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Following a number of knee and hip replacement recalls in recent years, a prominent consumer watchdog group is calling for the creation of a “lemon law” for artificial implants, which would provide consumers with a warranty to cover the costs associated with problems that may ultimately be discovered with the design of the product after they are implanted.
Consumers Union issued a report on September 10, suggesting that new warranty requirements should be established for hip and knee replacements.
The group, which is the policy arm of Consumer Reports, found that 20% of all hip implant surgeries conducted every year, and 10% of all knee implant surgeries, are revision surgeries. That means that the owners had already been implanted with an artificial hip or knee and that the device had failed.
The group indicates that medical device manufacturers should be required to guarantee the devices or replace them at no cost.
Metal-on-Metal Hip Replacements
In recent years, a number of different recalls and problems have been discovered with hip and knee replacement products after they were introduced, when higher-than-expected numbers of consumers experienced problems with loosening or failure of components.
Thousands of product liability lawsuits have been filed over the past few years involving newer designs, including metal-on-metal hip replacements, modular hip implants and certain knee replacements that were introduced and marketed as superior alternatives to older designs.
The company facing the bulk of the lawsuits is DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which faces more than 10,000 lawsuits over the recalled DePuy ASR metal hip system, which was removed from the market in August 2010 after it was discovered that about one out of every 8 implants was failing within five years. However, other reports have suggested that design problems may cause a far greater number of the artificial hips to fail the longer they remain in place.
Although the manufacturer has acknowledged the problems, Johnson & Johnson has not agreed to offer adequate compensation to settle DePuy ASR lawsuits filed by many of the estimated 35,000 people who received one of the defective implants in the United States.
In addition to claims brought by individuals who received an ASR implant, a number of other metal-on-metal hip lawsuits have been filed against the manufacturers of artificial hip systems that feature a similar design, including DePuy Pinnacle hip lawsuits, Biomet Magnum hip lawsuits and Wright Conserve hip lawsuits.
Modular Hip Implant Problems
Problems associated with the design of modular hip replacements have also surfaced in recent years, which involve a femoral component that features two pieces that fit inside each other to allow the surgeon to adjust the length of the component for each patient. However, as the parts rub against each other, at least two modular hip designs have been shown to experience problems.
A Stryker Rejuvenate and ABG II hip recall was issued in July 2012, after the manufacturer acknowledged that a higher-than-expected number of patients were experiencing problems where the modular hip fretted, corroded, loosened and ultimately failed, often resulting in risky revision surgery.
Similar problems with Wright Profemur hip implants have surfaced in recent years, where the modular implant has been found to fracture or break at the femoral neck.
Knee Replacement Lawsuits
Manufacturers of knee replacement systems have faced similar problems in recent years. More than 1,000 Zimmer NexGen knee lawsuits are currently pending throughout the country involving different types of components in the NexGen line, including certain “flex” models that have been associated with reports of loosening, pain and complications.
The Zimmer NexGen system was first introduced in 1995, with most components later approved without extensive trials or FDA investigation into their safety through the 510K fast-track approval program, which only requires that devices be “substantially equivalent” to medical devices already on the market to obtain marketing approval.
All of the complaints involve similar allegations that plaintiffs experienced problems with certain Zimmer knee replacements, which were allegedly caused by design defects or Zimmer’s failure to provide accurate information about the risk of problems.
Similar allegations have been raised in lawsuits over Smith & Nephew Journey knee replacements, some of which were recalled following reports of problems that suggest the base plates may break, leading to instability and premature wear of the knee replacement.
Hip and Knee Replacement Warranty
Although medical device manufacturers generate substantial profits from the sale of hip and knee implants, consumers and their insurance carriers are often left with the immediate costs associated with treatments required when problems are discovered.
According to Consumer Union, requiring a warranty would allow patients to get revision surgery free of charge when an implant turns out to be defective or fails prematurely.
“While patients may be told by their surgeon how long a device can expect to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty,” Lisa McGiffert, director of Consumer’s Union’s Safe Patient Project, said in the report.
Consumer Union’s Safe Patient Project has gathered information on all hip and knee recalls issued over the past decade, finding that all major manufacturers have been forced to remove components from the market after problems were discovered, and sometimes these recalls involved issues that posed a serious health risk for consumers. However, manufacturers fail to stand behind their products by providing warranties to adequately protect patients when the implants turn out not to be dependable or safe.