DePuy’s parent company denies that its hip implant was defectively designed. The second of some 10,700 lawsuits brought over DePuy Orthopaedics’ ASR metal-on-metal implants is underway and, not surprisingly, Johnson & Johnson, DePuy’s parent company, denies that its hip implant was defectively designed.
Last week, the defendant in the first case was awarded $8.3 million in compensatory damages over the ASR hip implant and the jury found that the ASR was defectively designed, said Bloomberg News.
This second case, brought by Carol Strum, 54, includes allegations that the DePuy ASR failed three years after implantation and caused her to have to undergo revision surgery to remove and replace the ASR. Strum also alleges that it is the DePuy ASR’s faulty design that caused its failure and the need for additional surgery.
Johnson & Johnson’s attorney argued against Strum
Johnson & Johnson’s attorney argued against Strum’s claims saying that the DePuy ASR was not defectively designed and maintained that DePuy did warn of the ASR’s risks, said Bloomberg News. Johnson & Johnson took the same stand in the prior lawsuit, saying that the plaintiff’s injuries had nothing to do with the now-recalled DePuy ASR device.
The jury disagreed.
The DePuy ASR was recalled globally in August 2010 after Johnson & Johnson stated that the device was linked to a 12 percent failure rate in five years in the United Kingdom. Since, an Australian joint registry revealed a more than 40 percent failure rate there. Johnson & Johnson said the recall was implemented over the device’s high failure rate and not a product defect, noted Bloomberg News.
In yesterday’s opening statements, an attorney for the device maker argued that no one single cause led to the high revision rate, maintaining that the ASR is not defective. “We said we don’t know. We need to figure this out,” he said, according to Bloomberg News.
Strum’s lawyer pointed out in his opening remarks that it was the ASR’s design flaws
Strum’s lawyer pointed out in his opening remarks that it was the ASR’s design flaws that led to its shedding chromium and cobalt into the plaintiff’s body, and that before she was ever implanted with the device, “DePuy knew that the design flaws in this defective device could cause it to shed those particles into patients, causing tissue death, causing high blood metal ion levels and the need for the serious and unnecessary second surgery,” wrote Bloomberg News.
The metal-on-metal implants were created for increased durability and longevity and with the objective being that the seemingly stronger device elements would be far superior over their traditional plastic- and/or ceramic-constructed counterparts.
Instead, metal-on-metal hip implants, as a class, have long been the subject of safety concerns in the orthopedic community. And, 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.
Studies have shown that metal hip replacement devices tend to fail more often than other implants
Studies have shown that metal hip replacement devices tend to fail more often than other implants leaving patients with significant, sometimes life-long, injuries. In fact, some experts allege 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) recently issued new guidelines to patients implanted with the ASR and other all-metal hip device saying, among other things, that doctors conduct physical examinations, diagnostic imaging, and metal ion testing, as needed in patients implanted with these devices.
The agency also proposed stricter regulations that would mandate that device makers prove their implants are safe and effective before selling them. From a legal standpoint, these changes are an important move toward attempting to hold manufacturers responsible for dangers associated with their products.