Three former executives of devicemaker Synthes and subsidiary Norian were sentenced to prison for their roles in illegal clinical trials of a bone cement in spine surgeries, federal prosecutors in Philadelphia said.
Former Synthes, Norian execs receive prison terms
Thomas Higgins and Michael Huggins were sentenced to nine months, and John Walsh was sentenced to five months. Each was ordered to pay a $100,000 fine. A fourth executive indicted in the matter, Richard Bohner, has yet to be sentenced. All four pleaded guilty to one misdemeanor count of shipping an adulterated and misbranded product.
According to a news release from the U.S. attorney's office in Philadelphia (PDF), the company was warned that the Norian bone cements reacted chemically with blood to form clots, yet marketed the products for use in vertebral compression fractures without testing required by the Food and Drug Administration, and three patients treated with the product died.
Norian last year pleaded guilty to a felony charge of conspiracy to obstruct the FDA and was required to pay a $22.5 million criminal penalty. The plea also required Synthes to divest Norian, and the unit was sold in May to Kensey Nash, Exton, Pa., for $22 million.
Synthes, a company based in Switzerland with U.S. headquarters in West Chester, Pa., has agreed to be acquired by Johnson & Johnson for $21.3 billion.
“Today's sentences should clearly put healthcare industry executives on notice that when they violate the law and harm individuals for the sake of corporate profits, they will go to prison,” U.S. Attorney Zane Memeger said in the release.
Higgins, 55, was president of Synthes Spine and then senior vice president of global strategy; Huggins, 54, was president of Synthes North America and then president of Synthes Spine; Walsh, 48, was director of regulatory and clinical affairs in the spine division; and Bohner, 56, was vice president of operations.
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