There has either been an increase in the number of announcements by US Attorneys offices around the country, meaning they have just discovered the press release, or there is an unusual amount of criminal roundups affecting medical products.
Let's review shall we?
- U.S. Attorney's Office in Northern California Announces Conviction of Former Biotech CEO – As noted here earlier, on September 29th, the U.S. Attorney's Office of Northern Calif0rnia announced that a conviction was achieved against the former CEO of Intermune for causing a press release to be issued that promoted an off-label use. The defendant was found guilty of wire fraud as a result.
- US. Attorney's Office in the Eastern District of Arkansas Announces Indictment of Doctor – On October 5, the US Attorney in the Eastern District of Arkansas announced the indictment of a Doctor of Osteopathic Medicine for one count of Health Care Fraud and 3 counts of Money Laundering. The announcement states that the physician in question was using a non-approved intrauterine device (IUD) and billing Medicaid for a more expensive, FDA approved device. The money laundering part of the indictment stems from the withdrawal of the Medicaid funds from the account used by the doctor for reimbursement.
- U.S. Attorney's Office in the Eastern District of North Carolina Sentences Man for Harvesting and Selling Human Tissue -Also on October 5, Ghoulish and in time for Halloween, the U.S. Attorney's Office in the Eastern District of North Carolina announced a 96-month sentence for three counts of mail fraud along with restitution in connection with activities involving the recover and sale of human tissue for medical implantation. The scheme involved the collection of tissues and materials from cadavers at homes and then involved the falsification of records that would ensure the acceptance of tissue that might otherwise have been rejected because of a number of issues, including the disease profile of the deceased. The U.S. Attorney characterized the crime as "heinous" and that the sentence "should give others working in industries critical to the public health a clear signal that this type of reckless dishonesty comes with serious consequences." The tissue, which otherwise would have been rejected, was implanted in patients around the United States.
- U.S. Attorney's Office in the District of Minnesota Indicts Two for Sending More than 15,000 Misbranded Drugs to Customers – The U.S. Attorney's Office in the District of Minnesota announced on October 7 that two men had been indicted on on count of importation of non-narcotic Schedule IV controlled substances and one count of introduction into interstate commerce misbranded drugs. The drugs were marketed under brand names and were used to treat hair loss and erectile dysfunction and while they contained some of the active ingredients of the drugs, they were not in fact the brand name drugs, making representations for them to be other drugs.
That's a lot of activity centered on medical products in a 10-day period. Is it yet another signal that enforcement is scaling up?