United States v. Norian Corp. No. 09-cr-403 (E.D. Pa. July 20, 2009)

On July 20, 2009, two Synthes, Inc. ("Synthes") executives plead guilty to charges stemming from their involvement in unauthorized clinical trials of bone cements for off-label use. The Synthes executives were charged with shipping adulterated and misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act.

The Synthes executives, Michael D. Huggins and John J. Walsh, are the president and director of clinical and regulatory affairs, respectively, of Synthes' Spine Division. A federal grand jury handed down indictments on June 16, 2009, charging Synthes, Huggins, Walsh, two other Synthes representatives, and Norian, Corp. ("Norian") with conducting unauthorized clinical trials of bone cements for off-label use. According to the government, Synthes and Norian conspired through their representatives to conduct clinical trials of Norian XR and Norian SRS without Food and Drug Administration ("FDA") approval.

Huggins and Walsh each were charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. In their guilty pleas, Huggins and Walsh stipulated that they were "responsible corporate officers" at the time these clinical trials occurred. Huggins and Walsh stipulated in their guilty pleas that, among other things, "Synthes and Norian trained spine surgeons to mix Norian SRS with barium sulfate and to use the resulting medical device" in certain surgeries. Norian SRS's labeling specifically provided that it was not to be mixed with any other substance.

Norian was charged with fifty-two felony counts, seven counts of making false statements in connection with an FDA inspection, and forty-four counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud. Synthes was charged with forty-four misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce.