Navigation Links
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 charges.

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 States.

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 Chief Counsel.

SOURCE U.S. Department of Justice

Back to top



SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. MAP Pharmaceuticals Reports 2009 Fourth Quarter and Year End Financial Results
2. Alexza Pharmaceuticals to Present at the Cowen and Company 30th Annual Health Care Conference
3. DUSA Pharmaceuticals, Inc.(R) to Host Fourth Quarter and Full Year 2009 Financial Results and Corporate Highlights Conference Call
4. Awards Strengthen Stonhard's Reputation for High-Performing Floors in the World's Most Prominent Pharmaceutical Facilities
5. Thomas Pharmaceuticals, Ltd to Merge with Global Medical Equipment of AZ
6. Abbott Completes Acquisition of Solvay Pharmaceuticals
7. Vestara and EXP Pharmaceutical Services Corp. Announce Partnership Making Available Industry's Only Automated Pharmaceutical Waste Management Solution to over 5,000 U.S. Hospitals
8. Huifeng Bio-Pharmaceutical Provides Preliminary 2009 Financial Results and 2010 Guidance
9. Six Key Areas of Learning for Pharmaceutical and Healthcare Marketing in 2010
10. Frost & Sullivan Ghanaian Pharmaceutical Industry Innovation & Advancement Award Conferred on LaGray Chemical Company
11. Viscira Expands Interactive Solutions to Reduce Marketing Expenses for Pharmaceutical Companies in Challenging Economic Times
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, McGaw YMCA’s ... learning in its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions ... 65 years, Brillianteen has been a treasured tradition for numerous families in the ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, ... from Bronx, N.Y. “I thought there had to be a convenient and comfortable way ... , The PROTECTOR enables disabled individuals to safely travel during cold or inclement weather. ...
(Date:11/25/2015)... ... 25, 2015 , ... Castlewood Treatment Center for Eating Disorders, ... as a result of the $20,000 raised at the center’s recent golf ... Club in Eureka, will help individuals who otherwise might not seek treatment for ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I ... regular bras were incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order ... developed the patent-pending RECOVERY BRA for added comfort and support. The bra is ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely ... resulting in a way for homeless people to have a more dignified and ... new initiative whereby they are repurposing plastic bags into sleeping mats for the ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Cell Surface Marker Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, a ... treatment outcomes for patients suffering from chronic pain, said ... a Temporary Restraining Order (TRO) enjoining Express Scripts from ... companies. --> --> ... of its legal options. --> ...
(Date:11/25/2015)... Kitov Pharma ceuticals ... biopharmaceutical company focused on the development of therapeutic candidates ... announced the closing of its previously announced underwritten public ... each representing 20 ordinary shares of the Company, and ... and warrants were issued in a fixed combination of ...
Breaking Medicine Technology: