DePuy Hip Lawsuit Says Company Avoided Necessary Testing

A recent DePuy ASR hip lawsuit claims that DePuy Orthopaedics did not submit its ASR hip replacement device to critical testing. The suit alleges that DePuy sought to market the device without clinical trials, and secured FDA approval under what is known as “section 510(k).” Section 510(k) does not require proof of safety or effectiveness, but simply “substantial similarity” to grandfathered devices.

The DePuy hip attorney claimed that the ASR was not proven to be safe. Although the device is a “Class III” device (which is supposed to undergo rigorous premarket FDA approval, which includes clinical tests) DePuy avoided premarket approval under the 510(k) process, by establishing similarity to a grandfathered medical device that was approved before May 28, 1976. Grandfathered devices are not required to undergo premarket approval.

Lawsuits Address DePuy Negligence

The plaintiff, Illinois resident, Theresa V. Sliwoski, had DePuy ASR hip implant surgery on July 6, 2009. Thereafter, she experienced pain, discomfort, difficulty walking, sleeping, and carrying on normal activities. Her surgeon determined that DePuy hip complications caused her pain. He then removed the hip and replaced it with another device in revision surgery almost a year before DePuy voluntarily recalled its ASR XL Acetabular Cup.

Sliwoski’s attorney claims that the ASR was never shown to be safe or effective. He stressed that the 510(k) process is at fault. He asserted that by telling the FDA that the ASR’s design was substantially equivalent to other hip devices, DePuy avoided the safety review needed for premarket FDA approval. Clinical trials and testing were not performed.

The Institute of Medicine, in 2011, stated that allowing new Class III devices to enter the market by the 510(k) process is a major problem that puts patients at risk. The Institute advised the FDA forgo the 510(k) process in favor of a new program that will better insure safety and effectiveness. The FDA has yet to act.

More alleged victims have filed DePuy ASR hip lawsuits, which have been transferred to federal multidistrict litigation in Ohio.  DePuy hip attorneys are claiming that most patients with a recalled ASR hip implant may have a good chance of receiving compensation.