Playing “Hard Ball” With FDA Might Lead to Criminal Prosecution

The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack and John R. Fleder discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position.   In United States v. Kaminski, the U.S. Court of Appeals for the Sixth Circuit affirmed in part and reversed in part a ruling by the U.S. District Court for the Southern District of Ohio concerning Ovimmune, Inc., its owner, Marilyn Coleman, and her business partner, Mitchell Kaminski, and the appropriate enhanced criminal sentences to be imposed after the defendants allegedly obstructed justice by complaining about FDA’s allegedly poor treatment of them during an investigation of claims about defendants’ hyperimmunized eggs product.  According to the article, “Ovimmune was a small corporation and the sale of the hyperimmunized eggs, although found to be adulterated and misbranded, did not apparently cause any physical harm.  Nevertheless, the hostilities that developed during the government’s investigation may well have caused the prosecution to be initiated, and surely increased the sentences that were imposed after conviction.”