In an article appearing in The New York Times on February 21, 2012, it was reported that the all-metal artificial hip replacement known as the DePuy ASR (articular surface replacement) manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which was implanted in 93,000 patients worldwide over eight years but was recalled in 2010, was referenced in an internal email by a DePuy Orthopaedics executive in August, 2009 that mentioned that the U.S. Food and Drug Administration (“FDA”) refused to approve the hip replacement device in the U.S. because studies conducted by DePuy showed that it had failed prematurely in “significant” numbers of patients that required patients to undergo further surgery (“revisions”).
The version of the implant rejected by the FDA (the “resurfacing” version) was not sold in the United States but was sold in other countries; however, a version of the implant sold in the U.S. that was recalled at the same time was implanted in about 30,000 patients in the U.S. Both the unapproved version and the version used in the United States had a common component: a solid metal cup that replaces a patient’s hip socket.
The executive’s email was written just days after the FDA confidentially advised the manufacturer that one version of the implant would not be approved for use in the U.S. The email noted that the implant did not meet the FDA’s approval standards because the clinical studies showed a high rate of revisions. The email further cautioned that providing the FDA with more data may not change the FDA’s position and that it may take years to undertake new studies in order to have the FDA approve the device.
While there was nothing illegal about Johnson & Johnson’s subsidiary, DePuy Orthopaedics, not disclosing the confidential communication from the FDA regarding its nonapproval of the DePuy ASR in the U.S. (which the FDA does not make public), DePuy Orthopaedics did not disclose the nonapproval by the FDA to doctors implanting the devices or to patients receiving them in the U.S. Nonetheless, DePuy Orthopaedics routinely blamed the orthopedic surgeons who implanted the devices for the early failures of the devices, blaming the surgeons for failing to position one of the components of the implants correctly. There are about 5,000 pending lawsuits in the U.S. related to the implants.
Artificial hips are expected to last at least fifteen years before they need replacement. However, data regarding the DePuy ASR hip replacement that were available by 2008 showed failure rates after just a few years. Another disturbing issue with the DePuy ASR was the metal debris that it sheds as it wears, causing injuries to some patients.
While the discovery of the executive’s email may be an embarrassment to DePuy Orthopaedics and to its parent, Johnson & Johnson, and may tarnish their respective reputations to some extent, the episode raises important issues when it comes to FDA approval of medical devices and patient safety.
While it is understandable that the FDA may wish to help protect the business interests of medical device manufacturers by not publicly disclosing nonapproval letters regarding medical devices, and manufacturers of such devices often would not voluntarily disclose such nonapproval of its devices to doctors or to the public, the public’s interests and the public’s right to know about potentially dangerous or ineffective devices must have precedence under such circumstances where similar versions of the medical devices are in use in the United States.
If you or a family member have been injured as a result of a defective medical device such as a defective hip implant, you may be entitled to compensation for your injuries.
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