Howard Sadwin thought he was going in for a routine hip replacement. He had a plastic hip implanted 16 years prior with no problems. He was given what his doctor called the “latest and greatest” in hip technology, a Smith and Nephew metal-on-metal hip. Ten months after the surgery, his nightmares began; fevers, rashes, no energy, ringing in ears, months later he suffered his first hip dislocation from the metal hip, after his third, he had surgery to remove the hip. It revealed muscles and tissue that had deteriorated to “gray mush” from the hip’s mental causing metal poisoning.
As a result of this metal hip, Howard suffered through 16 surgeries, ten months in the hospital, and now relies on a walker to get around.
It gets worse.
Howard’s hip was the first metal-on-metal hip design, the one that all the other metal hips, like the DePuy, were based upon. This means the FDA approved Howard’s hip through the most stringent pre-market review process, PMA.
In 2008, the Supreme Court ruled in Riegel v. Medtronic that medical devices approved by the FDA’s PMA process are IMMUNE from liability. The Supreme Court gave Smith and Nephew and other devcie manufacturers a “get-out-of-jail-free” card.
And who is stuck with the bill for Howard’s 16 surgeries—his insurance company and tax payers who fund Medicare. The device company won; Howard and tax payers lost.
There is no justice when a medical device company makes a dangerous product that is protected by the Supreme Court, even when a bad device has been recalled from the market.