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In August of 2010, after the release of data from patient registries in the UK indicating high failure rates, Johnson & Johnson’s DePuy Orthopaedics division issued a worldwide recall for 93,000 of its ASR (Articular Surface Replacement) hip systems, one of the largest such recalls in history. The ASR XL Acetabular Hip had been on sale in the United States since 2005. The ASR Hip Resurfacing System was only cleared for use internationally and never sold in the United States.
DePuy had actually begun to pull the implants from the market in late 2009. The company claimed that action was prompted by poor sales and explicitly denied it was related to problems with the device, though physicians and patients had been complaining about complications and device failure for some time. Prior to the release of comprehensive patient data, the company typically blamed side effects on surgical error.
If you believe you may have received a DePuy ASR hip replacement, you should immediately contact your doctor to schedule follow-up tests, even if you are not experiencing any symptoms or complications. Tests may include X-ray, blood and joint-fluid samples, ultrasound or MRI.
Complications of DePuy ASR Hip Systems
Like other metal-on-metal hip systems, DePuy’s ASR devices were cleared under the FDA’s 510(k) clearance protocols, and are prone to the same complications, including:
Debris from everyday wear and tear
All of these complications can lead to pain, swelling, stiffness, dislocation, and, ultimately, device failure. Patients whose hip implants fail will usually need to undergo revision surgery to correct the problem. Revision surgery can be costly and difficult, with more risk and a longer recovery than the initial hip replacement procedure.
The 2010 UK registry data demonstrates ASR total hip replacement failure rates as high as 12% within 5 years of implantation. Additional data from a 2013 study of Australian patient data found that DePuy’s implants fail within 9 years in 43% of patients. Internal Johnson & Johnson documents show a 37% failure rate within 4.6 years, according to a report in Bloomberg News.
In response to the patient data, the UK’s National Institutes of Health have taken steps to ban the use of implants with higher than a 5% failure rate, which would affect both ASR hip systems if they were not already recalled.
Johnson & Johnson maintains that it had no knowledge of the problems associated with its device prior to the release of the UK data. A website set up by the company specifically cites that data as the reason for the recall. In fact, DePuy’s president, Andrew Ekdahl, wrote a letter to The New York Times reiterating that claim in response to an editorial that he said mischaracterized the recall.
Pinnacle Hip System
DePuy discontinued the metal-on-metal version of its Pinnacle implant, but did not issue a recall. The design of the Pinnacle is based on that of an earlier implant, the Ultima. Both types of implants have caused similar side effects to other metal-on-metal implants. Doctors estimate the failure rate of metal-on-metal Pinnacle implants to exceed 10% within 5 years of implantation.
Criticism of DePuy’s Hip Replacement Recall
According Reuters, Johnson & Johnson has come under fire for the way it handled the recall of DePuy’s ASR hip systems. The company hired a third party, Broadspire Services Inc., to handle patient and doctor recall claims, empowering that company’s physicians to determine whether to pay for patients’ revision surgeries. (Broadspire was also hired by Stryker Orthopaedics to handle that company’s own hip recall.) In practice, that has lent Broadspire the ability to determine whether or not patients will actually have their hips revised, in some cases effectively overruling a patient’s own doctor.
J&J also paid doctors to have patients fill out forms waiving their right to privacy and allowing the company access to their medical records, a practice that many doctors expressed discomfort with.
J&J also paid doctors to have patients fill out forms waiving their right to privacy and allowing the company access to their medical records, a practice that many doctors expressed discomfort with. The company was accused of aggressively trying to settle with patients who lacked a complete understanding of their legal rights or the possible extent of their future medical costs.
Lawsuits, Settlement and Compensation
Under the terms of the recall, DePuy offers compensation for certain costs related to its ASR hip systems, including co-pays, deductible expenses, lost wages and travel costs. It has set up a website and a hotline to provide patients and surgeons with more information about the recall.
Thousands of patients have sued manufacturers of metal-on-metal hip replacements over complications and device failure, and in November 2013, Johnson & Johnson agreed to a $4 billion settlement with more than 7,500 patients who experienced complications with their ASR hips, for an average payout of over $300,000 per plaintiff. The settlement is uncapped, meaning that patients who did not take part in the suit may be eligible, raising the total payout. Bellwether cases in multidistrict litigation related to the Pinnacle hip system are scheduled to begin in September 2014.
If you choose to contact the company about the recall, remember that any information they provide you will be in the company’s best interests, not necessarily your own. You should speak to an attorney before agreeing to any terms, as accepting them may preclude you from pursuing additional compensation.