New testimony in the first trial of some 10,000 cases over the DePuy ASR metal-on-metal hip device reveals that Johnson & Johnson’s DePuy Orthopaedics unit pulled the now-recalled device off the market over safety concerns.
The testimony, presented by DePuy ASR designer and engineer, Graham Isaac, is in stark contrast to what Andrew Ekdahl, president of DePuy Orthopaedics said in taped testimony presented to jurors last week. In fact, throughout his previously taped deposition, Ekdahl maintained that 93,000 DePuy ASR hip devices were recalled, not for safety reasons, but because the devices, “did not meet the clinical needs for the product.” Ekdahl later stated “It was taken off the market because it did not meet the clinical needs for the product in the marketplace,” according to Bloomberg.com previously. The ASR device was recalled in August 2010.
Isaac was questioned by the attorney representing Loren Kransky, 65, the plaintiff in the case, about the ASR XL’s “higher than expected” failure rate, which prompted the recall. When asked if the failure rate “was a safety issue, right?” Isaac, agreed that it was, said Bloomberg.com. When the device was recalled, Johnson & Johnson said that 12 percent of the DePuy ASRs failed. Kransky and his attorneys contend that officials at DePuy were aware the failure rate was higher than public figures indicated.
Kransky’s attorney told jurors that a 2011 internal DePuy review revealed a 37 percent failure rate in ASRs within 4.5 years and noted that Australian national joint registry data from last year indicated a 44 percent failure rate after seven years, said Bloomberg.com.
Isaac explained to jurors that “patients are always exposed to ions” of the materials used in the devices, whether they be all metal or other components, said Bloomberg.com. Isaac also said that scientists and doctors have not yet agreed on what is considered a safe ion exposure level; however, when asked if 50 microns of ions would be safe, Isaac stated, “that would be high.” When Isaac was asked if he would have recommended DePuy not release the ASR hip to market if he knew the device would expose patients to 50 microns of the ions, he admitted, “In all likelihood, no.”
According to Kransky, debris from his ASR device blackened tissue and entered his bloodstream, said Bloomberg Businessweek previously. Johnson & Johnson denies the accusations and blames Kransky’s issues on his health, calling Kransky a vasculopath, which means his body is riddled with diseased blood vessels.
The California Poison Control System has said that cobalt levels above seven micrograms per liter are considered harmful. Kransky, who was implanted with the ASR in December 2007 had a cobalt level of 53.6 on September 1, 2011—nearly eight times greater than the acceptable level, wrote Businessweek. Kransky’s cobalt level dropped to five micrograms per liter in February 2012 after he underwent revision surgery to remove and replace the ASR.
As we’ve long written, research has linked metal-on-metal hip implant devices, such as the DePuy ASR, to an increasing array of adverse events that include tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more, reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.
Earlier last month, the U.S. Food & Drug Administration (FDA) issued new guidelines for patients with metal-on-metal hip implants, warning that the devices can cause bone and tissue damage due to the release of metal ions, and advising patients who experience pain; swelling; a change in their ability to walk; or who hear noises emanating from the hip, such as popping, squeaking, and grinding, to speak with their physicians. These symptomatic patients should be considered for metal ion testing, the agency said. The FDA also recommended that metal-on-metal hip implant patients undergo regular physical examinations, routine radiographs, and diagnostic imaging for ongoing assessment of patient reaction to metal-on-metal devices.