The first trial representing a multidistrict complaint against Johnson & Johnson subsidiary, DePuy Orthopaedics, has been delayed by court order.
The bellwether, which was scheduled for May, has been re-scheduled for June 3, 2013, which also moves the final pretrial meeting to May 14 and jury selection for the bellwether to May 30, said Mass Device, citing legal documents. No reasons were given for the court filing which followed U.S. District Judge David Katz of the Northern District of Ohio’s recent order.
The Ohio-based multidistrict lawsuit represents thousands of complaints brought against DePuy over its all-metal hip implant devices. The lawsuits began mounting in earnest in June 2010 following accusations made by a Florida woman that alleged DePuy knew about the device’s flaws but never warned physicians. A few days after that lawsuit was filed, three California residents filed lawsuits after they had to undergo revision surgery to remove and replace their DePuy devices when the implants began detaching from their hip sockets, said Mass Device.
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.
We’ve long followed the myriad issues associated with the ASR device 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.
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.