DePuy ASR Recalled Due to Safety Issues, Company Engineer Testifies


DePuy ASR Recalled Due to Safety Issues, Company Engineer TestifiesOverview: The DePuy ASR recall that affected over 93,000 hip implants worldwide was based on safety concerns, a witness said yesterday during the bellwether trial in Los Angeles state court. Yesterday, DePuy engineer Graham Isaac testified in the trial of Loren Kransky, a 65-year old former corrections officer who alleges that the metal-on-metal hip implant caused complications, including elevated metal ion levels. The lawsuit is the first of 10,000 to go to trial.

  • DePuy engineer Graham Isaac testified yesterday during the DePuy ASR trial; he agreed that the metal hip implants were recalled because of safety issues
  • Previously, a DePuy executive insisted that the recall was issued because it did not meet clinical needs
  • A DePuy analysis showed that the hips failed in 37% of patients within five years

Product: DePuy ASR Hip Implant

Manufacturer: DePuy Orthopaedics/ Johnson & Johnson

Side Effects & Complications

  • High failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Pain at the implant, sometimes spreading to the groin and back
  • Osteolysis (bone loss)
  • Fluid collections/solid masses around the hip joint

DePuy Engineer Says Recall was Due to Safety Concerns

Yesterday, DePuy engineer Graham Isaac testified in the first DePuy ASR trial in Los Angeles state court. In mid-2010, Johnson & Johnson’s DePuy unit recalled 93,000 ASR hip implants worldwide, including 37,000 in the United States. When asked to confirm if this recall was due to safety concerns, Isaac agreed. At the time of the recall, the company said that the implant failed in 12 percent of patients within five years. Kransky’s attorneys have cited internal DePuy analysis showing that the hips fail at a rate of 37 percent in 4.5 years; last year, an Australian national registry showed that it failed at a rate of 44 percent in seven years.

Isaac was also asked about the release of metal ions, an alleged defect of the ASR hip implant. Kransky’s lawsuit alleged that the metal debris blackened tissue and entered the bloodstream. During the questioning, Isaac acknowledged that DePuy did not disclose the ion exposure issue to DePuy ASR patients.

DePuy ASR Background

DePuy lawsuits have continued to mount following the recall in 2010. The all-metal hip replacement is now considered one of the biggest medical device failures in recent history. In total, DePuy and parent company Johnson & Johnson are facing over 10,000 lawsuits over the recalled hip implant; about 2,000 are pending in California state court alongside Kransky’s, while some 7,000 are pending in federal court as part of the multidistrict litigation in Ohio.

During the trial, DePuy executive Andrew Ekdahl insisted that the recall was issued because the hip implant “did not meet the clinical needs for the product” rather than safety concerns. A growing body of evidence, however, continues to suggest otherwise.