PHILADELPHIA ? The pursuit of profits blinded medical company officials to the "the sanctity of human life," a federal judge said Monday in sentencing them to nine months in prison for unapproved testing of a bone-cement product that left three people dead.
The Synthes North America officials wanted to beat their competitors to market without going through the lengthy process of getting their products approved by the U.S. Food and Drug Administration, the judge found. So they plotted to train select surgeons in the off-label use of their bone cement and then have the doctors publish their findings, U.S. District Judge Legrome D. Davis said.
The program continued even after a patient died in surgery in Texas in 2003 and another in California. The patients suffered a sharp drop 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," Davis said. "I can't understand how there wasn't a stop sign."
Former President Michael Huggins, of West Chester, Pa., and former Senior Vice President Thomas B. Higgins, of Berwyn, were the first of four executives sentenced. Two others, ex-director of regulatory and clinical affairs John J. Walsh, of Coatesville and former Synthes Vice President Richard Bohner, of Malvern, were being sentenced Monday afternoon.
Davis called the officers' conduct egregious and said they showed "disregard for the safety of others ... and for the sanctity of human life." He denied Huggins' bid for probation and ordered him to prison immediately. Higgins, who ran the spine unit, received the same nine-month sentence, but was given two weeks to report to prison because of family issues.
They became the rare corporate officials sent to prison after pleading guilty to a misdemeanor as "responsible corporate officers" under the so-called Park Doctrine. The statute typically involves corporate leaders taking the fall for things that happened under their watch. In this case, Davis said they planned and executed the scheme, and sentenced them above the zero- to six-month guidelines.
"There's a perception that this is not the type of conduct that tends to result in a jail sentence," Davis 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 from the `hood."
The judge, though, denied prosecutors the maximum one-year sentence they had sought, giving the men credit for his pleas.
Huggins and Higgins declined to make any statements in court.
Both Synthes, a Swiss company with a U.S. headquarters in West Chester, and its former subsidiary Norian Corp. pleaded guilty to corporate health care 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 it for $21.3 billion.
According to prosecutors, the Synthes North America executives also failed to report the deaths and lied to FDA investigators during a three-week audit.
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, Calif., who had been 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, 27, of New York.
All four executives have lost their careers, and agreed to pay fines of $100,000 apiece. Davis questioned why men who had otherwise led good, moral lives came to make such unconscionable decisions at work.
Davis said that other companies "need to hear the lesson loud and clear. The conduct ... needs to change."
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