Overview: Johnson & Johnson’s recalled DePuy ASR hip implant has sparked international safety concerns over metal-on-metal hip implants. Following a recall of 93,000 hips in 2010, the company is facing 10,000 lawsuits alleging injuries from the device. The first lawsuit has gone to trial in Los Angeles state court. According to Bloomberg, Plaintiff Loren Kransky testified that he feared his hip revision surgery would kill him; ultimately, he said he only agreed to the procedure because he felt the implant would present a life-threatening risk either way. Throughout the trial, Johnson & Johnson has repeatedly insisted that the ASR did not poison Kransky by generating metallic debris.
- According to Loren Kransky’s testimony, he was afraid that the revision surgery to remove his ASR would kill him; he told jurors he agreed to the operation because thought he would die with the implant regardless
- Kransky was told that his ASR hip implant may be poisoning him; his cobalt levels were exceedingly high compared to the amount recommended by the MHRA
- Kransky’s lawsuit is one of thousands alleging that the ASR is defective and released toxic amounts of metal ions, causing complications and the need for revision surgery
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
Bloomberg reports that Kransky testified before jurors in Los Angeles state court. His lawsuit alleges that the ASR hip implant is defective and caused a number of injuries since he received in 2007. According to his testimony, he described feeling “a kind of stabbing type of pain. It was debilitating. I couldn’t do anything, couldn’t walk long distances.” Kransky recalled fearing for his life before undergoing revision surgery to remove the hip implant last February. “I thought that surgery was going to kill me. I thought I was going to die.” he said. Kransky testified that he only got the revision surgery because he believed the implant presented a life-threatening risk if it remained in his body. “I came to believe that I was going to have to do it because I was told that something in my body was poisoning me…I was told it could be the hip. I thought, ‘I’m going to die either way.’ One way would be slow and one would be fast. I took the lesser of two evils.”
DePuy ASR Safety Issues
At the time of the recall, Johnson & Johnson cited unpublished data indicating that the hips failed in 12 percent of patients in five years. Kransky’s attorneys have claimed that, according to data from an Australian registry, the hip’s failure rate exceeds 40 percent. The ASR recall has come to be known as one of the biggest medical device failures in recent history, and analysts estimate that the litigation could cost J&J billions. The FDA has recently issued new guidelines for patients with metal-on-metal hip implants such as the DePuy ASR, recommending metal ion testing for the first time. Many of the lawsuits point out the fact the ASR was never clinically tested for safety, something that the FDA is also trying to address by proposing new regulations.