ST. LOUIS (AP) — The former chairman and CEO of St.
Louis-based KV Pharmaceutical Co. was fined $1 million after pleading guilty
Thursday to misdemeanor counts related to manufacturing oversized tablets of a
pain-relief drug called morphine sulfate.
Marc S. Hermelin, 69, also was sentenced to a month in
prison after pleading guilty to two federal counts of misbranding drugs. He
also agreed to forfeit $900,000 to the federal government.
“FDA’s drug-labeling laws and regulations are designed
to ensure that Americans can safely consume effective drug products,” said
Patrick Holland, the agent in charge of the Food and Drug Administration’s
Office of Criminal Investigations. “We will continue to work with the U.S.
Attorney’s Office and the Department of Justice to investigate those companies
and individuals who participate in the distribution of misbranded drugs.”
Calls seeking comment from the company went unanswered
KV Pharmaceutical manufactured generic prescription drugs,
including morphine sulfate, a pain relief and opiate drug. Prosecutors said
Hermelin decided to increase production of the drug, from an average 4.1
million daily doses in 2006 to 10.6 million in April 2008.
Later in 2008, the company shipped oversized tablets to
retailers in California and Canada that
were falsely labeled as having the same strength as the regular morphine
sulfate tablets — they actually had more of the active ingredient. KV also
received complaints from consumers concerned about oversized and
irregularly-shaped drug tablets, the U.S. Attorney’s office in St. Louis said.
Prosecutors said the California
morphine tablets weighed more than twice the amount they were supposed to, and
morphine tablets were 65 percent stronger than the label claimed. KV’s own safety
assessment from May 2008 concluded that oversized morphine tablets raised
potential safety concerns, including the possibility of an overdose that could
cause a coma or death.
KV does not currently manufacture morphine sulfate tablets.
Since March 2009, KV has been under a civil consent decree that regulates its
ability to manufacture drugs.
Hermelin resigned from KV’s board in November. He was
removed as chief executive in December 2008 following an investigation into
mismanagement by the board.
A wholly-owned subsidiary of KV, Ethex Corp., pleaded guilty
in March 2010 to two felony fraud counts as part of the same investigation.
Ethex was ordered to pay $27.6 million in fines and restitution.