A new hip lawsuit claims flaws in the design of the Pinnacle hip replacement system led to complications for one hip replacement surgery patient and his wife.

Plaintiffs in this hip lawsuit are Beverly and Brian G., a couple from New York state. They say Robert underwent right hip replacement surgery in January 2010, receiving a Pinnacle hip implant made by defendant DePuy.

Later, he says, he started experiencing pain, discomfort and inflammation around the implant. He also had problems with the implant slipping and dislocating, and he had a sensation that the implant could not support his weight. He says he also experienced significant metallosis, a reaction to the presence of toxic amounts of metal in the body.

The couple attributes Brian’s complications to defect in the design and manufacture of the Pinnacle and to the inadequate warnings provided by its manufacturers. Their hip lawsuit names as defendants DePuy Orthopedics and its parent company Johnson & Johnson, along with their associated business entities.

Hip Lawsuit Challenges Design, Marketing

Beverly and Brian cite several problems that are purportedly inherent to the metal-on-metal nature of the implant Brian received. These hip replacement systems consist of an artificial head to replace the natural femur head and an artificial acetabulum that takes the place of the natural socket in the hip joint.

In the Pinnacle system used in Brian’s surgery, a metal femoral head rotates inside a metal acetabular liner, branded the Ultamet liner by its manufacturers.

The plaintiffs say this design causes particles of metal to be shed into the surrounding tissue when the device fails. These metal particles result in “metallosis, biologic toxicity, tissue death and the growth of pseudo tumors,” they say. This metal poisoning can also cause “infection, inflammation, severe pain, loss of mobility, bone loss and death of the surrounding tissue.”

The plaintiffs allege that the defendants returned to using the previously-abandoned concept of metal-on-metal implants in the 1990s as part of an effort to “aggressively” market hip implants to a younger, more active demographic of patients.

Beverly and Brian claim this second generation of metal implants was plagued with the same problems that caused manufacturers to stop producing the first generation.

Beverly and Brian also suggest that DePuy used an expedited FDA approval process to avoid fully evaluating the safety of the Pinnacle system. This process allows a new medical device to be approved for use quickly if it is “substantially equivalent” to another device that had already been marketed.

Beverly and Brian say DePuy exploited this process by claiming the Pinnacle was substantially similar to a much older metal hip replacement system from decades ago.

The plaintiffs also note a prosecution by the United States Attorney’s Office in which the defendants were accused of paying hundreds of millions of dollars to doctors and medical facilities to promote use of the Pinnacle and other metal-on-metal hip replacement systems. This prosecution ended with the defendants paying $80 million in penalties and agreeing to cease the suspect marketing practices.

Beverly and Brian’s hip lawsuit is filed under case no. 1:16-CV-00050 in the U.S. District Court for the Western District of New York.