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July 17, 2018

Johnson & Johnson Pinnacle Hip Released Without Clinical Trials

A new lawsuit alleges that Johnson & Johnson and its DePuy unit released their Pinnacle hip replacement system without any clinical trials to ensure that the implant was safe or even worked, generating massive profits while using patients as guinea pigs for the ultimately defective hip system.

Karolyn White and her husband, Gervis White, filed the complaint July 10 in the Eastern District of New York. White indicates that she received the Pinnacle hip implant in June 2009 during total hip replacement surgery. She maintains that J&J and DePuy could have saved countless individuals from painful, debilitating, and sometimes irreparable injuries that usually require additional risky surgeries to address in any capacity if only they had exercised any level precautionary safety testing before placing the device in the stream of commerce.

The attorney who led the legal team that won a staggering $1.04 billion verdict against J&J and DePuy in late 2016 placed the blame for egregious injuries directly on the companies cutting corners to rush the device to market.

“The problem is that DePuy, Johnson & Johnson Pinnacle metal-on-metal was never tested in one single human being before they started selling it,” he said. “And the company basically made guinea pigs out of everyone who received it.”

Consequently, White was a participant in an experiment-for-profit gone terribly awry. She suffered catastrophic Pinnacle hip implant failure that will follow her for the rest of her life. Because of the defective Pinnacle device, White developed “serious and dangerous side effects, including, but not limited to component loosening, component mal-alignment metallosis, pseudotumors, infections, fracture of the bone, dislocation, metal sensitivity and pain, irritation and discomfort, as well as the need for additional procedures to remove and replace the device, as well as other severe and permanent health consequences,” her lawsuit states.

FDA Loophole Allowed Pinnacle on the Market Without Clinical Trials

J&J and DePuy allegedly rushed the metal-on-metal hip implant to market without ever testing it on humans, pushing for faster profits at the expense of patient safety. Like many other medical device manufacturers, Depuy and J&J used a regulatory loophole to fast-track the metal-on-metal Pinnacle implant through the FDA clearance process.

The FDA’s 510(k) regulatory pathway allows medial device manufacturers to skip clinical trials, provided that the manufacturers can demonstrate that devices are “substantially equivalent” to ones already in use.

In 2013, public health experts appealed to the FDA to close the loophole, citing that human studies “might have identified the high revision rate of the ASR,” another metal-on-metal hip replacement device based on Pinnacle's design that DePuy recalled in 2010 due to skyrocketing early failure rates. Ultimately, J&J and DePuy reached a $2.5 billion settlement agreement to resolve thousands of ASR lawsuits.

“As thousands of Americans are painfully learning, there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts," the experts wrote.

As concerns over metal-on-metal hips continued to grow, the FDA began taking measures to close this regulatory loophole in 2013. The agency noted the “unique risks” inherent to all metal-on-metal implants and said it would begin to require manufacturers to prove implant safety through clinical trials or stop selling them. Unsurprisingly, many manufacturers simply stopped selling the devices, quietly removing the products from the market and sneaking off like thieves in the night with their ill-begotten profits from thousands of human guinea pigs.

Pinnacle Hip Problems

A one-time “consultant surgeon” for DePuy, Dr. Tony Nargol, testified at a recent trial that he tried to warn DePuy that metal-on-metal Pinnacle hips were failing at high rates at his England hospital.

Dr. Nargol detailed “horrible, rotten, damaged flesh” he’d found inside some patient’s bodies while removing and replacing their Pinnacle hip implants.

“It’s quite unbelievable in the bad cases,” Dr. Nargol said. “You go in there. You touch a muscle, and it just disintegrates. It just liquefies. It’s just destroyed in your hand.”

The surgeon testified that DePuy was in “total denial,” when he reported the Pinnacle hip’s horrific side effects. Instead, the company ignored his warnings and put the blame on doctors. Dr. Nargo’s hospital eventually issued its own recall, checking patients for pseudotumors and high levels of toxic cobalt and chromium from the metal-on-metal wear releasing metallic debris into the patients’ bodies.

Dr. Herbert Huddleston also testified in the trial, telling jurors that even he did not know that Depuy had not tested the implants in humans and detailing grotesque findings in the high numbers of revisions he had performed due to Pinnacle hip failure.

“The bone and soft tissue around the hip start to look like pieces of cheese…except pitch black pieces of cheese,” Dr. Huddleston told Eyewitness News of the damage from the Pinnacle hip implants. “Sometimes we get in there and it looks like it’s filled with old oil that you’ve drained from your car.”

DePuy’s Reaction to Pinnacle Hip Catastrophic Failures

By 2004, DePuy knew from its own investigation that its metal hip implant released metallic debris into the body, settling into major organs and killing "the bone and soft tissue around the hip.”

In 2010, on of DePuy’s own Pinnacle design surgeons, who received royalties from Pinnacle sales, wrote to marketing executive expressing concern about the company’s “head in the sand response” to metal hip problems, saying that it was “unethical to continue to market the product until the issues are elucidated. These products are harming patients.”

In response to a 2008 “Complaint Crisis” due to an increasing number of patients undergoing painful revision surgeries to remove and replace the defective implant, DePuy created a marketing PowerPoint with creative solutions to the ongoing crisis.

“Let’s train our sales force not to report revisions,” the DePuy PowerPoint suggested. “And if our sales force will not report the revisions, it will make us look better with the FDA, it’ll make us look better compared to our competitors.”

Meanwhile, the hip remained on the market for five more years as thousands suffered from entirely preventable injuries, as DePuy and Johnson & Johnson made billions.

 

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