An estimated 150,000 Americans unknowingly became guinea pigs when they were fitted with a metal-on-metal artificial hip implant that had not been tested on humans. Although the defective medical device was taken off the market in 2013, many Americans are still dealing with painful side effects. A federal jury recently found that DePuy and its parent company, Johnson & Johnson, negligently designed, sold, and fraudulently marketed the implants while failing to properly warn doctors and concealing the potential risks associated with the implant. What’s even worse is that the government allowed these implants to be put in use without testing on humans thanks to an FDA loophole.
One plaintiff in a recent injury case regarding the implants testified that she had a pseudotumor the size of half of a grapefruit full of fluid and metal debris. When the metal pieces of the hip implant grind against each other, they shed traces of metal ions—including cobalt—and debris into the body. This is when catastrophic injury can occur. The metal ions are small enough to enter the bloodstream and travel through a person’s body. What’s even worse? A recent government report has found that cobalt ions are “reasonably anticipated to be a human carcinogen.”
Despite warnings from doctors who spoke of, “horrible, rotten, damaged flesh,” that they found when removing and replacing the metal-on-metal hips that had experienced problems, DePuy continued to manufacture and market them. In an interview with Eyewitness News, one doctor testified that in particularly bad cases the muscle surrounding the defective medical device would disintegrate when touched. Another surgeon who had taken out dozens of the failed implants testified that the bone and soft tissues around the hip had started to look like “pitch black pieces of cheese.”
Many people wonder how it is possible for a company to implant a new medical device not yet tested on humans into hundreds of thousands of people. The FDA currently has a loophole (officially known as the 510(k) regulatory pathway) in place that allows manufacturers like DePuy to skip clinical trials if they can show that the new device is “substantially equivalent” to similar devices already in use. In DePuy’s case (and many others) this allowed them to use mechanical simulators instead of actual humans to prove their “substantial equivalency.” This is not enough regulation, as evidenced by the catastrophic injury caused by the metal-on-metal hip implants that passed through this loophole as a Class II device. The problem with substantial equivalency is that manufacturers have a very low bar set for them—it is still legal for them to prove substantial equivalency to devices that are no longer being used or to pick and choose parts from different devices.
In 2013, the FDA began to close the loophole for metal-on-metal implants but that was only a temporary solution to a permanent problem. This loophole applies mainly to Class II medical devices as most Class I devices are exempt from this process. It does not apply to Class III medical devices which are subject to more rigorous testing. According to the FDA, most medical devices are considered Class II devices. Many public health experts have been calling on the FDA to close the 510(k) loophole for years.
It’s time for the government to place tougher regulations on medical devices before more catastrophic injury occurs to innocent people. Either the 510(k) loophole needs to be amended or more medical devices need to be reclassified as Class III devices instead.
If you or someone you love has suffered catastrophic injury due to these dangerous and defective medical devices Paul Thomson, Roanoke Defective Medical Device Lawyer can help. Call The Thomson Law Firm for a FREE consultation. (540) 777-4900
