DePuy ASR and Pinnacle Metal-on-Metal Hip Implants
DePuy, a subsidiary of Johnson and Johnson, cornered a significant portion of the metal-on-metal hip implant market with its ASR Hip Resurfacing System and ASR Acetabular System. The ASR implant was based on its being substantially similar to another DePuy hip implant—the Pinnacle. The Pinnacle has suffered its share of problems as well, although it has not yet been recalled.
The DePuy Pinnacle Hip Implant
The DePuy Pinnacle Hip Replacement System was approved by the FDA in 2000, and offered several options for the ball and socket surfaces including ceramic-on-ceramic, metal-on-metal, ceramic-on-polyethylene, ceramic-on-metal, and metal-on-polyethylene. DePuy’s goal was to allow surgeons more freedom in choosing a bearing surface for their individual patient based on the patient’s age, body type and level of activity. The Pinnacle metal-on-metal acetabular cup liner is a metal liner used with certain Pinnacle acetabular shells, and approved by the FDA based on DePuy’s Ultima model.
The Pinnacle metal-on-metal system generated a significant number of adverse reactions in patients (as did the Ultima). In fact, in a study done in the UK, 90 Ultima implants out of 545 patients failed, requiring revision surgery. During those revision surgeries, surgeons found evidence of severe tissue death, ruptured tendons and cloudy pockets of fluid surrounding the hip. The Pinnacle and Ultima metal liners caused friction and corrosion between the cup and ball-shaped head, resulting in the generation of excess metal ion debris. Inflammation, pain and mobility difficulty as well as long-term adverse side effects including cobalt poisoning were reported. Despite known issues with the Pinnacle, DePuy never recalled the hip implant, merely discontinuing the metal liner in mid-2013.
Regardless of the more than 1,300 adverse event reports submitted to the FDA regarding the Pinnacle as well as the more than 3,000 current federal lawsuits and numerous state lawsuits filed against DePuy for harm suffered from the Pinnacle, DePuy continues to steadfastly maintain there is no defect in the design of the Pinnacle hip replacement. At least one DePuy lawsuit alleges the company was well aware of the potential safety hazards of the Pinnacle, yet concealed the defects and misrepresented to consumers that the implant was safe and effective. When the Pinnacle is used with a metal liner, consumers have experienced the following adverse health symptoms:
· Chronic, unexplained hip pain
· Total failure of the Pinnacle device
· Difficulty in standing or walking
· Loosening of the Pinnacle hip device
· The necessity of undergoing revision surgery
· Development of metallosis symptoms including cobalt and chromium poisoning
The first trial from plaintiffs alleging harm resulting from a DePuy Pinnacle implant is scheduled for March, 2014, although depositions began last January, 2013. The U.S. District Court Judge, Judge James Kinkeade, issued very strong warnings to DePuy regarding the fact that many hospitals had refused to turn over explanted Pinnacle devices which could cause a problem with preservation of evidence. Judge Kinkeade asked the Special Master to call these hospitals, issuing an ultimatum: turn over the implants taken from Pinnacle patients who had been forced to undergo revision surgery or risk further “communication” with the judge.