A California jury recently found in favor of a plaintiff who brought the first of some 10,700 lawsuits against Johnson & Johnson over the ASR XL metal-on-metal hip implant. The device was manufactured through the health care giant’s DePuy Orthopaedics unit
We’ve long followed the myriad issues associated with the ASR device and related legal actions brought against Johnson & Johnson. In this first trial of thousands of lawsuits, the plaintiff alleged that the faulty design of the ASR caused his serious injuries. Johnson & Johnson has 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.
In this first DePuy ASR lawsuit to go to trial, the jury found that Johnson & Johnson properly warned of the device’s risks and does not owe punitive damages. The jury’s verdict included $338,136 in medical expense damages and $8 million for physical pain and emotional suffering.
Johnson & Johnson recalled 93,000 DePuy ASR devices in 2010 when the ASR’s failure rate reached 12 percent in the United Kingdom; however, since, 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. Since these devices were approved using the fast-tracked 510(k) approval route, clinical testing was not needed before the devices were sold to the public. 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. In fact, 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.
The U.S. Food and Drug Administration (FDA) also stepped in, recently issuing new guidelines to patients implanted with the ASR 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.
At the time this trial ended, Johnson & Johnson said it would appeal. “We believe the ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible,” said Lorie Gawreluk, a DePuy spokeswoman, in a statement. “We plan to appeal the jury’s decision on design defect,” the statement continued, said Bloomberg News. The device maker continues to blame the plaintiff’s injuries on other health issues and not the failed, recalled, DePuy ASR device.
Now, said MassDevice, DePuy has asked the Los Angeles Superior Court for a stay on the final judgment in this matter. This would allow DePuy to file an appeal without bond and place a hold on the jury’s decision, enabling the device makers to avoid paying the multi-million dollar award.