Device maker Biomet promotes the metal-on-metal components of its M2a Magnum Hip System as having better durability, “greater resistance to wear” and “improved implant stability” over other types of implant components. But according to researchers and a growing number of injured consumers, metal devices like the M2a Magnum do not live up to the marketing hype and actually carry an alarming risk of failure.
According to research reported in the British Medical Journal, metal-on-metal implants developed in recent years do not appear to be more effective or durable and may even pose more risks than older implants. The U.S. Food and Drug Administration (FDA) reports that in 2011, metal-on-metal devices were linked to more than 12,000 adverse medical events, compared with 6,332 for other types of implants.
The most commonly reported problem with all metal implants was the need for revision (e.g., surgery to remove or replace an implant). The severity and number of injuries has prompted the FDA to issue safety alerts about potential risks and to also call for more consistent monitoring of these devices. Regulators in the U.K., Canada and Australia have also issued safety alerts.
Despite concerns that that friction between metal components produces metal shards that damage surrounding tissues, devices like the M2a Magnum remain on the market. Injured consumers endure tremendous pain and additional painful, costly surgery that doesn’t necessarily eliminate their suffering. Hundreds of them have filed lawsuits to hold Biomet accountable.
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Status of Biomet Hip Lawsuits
As of May 2013, more than 300 federal lawsuits were filed against Biomet over M2a Magnum implant injuries. Lawsuits have also been filed in various state courts, including courts in New Jersey.
In October 2012, a federal judicial panel centralized federal Biomet M2a Magnum hip implant lawsuits. In addition to transferring eight cases pending in various federal courts, the panel ordered the transfer of future case filings to the U.S. District Court for the Northern District of Indiana. The panel anticipates a significant number of Biomet lawsuits and centralized the cases in the Northern District of Indiana in order to process the cases more efficiently. Judge Robert L. Miller, Jr. will preside over the litigation, known as Multidistrict Litigation (MDL) No. 2391.
The defendants in the lawsuits include Biomet, Inc. and various Biomet business units, including Biomet Orthopedics, LLC; Biomet Fair Lawn, LLC; Biomet Manufacturing Corp.; and Biomet U.S. Reconstruction, LLC (collectively “Biomet”). Biomet opposed establishment of the MDL, but preferred the District of New Jersey or the District of New York if the panel ordered creation of the MDL.
Although no party suggested the Northern District of Indiana, the panel decided that it was the most appropriate district since that’s where Biomet, Inc. is headquartered and where many of the documents and witnesses are located. Another factor the panel considered was the court’s “favorable docket conditions.” This means that the court has a manageable case docket.
Judge Miller has already held multiple case management conferences to discuss scheduling and decide how discovery will proceed. One hearing also featured “a tutorial on scientific and technical issues” to educate the court on issues relevant to the litigation. Judge Miller has also set Fort Wayne and South Bend, Ind.,, as the locations for depositions of Biomet employees.
As the size of the federal MDL is expected to grow, state court filings are also expected to continue. Several Biomet cases have been filed in New Jersey state court. In the past, the New Jersey Supreme Court has centralized litigation involving other hip implants.
For instance, the Bergen County Superior Court is currently managing more than 600 cases involving Depuy’s ASR hip implant, with the first trial scheduled for October 2013. The same court is managing more than 160 cases involving Stryker Rejuvenate and ABG II Modular-Neck Hip Stems. The New Jersey Supreme Court may likewise order centralization of Biomet cases as case filings increase.
How We Can Help
Drugwatch’s mission is to inform and support people whose lives have been harmed by dangerous devices like Biomet hip implants. Hip implant injuries cause severe pain and financial hardship. We offer information and resources to help cope with these problems.
Our Patient Advocates are also available seven days a week to offer free advice and support for people who have been injured by Biomet hip implants. If you or a loved has been injured, contact a Patient Advocate to talk one-on-one about your concerns and to receive more information about our resources.
We can also provide information on pursuing a legal claim like the many injured people who have already filed Biomet hip implant lawsuits. If you’d like more information on legal options for yourself or your loved one, a Patient Advocate can help you find an experienced Biomet hip implant lawyer to explain the legal process and also help you decide whether to file a claim.
Why Should You File A Biomet Hip Lawsuit?
When metal components of devices like the Biomet M2a Magnum Hip System rub against each other, they can produce metal shards. This metal debris can affect tissue surrounding the implant, leading to metallosis and premature device failure. In addition to pain and swelling in the implant area, people can experience adverse reactions in other parts of the body after the debris enters the bloodstream. Treating side effects like inflammation in the joint lining and receiving revision surgery take substantial physical, emotional and financial tolls on the injured and their loved ones.
Device makers are under a legal duty to adequately design and test their products and to ensure their safety. Yet device makers usually aren’t quick to take responsibility for injuries caused by their products. Hip implant manufacturers may instead attribute any problems to infections and surgical errors, rather than their product design. And manufacturers who issue voluntarily recall their defective products do not necessarily compensate injured people for all of their medical expenses.
