Marc Hermelin, the former chairman and ceo at KV Pharmaceutical, pleaded guilty to presiding over the production and distribution of oversized morphine sulfate tablets. As a result, he was ordered to pay a $1 million fine, forfeit $900,000 and must serve a 30-day jail sentence. Specifically, he pleaded guilty to two misdemeanor violations of the Food, Drug and Cosmetic Act.

The move comes four months after he was banned from participating in federal health care programs, such as Medicare and Medicaid in connection with the same violations (back story). Hermelin also served as an officer of KV’s Ethex subsidiary and so was a “responsible corporate officer” with the authority and responsibility to prevent and correct violations. [By the way, this is the same KV that is causing a ruckus with the high price of its new med for premature births].

In his plea, Hermelin admitted that KV introduced misbranded morphine sulfate tablets into interstate commerce in 2007 and 2008. The feds charged the morphine sulfate included some oversized tablets, which contained more active ingredient - specifically, morphine - than was specified in labeling. This made the morphine sulfate misbranded under federal law, according to the feds.

And the feds go on to say that a pharmacist in California noticed that the oversized pills actually weighed twice as much as a normal pill. One oversized tablet found by a Canadian drug distributor was approximately 65 percent heavier than a normal pill. Both oversized tablets had been made on “BB2” pill press machines, which KV used to make many other tablet drugs.

Three years ago, KV told the FDA about the oversized tablets and publicly recalled various morphine sulfate lots. But the feds says KV knew of other oversized, BB2-made tablets and that its BB2 machine could randomly produce some oversized tablets, but did not tell the FDA. The agency subsequently investigated and the Justice Department subsequently filed a civil lawsuit against KV, Ethex and several execs, including Hermelin.

Last year, the Justice Department filed criminal charges against Ethex, which pleaded guilty to two felony offenses as a result of its failure to file required reports with the FDA about oversized tablets. Ethex was ordered to pay $28.1 million in fines, forfeitures and restitution, and was placed on probation for five years, according to the DOJ (here is the statement).