In 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System due to their higher-than-usual failure rates. The failures necessitated that patients have a second surgeries to replace the replacement, but some people still ended up with severe tissue damage that left them in pain.
Before the recall, Johnson & Johnson refused to acknowledge that the medical device was flawed. But now, in an article published in The New York Times, it seems that Johnson & Johnson was aware of the high failure rate—and an email stating so was written by a DePuy vice president and sent to top executives in the corporation. In the email, Pamela Plouhar:
…reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.
In addition, Ms. Plouhar’s email stated that there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”
That means that the FDA, Ms. Plouhar, and—after the email was sent—other J&J executives all knew that there were significant problems with the hip replacement devices. And yet, the company did not notify doctors or patients about the problems. In fact, they continued marketing and selling the device in the United States and around the world…at least until the recall was announced in August 2010. In all, about 93,000 people received a DePuy hip replacement.
Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.
This new information is not going to help Johnson & Johnson’s reputation, which has recently been turning from gleaming to rusty. Perhaps this is why J&J CEO William C. Weldon announced that he will step down in April. Analysts believe he would rather retire by choice than be forced to resign.
HensonFuerst Video about the DePuy recall: DePuy Orthopaedics Hip Replacement Recall
If you believe you have been injured by a DePuy hip replacement and would like to discuss your legal options, please feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at https://www.lawmed.com/. If you have questions, HensonFuerst has answers.
RESOURCES
To read the full story in The New York TImes, click here: Hip Maker Discussed Failures
To read our blog about the DePuy recall, click here: DePuy Hip Replacement Recall