11,000 lawsuits Johnson & Johnson faces over the recalled DePuy Orthopaedics ASR metal-on-metal hip device implant is underway. The second of nearly 11,000 lawsuits Johnson & Johnson faces over the recalled DePuy Orthopaedics ASR metal-on-metal hip device implant is underway. DePuy Orthopaedics is a unit of Johnson & Johnson.
The defendant in the first case was recently awarded $8.3 million in compensatory damages over the DePuy ASR after the jury found that the ASR was defectively designed. The second case, brought by Carol Strum, 54, includes allegations that the ASR failed three years after implantation, necessitating her revision surgery, a painful and costly process in which the ASR was removed and replaced. DePuy ASR’s faulty design caused its failure and the need for additional surgery, Strum alleged.
Johnson & Johnson’s attorney argued that the ASR was not defectively designed and that DePuy appropriately warned of the ASR’s risks
Johnson & Johnson’s attorney argued that the ASR was not defectively designed and that DePuy appropriately warned of the ASR’s risks, said Bloomberg News. In the prior lawsuit, Johnson & Johnson argued that the plaintiff’s injuries were not related to the now-recalled DePuy ASR device. The jury disagreed.
The DePuy ASR was recalled worldwide in August 2010 after Johnson & Johnson stated that the device was associated with a 12 percent failure rate in five years in the United Kingdom. Since then, Australian joint registry data has revealed a more than 40 percent failure rate there. Johnson & Johnson said the recall was implemented over the device’s high failure rate, not due to a product defect.
All-metal hip devices were created for greater durability and longevity. The seemingly stronger components were thought to be far superior compared with more traditional components constructed out of plastic or ceramic elements. Metal devices, however, have come under fire for failing at unexpectedly high rates and leaving patients with significant and often life-long injuries. Some experts have said that European and American regulators worked to make sure patients were not aware of the risks associated with all-metal devices, and many have criticized device makers for putting finances before patient safety.
The U.S. Food and Drug Administration (FDA) recently issued new guidelines to patients
The U.S. Food and Drug Administration (FDA) recently issued new guidelines to patients implanted with the ASR and other metal-on-metal hip devices. The agency advised doctors to conduct physical examinations, diagnostic imaging, and metal ion testing as needed, and also proposed stricter regulations to mandate that manufacturers prove 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.