Norian Corporation, Synthes, Inc. and four top Synthes executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh have been indicted and face charges for their alleged involvement in conducting ™clinical trials of a medical device without the authorization of the Food and Drug Administration.
The indictment charges Norian with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the United States; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud.
The parent company, Synthes, is charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Huggins, Higgins, Bohner and Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce.
These actions allegedly prevented the FDA from carrying out its role of supervising clinical trials of significant risk devices, and deprived patients of the safeguards provided by FDA oversight of clinical trials.
Synthes, a Delaware corporation based in West Chester, Pennsylvania, is the United States branch of a large multinational medical device manufacturer, which specializes in trauma products to treat damaged human bone.
Norian is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pennsylvania.
The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes’s medical devices — Norian XR and Norian SRS — in surgeries to treat vertebral compression fracture of the spine (“VCFs”), a painful condition commonly suffered by elderly individuals.
These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine. According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots.
The research also showed, in a pig, that such Norian-caused clots became lodged in the lungs. Notwithstanding this knowledge, the company allegedly proceeded to market the product for VCFs without putting it through FDA-required testing.
The indictment contends the company did not stop marketing the product until after a third patient had died on the operating table. It further maintains that after the death of the third patient in January 2004, Norian and Synthes did not recall Norian XR from the market — which would have required them to disclose details of the three deaths to the FDA — but, instead, compounded their crimes by carrying out a coverup in which they lied to the FDA during an official inspection in May and June 2004.
If convicted Norian faces a maximum possible sentence of a fine of $26,000,000, five years probation, full restitution, forfeiture of $469,800 and special assessments of $20,800.
Synthes faces a maximum possible sentence of a fine of $8,800,000, five years probation, full restitution, forfeiture of $469,800 and a special assessment of $5,500.
Each of the individual defendants faces a maximum sentence of one year in prison, a fine of $100,000, full restitution and one year of supervised release.