FDA Could Have Warned Patients Sooner

The FDA Could Have Warned Patients Sooner About the Defective ASR

When DePuy Orthopaedics recalled the ASR XL Acetabular System and ASR Hip Resurfacing System last August, it did so voluntarily, without any warnings from the Food and Drug Administration. By this time, there was ample amount of data and reports, accumulated through a few years, which showed the unusually high revision rate associated with the ASR hip implant. The New York Times article published after the announcement of the recall, titled “Johnson & Johnson Recalls Hips Implants,” noted that by the time of the issued recall, the FDA had received 400 complaints about the ASR since the beginning of 2008.

In the fall of 2009, DePuy announced it was discontinuing the production of the ASR, with plans to phase out sales of the device by the end of 2010. The reason for the discontinuation of production was declining sales–and not safety concerns. In December of the same year, DePuy pulled the ASR from the Australian market all together, yet continued to sell it in other countries. Then in March of 2010, the company issued a Field Safety Notice regarding the high revision rates for both versions of the ASR when used with head sizes smaller than 50 mm in diameter. The notice referenced the revision rates reported in the Australian National Joint Replacement Registry, and emphasized adhering to surgical technique, selecting the appropriate patients for the surgery and the importance of cup placement.

During this chain of events, beginning from when the FDA first began to receive complaints up to the recall in August, the Food and Drug Administration issued no warnings about the high revision rates for the ASR implant, despite available data and reports.

The Medicines and Healthcare Products Regulatory Agency, England’s version of the FDA, is responsible for the regulation of medicines and medical devices. Several weeks after DePuy’s Field Safety Notice, the MHRA released a medical device alert regarding all metal-on-metal hip implants and recommended surgeons to follow up on patients with these types of hip implants and conduct testing for cobalt and chromium ion levels in the blood. A month later, on May 25th, the agency released another Medical Device Alert specific to the DePuy ASR, reiterating the recommendation DePuy made in its March Field Safety Notice regarding cup inclination angle and following up on patients and conducting metal ion level tests and MRI or ultrasound scans.

The FDA however, made no recommendations, notices or alerts concerning the high revision rate and reports of patients with metallosis due to the defective design of the ASR. A new section on the FDA website informs patients about hip replacement surgeries and the various types of devices that are available, including warnings of the risk of metal-on-metal hip devices. Metal-on-metal implants inevitably shed metal debris due to the contact of the ball with the cup; the amount of debris though is dependent on the design of the device and how well the surgeon implants the device.

Half of the world’s joint replacements surgeries are performed in the U.S. and it is very unfortunate that the FDA did not issue a warning about the risks of the DePuy ASR hip implant earlier. The company could have recalled the device earlier, but instead continuously refused to address data from joint registries, studies, and concerns expressed by surgeons regarding the high revision rate for the ASR. In the circumstance in which a company shows negligence towards the under-performance of one of its products, the FDA is expected to step in and take appropriate actions when a device is not functioning properly. A careful overview of all the available data would have led the FDA to make a more prompt decision about the risks of the DePuy ASR hip implant

Australian Class Action Suit on Behalf of 5000

On Monday, February 28, 2011, a class action suit was commenced in the Federal Court of Australia against DePuy Orthopaedics. The suit centers around a recalled DePuy ASR hip implant which is manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The leading plaintiff in the action is Tammy Sanford, a resident of Hobart, Tasmania.

Ms. Sanford, a teacher and mother of two, is only 40 years old, but already had three operations since she had the DePuy ASR implanted in her hip five years ago. In her interview with Australia’s The Mercury news, Ms. Sanford described what was found in her body during her most recent January surgery:

“There was a lot of wear and tear in my body and he [the doctor] actually described what he had to scrape out as a black tar, gunky substance and the images of that were just terrifying, thinking that I had that inside me.”

The doctor also found that Ms. Sanford’s hip joint was inflamed, and that the tissue around her bone and joint had severely degenerated. The damage and pain are so severe, that Ms. Sanford is now unable to return to her teaching job. She walks with the aid of crutches and is reliant upon pain relief medications.

The Australian national joint replacement registry estimates that over 5500 patients have been implanted with the DePuy ASR metal hip systems in Australia between 2003 and 2009. The class action suit, led by Ms. Sanford, is on behalf of all these patients and seeks compensations for personal injury, pain and suffering, and economic damages.

DePuy Orthopaedics phased out sales of the ASR implant in Australia, the United States and other countries in late 2009 and early 2010. However, it did not officially recall the product in the United States until August 2010. Prior to the recall, it is estimated that more than 90,000 DePuy ASR systems were sold worldwide, and the latest data shows that 12-13%, or 1 in 8, of these implants may fail within 5 years. As doctors continue to monitor patients who received the ASR implant, the rate of failure is expected to increase past 30%.