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Arguments Heard in Proposed Biomet Metal-On-Metal Hip Implant MDL

Arguments are being heard in a proposed Biomet metal-on-metal hip implant multidistrict litigation (MDL). NewsInferno recently wrote that a lawsuit filed in a Nevada federal courtroom claimed the Biomet M2a-Magnum metal-on-metal hip system is both defective and has a high early failure rate; these issues led to serious and debilitating injuries from, yet another, patient implanted with these devices.

The question remains: Will the Biomet M2a-Magnum hip implant device lawsuits will be consolidated in one court? An answer is expected this week following a hearing before the U.S. Judicial Panel on Multidistrict Litigation (JPML) on September 20, 2012, said The Legal Examiner. To date, some 40 Biomet lawsuits have been filed in federal courts nationwide, with plaintiffs alleging that the device leads to metal poisoning—metallosis—and early loosening, which, in turn, necessitate complex and painful revision surgeries. (more…)

Seven Sue Stryker Over Recalled Rejuvenate Hip Implant

Seven are suing device maker, Stryker, over its recalled Rejuvenate hip implant. Stryker recalled the Rejuvenate and AGB modular-neck hip stems and ceased global distribution of the products this July.

An additional seven plaintiffs have filed lawsuits in Superior Court in Hackensack, New Jersey, alleging that Stryker was negligent in selling them a defective hip replacement device, said NorthJersey.com. The seven additional plaintiffs are from Arizona, Florida, and Minnesota. (more…)

Statutes of Limitations Could Jeopardize Some DePuy ASR Hip Implant Claims

A statute of limitation could put some DePuy ASR hip implant claims in jeopardy, a potential relief to beleaguered Johnson & Johnson subsidiary, DePuy Orthopaedics.

If states and judges intend on upholding a two-year statute of limitation on filed claims, some patients may find themselves out of time to file lawsuits against DePuy over its ASR hip implants, said Mass Device. The recall’s two-year anniversary just passed this month. (more…)

Johnson & Johnson Settles First DePuy ASR Hip Implant Lawsuits

Health care giant Johnson & Johnson has settled its first DePuy ASR hip implant lawsuits, the first of some 8,000 filed over it defective, recalled hip implants.

Following its 2010 recall, the device maker agreed to pay $600,000 to resolve the first three cases in the litigation, said Bloomberg.com, citing those familiar with the issue. The cases involve actions brought about in Las Vegas, Nevada. (more…)

Metal-On-Metal DePuy Pinnacle Hip Implant Named in 1,800 Lawsuits

The metal-on-metal DePuy Pinnacle hip implant has been named in 1,800 lawsuits and more are expected.

The defective Pinnacle hip implant lawsuits concern problems with the version that consists of an all-metal design, which is allegedly associated with serious risks for permanent injuries, including tissue and organ damage. Like other metal-on-metal hip implants, the DePuy Pinnacle model is prone to shed small metal fragments through normal implant wear-and-tear, which causes an accumulation of the toxic metals cobalt and chromium in the patient’s body. If not resolved, dangerous complications, including the growth of small tumors, death to muscle and tissue, and organ damage, can occur. (more…)

Biomet Metal-On-Metal Hip Implant Alleges Injuries Led to Risky Revision Surgery

Another Biomet metal-on-metal hip recipient says her implanted hip caused her to undergo risky revision surgery. Twice. The national law firm, Parker Waichman LLP, filed a lawsuit on behalf of the woman who was implanted with the Biomet M2a Magnum Hip System. Biomet. Inc., Biomet, LLC, and Biomet Orthopedics, LLC have been named as defendants.

This Biomet metal-on-metal implant has been associated with a high rate of early failure and, according to the lawsuit, the Biomet implant failed twice in this woman, forcing her to undergo two revision surgeries.

According to the complaint, the woman was implanted with the Biomet M2a Magnum Hip System on her left hip in December 2005. That implant failed and she was forced to undergo revision surgery to replace the original device with a new M2a Magnum Hip System. The replacement also failed, and the patient had to undergo a second revision surgery.

Revision surgery is performed when complications associated with a hip implant become unbearable or pose unreasonable risks. According to the lawsuit, this procedure is more complex and risky; revision surgeries typically take longer than initial implantation and are associated with a higher rate of complications. In light of the fact that the woman underwent two revision surgeries on her left hip, the lawsuit alleges that she has been exposed to much greater risks. The lawsuit also alleges that the device caused the woman to suffer from economic damages—lost wages and medical expenses—severe and potentially permanent injuries, pain, suffering, and emotional distress.

