A Maryland woman has added her metal on metal hip implant lawsuit to the multidistrict litigation over DePuy Orthopaedics’ Pinnacle artificial hip system.

Plaintiff Eileen L. says she was implanted with a Pinnacle Acetabular Cup System in February 2009. She alleges in her metal hip replacement lawsuit that the Pinnacle’s artificial hip led to pain, discomfort, difficulty walking, and hip implant metal poisoning. She later underwent revision surgery in August 2013.

Eileen is now suing DePuy Orthopaedics and Johnson & Johnson — the companies responsible for designing, manufacturing and marketing the Pinnacle artificial hip she received.

As part of her hip implant lawsuit, Eileen argues that DePuy and Johnson & Johnson used a special shortcut to FDA approval that allowed them to bypass full clinical testing of the Pinnacle artificial hip. She says the Pinnacle system was approved through what’s known as the 510(k) process under the Medical Device Amendments to the Food, Drug, and Cosmetics Act of 1938.

The 510(k) process allows the FDA to approve a medical device for sale if it is “substantially equivalent” to some other, previously approved device. The DePuy reportedly sought and received approval under section 510(k), based on their own assurance that the Pinnacle was “substantially equivalent” to an older device. Eileen believes this allowed the Pinnacle artificial hip to hit the market without having been properly evaluated for safety and effectiveness.

Reports of Pinnacle Hip Implant Complications

Since releasing the Pinnacle for sale, the DePuy and Johnson & Johnson have received over 1,300 adverse event reports related to it, including over 250 such reports in the first three months of 2011 alone, the metal hip implant lawsuit says.

Despite those reports, DePuy has not recalled the Pinnacle hip implant system, nor has it publicized these reported problems, Eileen says.

Had the Pinnacle been properly evaluated, Eileen believes, its alleged problems would have been discovered sooner. Instead, aftermarket reports revealed that the metal on metal hip replacement was followed by cases of hip implant metal poisoning. Other reports cited problems that included pseudotumors, loosening of the artificial hip, pain, and a high rate of failure.

Eileen argues that as a metal on metal hip replacement, the Pinnacle is defectively designed, making it unsuitable for its intended purpose. She believes that defendants DePuy and Johnson & Johnson had information about the problems associated with the Pinnacle system yet purposely concealed that information from the public.

The hip implant lawsuit raises claims based on theories of negligence, defective design, defective manufacture, failure to warn, breach of warranty, fraud, misrepresentation, and violation of state laws against unfair and deceptive trade practices.

Eileen seeks compensation in the form of compensatory and punitive damages to cover her injuries, emotional distress and medical expenses. She is also asking for reimbursement for her attorneys’ fees and costs of litigation.

This hip replacement lawsuit is part of a multidistrict litigation, or MDL, that focuses on problems with the DePuy Pinnacle artificial hip. This MDL is a collection of individual hip implant lawsuits from patients who suffered hip implant metal poisoning and other complications after receiving a Pinnacle metal on metal hip replacement.

The De Puy Pinnacle Hip Replacement Lawsuit is Case No. 3:15-CV-04047-K, filed in the U.S. District Court for the Northern District of Texas. The DePuy Pinnacle Hip Implant MDL is In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, Case No. 2244, in the U.S. District Court for the Northern District of Texas.