A Massachusetts biotechnology company that has been the target of a lengthy investigation by federal authorities was indicted Wednesday along with four former and current executives.
Hopkinton, Mass.-based Stryker Biotech LLC employees engaged in a scheme to deceive doctors into using its bone-healing devices for purposes that had not been approved by the U.S. Food and Drug Administration, the government alleged.
Stryker Biotech is a unit of Michigan’s Stryker Corp. (NYSE: SYK)
The parent company said in a statement late Wednesday: “The company is disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter. Conviction of these charges could result in significant monetary fines and Stryker Biotech’s exclusion from participating in federal and state health care programs, which could have a material affect on Stryker Biotech’s business.”
Stryker Biotech’s devices were used to stimulate bone growth in so-called long bones and the spine.
The FDA had approved their use for very narrow purposes. But Stryker employees encouraged medical professionals to pursue other uses, the government alleges.
Additionally, the government alleges, some Stryker executives encouraged doctors to inappropriately mix Stryker products.
Facing five counts each of wire fraud and one count each of conspiracy are: Stryker Biotech LLC, Mark Philip, William Heppner, David Ard and Jeff Whitaker.
Stryker, Ard and Whitaker also were charged with misbranding.
Stryker and Philip were charged with making false statements to the FDA. The government alleges Philip attempted to mislead the agency as to whether the company knew how much of its products certain patients were using.
Philip, of Lexington, Mass., is a former president of Stryker Biotech
Heppner, of Illinois, Ard, of California, and Whitaker, of North Carolina, are sales managers.
If convicted, the defendants face possible prison sentences of up to 20 years and fines of $250,000 per count.
When the investigation began is unclear from court documents, but indictments of Stryker employees began at least a year ago. Darnell Martin, a former sales representative, was charged in the case.
The case was investigated by Acting U.S. Attorney Michael Loucks’s office, the FDA, the federal office of Health and Human Services and the FBI.