For these reasons, many people who have been injured themselves or have loved ones who have been injured by metal-on-metal hip implants have filed lawsuits seeking compensation for their injuries.
|If you or your loved one has been injured, you may be eligible to receive an award for:|
|Compensatory damages (e.g., hospitalization costs, medication, revision surgery and other medical expenses; caregiving services; lost income from diminished ability to work)|
|Pain and suffering|
|Loss of consortium (e.g., damages to spousal relationship)|
|Punitive damages (e.g., awards to discourage future misconduct)|
People Who Filed Biomet Hip Lawsuits
Hundreds of people filed Biomet M2a Magnum implant lawsuits. Plaintiffs include people like Leon Vincent, a North Carolina man who received an M2a Magnum implant to replace his left hip in August 2008.
After receiving the device, Vincent experienced debilitating pain and soreness, discomfort, loss of mobility and dysfunction. His symptoms progressively worsened. He said that friction between the metal head and metal liner of his hip replacement device shed toxic chromium particles into his bloodstream and the tissue surrounding the implant. He underwent revision surgery in 2009.
He sued Biomet companies in federal court in October 2012, alleging the defective implant caused his injuries. He also said that Biomet representatives frequently met with orthopedic surgeons, including his own doctor, to aggressively promote the M2a Magnum implant.
According to Vincent’s complaint, they assured the surgeons repeatedly that the device was “the best on the market, had an excellent track record, would last longer than traditional hip implants, and had a low and acceptable failure rate.” He also said that Biomet continued to maintain and “defend” the safety of the device to surgeons although it was aware of “numerous and serious complications” with the device.
Vincent also claimed that he will likely have to receive more surgeries, incur additional medical expenses and that he has suffered permanent harm because of the defendants’ negligence. His case is pending in MDL No. 2391.
Other people who filed lawsuits include:
Patricia Gill, from New York, received an M2a Magnum implant in 2005 in her right hip. She said that friction and wear between the metal components released chromium particles into her blood and tissues, causing severe pain and inflammation. She received revision surgery to replace the implant, but continues to suffer permanent damage and will likely require additional surgery. She said that revision surgery would not be necessary if the Biomet device had performed satisfactorily. She seeks compensation for medical expenses, pain and suffering, lost wages and punitive damages. The lawsuit was filed in federal court in May 2013 and includes her husband’s loss of consortium claim.
Christina Kirk, an Ohio woman, received an M2a Magnum hip implant when she underwent a total right hip replacement in 2007. Like other plaintiffs, she has suffered severe physical injuries caused by the release of metal ions into her body. Her injuries will likely worsen and require revision surgery to remove and replace the device. She filed a lawsuit in federal court in May 2013.
All plaintiffs allege that Biomet knew about the risks prior to their surgeries, but concealed the information.
|People injured claim Biomet:|
|Failed to exercise reasonable care in the design, manufacture and testing of the M2a Magnum Hip System.|
|Misrepresented that the M2a Magnum Hip System was safer and more reliable than other hip replacements despite knowing about the dangers.|
|Failed to adequately warn or disclose information regarding the risks of severe and permanent injury.|
|Did not provide health care professionals with sufficient information to avoid or mitigate injuries caused by the product.|
Plaintiffs claim that, had they or their health care providers been warned about risks associated with the M2a Magnum Hip System, they would not have been implanted with the device and subsequently injured.
Questions to Ask Your Biomet Hip Lawyer
A Biomet hip implant attorney can help you determine whether you are eligible to file a legal claim for compensation for your injuries. In addition to answering questions about whether you have a valid claim, your attorney can explain the case process, in general, and what you can expect. Your attorney can also tell you how much time you have to file a complaint, since each state limits the amount of time available to file a claim.
Also be sure to discuss with your Biomet hip implant attorney how hip implant lawsuits may differ from other types of lawsuits. In particular, be sure to ask what you should do to protect your legal claim while seeking medical treatment for your injuries. Device makers sometimes ask doctors to return defective implants after revision surgery, but doing so could mean losing possession of important evidence needed for your legal claim. So be sure to ask your attorney about taking the proper steps to protect your evidence if you receive revision surgery.
Also ask your attorney what you should do if the manufacturer recalls the implant in the future. Sometimes manufacturers use information obtained during the recall process to prevent you from filing a lawsuit. In particular, the manufacturer may try to get you to sign a release or waiver in order to get a new device or compensation for medical expenses. But you should be aware that settlements offered during a recall won’t necessarily cover all of your medical expenses and may be substantially less than what you may be eligible to receive from a lawsuit.
If you sign a waiver or release, you may not be able to file a lawsuit. Always talk to your attorney before signing any documents or providing any medical information as part of a recall. If you have questions about filing a lawsuit, recalls or finding an attorney, our Patient Advocates are available to help.