ST. LOUIS (KMOV) – Former KV Pharmaceutical CEO Mark Hermelin pleaded guilty Thursday to two federal charges of misbranding drugs.
Hermelin, 69, was sentenced to one month in prison and a one million dollar fine. He will also pay a $900,000 forfeiture to the United States as part of a plea agreement.
According to documents filed with the U.S. Attorney’s office, KV manufactured generic prescription drugs under Hermelin’s leadership
From 2006-2008, Hermelin decided to increase the company’s production of morphine sulfate, an analgesic pain relief drug and opiate, on a daily and annual basis.
During that time, KV’s drug production increased approximately 182 percent. KV’s internal manufacturing controls also discovered oversized and irregular tablets of several different types of drugs, and also received consumer complaints about the oversized and irregularly shaped tablets.
In Hermelin’s plea agreement, he admitted that during the summer of 2008, KV shipped two oversized morphine tablets to retailers in San Francisco, California and Canada. The drugs’ labeling was false and misleading because it stated that the drugs were of uniform strength when the tablets of the drugs were oversized and contained more of the active ingredient of the drug than what was specified on the labels.
The California morphine tablet weighed over twice the specified amount, while the Canada morphine tablet was 65 percent stronger than what the label claimed.
The misbranded morphine tablets had the same color and engraving as a normal pill.
KV conducted a safety assessment in May 2008 concluding that oversized morphine tablets raised potential safety concerns for patients, including the possibility of acute over-dosage, respiratory depression, stupor, coma, and death.
Since March 2009, KV has been under a civil consent decree that was filed in federal court and regulates the company’s ability to manufacture drugs.
Currently, KV is not manufacturing morphine sulfate tablets, and Hermelin is no longer the company’s CEO. He also resigned from KV’s Board of Directors after receiving a notice of exclusion from participation in the United States’ Medicare and Medicaid programs.
In the same investigation, Ethex Corporation, a subsidiary of KV, pleded guilty to two felony counts of failing to file two field alerts with the FDA. The alerts pertained to manufacturing problems related to oversized tablets of propafenone and dextroamphetamine sulfate that failed to meet product specifications.
The Court sentenced Ethex with $23,437,382 fine, as well as ordering restitution payments to the Medicare program in the amount of $1,762,368 and the Medicaid program in the amount of $573,000 to reimburse the programs for their expenditures for drugs from KV that were consumed by program beneficiaries during 2008. Ethex also forfeited $1,796,171.
“FDA's drug-labeling laws and regulations are designed to ensure that Americans can safely consume effective drug products,” said Special Agent-in-Charge Patrick Holland, FDA’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.”
The case was prosecuted with the assistance of the Office of Consumer Litigation for the United States Department of Justice, and investigated by the Office of Criminal Investigations for FDA, with assistance from the United States Postal Inspection Service and Federal Bureau of Investigation.