In the second of nearly 11,000 lawsuit it faces over the recalled DePuy Orthopaedics ASR metal-on-metal hip device implant, Johnson & Johnson continues to deny that the ASR was defectively designed.
The defendant in the first case was awarded $8.3 million last week in compensatory damages over the DePuy ASR. The jury in that case 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. This caused Strum to undergo revision surgery, a typically painful and costly process that involves removing and replacing the ASR. DePuy ASR’s faulty design caused its failure and the need for additional surgery, Strum also alleged.
Johnson & Johnson’s attorney argued that the DePuy ASR was not defectively designed and that DePuy did appropriately warn of the ASR’s risks, said Bloomberg News. In the prior lawsuit, Johnson & Johnson said that the plaintiff’s injuries had nothing to do with the now-recalled DePuy ASR device. The jury disagreed in that case.
The DePuy ASR was recalled globally 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, 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 a product defect, Bloomberg News noted.
In yesterday’s opening statements, an attorney for the device maker said 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,” wrote Bloomberg News. But, 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 ASR, “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,” Bloomberg News wrote.
The all-metal 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, which are 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 recently weighed in, issuing new guidelines to patients implanted with the ASR and other all-metal hip replacements. The agency advised, among other things, that doctors 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 toward attempting to hold manufacturers responsible for dangers associated with their products.
Meanwhile, the Los Angeles jurors did not hear evidence concerning the FDA’s review and clearance of the ASR and also did not hear evidence concerning the recall, said Bloomberg News. The Chicago jurors will hear about both the review and the recall.