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Depuy Asr Hip Replacement Recall Lawsuit Update
The Depuy ASR hip replacement device was recalled by the DePuy Orthopaedics division of Johnson & Johnson in August 2010. At the time, the company cited reports from a joint replacement registry in the United Kingdom that indicated a high number of patients with the implants required additional surgery due to failures from the ASR device. According to the UK report, 13 percent of patients who had ASR hip replacements were required to have revision surgery.
History of Depuy ASR Hip Replacement
The United States Food and Drug Administration approved the Depuy ASR XL Acetabular System in 2005 under their 501(k) approval program. The 501(k) approval process is a less stringent program that allows manufacturers to bring new products to the market more quickly. If the manufacturer can demonstrate that the product is similar to a device already on the market, such as an artificial hip, they can avoid the need for clinical trials on the new device. The ASR device was a total hip replacement so that the joint and neck of the femur are replaced. At the same time, Depuy sought approval for the ASR Hip Resurfacing device, but were required to undergo clinical trials as resurfacing was a new technique.
Problems During Clinical Trials
Problems surfaced during the clinical trials for the resurfacing device with more fractures of the femur occurring than the company expected. Although Depuy withdrew their FDA approval request for the resurfacing device, they continued selling the ASR XL Acetabular systems, despite the fact that the device used the same cup and ball design and it was that portion of the device that caused problems in the clinical trials. In addition, doctors could choose to implant the ASR resurfacing device in what is known as an “off-label” use. There is no documentation on how often this occurred as there is no national or global reporting requirement.
Lack of Information
Because there are no reporting requirements, doctors remained unaware of problems with the DePuy ASR system. The FDA does allow complaints to be filed with their agency, there is no requirement for such reporting. Because reports are not required, many doctors don’t file them and it is widely believed that product issues go underreported in the United States. Even with the underreporting issue, more than 300 complaints were filed with the FDA related to the Depuy hip replacement systems.
Kickbacks to Physicians
In 2007, Depuy was among four medical device manufacturers who settled with the United States government for providing kickbacks to doctors who implanted their devices over those of their competitors. In order to keep from being criminally prosecuted, Depuy paid $84.7 million and agreed to change their incentive practices.
Patient Problems Grow
Doctors who had implanted the Depuy systems began noticing that patients were requiring more revision surgeries with those devices than with others. In addition, researchers in Britain had found metal ion debris reactions in some patients, concluding that the cause of this debris was due to metal wear in the hip replacement devices. At the same time, an Australian study found that the Depuy ASR system had double the revision rate of other replacement devices. As more studies were completed, it became clear that the Depuy ASR system either failed more quickly than other devices or caused metal ion reactions in an unacceptable number of patients.
In 2009, Depuy finally pulled the ASR system from the market in Australia, but claimed they were doing so due to decreased demand. In 2010, the system was removed from all markets around the world, with Depuy claiming that they were doing so due to poor sales, not because of the safety hazards the product presented. However, in 2010, the company did issue an alert letter to doctors informing them of the results of an Australian Joint Registry review which demonstrated the higher-than-average failure rate of the system. Yet, the company continued to allow doctors to implant the hips, despite the findings, until August 2010. At that time they issued a worldwide recall, claiming “new evidence” that showed higher than normal revision rates, despite the fact that there was evidence that the company was told as far back as 2007 about the problem.
According to the FDA, metal-on-metal hip implants, like the Depuy ASR system, present unique risks to patients. Because the ball and joint components rub against each other, tiny metal particles can be released, some of which can enter the bloodstream. In addition, metal particles can damage the bone or soft tissue surrounding the artificial hip joint as well. Patients have reported such symptoms as:
- Hip dislocation, when the ball of the femur slips out of the socket
- Bone fracture
- Joint infection
- Pain in the groin, hip or leg
- Popping, grinding, clicking or squeaking noise from the hip joint
One of the complications discovered after doctors implanted Depuy ASR systems was an increase in diagnoses of metalosis, a rare condition caused by the build-up of metal in the body. Because the Depuy ASR resurfacing system was used in young people who are more active, the incidences of metalosis were higher for that device than others, although it did occur in almost all metal-on-metal systems. Patients who have a condition known as mental sensitivity, metalosis can lead to metal poisoning. Patients have suffered from:
- Severe joint pain
- Implant failure
- Implant loosening
- Local tissue necrosis
- Deterioration of bone
- Fromation of cysts or tumors
- Bone loss
If the metal ions spread throughout the body and grow to significant levels, patients can develop problems in mental cognition, emotional balance, and the nervous system.
In early 2014, a California jury awarded $8.3 million in damages to one plaintiff who suffered after having a Depuy ASR system implanted. Later that year, Depuy agreed to pay out at least $2.4 billion to settle claims with more than 98 percent of those eligible enrolling in the settlement program. According to reports, payments were to begin in August 2014 to those who had additional surgeries prior to August 2013. Those whose replacements occurred after that are continuing to litigate their claims.
If you or a loved one has suffered injury after a Depuy hip replacement, or if a loved one has died due to complications of the surgery, contact our office for a free consultation to determine if you are eligible for a Depuy hip replacement lawsuit.