Thousands of Patients Claims Allege Cobalt Toxicity From DePuy Pinnacle Metal-on-Metal Hip Implants
In a recent article from ABC 7 in Los Angeles, investigators explore metal poisoning claims that arose from the use of DePuy Pinnacle brand metal-on-metal hip implants. Angie Rodriguez is just one of the thousands of patients who argues that the metal-on-metal hip implants caused serious injuries.
After her hip implant surgery, Angie began to notice a growth on her right hip. She recalled, “It was half of a grapefruit-sized pillow of fluid is what it turned out to be, and they said it was a pseudotumor…they said it was a pocket full of fluid and metal debris.”
Angie also showed the investigators a pathology report that showed metal in her hip tissue. Ultimately, both of Angie’s DePuy Pinnacle hip implants failed.
Angie joins five other plaintiffs in California who have filed a federal hip implant lawsuit over their painful experiences. They argue that they were unknowingly subjects in a “science experiment.” Additionally, they claim that DePuy Orthopaedics, the company that manufactured the hip implants, ignored its own team of surgeons, who advised that the hip implants could have devastating side effects. The lawsuit also alleges that some surgeons were paid seven figures to promote the hip implants.
The Pinnacle hip made so much money for DePuy, it became known as the manufacturer’s “Billion Dollar Baby” before it was ultimately removed from the market in 2013.
Though roughly 150,000 patients throughout the United States received the Pinnacle hip, it was never tested in humans. Through DePuy Orthopaedics designed, manufactured, and marketed this device as safe, the company never engaged in any clinical trials that ensured the implant was safe for people to receive.
Metal-on-metal hip implants often grind together in some places. When this grinding occurs, the implant may shed chromium and cobalt ions or debris into the surrounding tissues. These materials can trigger the growth of pseudotumors, which often ravage bones and muscle tissue. Further, the metal ions can travel throughout the body in the bloodstream.
At the end of 2016, Attorney Mark Lanier represented a group of plaintiffs that ultimately won an impressive $1.04 billion verdict against both DePuy and Johnson & Johnson, DePuy’s parent company. The trial dragged on for eight weeks in a federal courthouse in Dallas.
Lanier commented, “The problem is the DePuy, Johnson & Johnson Pinnacle metal-on-metal was never tested in one single human being before they started selling it. And the company basically made guinea pigs out of everyone who received it.”
In the verdict, the jury concluded that the companies failed to properly warn doctors about the risks associated with the implants, hid these potential dangers, negligently designed and sold the implants, and fraudulently marketed the devices.
Attorneys for DePuy and Johnson & Johnson have appealed the verdict.
Millions were paid to doctors to recommend the hip implants
Doctors were receiving exorbitant amounts of money to promote the Pinnacle hip, Lanier said. He recalled, “Two banker’s boxes of spreadsheets of the payments they’ve been making to doctors.” Ultimately, Lanier presented evidence at trial that showed the manufacturer paid more than $184 million royalty payments to physicians. Eleven surgeons were paid sums of between $2 million and $44 million dollars. DePuy argued that it was not unethical to pay design surgeons for their work.
However, Lanier argued in court that the company really used the surgeons to market the devices and that the royalties were really “kickbacks.” Design surgeons are paid a percentage of most of the products that sell. According to Lanier, this creates ethical issues, because design surgeons are incentivized to write glowing reviews of the devices.
This is not the only time DePuy has been under the FDA’s watch for allegedly providing kickbacks to surgeons. In 2007, DePuy signed a Deferred Prosecution Agreement, which did not require an admission of wrongdoing. DePuy was accused of attempting to violate federal anti-kickback statutes by paying surgeons by implementing “consulting agreements.” The surgeons were to only use DePuy devices and products. No charges were filed resulting from the Deferred Prosecution Agreement. Ultimately, DePuy had to undergo an 18-month monitoring period and had to take on new compliance measures.
Four years later, in 2011, Johnson & Johnson shelled out $70 million to finalize both civil and criminal charges that were filed under the Foreign Corrupt Practices Act. The suits alleged that some of Johnson and Johnson’s foreign subsidiaries bribed Polish, Greek, and Romanian doctors. The company was also blamed for providing kickbacks to Saddam Hussein’s regime under a crooked United Nations Oil-for-Food program.
How did the hip implants ever make it onto the market?
Lanier argued that DePuy hurried the device onto the market. DePuy used an FDA loophole to do so. Under the 510(k) regulatory pathway, clinical trials could be skipped. Instead, the manufacturer could test the devices on mechanical simulators if the devices were “substantially equivalent” to other devices that had already obtained FDA approval. Many have asked for this loophole to be closed. DePuy argued that 21 other manufacturers used this loophole to put 188 all-metal hip implants on the market.
Since the dangers of metal-on-metal hip implants were revealed, the FDA has begun to close the loophole. It stated that metal-on-metal hip implants would not receive approval through the 510(k) regulatory pathway again.
Doctors Tried to Warn DePuy About the Dangers of the Implants
Dr. Tony Nargol is one of the surgeons who tried to warn DePuy about the metal-on-metal implants. At trial, Dr. Nargol recalled the “horrible, rotten, damaged flesh” he would observe as he removed and replaced the hip implants. He said, “It’s quite unbelievable in the bad cases. You go in there, you touch the muscle and it just disintegrates—it just like liquefies—it’s just destroyed in your hand.” He said that when he addressed his concerns with DePuy, the company was in “total denial.”
Further, DePuy investigated another one of its own products, the Ultima, in 2004 in the United Kingdom. That investigation concluded that “metal ions released have killed the bone and soft tissue around the hip.”
DePuy even told its sales force to keep reports of revision surgeries quiet.
The future is unnerving for those who have received metal-on-metal hip implants
In 2014, a Minnesota woman died of heart failure secondary to cobalt toxicity. She had received two Pinnacle Ultamet all-metal hip implants. In addition, a government report has demonstrated that cobalt ions could be a carcinogen. For patients who have received the devices, they now have to worry about a cancer diagnosis in the future.
If you have a metal-on-metal hip implant and were injured, you should consult an experienced medical device products liability attorney as soon as possible. These attorneys will ensure that your legal rights are protected and that you obtain the money you deserve from the device manufacturer. No device manufacturer should be able to mislead the public and the medical community about the dangers of its products without consequence.
Call Parker Waichman LLP today for Your Free Consultation
At Parker Waichman LLP, our DePuy Pinnacle Metal-on-Metal Hip Implants Poisoning Lawsuit attorneys are experienced in medical device claims. To talk with one of our seasoned lawyers, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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