Plaintiffs Mark R. and JoAnne R., residents of Monroe County in the state of New York, have recently filed a new lawsuit against DePuy Orthopedics and Johnson and Johnson Inc., the makers of the DePUy ASR hip implant system.

At the heart of this legal complaint is the need for Mark R. to get early DePuy ASR revision surgery in September 2017. Mark R. is 51 years old and had a total hip arthroscopy using the prosthetic unit ASR XL acetabular hip replacement system in the summer of 2008.

The ASR XL hip was designed, according to the legal documentation, with a metal femoral head to come in direct contract with a metal acetabular cup. These two pieces come together without the aid of a liner and have allegedly caused numerous recipients to need early DePuy ASR revision surgery after implantation.

The early DePuy ASR revision surgery is often needed because of a possible complication known as metallosis. Metallosis is a build-up of chromium and cobalt in the blood to unhealthy levels. This is caused by metal debris being shed into nearby tissues due to the direct metal-on-metal movement of the femoral head inside the acetabular cup.

This debris has been linked to blood poisoning that can contribute to cancer and heart difficulties. Near the replaced joint, it can lead to bone or tissue death at worse or the development of pseudotumors that affect the function of the new hip.

The ASR XL acetabular hip replacement system was approved by the Federal Food and Drug Administration (FDA) through a loophole known as the 510(k) process. This loophole allows pharmaceutical and medical device companies such as the defendants to get their products to market without doing extensive clinical trials and safety reviews.

They just have to prove that the drug or device is “substantially equivalent” to a drug or device that is already on the market and has gone through these trials and reviews.

Unlike earlier prosthetic hip implants, the ASR hip implant does not have a polyethylene plastic acetabular liner to prevent direct metal-on-metal rubbing.

According to the narrative of this complaint, thousands of recipients like the plaintiff have had to experience early DePuy ASR revision surgery with all its additional risks like potential blood clots, infections, bone loss, potential failure of secondary prosthetic, and infections from hospital environment.

The Plaintiff’s Allegations

Because of Mark R.’s need for early DePuy ASR revision surgery, he  and JoAnne R. are bringing the following counts against the related companies :

Count One –Strict Products Liability, Defective Design; Count Two –Strict Products Liability, Failure to Warn; Count Three –Negligence; Count Four –Breach of Express Warranty; Count Five –Breach of Implied Warranty of Merchantability; Count Six –Breach of Implied Warranty of Fitness; Count Seven –Violation of New York General Business Law; and Count Eight –Derivative Claim on Behalf of Spouses.

The couple are asking for a trial by jury and damages in excess of $75,000. They wish for the return of all court costs and attorney’s fees as well.

The DePuy ASR Lawsuit is Case No. 6:17-cv-06661-DGL in the U.S. District Court for the Western District of New York.