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Two Guilty Pleas in Norian XR Bone Cement Case

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U.S. prosecutors have won two guilty pleas from two Synthes Inc. executives involving allegations that the company conducted illegal clinical trials of Norian XR bone cement.

According to The New York Times,  Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa.,  have pleaded guilty to a single count each  of shipping misbranded Norian XR in interstate commerce.  They face up to a year in prison and a $100,000 fine, the Times said.

According to the Philadelphia Business Journal, Huggins served as president and COO of Synthes’ spine division from 1994 to January 2008; Walsh is director of regulatory and clinical affairs for the spine division, a post he has held since 2003.

Norian XR bone cement was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine.  Last month, Synthes Inc. and its Norian subsidiary were indicted on charges of illegally testing Norian XR bone cement on humans.   Federal prosecutors allege that Synthes conducted clinical trials in which Norian XR was injected during spinal surgery on about 200 patients, the Associated Press said. The surgeries took place between 2002 and 2004, and many involved elderly people with compression fractures. The illegal trials ended after the third patient death, prosecutors claim.

The indictment charged  Norian with a total of 52 felony counts, including conspiracy to impede the functions of the FDA, making false statements in connection with an FDA inspection, and shipping adulterated and misbranded Norian XR bone cement in interstate commerce. Synthes faced 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce between 2002 and 2004.  In addition to Huggins and Walsh, two other Synthes executives were indicted on misdemeanor charges of shipping misbranded Norian XR in interstate commerce.

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