A surgeon who designed the recalled DePuy ASR metal-on-metal hip device testified that he provided the marketing department with complaints about the faulty device. DePuy Orthopaedics is a unit of Johnson & Johnson; the health care products giant is facing the first of some 10,000 lawsuits brought about over the ASR.
Thomas Schmalzried, the California surgeon who designed the metal hips said in testimony that while he provided the marketing department with complaints about the ASR, he was unaware that the firm had a group created to investigate those matters, said Bloomberg.com. Schmalzried also testified in state court in Los Angeles that he earned $3.6 million in royalties on the ASR hip and that, since 2000, DePuy paid him $20 million, in great part for his work on other devices, according to Bloomberg.com. Schmalzried led the ASR surgeon design team.
In prior testimony, DePuy employees stated that company policy mandated all complaints be sent to the vigilance and complaint department, said Bloomberg.com. Schmalzried testified, when asked on cross-examination if he sent surgeon complaints about hip failures to that department, “They don’t have a vigilance department,” according to Bloomberg.com
The surgeon/designer was also asked if he knew Paul Arnott, the head of the vigilance and complaint department, who testified earlier in the trial. “I can’t put a face with that name,” Schmalzried said, wrote Bloomberg.com.
This first case being heard was brought about by Loren Kransky, 65, who alleges the recalled DePuy ASR hip implant caused a number of serious complications that forced him to undergo revision surgery, a painful, complex process that involves removing the defective device and re-implantation with another, different device. As we’ve mentioned, The New York Times has referred to the DePuy ASR recall as one of the biggest medical device failures in recent history.
Johnson & Johnson is faced with over 10,000 lawsuits in the United States alleging that the ASR is defective and caused injuries. The international recall of 93,000 ASRs in August 2010 sparked concerns about the implant, as well as metal-on-metal hip implants as a class of medical devices.
In addressing reports of high failure rates and complications associated with metal ion debris, the U.S. Food and Drug Administration (FDA) issued 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 tested, as needed. The agency also proposed stricter regulations that would require manufacturers to prove the implants are safe and effective before selling them.
Schmalzried said the marketing department was his “primary conduit” for information about issues being experienced by other surgeons who were using the ASR, said Bloomberg.com. When he learned a patient underwent implant revision surgery, he said he advised the marketing department.
Schmalzried said he no longer implants metal-on-metal hips, said Bloomberg.com.