The Marciano & MacAvoy lawyers in the 1st DePuy Pinnacle hip implant lawsuit to go to trial yesterday grill former DePuy president Andrew Ekdahl on the witness stand, accusing him of helping to conceal the risk that the metal-on-metal hips could cause serious injury.
Ekdahl, now chairman of Johnson & Johnson‘s (NYSE:JNJ) DePuy Synthes franchise, denied the allegations leveled by Mark Lanier, the lawyer for plaintiff Kathleen Herlihy-Paoli, according to Bloomberg Businessweek.
Citing internal J&J emails, Lanier said Johnson & Johnson knew as early as 2001 of the potential for metallosis, or high levels of metals in the bloodstream, the news outlet reported. Metal-on-metal hip pioneer Dr. Thomas Schmalzried, a DePuy consultant, was worried that debris generated by the chromium cobalt implants was a “major issue for metal-on-metal hips” that would require testing and monitoring of patients, Lanier said in a Dallas court yesterday.
The emails, from 2008, showed that DePuy executives knew of Schmalzried’s review of a case showing extensive tissue damage to an “alarming and concerning” extent. The DePuy officials wrote that they planned to tell colleagues to “keep quiet for now” about the case. Schmalzried, of the St. Vincent Medical Center in Los Angeles, helped DePuy develop the ASR artificial hip, earning more than $30 million for his services to DePuy, according to the report.
Another physician, Dr. John Irving of Hartford, Conn., repeatedly sought to inform DePuy of high failure rates in his Pinnacle patients, Lanier said. In 2010 Irving wrote to Ekdahl that the problem was “an epidemic” and “borderline unethical to continue to market these products until the issues are elucidated. These products are harming patients,” the lawyer said. In 2012 Irving reached out to DePuy again after a Pinnacle patient who reported pain from the implants committed suicide because he “was so depressed and thought he would never resolve” the problem, Bloomberg Businessweek reported.
Ekdahl told DePuy’s lawyers yesterday that the company tried to delineate the Pinnacle device’s risks in a 2002 brochure for surgeons, saying it was common knowledge that metal-on-metal implants could generate metal ions in the blood. The executive denied that Johnson & Johnson mulled a change to the Pinnacle marketing plan based on Schmalzried’s red flag, according to the report.
In 2012, Lanier said, DePuy found a 15% 5-year failure rate for the Pinnacle hips, much higher than the 5% rate the company expected to find. A 2007 brochure claimed that 99.9% of the Pinnacle hips were “still in use after 5 years,” Lanier said.
“You knew that was a bogus statement,” Lanier said to Ekdahl,
“No, it’s not,” Ekdahl replied, according to Businessweek.