DePuy ASR Hip Replacements
Metal-on-Metal Acetabular Systems
What is the DePuy ASR XL Acetabular System?
The Depuy ASR hip replacement systems first became available in July 2003 and was recalled on August 24, 2010. The device was designed with a shallow cup and a metal-on-metal articulation surface at the ball and cup juncture. Many other systems have a liner inside of the cup that can be switched out. The ASR was a monoblock system, which meant the cup stood by itself and did not hold a liner.
Due to the metal-on-metal structure and the way the cup was designed, the metal wore at an even faster rate than other metal-on-metal hips.
Although the symptoms related to the DePuy ASR XL Acetabular System will differ from person to person. Some of the most severe problems include:
- Serious pain
- Necrosis (death) of surrounding tissue
- Elevated metallic ion levels (chromium and/or cobalt) in bloodstream
- Loosening of the implant, with possible detachment
- Dislocation of the hip implant
- Fracture of the bone around the hip implant
- Difficulty walking
- Need for a second hip implant surgery (revision surgery)
How was the DePuy ASR system approved?
The DePuy ASR XL system was passed through the FDA through the 510(k) clearance program, which does not require rigorous clinical trials before it is approved for the U.S. market. However, the ASR Resurfacing System (different from the ASR XL system) did not qualify for 510(k) clearance, thus requiring the FDA’s review of clinical trials. After their review, the FDA rejected DePuy’s application, requesting additional trials due to safety concerns. In August of 2009, internal emails uncovered executives’ doubts that additional testing would improve safety data.
DePuy ASR Timeline Leading to Trials
In August of 2010 DePuy Orthopedics – a subsidiary corporation of Johnson & Johnson – recalled approximately 93,000 hip implants, admitting to a failure rate of 13% within the first five years after initial hip replacement surgery.
A multidistrict litigation (MDL) was centralized in the Northern District of Ohio for the Depuy ASR litigation. The MDL is still ongoing.
In March of 2011 the British Orthopaedic Association published a study show that the rate of second hip replacement surgeries (revision surgeries) ranges from 21% after four years to 49% after six years. At higher risk for failure were hip implants with smaller sized parts.
David Floyd, the President of DePuy Orthopedics since 2007, announced his resignation in March of 2011 following an announcement made by J&J stating that the company had set aside approximately $1 billion to deal with potential settlements and litigation involving the ASR.
Following Depuy’s attempts to compensate doctors for obtaining extracted ASR hips and sending in X-Rays and medical records of revision patients, Judge David Katz, who is presiding over DePuy ASR lawsuits, issued a preservation order that banned destruction of DePuy ASR components after they are explanted from patients. A preservation order is a judicial mandate rendering all parties responsible for the preservation of certain “documents, data, and tangible things” related to the litigation. The extensive 40 page order explained the procedures that both parties must follow in preserving the device after it is taken out in revision surgery.
The retrieved components are the centerpiece of product liability litigation against DePuy. They often show signs of degradation that expose their deficiency as well as their responsibility for the victims’ injuries. Should the unit be destroyed, the plaintiff has a much harder time meeting his or her burden of proof.
The DePuy ASR Trials
Two cases were tried – one in California and one in Chicago. The jury awarded $8.3 million to the Plaintiff in California. The jury did not find liability on the part of Defendants in the Chicago case.
DePuy Questioned for Cover-Ups in California ASR Trial Resulting in Verdict of $8.3 Million in Favor of Plaintiff
In the first ASR trial beginning in January 2013, plaintiff attorneys introduced evidence that proved DePuy was aware of design flaws in their ASR hip devices for years before they initiated a recall. Internal documents disclosed at the ASR trial revealed that the company had received complaints even as they started to market the U.S. version of the device in 2005.
Another document used in the DePuy ASR trial, an internal research and development report from June 2007, stated that the ASR did not meet acceptance criteria when compared to a similar metal-on-metal (MoM) device. The report showed that metal-on-metal wear with the ASR was above the already concerning level of wear found in the Ultamet, made by Biomet. They discussed redesigning the device later that year, but nothing was done.
Further, an email from May 2008 proves that the following was known about the devices:
1.) In “certain conditions,” the ASR is susceptible to extreme metal ion levels, whereas in the hands of the same surgeon, another MoM device does not have the same problems. (This was based on clinical data comparing ion levels of the ASR and yet another MoM device).
2.) Females are more susceptible [to higher metallic ion levels] because the difference seemed to be related to the use of small cups.
3.) Data expected to appear in medical journals would “seriously affect” their business.
In September 2009, still almost a year before a recall was announced, another email discussed the amount of business they could expect to lose by phasing the device out. It pointed out that more customers would be retained if they did so within 6 months than if they did so immediately.
In late 2009, the company announced plans to phase out the model but cited tapering sales, not safety concerns. Before the recall, executives insisted that the device was performing up to standard.
According to The New York Times, DePuy attorney Alexander G. Calfo reiterated this to jurors, maintaining that DePuy had behaved ethically leading up to and after the recall.
In March 2013, the Los Angeles jury awarded DePuy ASR hip recipient, Loren “Bill” Kransky, $8.3 million for his injuries involving his hip replacement. This was the first DePuy ASR hip lawsuit to go to trial. The jury’s verdict, which came after 6 days of deliberation, included $338,136 in damages for medical expenses and $8 million for physical pain and emotional suffering.
DePuy ASR Settlement
In November of 2013, Johnson and Johnson and Depuy agreed to a global settlement, paying $4 billion in total, to resolve all cases where an individual had the DePuy ASR implanted and then revised.
In March of 2015, there was a second settlement to compensate those individuals who experienced a revision after the 2013 settlement. There are still people who have had this device fail since the 2015 settlement. Although the supposed deadline to participate in the settlement was May 1, 2015, the MDL is still ongoing.