KV Pharmaceutical Subsidiary Pleads Guilty to Two Felonies Regarding Oversized Drugs
Judge Sentences St. Louis-Based Company to Pay $27.6 Million in Fines, Restitution and Forfeitures
WASHINGTON, March 2 /PRNewswire-USNewswire/ -- Ethex
Corporation, a wholly owned subsidiary of St. Louis-based drug
manufacturer, KV Pharmaceutical Company, pleaded guilty to two
felonies and was sentenced today in connection with the
manufacturing of oversized prescription drug tablets, the Justice
Department announced today. The government had charged that,
despite having knowledge that the two drugs did not meet required
specifications, Ethex violated the law by intentionally withholding
this information from the Food and Drug Administration (FDA). Given
the seriousness of Ethex's conduct and the risk it posed to
consumers of its drugs, the Justice Department pursued felony
According to charges presented in U.S. District Court in St.
Louis today, Ethex failed to submit required "field alert reports"
to the FDA in 2008 concerning two drugs, propafenone and
dextroamphetamine sulfate. Following the recommendations of a plea
agreement that was filed today, Judge E. Richard Webber sentenced
Ethex to pay a fine of more than $23.4 million, pay approximately
$2.3 million in restitution to Medicare and Medicaid for their
approximate losses, and forfeit nearly $1.8 million to the United
Under the Food, Drug and Cosmetic Act, a drug manufacturer must
thoroughly investigate why a drug fails to meet specifications,
whether or not the drug has been distributed into interstate
commerce. Moreover, when a manufacturer receives information
concerning a significant chemical change in a distributed drug or a
failure of a distributed drug batch to meet specifications, it is
required to promptly file a field alert report with the FDA. A
manufacturer's failure to file such a report, if done with the
intent to defraud or mislead, is punishable by a term of up to five
years' probation and a fine of $500,000 or twice the gross amount
gained from the offense.
The government had alleged that in May 2008, KV and Ethex
received complaints from a pharmacy in California and a distributor
in Canada of oversized morphine sulfate pills, a pain-relief
medication which had been manufactured by KV and distributed by
Ethex. In response to the complaints, KV recalled specific lots of
morphine sulfate in June 2008 and filed a field alert report
regarding the oversized tablets with the FDA.
According to the charges, a KV internal investigation that began
in May 2008 discovered sporadic instances of various oversized
KV-manufactured drugs, including morphine sulfate, propafenone and
dextroamphetamine sulfate. Propafenone is an anti-arrhythmia drug
that is used to treat some kinds of heart disease.
Dextroamphetamine sulfate is used to treat attention deficit
disorder in children. The charges alleged that despite the fact
that KV's internal investigation uncovered evidence of various
oversized propafenone and dextroamphetamine sulfate tablets, Ethex
did not file the required field alert reports with the FDA.
"Even though they were aware of serious manufacturing problems
concerning their oversized drugs, Ethex failed to notify the FDA as
required by law," said Assistant Attorney General Tony West, who
heads the Justice Department's Civil Division. "The Justice
Department will vigorously prosecute those who pursue profits at
the expense of consumer safety."
The case was investigated by the FDA's Office of Criminal
Investigations and is being prosecuted by the U.S. Attorney's
Office for the Eastern District of Missouri and the Civil
Division's Office of Consumer Litigation at the Justice Department.
Additional assistance is being provided by the FDA's Office of
Source: U.S. Department of Justice
CONTACT: U.S. Department of Justice Office of Public
+1-202-514-2007, TDD +1-202-514-1888
Web Site: http://www.justice.gov/
Posted: March 2010