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John Roth

FDA Compliance

When Conduct Becomes a Crime

FDA’s Office of Criminal Investigation steps in

Published: Monday, June 17, 2013 - 11:26

In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4 billion—yes, billion—paid in criminal and civil penalties to the United States.

Sometimes, however, the conduct of entities evinces such a complete disregard for the health and safety of the public that a criminal response is necessary.

A case that still resonates with the FDA and the law enforcement community involves the OCI investigation of the conduct of Synthes, a medical device maker, in the marketing of a bone cement product called Norian XR. The product was cleared by the FDA for use in certain instances, but was specifically rejected for the use Synthes wanted: injection into the spine as part of a mixture.

In fact, the FDA-approved label specifically warned against such use. Rather than attempt to get FDA approval through scientifically-validated clinical trials (at a cost of about $1 million, and taking about three years), Synthes decided to convince doctors to perform the procedure and then publish the results, notwithstanding the risks. And certainly, Synthes had reasons to understand the risks. Before the marketing program began, pilot studies showed 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 cement-caused clots became lodged in the lungs.

Nevertheless, Synthes executives plunged forward with a plan to conduct what amounted to an unauthorized clinical trial of the use of Norian to treat vertebral compression fractures of the spine. Equally appalling, the company marketed uses of the product in contravention of a “Black Box” warning—the most serious warning the FDA can require.

The ensuing tragedy was inevitable. Three patients injected with the medication died on the operating table.

Despite this, the company did not recall the product from the market, an action that would have required it to disclose details of the three deaths to the FDA. Equally egregious, Synthes officials deliberately misled the FDA during an official inspection in May and June 2004.

After painstaking and complex work by OCI investigators, working with their colleagues in the FDA’s Office of Regulatory Affairs and the scientists and public-health experts in the FDA’s Center for Devices and Radiologic Health, in 2010, Synthes pled guilty and paid the maximum fine allowable by law—in excess of $23 million for the company and its corporate parent. In 2011, four executives were convicted and sentenced to prison terms.

Another similarly tragic case of reckless conduct involved ApothéCure, a compounding pharmacy in Dallas that shipped colchicine injectable solution to a medical center in Portland, Oregon. Colchicine is used to prevent gout attacks and relieve the pain of gout attacks when they occur. In 2007, three patients, within hours of receiving the drug, died.

FDA testing of vials selected from the shipment revealed some vials as super potent—containing more than 640 percent of the level of the drug that was declared on the label. Others were subpotent, containing less than 63 percent of the declared strength. After an OCI investigation, the pharmacy and its owners pled guilty to criminal charges in 2012.

The penalties imposed on these two firms, Synthes and ApothéCure, and the responsible individuals cannot bring back the lives of those six innocent individuals, but OCI’s determined work produces results, gives the FDA unique fact-finding tools, and provides for strong, industrywide deterrence. We trust our forceful actions, then and now, continue to deter other companies and individuals from such reprehensible conduct.


About The Author

John Roth’s picture

John Roth

John Roth is the director of the Food and Drug Administration’s (FDA) Office of Criminal Investigations. Prior to joining the FDA in June 2012, Roth served in several sectors of the U.S. Department of Justice beginning in 1987.