Updates on the DePuy ASR Acetabular Hip Replacement Litigation and Medical Research
One of the hot topics in medical device litigation right now relates to the recall by DePuy, which is a subsidiary of Johnson & Johnson, of their articular surface replacement (“ASR”) hip prostheses. The DePuy ASR is a metal on metal device, meaning that the ball itself is made out of metal, and the cup within which the ball rests and moves is also made out of metal. The metals involved are made out of cobalt and chromium. In short, some of the problems associated with the system include a process whereby the metals would wear and result in tiny metal shavings going into the surrounding tissue and bloodstream, often resulting in dramatically elevated levels of those metals in the blood and other body fluids.
This particular device was never specifically approved by the FDA. Now, it is being called “one of the biggest disasters in orthopaedic history.” Click here to read more about the process and politics involved which lead to widespread use of this device even in the absence of FDA approval. Many doctors are concerned that those elevated metallic levels can or will produce cardiac and/or neurologic symptoms. Click here to read more.
Rather, it was used “off label” by surgeons in the U.S. In a recent bulletin, the FDA described some of the symptoms to look for to indicate a need for revision surgery, and recommended ongoing vigilance for a variety of symptoms. Click here to view the FDA bulletin. Curiously, the FDA did not advocate checking metallic levels in the blood in the absence of symptoms. Other medical authorities have documented kidney disease resulting from elevated cobalt levels, and point out that kidney disease and other health problems can exist even in the absence of a report of localized hip pain which might more obviously indicate a failure in the device. Click here to read more.
A prudent patient would be advised to consider the medical literature currently available and to discuss with his or her own doctor the need for blood or serum testing, as well as a plan for monitoring into the future as the effects of this unfortunate (but avoidable) disaster gain clarity. From a legal standpoint, the multidistrict litigation in the Northern District of Ohio is continuing. Victims should obtain qualified legal counsel and should generally be wary of settling these cases before more information regarding the adverse health effects.