US v. Caputo, 06-3612
Convictions on charges related to the sale of an unapproved medical device are affirmed where: 1) a larger version of a previously approved device was a new device that required approval, thus its sale was unlawful and the FDA could regulate its promotion; 2) the distinction between a new and modified device did not violate the Due Process Clause of the 5th Amendment since the FDA provided ample notice that the larger device required additional approval; 3) the instructions to the jury were proper; 4) the court properly excluded expert testimony about the meaning of the applicable statute and regulations; and 5) the defendants were not entitled to a new trial because of the jury foreman's undisclosed criminal convictions. The district court's restitution order is remanded for further calculation of the amount owed to the vendor's customers.
- Decided 02/27/2008
- Published 02/27/2008
- EASTERBROOK, Chief Judge., Before EASTERBROOK, Chief Judge, and KANNE and EVANS, Circuit Judges.
- United States Seventh Circuit
- For Appellees:
- