US Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz announced the return of an indictment against Norian Corporation (Norian), Synthes, Inc. (Synthes), and four top Synthes executives, Michael D. Huggins (Huggins), Thomas B. Higgins (Higgins), Richard E. Bohner (Bohner) and John J. Walsh (Walsh), charging them for their involvement in conducting clinical trials of a medical device without the authorization of the US Food and Drug Administration (FDA).
Joining in June 16, 2009’s announcement were Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent-in-Charge Kim A. Rice; Department of Health and Human Services (HHS) Office of Inspector General Office of Investigations Special Agent-in-Charge Patrick Doyle; Defense Criminal Investigative Service (DCIS) Special Agent-in-Charge Edward Bradley; and Department of Veterans Affairs (VA) Special Agent-in-Charge Jeffrey G. Hughes, Northeast Field Office, Office of Inspector General.
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 US; seven 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, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, are each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce. As explained below, these crimes 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.
According to the indictment, Synthes, a Delaware corporation based in West Chester, Pa., is the US branch of a large multinational medical device manufacturer which specializes in trauma products to treat damaged human bone. Norian, it is alleged, is a wholly owned subsidiary of Synthes, specializing in the manufacture of osteobiologic medical devices, with a principal place of business in West Chester, Pa.
Defendant Huggins was allegedly employed by Synthes as the President of Synthes North America, a subsidiary of Synthes. It is alleged that in February 2004, Huggins became the President of Synthes Spine, a division of Synthes. Defendant Higgins was allegedly the President of Synthes Spine, a division of Synthes, reporting to Huggins. In February 2004, Higgins allegedly left that position and became Synthes’s senior vice president of global strategy. The indictment alleges that defendant Bohner was employed by Synthes as its Vice President of Operations, reporting to Huggins. Defendant Walsh was allegedly employed by Synthes starting in August 2003 as its director of regulatory and clinical affairs, Spine Division, and reported first to Bohner and later to Huggins.
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(2.), in surgeries to treat vertebral compression fractures 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 company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. The indictment further alleges 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.
Levy said, We have an FDA approval process to be certain that medicines and medical devices that are used in the US have gone through appropriate testing to determine that the products are safe and effective. The FDA requires its independent review of the tests to ensure that companies do not put their financial interests ahead of the health and safety of the American people. The defendants charged today bypassed the process, with the knowledge that the product that they were marketing posed potentially significant risks. When predictable bad results occurred, they lied to the FDA investigators. They put their profits ahead of responsible business practices and the truth.
Hertz said, This case is another example of the Department of Justice working together as a team to enforce the Food, Drug, and Cosmetic Act against companies and individuals that fail to market their products in compliance with that statute.
The FDA’s Office of Criminal Investigations aggressively pursues and supports the prosecution of those who endanger the public health by circumventing the safeguards the FDA has in place to ensure that clinical trials are adequately supervised and controlled and that the public receives medical devices that have been shown to be safe and effective, said Michael Chappell, acting associate commissioner for regulatory affairs. We will continue to do all we can to protect the public against companies and their representatives who are not truthful, put patients’ health at risk and undermine the regulatory process.
It is never acceptable for the health care industry to place the profit motive over people’s well being, said Patrick Doyle. The FDA review process was put in place to protect the nation’s citizens. Should these companies and executives ultimately be found guilty, they will have to pay a price for placing at risk the very people for whom they purported to provide relief.