While a recall for the DePuy Pinnacle hip system was never issued, thousands of claims have been filed for complications related to the Pinnacle, such as metallosis, hip implant failure, tissue damage and cobalt and chromium metal poisoning. There are currently more than 6,400 product liability lawsuits filed against DePuy and its parent company Johnson & Johnson after more than 1,300 adverse event complaints were sent to the FDA regarding the Pinnacle. The majority of these cases have been consolidated before U.S. District Judge Ed Kinkeade, in the Northern District of Texas under what is known as multidistrict litigation—or MDL.
DePuy Pinnacle Bellwether Trials
A small group of cases has been prepared for early trials and are known as bellwether lawsuits. Bellwether trials are meant to gauge how juries and judges will react to evidence, information and testimony that will likely be the same in all of the cases in the group. Despite DePuy’s last-ditch efforts to have the cases thrown out, the first DePuy Pinnacle bellwether trial is set for September 1, 2014, followed by three more DePuy Pinnacle bellwether trials set for November 3, 2014, and three more set for January 12, 2015.
The September 1st bellwether trials involve allegations from Kathleen Herlihy-Paoli and Toni M. Lamay. Both plaintiffs allege DePuy sold them poorly designed metal-on-metal hip implants and that the devices were destined to fail. Ms. Herlihy-Paoli was forced to have her Pinnacle device removed less than two years after the initial surgery due to intense hip pain and high levels of cobalt and chromium in the bloodstream. Herlihy-Paoli’s doctor noted the Pinnacle implant had turned black due to metallosis.
Within four years of the time Ms. Lay received her Pinnacle hip implant, doctors found she had dangerously high levels of cobalt and chromium in her bloodstream and had suffered significant tissue death surrounding her implant. Further, a space filled with whitish-green fluid was discovered during Lay’s revision surgery. Most all the allegations from plaintiffs regarding the Pinnacle device allege it was unreasonably dangerous due to the design which allows a metal femoral head to rotate within a metal acetabular cup, resulting in cobalt and chromium ions shearing away from the device, burrowing in surrounding hip tissues or traveling to the bloodstream.
Pinnacle Used to Obtain Approval of Recalled ASR
The controversial 510(k) FDA approval process was implemented to gain approval for DePuy’s recalled ASR hip implant; Johnson & Johnson maintained the DePuy ASR featured a design which was substantially similar to the already-released Pinnacle. A DePuy ASR recall was issued in August, 2010, after the manufacturer acknowledged that the implant carried a higher-than-normal expected rate of failure. Johnson & Johnson agreed to pay more than $2.4 billion to settled the ASR lawsuits for the more than 12,000 litigants. Even so, Johnson & Johnson has continued to defend the Pinnacle device. The DePuy Pinnacle hip replacement system has been a popular metal-on-metal device since it was first introduced in 2001.
The Pinnacle was marketed toward a younger, more active group of consumers, providing smooth range of motion, and since 2001, over 150,000 Pinnacle devices have been sold. Some of the Pinnacle lawsuits allege the company was aware of the high failure rate as early as 2006, yet failed to warn consumers of the risks. If you are the recipient of a DePuy Pinnacle hip implant, you are encouraged to speak to an experienced Pinnacle hip attorney at the earliest possible time.