A husband and wife have filed a DePuy Pinnacle hip replacement lawsuit in Texas federal court as part of the multidistrict litigation currently underway against DePuy Orthopaedics and its parent company Johnson & Johnson.

Plaintiffs Susan and Bob G., both Montana residents, have brought forth this action against the manufacturers of the DePuy Pinnacle hip replacement

In September 2009, the couple says, Susan underwent surgery to have a total right hip replacement performed, and the DePuy Pinnacle hip replacement was implanted in her.

“After the surgery, friction and wear between the cobalt-chromium metal head and the cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into Plaintiff’s blood and tissue and bone surrounding the implant,” the Pinnacle lawsuit states.

“As a result, Plaintiff has been experiencing severe pain and discomfort and inflammation in and around her implant.”

Susan says she had to undergo a revision surgery in February 2017 to replace her implant, and it was at that time that she made the causal link between her DePuy Pinnacle hip replacement device and the subsequent medical issues she suffered from.

Plaintiffs: DePuy Pinnacle Hip Replacement Sidestepped Full FDA Review

The Pinnacle lawsuit alleges that the manufacturers did not seek adequate premarket evaluation of their device, “and thus the FDA made no finding that the Pinnacle device is safe or effective.”

The manufacturers were able to get an exception to full premarket approval under the FDA’s 510(K) approval process. That process “only requires the manufacturer to notify the FDA under section 510(K) of the MDA of its intent to market a device at least 90 days prior to the device’s introduction on the market, and to explain the device’s substantial equivalence to a pre-MDA predicate device,” the plaintiffs explain.

“The FDA then may approve the new device for sale in the United States.”

The Pinnacle lawsuit goes on to state that if DePuy and Johnson & Johnson had gone to the trouble of conducting more complete clinical trials prior to the market release of the Pinnacle Device, “they would have discovered at that time what they ultimately learned in and around 2007 – that the Pinnacle Device results in a high percentage of patients developing metallosis, biologic toxicity and an early in high failure rate due to the release of metal particles and the patient’s surrounding tissue when the cobalt-chromium metal femoral head rotates within the cobalt-chromium metal is acetabular liner.”

When the cobalt and chromium ions are shed from the device and are released into the body, the metal ions can migrate into the tissue and blood stream of the patient, causing systemic and localized effects.

The tissue surrounding the implant which is exposed to the metal ions can die or become infected, and pseudotumors may form in the area. With the tissue surrounding the metal implant not as strong, the device may begin to loosen, causing pain and damaging nearby body areas.

Systemically, when cobalt and chromium go into the bloodstream, they can cause organ toxicity and can disrupt a variety of bodily symptoms, especially the endocrine system which can cause a variety of hormonal problems.

The Pinnacle lawsuit states that over 1,300 adverse reports have been submitted to the FDA that detailed problems linked to the implantation of the Pinnacle device.

Susan and Bob have brought forth a number of allegations against the manufacturers including negligence, strict liability for failure to warn, manufacturing defect and design defect, negligent misrepresentation, breach of express and implied warranties, fraud, violation of the Montana Consumer Protection Act, and loss of consortium (spousal companionship).

The plaintiffs are seeking a jury trial and an award of damages related to pain and suffering, wage loss, medical expenses, mental anguish and distress, loss of enjoyment of life, disfigurement, physical impairment. They also seek treble damages, punitive or exemplary damages, attorneys’ fees and any additional relief as deemed proper by the Court.

The DePuy Pinnacle Hip Replacement Lawsuit is Case No. 3:17-cv-00778-K, and is part of the DePuy MDL, MDL 2244, in the U.S. District Court for the Northern District of Texas, Dallas Division.