OFFICE OF THE UNITED STATES ATTORNEY
WESTERN DISTRICT OF MISSOURI
BRADLEY J. SCHLOZMAN
Contact Don Ledford, Public Affairs ● (816) 426-4220 ● 400 East Ninth Street, Room 5510 ● Kansas City, MO 64106
MARCH 2, 2007
FOR IMMEDIATE RELEASE
FLORIDA MAN SENTENCED FOR
$42 MILLION LIPITOR FRAUD
KANSAS CITY, Mo. – Bradley J. Schlozman, United States Attorney for the Western District of Missouri, announced that a Fort Lauderdale, Fla., business owner was sentenced in federal court today for participating in a $42 million conspiracy to sell counterfeit, misbranded and illegally imported Lipitor.
Michael Allyn Carlow, 54, of Fort Lauderdale, Fla., was sentenced by U.S. District Judge Ortrie D. Smith this morning to five years in federal prison without parole. The court also ordered Carlow to pay $3,410,379 in restitution.
“This defendant reaped obscene profits at the expense of many others, including patients who needed prescription drugs,” Schlozman said. “Carlow played a major role in that criminal scheme, and he will now face the consequences of his greed.”
On Nov. 3, 2006, Carlow pleaded guilty to his role in the conspiracy. Carlow also agreed to plead guilty to related mail fraud charges filed against him the Middle District of Tennessee. A change of plea hearing for that case, which has been transferred to the Western District of Missouri, has not yet been scheduled.
Carlow is also the subject of pending charges in Broward County, Fla., Although he requested his federal sentence be ordered to run concurrently with any sentence imposed in Florida state court in the event of a conviction, Judge Smith explicitly declined to grant that request.
Carlow owned and operated G&K Pharma, a company that was used to buy and sell pharmaceutical drugs in the secondary wholesale market. Carlow admitted that he knowingly participated in a scheme to distribute Lipitor that he knew was not manufactured by Pfizer for distribution in the United States, and that he helped other members of the conspiracy traffic in pharmaceuticals that all of them knew were not manufactured for distribution in the United States.
Members of the conspiracy purchased Lipitor that was intended for distribution in South America and smuggled it into the United States. Because the cost of purchasing Lipitor intended for distribution outside the United States is lower, Schlozman explained, members of the conspiracy were able to sell the drugs for a lower price.
During the 11-month time period from May 8, 2002, to April 4, 2003, co-defendant Douglas C. Albers , 55, of Leawood, Kan., owner of Albers Medical Distributors, paid G & K Pharma more than $42 million to purchase counterfeit, misbranded and illegally imported drugs from Carlow.
Carlow is the first co-defendant to be sentenced on charges contained in a Dec. 14, 2005, superseding indictment. Seven co-defendants have pleaded guilty and await sentencing.
* Paul Louis Kriger, 49, of Thousand Oaks, pleaded guilty on Jan. 26, 2007, to participating in a conspiracy to sell stolen pharmaceutical drugs. Kriger was the owner and operator of OTS Sales, Inc. (OTS), a California corporation engaged in the wholesale brokerage of prescription drugs in the secondary market on behalf of co-defendant Albers Medical Distributors, Inc. In late December 2001 and early January 2002, OTS brokered for Albers Medical Distributors the purchase of Imitrex, Advair, Flovent and Flonase from Welcome Rx, a Pennsylvania corporation operated by co-defendant Frank Anthony Ianeillo, 62, of Stillwater, Penn. Albers Medical Distributors paid commissions to OTS of approximately $106,000 for brokering the purchase of the drugs.
Kriger admitted that OTS brokered the purchase without first obtaining copies of the required licenses from Welcome Rx, or a signed indemnity agreement from Welcome Rx, or any pedigree papers showing the origin and prior sale dates of the drugs. Those drugs, which were manufactured by Glaxo-Smith, had been stolen from a warehouse in Miami, Fla., in December 2001. The stolen drugs were purchased by co-defendant Albert David Nassar, 51, of New York, N.Y., then sold and re-sold through a series of secondary wholesale distributors, including Kriger, Ianeillo and co-defendant Noah Salcedo-Smith, 35, of San Fernando, Calif. In a series of purchases in January 2002, Albers paid approximately $3.3 million for some of the stolen Glaxo drugs. Albers then re-sold the drugs to other distributors for approximately $3.5 million.
The failure to properly investigate and obtain any of this information constitutes willful blindness and deliberate ignorance by Kriger as to the legitimacy or the safety or origin of the drugs. Kriger’s willful blindness and deliberate ignorance as the control person at OTS constitutes criminal conduct in furtherance of a conspiracy to defraud the United States by impeding, obstructing, and defeating the lawful functions of the U.S. Food and Drug Administration to regulate the interstate sale and distribution of prescription drugs.
