Synthes Charged With Unauthorized Spine Repair Trial, Faces $34 Mil. Fine

Full article reprinted from "The Gray Sheet" - June 22, 2009

Orthopedic device maker Synthes and its Norian subsidiary face $34.8 million in potential fines for allegedly skirting FDA requirements and conducting unauthorized clinical trials of their Norian XR and Norian SRS bone cement for vertebral compression fractures. Read more...

Synthes Charged With Unauthorized Spine Repair Trial, Faces $34 Mil. Fine

Full article reprinted from "The Gray Sheet" - June 22, 2009

Orthopedic device maker Synthes and its Norian subsidiary face $34.8 million in potential fines for allegedly skirting FDA requirements and conducting unauthorized clinical trials of their Norian XR and Norian SRS bone cement for vertebral compression fractures.

The charges are outlined in a June 16 indictment issued by the U.S. Attorney's Office in Philadelphia.

Felony counts against Norian include conspiracy to impair and impede the lawful functions of FDA, making false statements in connection with an FDA inspection and shipping an adulterated and misbranded product in interstate commerce with intent to defraud.

Four top Synthes execs also face misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and could receive up to a year in prison if convicted.

The executives include Synthes Spine President Michael Huggins, Synthes Senior VP of Global Strategy Thomas Higgins, Synthes VP of Operations Richard Bohner and John Walsh, director of regulatory and clinical affairs, Synthes Spine. Huggins left in 2007 to pursue "other interests" while the others remain with the company, according to Synthes.

The firm allegedly did not stop illegal promotion of the product until three patients died on the operating table from hypertensive events.

The U.S. Attorney for the Eastern District of Pennsylvania, Michael Levy, said Norian, based in West Chester, Pa., conducted unauthorized clinical trials of Norian XR and predecessor device Norian SRS from May 2002 until fall 2004.

The firm also promoted the products for off-label treatment of vertebral compression fractures of the spine, despite a warning in FDA-cleared labeling against such use, according to Levy.

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