Getting to the Bottom of the Bottomley Case?

By JP Ellison –

Last week, John Roth, the Director of FDA’s Office of Criminal Investigations posted on FDA’s blog, FDA Voice.  His post concerned a criminal case that had interested us about a Montana resident who had pled guilty and been sentenced on a single count of misprision of a felony in connection with the import of counterfeit Avastin.  In his post Mr. Roth demonstrated yet again that the government can pursue its enforcement agenda not only at all phases of the civil and criminal cases, but also in the court of public opinion.  Individuals and companies who find themselves in FDA’s crosshairs need to understand all the tools available to FDA.

Misprision of a felony is a federal crime, punishable by a maximum three (3) year term of imprisonment, that one most frequently sees in connection with plea agreements.  Generally speaking, the elements of the crime are that a federal felony was committed, the defendant knew about the felony, failed to report it to authorities, and took some steps to conceal it.  While each plea negotiation is unique, the prevalence of misprision as a charge in pled cases – as opposed to jury trials – may be explained by the fact that the charge secures a felony conviction for the government without a defendant admitting to active participation in the underlying crime. For those blog readers familiar with the Park doctrine (see here)  and repeated government statements that they will increasingly seek to hold responsible corporate officers criminally liable for the acts of their companies (see here), misprision might be considered the Park doctrine on steroids, holding anyone with knowledge  of a crime responsible if they fail to report and conceal it.

Getting back to Bottomley, he had pled guilty to misprision in April of this year, and was sentenced earlier this month.  Bottomley’s case arose out of an extensive federal investigation into the import of unapproved foreign drugs and/or counterfeit drugs that spanned several continents.  From publicly available documents, it appears that Bottomley was actively involved in the import of unapproved drugs, but had no involvement in the import of a counterfeit version of what is marketed in this country as Avastin.  

Bottomley had been the owner of a company that had imported and distributed foreign versions of U.S. drugs.  He had sold his company in 2010.  After the sale the new ownership expanded the catalog of drugs that they imported.  Although Bottomley remained involved with his former company as a consultant, the government agreed that Bottomley “had no involvement in the importation or distribution of counterfeit Avastin.”  Presumably, this lack of involvement helps explain the misprision plea. 

Despite the plea agreement, even back in April, Bottomley presumably knew that FDA OCI and Mr. Roth didn’t embrace the picture of Bottomley as uninvolved in culpable conduct.  In the same press release with the “no involvement” language, Mr. Roth is quoted as saying that Bottomley “violated the law by selling grey-market, unapproved pharmaceuticals” and the Montana U.S. Attoney said Bottomley “sold potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians all for a healthy profit,” none of which was the basis for his guilty plea.  In addition to his criminal case, the government had pursued, and Bottomley agreed to, a civil forfeiture of several million dollars of Bottomley’s assets based on a prosecution theory that required his active involvement in a crime.

Even though Bottomley apparently cooperated with the larger criminal investigation, his sentencing was a contested one, with the government seeking a term of a year imprisonment and Bottomley arguing that he’d already been punished enough.  The court rejected the government’s call for prison time and imposed a sentence of 5 years of probation with 6 months of home confinement and 200 hours of community service.  Despite its setback in the sentencing phase of the criminal case, the government reiterated its view of Bottomley in its sentencing press release and on its blog, with Mr. Roth stating that Bottomley was “sentenced as a result of his participation in the wholesale marketing of unapproved and misbranded cancer medications.”

The Bottomley case is notable, not because it is exceptional, but rather because it reflects the complexities of most FDA investigations.  We have previously posted about cases in which the government accepted an FDC Act misdemeanor plea but nevertheless attempted to prove fraud at sentencing.  It should come as no surprise that federal prosecutors will use all the tools available to them in pursuit of their enforcement agenda.  The Bottomley case is a reminder that there are a number of angles to an FDA investigation, including but not limited to contested sentencings, civil forfeitures, and last but often not least, the battle in the court of public opinion.