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Stryker division faces federal grand jury investigation
The U.S. District Attorney in Massachusetts is investigating the biotech division of Stryker Corp. for submitting false reports to the Food and Drug Administration, illegally promoting some of its products and selling misbranded medical devices, according to a recent press release.
Stryker was informed of the probe in a March 5 letter from the U.S. attorney’s office for the district of Massachusetts, the company said in a regulatory filing.
The company said the investigation relates to its OP-1 products and Calstrux bone filler.
Stryker, based in Kalamazoo, Mich., said former employees have pleaded guilty to charges related to the investigation, and current and former employees have been subpoenaed.
Former sales territory manager Jason Demming pleaded guilty in February to felony misbranding, and in November, former sales representative Darnell Martin pleaded guilty to making a false statement and felony misbranding, both involving OP-1 products.
Stryker’s biotech division has come under fire during the past year for a few alleged legal and regulatory infractions.
In May, the biotech division received a warning letter from the FDA related to quality systems and compliance issues at its Hopkinton, Mass., site. The warning letter concerned observations made during an inspection initiated in September 2007. The letter primarily cited issues relating to Stryker Biotech’s handling of a past clinical study; its quality system, including medical device reporting procedures; and the integrity of hospital Institutional Review Board documentation used to approve implantation of humanitarian use devices.
Several corrective actions and changes to processes initiated by Stryker Biotech were noted in the letter, and future improvements are forthcoming as the division continues to work with the FDA, according to the press release.
J. Patrick Anderson, vice president of corporate affairs for Stryker, said the company is unable to comment on the legal aspects of the case, but is in the process of responding to the Department of Justice.
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