The lawsuit explained that the Biomet M2a Magnum hip system uses a “monoblock” system that prevents the patient from being able to use any type of acetabular liner. As a result, the device’s metal surfaces rub together with the full weight of the body.

The lawsuit alleges that this metal-on-metal design is defective, and causes an excessive amount of cobalt and chromium ions to corrode from the implant; these particles can cause the body to react negatively, and result in pain, looseness, dislocation, squeaking and popping sounds, fluid build-up, and necrosis of bone and soft tissue.

The lawsuit states that, at the time the woman received her first implant, there were already over 100 adverse event reports associated with the M2a Magnum. The lawsuit also alleges that the defendants hid this information from the patient, her orthopedic surgeon, and the public and that the surgeon would not have used the hip system if the defendants had not made misleading statements about its safety and efficacy.

Metal-on-metal hips, which gained notoriety after the DePuy recall in August 2010, are associated with a high rate of early failure. In March, the Lancet published a study showing that all-metal hips fail at a rate of six percent in five years, whereas metal-on-ceramic or metal-on-plastic implants fail at a rate of approximately two percent. Last month, a study published in the journal, Orthopedics, investigated patients with failed metal hips and found that 92 percent of the revisions were performed within three years.

The U.S. Food and Drug Administration (FDA) has asked a number of manufacturers to conduct post-market safety studies of metal-on-metal hips, hoping that the research will provide insight as to whether the devices release toxic amounts of metal ions into patients’ bodies. In June, the agency also convened an independent expert advisory panel to weigh the risks and benefits of the devices. Overall, the panelists agreed that there is little reason to use metal-on-metal hips in the future.

Wright Medical Tried to Block Approval of Rival’s Birmingham Metal-On-Metal Hip Implant

Device maker, Wright Medical, worked to block approval of its rival, Birmingham’s, metal-on-metal hip implant device from reaching United States implant patients, according to U.S. Food & Drug Administration (FDA) filings. At the same time that the agency was reviewing a pre-market approval (PMA) application for the Smith & Nephew’s device—the first metal-on-metal implant—Wright filed a citizen’s petition that claimed the study behind the PMA application was not sufficient to prove the device’s safety and efficacy, said MassDevice (more…)

Stryker Hip Component Recall Undermines Defense in Metal-On-Metal Lawsuits

Stryker Corp.’s recent recall of hip device components is expected to undermine the device maker’s defense in metal-on-metal hip implant lawsuits. Stryker recently recalled its Rejuvenate Modular and ABG II modular-neck hip stems.

Some hip implant device makers can also expect to be hit hard by the news. At the center of a debacle involving the safety and longevity of metal-on-metal hip implant devices, many manufacturers maintain that their devices are safe, despite unprecedented early failure rates and patient surgeries to remove faulty devices. Sryker’s recall of two metal hip replacement components calls into question device makers’ arguments with similar injuries seen in these components and in implants involved in litigation. (more…)

Stryker Report Finds Hip Implant Modular Neck Stem Pose Metal Ion Risks

A Stryker report finds that hip implant modular neck stems pose metal ion risks. Not surprising, given that, more-and-more, tests are revealing that patients implanted with metal-on-metal hip replacement devices are suffering from increased metal ion levels that have led to metallosis, pain, and masses in the area surrounding the implants.

Device maker, Stryker, just released a report regarding the continuing debacle surrounding metal-on-metal implants, said Mass Device. The controversy led to regulatory investigations following a global recall by Johnson & Johnson’s DePuy Orthopaedics unit over a higher-than-expected failure rate in its hip implant device systems. (more…)

DePuy ASR Hip Implant Test Trials To Start Later This Year

DePuy ASR hip implant test trials are scheduled to begin later this year. DePuy Orthopaedics is a unit of medical device giant, Johnson & Johnson.

DePuy Orthopaedics issued a worldwide recall of its ASR Hip Resurfacing System and ASR Acetabular System in August 2010. The recall followed release of data from the National Joint Registry of England and Wales in which it revealed that 1 out of every 8 patients—approximately 12%-13%—who had received the devices required revision surgery within five years. (more…)

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