A woman from California who was forced to undergo total hip replacement revision surgery for her DePuy ASR hip prosthesis has filed a complaint against the manufacturer. Plaintiff Dawn W. alleges personal injury and economic loss as a result of device failure and seeks compensatory and punitive damages.

Background of the Case

Dawn, age 51, says she underwent replacement surgery for her right hip in February, 2007 with a DePuy ASR hip prosthesis. According to her complaint, she is not certain of exactly when the device failed, since the defects leading to the implant’s failure were not immediately apparent. She does however say that her injuries are “ongoing and continuing in nature.”

Dawn says she required total hip replacement revision surgery to remove the implant just five years after receiving the device. However, she alleges that by then, much of the damage had been done: subsequent blood tests allegedly revealed “excessive levels of chromium and cobalt,” resulting in a condition known as metallosis. This condition causes tissue necrosis and bone damage. Total hip replacement revision surgery prevents further release of metal but does not remedy the existing metallosis.

About the DePuy ASR Hip and Total Hip Replacement Revision Surgery

The DePuy ASR XL Acetabular System, marketed as a “total hip replacement,” was approved by the FDA through the 510(k) Premarket Notification process. This type of approval, which has become very controversial in recent years, allows a medical device manufacturer to bypass the usual rigorous clinical studies normally required for new products. The manufacturer can make minor changes to an existing product (known as a “predicate”).

According to The New York Times, this allows medical device manufacturers to “bundle a component from an unapproved implant into an existing design and sell a device with minimal testing.”

Problems with the device later became apparent. Reports of femur fractures came more often than expected, and the metal-on-metal construction was reportedly causing microscopic metallic shards to become embedded in adjoining tissues, resulting in tissue death (necrosis) and the development of pseudotumors as well as a host of general health problems that in many cases led to total hip replacement revision surgery.

What Did DePuy Know?

DePuy ASR hip defects became apparent as early as 2007. The U.K. Medical Registry reported that total hip replacement revision surgery was required in nearly 30 percent of patients who had received the DePuy device. Similar warnings were issued in Australia. However, this information did not become available to U.S. consumers until a recall was issued for the device in August 2010. That recall came eight  months after DePuy announced it would be phasing out the product, citing declining sales.

In 2014, DePuy’s parent company, Johnson & Johnson, announced a $2.5 billion global settlement with 8,000 plaintiffs who had required total hip replacement revision surgery for their ASR implants. The company has not admitted to any wrongdoing, however.

Have You Been Injured?

Dawn’s complaint alleges negligence, design defects, failure to warn, breach of warranty, fraudulent misrepresentation and infliction of emotional distress. With thousands of DePuy ASR hip replacements distributed around the world, it is likely that litigation over this product will not end anytime soon.

Dawn’s Total Hip Replacement Revision Surgery Lawsuit is Case No. 1:18-dp-20097-JJH, MDL No. 1:10 md 2197, U.S. District Court for the Eastern District of Pennsylvania.