Patients with DePuy ASR Hip Devices at Risk for Hip Failure and Revision SurgeryMar 24, 2017
Many patients who have had a hip replacement with a DePuy ASR hip replacement device have experienced serious complications and they are seeking remedies.
The DePuy ASR hip has been at the focus of medical concern for a number of years. Years. DePuy Orthopaedics, a unit of Johnson & Johnson, recalled 93,000 ASR hips in August 2010. The recall followed a review of data from the United Kingdom joint registry that showed a troubling incidence of revision surgeries in patients who had the DePuy ASR hip.
Higher than Expected Revision Surgery Rate for DePuy ASR
According to the U.K. joint registry, 13 percent of DePuy ASR hip replacement patients had to undergo revision surgery-surgery to remove and replace the implant. The patients suffered debilitating injuries including joint pain, difficulty walking, implant failure, implant loosening, deterioration of the bone around the implant, cysts and pseudotumors, and metal poisoning. Some of these complications are attributed to the ASR hip's metal components. When the ball and the cup of the device are both metal, the components rubbing against each other during normal movement release metallic debris into the bloodstream and the tissues at the joint.
The personal injury attorneys at Parker Waichman have advised and represented many individuals who have suffered serious injuries or have needed revision surgery to replace a defective hip device.
Patients have hip implants to regain mobility lost to joint disease or injury. Older hip models, made of plastic or ceramic or mixed components, have an expected useful life of about 15 years. This means that many hip recipients will eventually need to have the joint replaced again. Longer life for a hip implant will extend the time between replacements. This is an important concern for younger hip recipients who may well live long enough to need more than one repeat surgery.
When a hip implant fails the recipient must undergo additional surgery-known as revision surgery-to remove and replace the defective hip. Revision surgery poses all the risks of the original surgery including pain and infection. Revision surgery often has poorer results than the original surgery because of bone loss and tissue damage caused by the defective implant. Patients can end up with permanently reduced mobility.
ASR Hips Fail to Meet Performance and Durability Expectations
Metal-on-metal hip devices were introduced to market in the United States with the promise that they would be more durable than the older models. Some metal-on-metal hip systems were designed to be customizable to patients. Metal-on-metal hip implants proved popular among younger patients because they could withstand strenuous physical movements like running and other athletic activities.
With all these perceived advantages, metal-on-metal hip implants quickly gained popularity. But almost as soon as the hips came to market, injury reports began flooding the manufacturers and the U.S. Food and Drug Administration (FDA), and patients began filing lawsuits seeking compensation for their injuries.
Some patients and their doctors place a large share of the blame on the FDA's approval process for many of these faulty hips. The 510(k) device clearance pathway permits a device to come to market without rigorous clinical testing if the device is deemed to be substantially equivalent to a similar device already on the market. The flaw in this process, critics say, is that even small changes in materials and design can have major impact on a device's safety and effectiveness. Some of the now-recalled metal-on-metal hips had an unexpectedly high early failure rate, failing in less than five years after implantation.
Plaintiffs allege that DePuy and other metal-on-metal hip manufacturers were aware of the risks the metal hips but failed to warn the medical community and the public. In 2013, Johnson & Johnson agreed to a $2.5 billion settlement of claims that the ASR hips were defective and caused metal poisoning in patients, Bloomberg reported. In 2015, Johnson & Johnson expanded the settlement was expanded by $420 million to resolve claims that were excluded in 2013. Legal experts say that patients who have undergone hip revision surgery since March 2015 may be eligible for compensation. According to Bloomberg, the original settlement and the 2015 expansion are expected to resolve about 90 percent of current ASR hip-revision claims.
Help for Those Who Have Suffered Metal-on-Metal Hip Injuries
Parker Waichman LLP has years of experience representing clients in hip replacement lawsuits. The firm offers free, no-obligation case evaluations. If you or someone you know has needed revision surgery or has suffered other side effects from a DePuy ASR or other metal-on-metal hip implant, you may consult one of our experienced attorneys today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).