In the second of nearly 11,000 lawsuits is being heard over the now-recalled DePuy Orthopaedics ASR metal-on-metal hip device implant. Johnson & Johnson, DePuy’s parent company, denies that the ASR was defectively designed despite the recall, mounting litigation, injury reports, failure reports, and probes.
An orthopedic surgeon and expert witness for Carol Strum, the plaintiff in this second trial, testified that his office created reports for medical conferences that stated that the recalled DePuy ASR was safe, said Law360. Some conferences were held just months before Strum’s surgery, said Tony Nargo, who testified that he had consulted for DePuy and received DePuy funding for his research.
We’ve long written that the relationships and finances exchanged between industry and researchers points to a bias in which patients are often not the prime concern. When industry pays physicians, treatment options are potentially influenced and doctors often opt for more expensive drugs and devices, which in turn, tends to drive costs. A prior The New York Times review revealed that about 25 percent of all physicians accept cash from drug and device makers and about 2/3rds accept meals in exchange for advice and speaking engagements. The Times also revealed that physicians receiving money from drug makers tend to practice medicine in different ways than physicians who do not accept industry gifts, and that doctors working with industry also tend to prescribe medications in riskier and unapproved ways.
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, said Bloomberg News. This second case, brought by Strum, 54, includes allegations that the DePuy ASR failed three years after implantation. This caused Strum to undergo revision surgery, a 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 and also caused her to develop high metal concentrations in her blood, Strum 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. The Los Angeles jurors did not hear evidence concerning the U.S. Food and Drug Administration’s (FDA) review and clearance of the ASR and also did not hear evidence concerning the recall, said Bloomberg News. The Chicago jurors in the second case will hear about both the review and the recall.
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.
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 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.