There are over 1,000 lawsuits in the DePuy Pinnacle hip MDL, the multi-district litigation set up by the Judicial Panel on Multidistrict Litigation. This MDL is being overseen by U.S. District Judge Ed Kinkeade of the District Court for the Northern District of Texas.
Following the massive recall of DePuy’s ASR and ASR XL models, a DePuy ASR hip implant MDL was set up in the Northern District of Ohio. The ASR implant was metal-on-metal. The DePuy Pinnacle implant can be used with one of three types of liners: metal, plastic, or ceramic. The metal liner is called the “Ultramet.” Like the recalled ASR hip implant, the FDA never approved the Pinnacle implant for use with a metal liner. DePuy relied on a grandfathering provision in the FDA regulations that allowed it to sell the Pinnacle metal-on-metal implant without having to conduct any clinical trials to establish the safety and efficacy of the device.
In February, the British Medical Journal (BMJ) published an article discussing problems with the DePuy Pinnacle metal-on-metal hip implant. The BMJ reports that DePuy altered its design of the Pinnacle by making the femoral head larger, but making the stem that it sits on much shorter. Internal DePuy documents reviewed by the BMJ show that as early as 2005, DePuy was aware of the damage that could be done to patients by metal-on metal-implants. E-mails reviewed by the BMJ show that Japanese surgeons warned DePuy in 2009 that metal debris from the Pinnacle was harming patients. And in 2010, a senior DePuy executive said in an internal document that he was “concerned” about problems with the metal-on-metal Pinnacle and similar implants, stating, “I feel the problem is emerging as more serious than first thought.”
The “concerns” regarding the problems with metal-on-metal Pinnacle implants are similar to the concerns with the DePuy ASR, e.g., inflammatory reactions, tissue damage, and elevated levels of chromium and cobalt in the blood stream from the metal debris caused by the friction between the metal ball and cup. The question is, why hasn’t the Pinnacle metal-on-metal device been recalled?