that such an argument would have no footing.”
Metal-on-Metal Hip Poisoning Concerns
The FDA has increased scrutiny of metal-on-metal hips in response to increasing concerns about the effects of metallic debris that may be released as the metal parts rub against each other, potentially causing tissue damage and metal blood poisoning, also known as metallosis.
In January, the FDA released new guidance for metal-on-metal hip replacements that called for them to go through the PMA process. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market.
Thousands of individuals throughout the United States are currently pursuing product liability lawsuits against the makers of metal-on-metal hip replacement systems, including the recalled DePuy ASR hip, Depuy Pinnacle metal hip, Biomet M2A Magnum Hip and Wright Conserve Cup System.
The complaints all involve similar allegations that the manufacturers failed to adequately research the design or warn about the risk of problems before introducing the products. However, AAJ is raising concerns that these lawsuits may be preempted if the FDA now approves the devices under the PMA process.
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5 Comments
TraciFebruary 9, 2016 at 2:00 am
I had corin Makoplasty hip replacement and since then had to have revision within year in half and also am permantly disabled have ended up with 3 back surgeries
EllisJune 9, 2014 at 5:54 am
How long are we injured patients going to allow Corin To get off the hook,with their defective Corin Cormet II ?. It is clear now that many patients have suffered enough,Corin needs to man up and take responsibility for their manufacturing defects with the acetabulm cup,the plasma separation,from cup And causing it to move,& misalign with the femoral head there fore emitting cobalt ions into our [Show More]How long are we injured patients going to allow Corin To get off the hook,with their defective Corin Cormet II ?. It is clear now that many patients have suffered enough,Corin needs to man up and take responsibility for their manufacturing defects with the acetabulm cup,the plasma separation,from cup And causing it to move,& misalign with the femoral head there fore emitting cobalt ions into our bodies ,I believe they knew it all along,and failed to provide a safe product,after all why would a company like Stryker cut ties with them,Stryker knew about it to And cancelled large orders for this device. As for the executive s at Corin you should be ashamed,settling cases out of court,trying to hush up the real truth... I will sue with a trial,we will win Corin will probably go Bankrupt....so hey all you Corin employees,what goes Around comes around.
JamesAugust 26, 2013 at 10:29 am
I had a metal on metal hip replacement done in 2006. The surgeon did a great job. In the last 7 years my over all health has done nothing but decline. The issues started within a year of the surgery. My Cobalt level when last checked this spring was at 11 bpm. I saw the surgeon that did the implant. He is taking the position that the metal poisoning problems are all unproven and would not consider[Show More]I had a metal on metal hip replacement done in 2006. The surgeon did a great job. In the last 7 years my over all health has done nothing but decline. The issues started within a year of the surgery. My Cobalt level when last checked this spring was at 11 bpm. I saw the surgeon that did the implant. He is taking the position that the metal poisoning problems are all unproven and would not consider any of the problems that I am having to be connected to the hip replacement. Had I know the effects the cobalt in my system would cause there is no way I would have ever had the replacement done.. I feel that my life has been shortened greatly due to this implant, and now to think that the FDA would help out the manufactures of these implants is like the last insult. I now am 61 and have no health insurance. The surgeon told me that if I was concerned about the metal poisoning that I could have the implant removed at a cost of between 75 and 100 thousand dollars. I have not joined any lawsuits as I know that I have already been beat and after reading of the FDA plan I know that I was correct. I will sign this as a unknowing human genie pig.
BarbaraJuly 7, 2013 at 12:40 am
It's is absolutely criminal. These preemption laws should not exist. It is corruption at its worst and I am going to fight!
HowardMay 14, 2013 at 9:31 pm
Thank you for your honest information on preemption law. There are too many people injured by this metal on metal hip ( Smith & Nephew ) BHR, and those seeking accountability and compensation are being discouraged by not being able to obtain representation in court because of the preemption laws. The other nemesis is the statute of limitation. It is a crime that folks don't know what is go[Show More]Thank you for your honest information on preemption law. There are too many people injured by this metal on metal hip ( Smith & Nephew ) BHR, and those seeking accountability and compensation are being discouraged by not being able to obtain representation in court because of the preemption laws. The other nemesis is the statute of limitation. It is a crime that folks don't know what is going on. If the voting public knew that a medical device manufacturer was protected and they not because of the preemption laws this law would have never passed in its present form. Smith & Nephew gets to hurt me (we) and there is little I ( we ) can due about it.