Metal-on-metal hip implants have been causing trouble for DePuy and parent company Johnson & Johnson for past few years. After the global recall of the ASR in 2010, lawsuits everywhere came flooding in. Eventually, DePuy and J&J agreed to a multi-billion dollar settlement for the ASR. The Pinnacle, however, continues to plight them.
Metal-on-metal hip implants on the whole have come under scrutiny. These devices, which release metal ions into the body when the surfaces rub together, were approved with no clinical testing due to regulatory loopholes that are not being largely criticized. The ASR and the Pinnacle (when used with a metal liner called the “Ultamet”) both fall into this category.
The review process, known as 510(k) allows devices to be sold and implanted into patients without any clinical testing. As long as a manufacturer was able to argue that the product is similar enough to a previously approved device, then no testing was needed. Now, experts have attacked the process, especially for Class III devices, which pose the greatest risk to patients.
In January, the U.S. Food and Drug Administration (FDA) proposed that new metal-on-metal hips go through premarket approval, a stricter review process. Additionally, manufacturers would have to conduct postmarket safety studies for devices that are already on the market. This was at least partly why DePuy has decided to phase out its metal hip sales. At the end of August, the company also decided to stop using the metal liner in the Pinnacle. The device has not, however, been recalled.
There are more than 5,000 lawsuits pending in the Pinnacle multidistrict litigation. The cases are consolidated in the U.S. District Court for the Northern District of Texas. The first Pinnacle bellwether trial is expected to take place this September.
Plaintiffs allege that the Pinnacle is defective and prone to a high rate of failure. The cases emphasize that the metal hip implant can lead to a number of complications necessitating the need for revision surgery. Hip recipients may suffer from pseudotumors, which are fluid filled sacs under the skin. Metallosis, which occurs when the cobalt or chromium ions seep into the bloodstream, tissue or bones, can cause the affected tissue to die (necrosis). Studies have found that metallosis can harm the kidneys, spleen and liver. Researchers have also linked the issue to heart and neurological problems.