The second largest healthcare giant in the world, Johnson & Johnson, continues to sell hip implants in European countries and elsewhere overseas after the U.S. Food and Drug Administration (FDA) rejected its sale in the United States, based on the review of company safety studies, as reported by The New York Times.
During that period, the company continued to sell a related model in this country, which earlier went on the market using a regulatory loophole, which did not require similar safety review.
An orthopedic hip replacement joint, called an articular surface replacement (ASR) Hip Resurfacing System was being sold in Europe and elsewhere overseas since 2003 by DePuy (a Johnson & Johnson company)
The FDA rejected a version of DePuy’s ASR hip replacement procedure called “resurfacing,” which is a bone-sparing alternative to standard surgery. Because resurfacing was a new procedure when the implant was first sold in 2003, the FDA required DePuy to conduct clinical trials before they could sell the device in the U.S.
In 2005, DePuy found a way to win FDA clearance to sell a version of the ASR, based on the same metal cup for use in joint replacement surgery. Since that version was similar to hip implants already on the market, the FDA was authorized to clear it for sale without testing.
During the eight years on the market, the two implants were used in approximately 93,000 patients worldwide, one third of them in the U.S. Both models were made of an all-metal hip socket cup, which experts say was faulty in design. Reports were received that the devices were failing at an unusually high rate.
There is no suggestion that Johnson & Johnson did anything illegal. Regulatory standards in European countries for approving the sale of medical devices are lower than in the U.S. A spokeswoman for the British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify them when the FDA refused to approve a product that was used in patients there.
In August 2009, the FDA sent a confidential letter to DePuy, listing problems with the clinical data and the devices concerning the ASR Hip Resurfacing System (which was already being sold overseas for about six years).
Within weeks of receiving the FDA letter, DePuy executives began to slowly phase out ASR sales, while directing surgeons to other company implants. Three months later, the company publicly announced its decision to phase out the ASR, stating the reason was declining sales, and that they had withdrawn their FDA application for the resurfacing version of the device.
In March 2010, The New York Times disclosed that FDA records showed that the agency had received 300 complaints regarding the ASR, almost all of them involving patients who had to undergo a second hip replacement, called a revision surgery, just a few years after receiving the device. The number of patient complaints has since reached about five thousand.
In August 2010, after data in a British registry of orthopedic patients showed high failure rates for the ASR, DePuy recalled both versions of the device.
The company advised patients with an ASR device, which was marketed to younger, more active patients to last about 15 years or more, to visit their surgeons to evaluate the implant’s performance. It also recommended annual monitoring to “ensure the ASR hip replacement is functioning well, even in the absence of symptoms.” Even without “symptoms”, many ASR patients were found to have elevated cobalt and chromium, which are metals found in the ASR systems.
Despite the fact that DePuy/Johnson & Johnson were aware that some patients were crippled by tiny particles of metallic debris, and thousands more required revision surgery, they still went ahead and sold their “rejected” implants overseas. However, the larger issue is the fact that the company did not disclose the contents of the FDA letter. This letter possibly could have had an impact on the health and safety of the company’s clients, the patients of the hospitals and doctors, as well as the financial status of the company. Why would DePuy keep the contents of the FDA’s letter under wraps?
Thousands of lawsuits by patients suffering with the ASR implants await an outcome to this unfortunate situation. It is said that last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. It is a disgrace to think that such a huge, well known healthcare giant like Johnson & Johnson can hide facts from us and knowingly risk the health and safety of human lives in other countries just to make a buck. Is this justice?
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