The outcome of a trial underway in federal court in Texas could affect the injury claims of thousands of people implanted with the DePuy Pinnacle metal-on-metal hip replacement device.
Five plaintiffs who have DePuy metal-on-metal hips, manufactured by the Johnson & Johnson subsidiary, are having their cases presented in one proceeding, Law360 reports. Federal Judge Ed Kinkeade issued an order consolidating the five cases for trial, which began on January 8, 2016.
The jury finding in these five cases could play a critical role in determining whether DePuy creates a settlement program to respond to Pinnacle injury claims. In 2013, DePuy began settling claims of individuals injured by its ASR metal-on-metal hip implants. The ASR was recalled in 2011. The similar Pinnacle metal-on-metal hip device has never been recalled, but it is no longer on the market, Law360 reports.
Metal-on-metal hip implants have had higher failure rates and higher rates of revision surgery—surgery to correct or remove and replace the device—than hip replacement devices made of other materials. These devices have been recalled by health authorities worldwide. The Food and Drug Administration (FDA) and health agencies in other countries have recommended that recipients of metal-on-metal hips regularly have their blood tested for metal ions that can be released into the bloodstream as the metal components of the hip rub against each other during normal movement. Revision surgery is recommended if metal levels exceed a certain threshold. These repeat surgeries are often more difficult and less successful for the recipient because of bone and tissue damage the person has sustained from the metal-on-metal device.
People who have been implanted with the Pinnacle hip device allege that it has caused a number of complications, including:
- Loosening of the implant
- Difficulty standing or walking; limited mobility
- Severe pain that spreads to the groin and/or back
- Necrosis (death of tissue) or soft tissue damage
- Elevated levels of cobalt and chromium ions
- Osteolysis (bone loss or damage)
- Fluid collections or pseudotumors
- Revision surgery (second surgery needed to correct or replace implant)
In articles published on January 24 and 25, the UK Daily Telegraph points to evidence that DePuy was aware of problems with the devices dating back to 2008. The newspaper says DePuy has admitted to “an error in measuring techniques,” in the manufacture of the Pinnacle hips that could lead to greater wear of the metal alloy used in the device. The newspaper also says DePuy reduced time spent inspecting implants beginning in 2006, Law360 reports.
Eight witnesses have testified thus far and there will be several more days of testimony before the case goes to the jury, Law360 reports.