A judge just rejected DePuy Orthopaedic’s request for a new trial and said the Johnson & Johnson subsidiary must pay $8.3 million to a patient who brought a lawsuit against the device maker over injuries associated with the ASR metal-on-metal hip device.
We’ve long followed the myriad issues associated with the ASR and related legal actions brought against Johnson & Johnson. In the first trial of thousands of lawsuits recently brought against the device maker, the plaintiff alleged that the faulty design of the ASR caused his serious injuries. Johnson & Johnson long maintained that the plaintiff’s injuries had nothing to do with the now-recalled DePuy ASR. The jury disagreed, awarding a total of $8.3 million in damages, Bloomberg News recently announced.
Judge Czuleger denied the attempt to appeal the ruling on the grounds that the plaintiff had provided enough evidence to establish that the products were defective in design, Law360.com reported. Last month, DePuy said it planned on having the decision reversed, according to MassDevice.
The DePuy ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System were recalled after data from a medical device registry in the United Kingdom indicated that the devices were failing in about 12 percent of patients within five years. At the time the devices were recalled, some 93,000 patients worldwide received one of the ASR models. Since the recall, the failure rate has been reported to be as high as 40 percent based on Australian joint registry data.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. These devices were approved using the fast-tracked 510(k) approval route, which bypassed clinical testing. Now, studies reveal that metal hip replacements tend to fail more often than other implants.
The hip implants were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries.
Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks and many have criticized device makers for placing profits before patient safety. For its part, the U.S. Food and Drug Administration (FDA) just issued new guidelines to patients implanted with the DePuy metal-on-metal and other all-metal hip replacements. Among other things, the agency advised that physicians conduct physical examinations, diagnostic imaging, and metal ion testing, as needed. The agency also proposed stricter regulations that would require manufacturers to prove the implants are safe and effective before selling them. From a legal standpoint, these changes are a big step in attempting to hold manufacturers responsible for dangers associated with their products.
In addition to the nearly 11,000 lawsuits brought over the ASR, more than 900 individual lawsuits have been consolidated into a multidistrict litigation (MDL) in U.S. District Court for Northern Texas under Judge Ed Kinkeade that accuse DePuy of negligence, fraud, and improper design, manufacture, and marketing of the Pinnacle system, according to a prior MassDevice report. Pinnacle hip implant recipients allege the hip’s faulty design caused problems including severe swelling, pain, bone and tissue damage, and loosening of the implant. Recipients often needed additional surgery to remove and replace the implant. Most recently, the federal judge overseeing the MDL ordered DePuy to provide the plaintiffs with compliance reports on its metal-on-metal Pinnacle hip implant.