Hip Replacement Lawsuit Center
As hip replacement manufacturers pull back their support for all-metal hip devices, thousands of patients who have suffered incapacitating injuries have filed hip replacement lawsuits in state and federal courts nationwide.
Johnson & Johnson’s DePuy division is the first among what is likely to be many manufacturers to pull out of the all-metal hip business. The company, which is facing a minimum of 13,300 hip lawsuits, announced it is phasing out production of all-metal devices. The New York Times said the move is an industrywide trend because of high early failure rates.
Trend Toward High Jury Awards
With the first jury award toppling $8.3 million for a Montana man who was implanted with the DePuy ASR (Articular Surface Replacement) XL device, many companies are likely to look for an easy exit from the all-metal hip business. The 12-member jury quickly found that the hip device caused the man’s ongoing injuries. Legal analysts and consumer advocates called it a landmark verdict that will set the tone for future hip litigation.
Metal on Metal Hip Replacements
Early on, hip replacements were made from plastics and ceramics. But by the 2000s, the trend was moving to an all-metal design because they were thought to be more durable and offer greater flexibility. Despite the many designs spanning several companies, the overall components were generally the same: a metal thigh piece with a ball, simulating the body’s natural femur, and a cup piece, simulating the acetabulum.
FDA Clearance for Hip Implants
Part of the problem started with the U.S. Food and Drug Administration (FDA) and its antiquated approval process. Because hip replacements were considered medical devices that were not considered essential, they underwent a far-less stringent approval process than essential devices, such as an artificial heart. Using the FDA’s 510 (k) approval process, hip manufacturers were able to get their products on the market without human testing. The only thing the company’s had to prove was that their devices were similar to ones already on the market -- even if that original device had been recalled.
Hip Implant Failure
As quickly as all-metal hip devices skyrocketed in popularity, they started showing signs of weakness. Hip replacements are supposed to last a decade or more; all-metal hips were failing in the first couple of years. Worse yet, the complications became potentially fatal: metal poisoning, infections and tumors. All of this because no one recognized early on that the friction between the all-metal pieces would cause metal shedding, or fretting.
Hip Implant Recalls
Despite the obvious problems, hip manufacturers weren’t readily admitting that their products were faulty. In fact, the move toward remedying the complications didn’t begin in the United States at all. In 2011, the National Joint Registry of England and Wales published the first report that DePuy’s ASR implant had an unusually high failure rate. Later, DePuy officials admitted that the company knew 40 percent of its ASR hip implants would fail. By the time the FDA stepped in, thousands had already been implanted with all-metal devices. To date, several companies have been the focus of hip recalls.
In 2010, DePuy recalled its ASR and ASR XL hip devices after finding a growing number of complications. By that time, more than 93,000 patients had a DePuy ASR device. The company said the devices could loosen and cause a host of problems including cobalt and chromium poisoning and pseudotumors. DePuy’s Pinnacle Hip Replacement System, another all-metal device, has also come under fire for similar problems. DePuy has set aside $3 billion to cover the litigation expenses.
Just three years after it hit the market, the Rejuvenate and ABG II hip models were recalled. The Stryker devices were designed to be unique in the all-metal market, offering a variety of interchangeable pieces for a custom fit. Research now shows that the Rejuvenate and ABG are no different than any other all-metal hip devices. What makes the situation even more complicated for patients is that the Stryker devices are implanted directly into the existing bone, so they are not easily removed and replaced.
Smith & Nephew
Up to 4,000 Smith & Nephew R3 Acetabular System hip replacements were distributed before the company recalled the device in 2012. Smith & Nephew said the R3 had a higher-than-normal failure rate.
After the company’s Durom Cup, also called the Durom Acetabular Component, was recalled in 2008, Zimmer put aside $69 million for injury compensations.
Other Problematic Hip Devices
In addition to the recalls, other hip devices have come under fire. Both Wright Medical Technology, which manufactures the Conserve Plus Total and the Profemur Z hip systems, and Biomet Inc., which manufacturers the M2a device, are facing increased scrutiny.
With the number of injured patients growing each day, many are seeking legal and financial remedies in court. Even though the manufacturers that have recalled devices have offered compensation packages, they are often inadequate. Many times these financial packages do not cover ongoing medical expenses and job-related losses. By signing a contract with your hip-replacement manufacturer, you may be limiting your options.
It is clear that the future of the hip-replacement litigation will benefit the injured patients. Even though FDA oversight of the hip-replacement systems failed from the start, medical device manufacturers still have a legal and ethical responsibility to keep patients safe.
Settlements for Defective Hip Replacements
Today, thousands of injured victims have joined the multidistrict litigation (MDL) lawsuits, although some legal analysts believe the trend is moving toward settlement rather than jury trials. Most manufacturers would rather move past the cases, and the accompanying bad publicity, than wrangle in court.
If you are considering a hip-replacement lawsuit, contact us today for more information. We will discuss your case and help you decide what is best for you and your family.