It’s been several years now since massive recalls were announced about controversial metal-on-metal hip implant systems because of alarmingly high failure rates.
In the wake of these failed systems many victims of defective metal-on-metal systems have filed lawsuits against the manufacturers because of the severe health problems they have suffered. Infections, fractures, constant pain are among the allegations in these hip implant lawsuits.
Many victims report they have been forced to undergo second operations. Others report that they have been left immobilized. Among the manufacturers named in these lawsuits are such large companies as Biomet, DePuy Orthopaedics, C.R. Bard, American Medical Systems, Boston Scientific Corp and Ethicon Inc.
So many lawsuits have been filed that the federal court system has decided to consolidate hundreds of them in what is called a multidistrict litigation in which the cases are overseen by a single judge coordinating settlements and trials.
Most of these lawsuits share similar allegations as those contained in the wave of hip implant lawsuits filed after pharmaceutical giant Johnson & Johnson in 2010 was forced to recall its DePuy ASR Acetabular System and the ASR Hip Resurfacing System. Both systems were failing at rates of up to 13 percent and over 90,000 systems were recalled.
It’s interesting to note that such lawsuits continue to be filed, such as an action recently filed in federal court in Georgia, where a man is suing Indiana-based Biomet over an M2a Magnum Hip System.
According to court records, Tony R. Bishop, a 41-year-old janitor, and his wife, Dawn Bishop are seeking damages “that far exceed $75,000” on claims that the hip implant system he had implanted to repair injuries from a fall from a horse was defective.
The lawsuit alleges that the M2a Magnum Hip System did not undergo adequate testing and was never approved by the FDA as being safe or effective for its intended purpose.
Biomet, according to the allegations, won approval for the system from the Food and Drug Administration through a controversial approval process in which the company claimed the device was substantially equivalent to similar systems that had already been approved by the FDA.
Tony Bishop underwent surgery to have the metal-on-metal system replace his hip in 2006. He claims in his hip implant lawsuit that the metal corroded, flaked off and suffered bone and tissue destruction and toxic levels of cobalt and chromium.
In his court papers, Bishop said that he was forced to have a second, four-hour surgery recently to have the system removed and now is facing other health problems, including dislocation and has been left unable to work.
Bishop, a 41-year-old former janitor, is no longer able to work, said one of his attorneys, Gabby Lee, of the Mount Pleasant-based Mason Law Firm.
Damages are expected to far exceed $75,000, according to the lawsuit. Read more on metal hip implants here.
The lawsuit alleges that Biomet met with orthopedic surgeons in Greenville and assured them the hip system was safe but that the company concealed serious complications and other “bad data.”
The M2a Magnum Hip System was not sufficiently tested and was never approved by the FDA as being safe or effective for its intended purpose, according to the lawsuit.
The defendants obtained FDA approval to market the device through a pre-market notification process that asserted the device was substantially equivalent to other hip replacement systems already on the market, the lawsuit alleges.
More than 350 reports of adverse events associated with the M2a Magnum Hip System have been filed with the FDA, the lawsuit alleges.
Growing concern about metal-on-metal hip implants led the FDA in May 2011 to order manufacturers to conduct post-market surveillance studies, according to the lawsuit.
Biomet and 20 other manufacturers have been ordered to submit research protocols to the agency for studies on specific safety issues, including adverse local tissue reactions and increased metal ions in the blood, the lawsuit alleges.
“To this day, Biomet continues to sell these defective hip implants to unsuspecting patients without any warning about the risks or failures that have been reported to the company,” according to the lawsuit.