Maryclaire Dale, AP
The pursuit of profits blinded executives of a medical devices company to the "the sanctity of human life," a federal judge said Monday in sentencing them to prison for unapproved testing of bone cement that left three people dead. The Synthes North America officials are among the first corporate officials sent to prison for misdemeanor pleas as "responsible corporate officers" under the 1975 Park Doctrine.
According to U.S. District Judge Legrome D. Davis, the Synthes officials wanted to beat their competitors to market without going through the lengthy process of getting the bone cement product approved by the U.S. Food and Drug Administration. So they plotted to train select surgeons in its off-label use and then have the doctors publish their findings, the judge said. The program continued even after a patient died in surgery in Texas in 2003 and another died in California. The patients suffered sharp drops in blood pressure after the bone cement compound was injected into their spines. Synthes only halted the training after a third death in 2004.
"One adverse event should have been enough to let you know that this course was not right," the judge said. "I can't understand how there wasn't a stop sign." Former President Michael Huggins and former Senior Vice President Thomas B. Higgins were sentenced to nine months in prison. John J. Walsh, the former director of regulatory and clinical affairs, worked at the company less time and received a five-month sentence. Former Synthes Vice President Richard Bohner had his sentencing postponed after his lawyer became ill in court.
The judge called the officers' conduct egregious and said they showed "disregard for the safety of others ... and for the sanctity of human life." He sent Huggins to prison immediately. Higgins, who ran the spine unit, was given two weeks to report to prison because of family issues. Walsh got a week to report to celebrate his child's birthday. The Park Doctrine typically involves corporate leaders taking the fall for things that happened under their watch. In this case, the judge found that they planned and executed the scheme and went above the zero to six month guideline range.
"There's a perception that this is not the type of conduct that tends to result in a jail sentence," the judge said. "We lose the ability to cause the industry to self-regulate, because the fear of jail for professionals is far greater than the fear of a young drug dealer." The judge, though, denied prosecutors the maximum one-year sentence they had sought, giving the men credit for their pleas. None of the three men sentenced made a statement in court.
Both Synthes and its former subsidiary Norian Corp. pleaded guilty to corporate healthcare fraud charges and agreed to pay $23 million in fines. As part of the plea, Synthes agreed to sell the subsidiary. In April, Johnson & Johnson agreed to buy Synthes, Inc., which had its global headquarters in Switzerland, for $21.3 billion.
According to prosecutors, the Synthes North America executives also failed to report the patient deaths and lied to FDA investigators during an on-site audit. The government applauded the sentences Monday. "It sends the right message, that lying to the FDA and disregarding patient safety has consequences," Assistant U.S. Attorney Mary Crawley said. The defendants denied any intent to violate FDA protocols, and at least one argued that he tried repeatedly to prevent off-label use.
"I didn't think at the time that we were doing anything illegal," Higgins wrote in a letter his lawyer read in court Monday. The bone cement, Norian XR, had been approved for surgical use in the arm but not in the weight-bearing spine. Pilot studies had shown it could cause blood clots in humans, and pig research suggested the clots could move to the lungs, causing death within 30 seconds, government experts said. Synthes used the cement in about 200 spine patients.
None of the surgeons could rule out the bone cement as a factor in the three deaths, but it also wasn't definitively blamed for them. One patient died in Plano, Texas, and two others in northern California.
The second victim was 83-year-old physicist Ryoichi Kikuchi, of Walnut Creek, California, once a visiting scholar at the University of California, Berkeley. Still mentally sharp, he opted for the surgery to relieve back pain, his grandchildren said. His family has long wondered why he didn't survive the surgery but only learned this past week of his connection to the case, according to two grandchildren who traveled to Philadelphia for the hearings. They called his death ironic, given his career devotion to careful scientific methodology. "Even if he had chosen to do this, his wish would have been for it to be part of an organized process, and not just, if something goes wrong, nothing comes of it," said grandson Alan Kikuchi, of New York.
All four executives have lost their careers and agreed to pay fines of $100,000 apiece. The judge questioned why men who had otherwise led good, moral lives came to make such unconscionable decisions at work. He said that other companies "need to hear the lesson loud and clear. The conduct ... needs to change."