A California jury just found in favor of a plaintiff who brought the first of some 10,000 lawsuits against health care products giant, Johnson & Johnson over its ASR XL metal-on-metal hip implant.
We’ve long been following the myriad issues associated with DePuy Othopaedics’ ASR device and the related legal actions brought against DePuy’s parent company Johnson & Johnson. In this first trial of thousands, Loren Kransky, 65, of Montana alleged that the faulty design of the ASR caused his serious injuries. Johnson & Johnson has long maintained that Mr. Kransky’s injuries had nothing to do with the now-recalled DePuy ASR device. The jury disagreed, awarding a total of $8.3 million in damages, Bloomberg News announced.
In this first of 10,750 lawsuits over the DePuy ASR to go to trial, the jury found that Johnson & Johnson properly warned of the device’s risks; therefore, noted Bloomberg News, the firm does not owe punitive damages. Although Kransky’s lawyers sought compensatory damages of $5.3 million and punitive damages upwards of $179 million, the jury’s verdict included $338,136 in medical expense damages and $8 million for physical pain and emotional suffering, said Bloomberg News.
Johnson & Johnson implemented a recall of 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. Meanwhile, 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.
Metal-on-metal hip implant devices 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 that 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 stepped in, just 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 great step in attempting to hold manufacturers responsible for dangers associated with their products.
In closing arguments, Kransky’s attorney said “This is not an imperfect hip, this is a public health disaster,” according to Bloomberg News. “This is the first day of reckoning for DePuy,” another Kransky attorney said. “We’ve learned a lot from this trial. We’ll get punitive damages in the next trial.” One juror, David Vega, agreed with the need for punitive damages. “I wanted punitive damages” based on the evidence that DePuy discovered the problem, yet took so long to issue a recall, said Bloomberg News.
Not surprisingly, Johnson & Johnson said it will 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 Kransky’s injuries on other health issues and not the failed, recalled, DePuy ASR device.
Analysts say the ASR lawsuits could run in the billions of dollars for Johnson & Johnson to resolve, said Bloomberg News.