Biomet, the maker of several medical devices and a number of artificial hip systems, has made many claims about its metal-on-metal hip components. These include that they resist wear, that they are durable, and that they are stable when compared to other, older hip systems. Unfortunately for too many of the people who had Biomet hips implanted, these claims may have been overblown and used to cover up some serious issues.
Metal-on-metal hips from Biomet, including the M2a Magnum, Stanmore, and Exceed ABT, have not lived up to the marketing promises and have instead spurred lawsuits over the high failure rates. The hips have caused people to need revision surgeries and may even have caused metal poisoning in some patients. These complications have caused a lot of patient to experience serious and debilitating pain, multiple revision surgeries, and in some cases permanent damage.
The Problems with Metal-on-Metal Hips
Artificial hips used in the U.S. and approved by the Food and Drug Administration (FDA), may be made of plastic, ceramic materials, metal, or a combination of two of these. Hips made of all metal parts, known as metal-on-metal hips, are some of the most recent types of hips to come on the market. Biomet and several other device manufacturers have developed these hips to be more durable, to stand up to more physical activity in younger and more active patients, and to last longer than hips made of other materials.
Many of these newer hips were approved through the FDA’s 510(k) approval process. This is an expedited process that allows for quick approval for devices that are similar to others already approved and on the market. The 510(k) process does not require rigorous testing. This may have proven to be a mistake for many new hips, including Biomet’s metal-on-metal hips. More involved testing may have uncovered some of the serious issues with the hip design.
While they were supposed to be better and more durable, the metal-on-metal hips have been found to fail early for many patients. One serious issue is that when the metal parts rub against each other, little pieces of metal wear off and can enter the bloodstream or surrounding tissues of the joint. This can lead to a reaction in the joint area, with inflammation and pain. It can also cause metallosis, or metal poisoning in some people when the metal flakes enter the bloodstream. Metal poisoning can cause gastrointestinal issues, headaches, organ damage, nerve damage, and even cancer.
Reasons to File a Biomet Hip Lawsuit
Many people have filed lawsuits against Biomet because of the damage caused by their metal-on-metal hips. The wear that occurs on the metal components of these hips releases metal fragments and the results can be painful and debilitating. Many patients have required numerous revision surgeries to correct the problems caused by the hips or even to replace the hips with new components. The result is high medical bills and a lot of pain and suffering, not to mention continuing problems with mobility.
If you hope to file a Biomet hip lawsuit, you can rely on a lawyer to help explain your rights and options. Generally people suing are asking for compensation to help cover the costs of medical expenses, surgeries, hospital stays, and lost income from being unable to go to work. They are also asking for money to compensate for pain and suffering, for damaged relationships, and for punitive damages to punish the company for pushing a product that proved to be harmful.
Biomet’s 2014 Settlement
The M2a Magnum hip made by Biomet was the subject of several lawsuits that were consolidated into a multidistrict legislation in 2014. The combined suits were heard in an Indiana federal court, which is where Biomet has its headquarters. Biomet never admitted negligence or any wrongdoing and continues to maintain that their hops did not cause any of the injuries or damages claimed by the plaintiffs.
In spite of the denials, Biomet did agree to a settlement in the multidistrict legislation by 2014. The settlement included a $50 million escrow account and a $6 million attorney fee fund. Plaintiffs received $200,000 each in compensatory damages, although there were several terms of the settlement that could reduce that amount, including statutes of limitations in some cases, and patients who received a plastic-on-metal, rather than metal-on-metal hip.
Some of the individuals involved in the settlements described terrible consequences after receiving a Biomet hip. One woman, experienced inflammation and severe pain after chromium particles were released from the hip. She had revision surgeries, but now lives with permanent damage to her hip. Another woman claimed similar issues, including pain and decreased mobility and had to have the entire hip removed and a new one implanted.
Claims against Biomet
Although in the Biomet hip lawsuits the company has refused to admit any wrongdoing, plaintiffs and their representation have made several claims against the company. They say that Biomet did not design, manufacture or test the hips well or in accordance with patient safety. They claim that Biomet misrepresented its metal hips, especially the M2a Magnum hip system, calling them safer and more reliable than other hip systems.
The plaintiffs also tried to make the case that Biomet did not adequately warn doctors and patients about the risk of severe injuries and illness cause by the hip. They claim that the company knew there were risks of the metal wear and tear, but kept that information from the public. Finally, the plaintiffs claimed that Biomet did not provide doctors and surgeons with all the information they needed to implant the hips so as to minimize injuries and wear on the metal surfaces.
If you have had a Biomet hip implant and have experienced a local area reaction, pain, inflammation, metal poisoning, or you required revision surgery, you may still be able to make a case against Biomet. Let a legal expert discuss your case with you and determine what your options are and if you may be able to recover any monetary damages.
Sources
- http://www.cbsnews.com/news/fda-to-scrutinize-safety-of-metal-on-metal-hip-implants/
- http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309404.pdf
- http://www.bjj.boneandjoint.org.uk/content/89-B/5/567
- http://www.reuters.com/article/us-biomet-settlement-idUSBREA1305Y20140204
- https://dockets.justia.com/browse/circuit-7/state-indiana/court-inndce?page=802
- https://dockets.justia.com/docket/indiana/inndce/3:2013cv00477/74281
- https://dockets.justia.com/docket/indiana/inndce/3:2013cv00452/74213