On August 24, 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. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement. Since then, we’ve written extensively about DePuy and other metal-on-metal hip replacement devices, and the sometimes-extensive destruction they can cause in the human body.
Now, The New York Times reveals that Johnson & Johnson continued to market the defective devices in Europe and elsewhere overseas. In addition, the company also continued to sell a related model in the United States, which earlier went on the market using a regulatory loophole. However, the U.S. Food and Drug Administration (FDA) wrote a confidential letter to Johnson & Johnson in August 2009 basically saying that the agency couldn’t determine the implant’s safety and effectiveness, and therefore couldn’t approve it for sale in the U.S.
According to the article:
There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.
However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.
There seem to be two moral issues at stake here: The morality of Johnson & Johnson continuing to sell a product that was clearly raising safety flags…and the morality of the FDA, which keeps its evaluations secret and confidential. A lawyer who specializes in FDA regulation said that companies that withhold a non approval letter containing important safety information could face damage to its brand. Funny, that doesn’t seem quite as important as the damage done to the unwitting patients who received these potentially harmful devices. And if the FDA is keeping secrets on behalf of corporations, who is looking out for our health?
To read the full article in The New York Times, click here: Hip Implants U.S. Rejected Sold Overseas
If you believe you have been injured as the result of a metal-on-metal hip implant and would like to investigate your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at https://www.lawmed.com/.
Previous HensonFuerst blogs:
DePuy Hip Replacement Recall Raises More Questions
Hip Replacements to be Evaluated for Safety
Hip Replacements Fail, Sometimes Without Symptoms
Diagnosing Hip Replacement Injury
VIDEO: DePuy Hip Replacement Recall (http://www.youtube.com/watch?v=18BkrJnKf3g)