According to a new Pinnacle hip lawsuit against Johnson & Johnson and its DePuy subsidiary over mispresenting the safety of their metal hip to the detriment of thousands of patients, the cobalt and chromium implant has the propensity to shed dangerously excessive amounts of carcinogenic metallic debris into patients’ tissue and bone.

Rocky Bartlett filed the complaint June 20 in the Northern District of Texas. Bartlett received the Pinnacle hip implant during right hip replacement surgery on October 24, 2007. He indicates that his physician relied on the manufacturers’ fraudulent misrepresentations that the Pinnacle hip was a superior and safe product that would last 20 or more years.

Since at least January 2008, Johnson & Johnson and Depuy were well aware of the Pinnacle device’s elevated potential for unusual, premature, and increased friction, as well as wear and tear and the formation of pseudotumors. This was three months after Bartlett’s initial implantation procedure. However, the manufacturers continued to actively conceal these risks and did not alert patients who had already undergone a Pinnacle hip replacement procedure about the device’s patently dangerous defects.

Bartlett’s Pinnacle Hip Failure

Following Bartlett’s first surgery, radiographs showed the implants were in their anatomically correct position. His wounds also healed well. But, he began experiencing debilitating pain in early 2017. In Summer 2017, Bartlett began treatment for lower back pain and his left hip. After conservative treatment and injections failed to alleviate his symptoms, Bartlett returned to the doctor who performed the original implantation procedure. His physician ultimately recommended a left hip replacement. Consequently, Bartlett underwent a left total hip replacement on December 13, 2017. Bartlett’s doctor also evaluated his right hip at this time and determined that revision surgery was necessary due to pain, elevated metal levels, and osteolysis.

On December 27, 2017, Bartlett underwent total right hip revision surgery to remove and replace the defective Pinnacle device, including the metal liner and femoral head. Post-operative notes confirm that the Pinnacle hip had failed, shedding large amounts of metallic debris into Bartlett’s body.

Excess amounts of metal debris in a person’s system can cause metallosis. Metallosis from cobalt poisoning has been linked to hearing loss, pain, rashes, diminished cognitive functions, memory loss, anxiety, mental fog, breathlessness, dizziness, tissue necrosis, metal staining, pseudotumors, and other serious medical conditions. Furthermore, increased cobalt and chromium levels have been linked to cancer in laboratory animals. According to the International Agency on Cancer, cobalt is a probable human carcinogen.

Despite these substantial risks, the manufacturers refused to pull the Pinnacle hip from the market even as studies began to reveal that metal-on-metal implants are prone to depositing substantial amounts of metallic debris into patients’ bodies as the devices wear down, necessitating revision surgery far sooner than industry standards.

Pinnacle Hip Lawsuits

Currently, there are almost 10,000 similar DePuy Pinnacle hip lawsuits pending in the ongoing federal multidistrict litigation (MDL). District Judge Ed Kinkeade is presiding over the MDL in the Northern District of Texas for pretrial proceedings and a series of bellwether trials to help parties evaluate the relative strength and weaknesses of their respective positions to guide any potential Pinnacle hip settlement negotiations.

Despite failing repeatedly during the bellwether process, Johnson & Johnson continues to refuse to negotiate any Pinnacle hip settlements, asserting that it will continue to defend the metal-on-metal implant. In May 2016, a jury ordered the manufacturers to pay $500 million for the Pinnacle device’s inherently dangerous defects. However, Judge Kinkeade reduced this award to $151 million due to Texas law limitations on non-economic damages. A federal appeals court also recently ordered a new trial as the jury heard evidence that was unnecessarily prejudicial against Johnson & Johnson.

But, the medical device companies have not fared much better in other bellwether trials. In November 2017, another jury hit the manufacturers with a $247 million verdict. This included $79 million in compensatory damages with $168 million in punitive damages to punish the companies for their reckless disregard for patient safety.

Previously, J&J agreed to pay more than $2.4 billion to settle DePuy ASR metal hip lawsuits. DePuy ASR is a recalled hip system based on the Pinnacle hip’s design. Although J&J and DePuy maintain that they intend to defend Pinnacle cases at trial and through appeals, they could face sustain staggering losses trying to face these lawsuits in court.