In the second of nearly 11,000 lawsuits brought over the now-recalled DePuy Orthopaedics ASR XL metal-on-metal hip implant device, the jury was urged to award at least $5 million dollars over injuries caused by the failed ASR. DePuy is a unit of Johnson & Johnson.
According to the plaintiff’s attorney, DePuy knowingly sold defective ASR hips until a global recall of 93,000 devices was implemented in August 2010. The recall followed release of information by Johnson & Johnson that the ASR 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 previously noted.
According to plaintiff Carol Strum, 54, 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 previously. DePuy maintains that Strum’s individual biology and health issues, not the ASR, necessitated the revision surgery.
Johnson & Johnson also continues to deny that the ASR was defectively designed and continues to maintain that the injuries alleged in this and the first case to go to trial, were not the result of a faulty device and were due to each plaintiff’s physiology. 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.
Medical records indicated blackened tissue in the area near the implant in Strum’s body, as well as increased blood metal ions, proof, said the plaintiff’s team, that the DePuy ASR implanted in her body was shedding metal debris and proved that the device was badly designed, according to Bloomberg News. Regardless, Johnson & Johnson maintains no defective design in the ASR.
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.
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.