Hip Design Problems Nothing NewMar 27, 2013
Design is likely the problem, DePuy’s former marketing director noted while providing testimony via video in the second lawsuit against Johnson & Johnson over its DePuy Orthopaedics Unit’s ASR metal-on-metal hip implant device.
Paul Berman, who had been director of U.S. hip marketing for DePuy, described a colleague's email — dated March 2009 and sent at least one year prior to the recall of 93,000 ASR devices in 2010 — as indicating that any issues the device was experiencing were likely due to its design, said Law360.
Berman confirmed that it was a vice president of marketing for DePuy's international operations who had linked the device’s design to issues DePuy was experiencing back then – which was about five years after the ASR was launched in areas outside the United States. According to Berman, he understood that the DePuy recall was implemented due to the high rate of revision surgery in people implanted with the ASR, said Law360.
"I don't remember being told that it was a defective product," Berman said.
The lawsuit, brought by Carol Strum, is the second of some 10,700 brought against Johnson & Johnson. Despite the recall, mounting litigation, injury reports, failure reports, and investigations, Johnson & Johnson denies that the ASR was defectively designed.
The defendant in the first case, which was heard in Los Angeles, was just awarded $8.3 million in compensatory damages over the recalled DePuy ASR. That jury found that the ASR was, in fact, defectively designed, said Bloomberg News previously. This second case, brought by Strum, alleges that the DePuy ASR failed three years after implantation, which caused Strum to undergo revision surgery, a painful and costly process that involves removing and replacing the ASR. Strum also alleged that the DePuy ASR’s faulty design caused its failure and the need for additional surgery, and also caused Strum to develop high metal concentrations in her blood.
In the prior lawsuit, Johnson & Johnson said that the plaintiff’s injuries had nothing to do with the DePuy ASR device. The jury disagreed. Although 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 evidence concerning the recall, the Chicago jurors in this second case will hear about both the review and the recall.
The DePuy ASR was recalled globally in August 2010 after Johnson & Johnson found that the ASR was associated with a 12 percent failure rate in five years in the United Kingdom. Australian joint registry data revealed a more than 40 percent failure rate.
The all-metal hip implants were created for greater durability and longevity, but in recent years, the metal devices have been hotly criticized for failing at unexpectedly high rates and leaving patients with significant, often life-long injuries. Some experts say that European and American regulators worked to ensure patients were not aware of the devices’ risks; many have criticized device makers for placing profits before patient safety.
Meanwhile, the FDA issued new patient guidelines for the ASR and other all-metal hip replacements in which it urges doctors to 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. Legally, these changes are a big step toward attempting to hold manufacturers responsible for dangers related to their products.