Testimony continues in the second of nearly 11,000 cases brought over the DePuy Orthopaedics ASR XL metal-on-metal hip implant device. DePuy is a subsidiary of Johnson & Johnson.
An orthopedic surgeon called as an expert witness by Johnson & Johnson testified that it was his belief that the plaintiff in this case, Carol Strum, developed a hypersensitivity to what he described as normal device debris. He also said, according to Law360, that he found no evidence of excessive wear in the plaintiff’s DePuy ASR device upon examination of the device after it had been removed from her body.
Yet, the DePuy ASR and other metal-on-metal hip implants has raised safety concerns due to reports suggesting that such devices have a tendency to fail early in the post-operative period. In light of these reports, the U.S. Food & Drug Administration (FDA) has sought to propose stricter guidelines for approving all-metal hip implants that would require device makers to show that their 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.
The FDA also issued new guidelines to patients implanted with the ASR and other all-metal hip replacements advising, among other things, that doctors conduct physical examinations, diagnostic imaging, and metal ion testing, as needed.
According to Strum, the ASR XL was defectively designed, causing it to shed significant metal debris into patients’ bodies, which made it prone to early failure. She alleges that the ASR XL device she received in 2008 failed in under three years, causing her to have to undergo revision surgery to remove and replace the DePuy product with another hip, said Law360. DePuy maintains that Strum’s individual biology and health issues, not the ASR, necessitated the revision surgery.
Some 93,000 DePuy ASRs were 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.
And, although Johnson & Johnson continues to deny that the ASR was defectively designed. The defendant in the first case, which was heard in Los Angeles, was recently awarded $8.3 million in compensatory damages over the DePuy ASR. That jury found that the ASR was defectively designed.
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.
We’ve repeatedly written that research has linked metal-on-metal hip implant devices, such as the DePuy ASR, to a number of adverse events such as tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more, reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.
Since the ASR recall, there have been mounting safety concerns about metal-on-metal hip implants as a class of medical devices and 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.