Under the terms of his plea agreement, the court will sentence Kriger to four years in federal prison without parole. A sentencing hearing is scheduled on May 18, 2007.
* Ianeillo pleaded guilty on Thursday, Jan. 25, 2007. Ianeillo admitted that he participated in a scheme to defraud the U.S. Food and Drug Administration by obstructing the lawful functions of the FDA to regulate the interstate sale and distribution of drugs and to safeguard the health and safety of consumers who purchase drugs. Ianeillo, a salesman involved in the secondary wholesale market, made no effort to determine or verify the legitimacy, source and origin of the drugs he purchased and then resold in furtherance of the conspiracy to defraud the FDA. Ianeillo also admitted that at the times he sold drugs, he did not provide his buyer with any paperwork or other documentation to establish the legitimate source, origin, and bona fide nature of the drugs sold.
* Salcedo-Smith pleaded guilty on Dec. 28, 2006, to defrauding the government by arranging for the purchase of stolen pharmaceutical drugs. Salcedo-Smith was a salesman involved in the secondary wholesale market. While acting on behalf of Albers Medical Distributors, Inc., and OTS Sales, Inc., Salcedo-Smith arranged for the purchase of prescription drugs from a seller who provided no pedigree documents establishing the legitimacy, source and origin of the drugs being sold. Those drugs, which were manufactured by Glaxo-Smith, had been stolen from a warehouse in Miami, Fla., in December 2001.
Salcedo-Smith also admitted that he helped create false pedigrees for the drugs, so that they could be resold in the secondary wholesale market by Albers Medical Distributors and appear to have a legitimate pedigree.
* Richard K. Rounsborg, 49, of Kearney, Neb., pleaded guilty on Nov. 30, 2006, to participating in a conspiracy to sell counterfeit, misbranded, and illegally imported drugs from February 2002 until at least April 2003, and to defraud the United States by impeding the lawful functions of the U.S. Food and Drug Administration. Rounsborg owned and operated Med-Pro, Inc., a privately held corporation located in Lexington, Neb. Med-Pro was engaged in the business of repackaging pharmaceuticals.
Rounsborg admitted three specific instances in which Med-Pro received misbranded Lipitor or Bextra for repackaging. Rounsborg acknowledged that the circumstances of his conduct constitute willful blindness with regard to a series of Lipitor and Bextra shipments received at Med-Pro for repackaging. Rounsborg’s willful blindness and actions as the control person for Med-Pro constitute conduct in furtherance of the conspiracy.
* Albert David Nassar, 51, of New York, N.Y., pleaded guilty on Nov. 30, 2006, to participating in a conspiracy to sell stolen pharmaceutical drugs from December 2001 to April 2003, and to defraud the United States by impeding the lawful functions of the U.S. Food and Drug Administration. Nassar was co-owner of Worldwide Pharmaceuticals, a firm that bought and sold pharmaceutical drugs in the secondary wholesale market.
Nassar admitted that he helped co-conspirators traffic in the illegal distribution of the stolen Glaxo-Smith drugs. Despite warning signs and circumstances known to him at the time, which suggested there was a high probability that the drugs were stolen, Nassar deliberately avoided taking any actions to confirm or deny his suspicion that the prescription drugs were stolen.
* Albers pleaded guilty on Oct. 18, 2006, to selling counterfeit and misbranded drugs. Albers agreed to pay a $500,000 civil forfeiture and to surrender his pharmacy licenses in Missouri and Kansas. Albers admitted that he sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen that earlier had been purchased and distributed by his firm. Neupogen is an injectable human growth hormone used to decrease the incidence of infections in persons with lowered immune systems, such as cancer and AIDS patients.
Although Albers specifically pleaded guilty to one count each of selling counterfeit Neupogen and misbranded Neupogen, Schlozman explained, federal prosecutors will argue that all of the conduct charged in the dismissed counts of the superseding indictment as well as any other uncharged related criminal activity should be considered relevant conduct for the purpose of determining an appropriate prison sentence and restitution order.
* Alexander Nassar, 43, of Miami, Fla., pleaded guilty on Aug. 28, 2006, to his role in the conspiracy. Nassar , also co-owner of Worldwide Pharmaceuticals, admitted that he participated in a scheme to distribute Lipitor that he knew was not manufactured for distribution in the United States.
Alexander Nassar also admitted that he participated in a conspiracy to buy, sell and traffic in stolen drugs from December 2001 to April 2003. Conspirators purchased and sold among themselves drugs that they knew were stolen. They created false pedigrees to conceal the fact that the drugs were stolen, and they sold the stolen drugs in interstate commerce, knowing that consumers ultimately would purchase the stolen drugs.
This case is being prosecuted by Senior Litigation Counsel Gene Porter. It was investigated by the Office of Criminal Investigations, U.S. Food and Drug Administration.
This news release, as well as additional information about the office of the United States Attorney for the Western District of Missouri, is available on-line at