Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
July 12, 2013
United States Attorney
District of Montana
The United States Attorney's Office announced that during a federal court session in Missoula, on July 12, 2013, before Chief U.S. District Judge Dana L. Christensen, PAUL DANIEL BOTTOMLEY, a 48-year-old resident of Belgrade, Montana, was sentenced to a term of:
Probation: 5 years with 6 months home confinement
Special Assessment: $100
Forfeiture (civil): $4,454,278.17
Community Service: 200 hours
Bottomley was sentenced in connection with his guilty plea to Misprision of a Felony.
In an Offer of Proof filed by Assistant U.S. Attorney Jessica T. Fehr, the government stated it would have proved at trial the following:
Paul Daniel Bottomley owned a company called Montana Health Care Solutions (MHCS) in Belgrade, Montana. MHCS was opened in 2008 and was sold to Rockley Ventures, Ltd., a division of Canada Drugs, Ltd., in October of 2010. While owned by Bottomley, MHCS imported and distributed misbranded and unapproved drugs from foreign countries to American physicians. Bottomley's conduct while the owner of MHCS was in direct violation of the Food, Drug, and Cosmetics Act (FDCA) of the United States.
Specifically, Bottomley as the owner of MHCS distributed what were classified as "new drugs" under 21 U.S.C. 321(p) that required approval by the U.S. Food and Drug Administration (FDA) under 21 U.S.C. 355 before they could be imported into the United States. The foreign prescription drugs distributed by Bottomley were not typically the versions that the FDA had approved for use in the United States, because, among other things, the drugs' labeling information did not conform to the FDA approved labeling for the United States versions. For example, the labeling for the foreign versions failed to contain the National Drug Code (NDC) numbers, which are part of the FDA approved labeling for versions approved for use in the United States. In addition, some of the drugs distributed by Bottomley contained non-English language labeling, including use and dosage instructions.
In October of 2010, Bottomley sold MHCS to Rockley Ventures, Ltd., a subsidiary of Canada Drugs, Ltd. Canada Drugs is an internet based pharmacy corporation located in Winnipeg, Manitoba, Canada. Rockley Ventures paid Bottomley $5 million for MHCS. Canada Drugs, Rockley Ventures, and the related companies retained Bottomley's company's name, website and domain name, any stock on hand, and his physician distribution list. The companies continued to solicit and distribute to Bottomley's previous customers using his company's name and letter head.
Bottomley was also to remain as an advisor to Rockley Ventures, Canada Drugs and related companies following the sale of MHCS. Bottomley was paid $10,000 per month for his advisory services by the companies. In his advisor capacity, Bottomley occasionally made sales calls to physicians and dealt with shipment and payment issues. On one occasion, Bottomley traveled to Tennessee, on behalf of Canada Drugs and its related companies, to work with Volunteer Distribution on their mail-order shipping of pharmaceuticals on behalf of the companies. In January of 2012, American officials were notified by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, that potential counterfeit oncology drugs known as Avastin(r) (marketed in Turkey as Altuzan) had been identified and shipped to the United States. The United Kingdom wholesaler shipped 41 of the identified packs of Avastin(r) to Volunteer Distribution, a company located in Gainesboro, Tennessee. Volunteer Distribution had a pharmaceutical distribution contract with QSP, a subsidiary company of Canada Drugs. Volunteer Distribution received oncology drugs with the understanding that they would ship those drugs to clients once they were provided with a client and packing list. The packing list also included "Montana Healthcare Solutions" in the upper left-hand corner with a symbol associated with MHCS.
Lab analysis of the Avastin(r) determined the drug to be counterfeit - the substance seized and tested did not contain any of the active drug ingredient bevacizumab that is found in legitimate versions of Altuzan and Avastin(r). It was determined that Volunteer Distribution had already shipped 36 of the 41 packs of Avastin(r) to American physicians for use with patients. The 5 remaining packs of the counterfeit Avastin(r) were shipped back to the United Kingdom wholesaler.
In a separate civil proceeding handled by AUSA Victoria Francis, Bottomley agreed to forfeit to the United States $1,088,378.17 in United States currency, a 2011 Aston Martin/Vantage V-12 (which recently sold for $110,000 during a U.S. Marshal's auction) and 10 parcels of real property in Gallatin County, Montana. The property was forfeited because the government established the property was the proceeds of the illegal activity outlined in the criminal case. The total forfeiture in the matter is valued at approximately $6 million.
The defendant's conduct in this case was motivated by greed. Bottomley utilized the grey market and sold potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians all for a healthy profit. The felony prosecution and sizeable forfeiture taken in the related civil case demonstrates that when an individual allows greed to induce them into dangerous criminal activity, they will be prosecuted," U.S. Attorney for the District of Montana Michael W. Cotter.
The defendant in this case violated the law by selling grey-market, unapproved pharmaceuticals, a dangerous practice that puts at risk the health and safety of the American consumer. FDA's Office of Criminal Investigations will continue to pursue those that threaten the safety and security of the public by engaging in the distribution of counterfeit and unapproved medicines. We commend the United States Attorney's office for their commitment to supporting this prosecution," John Roth, FDA-OCI Director.
The investigation was conducted by the Food and Drug Administration, Office of Criminal Investigations.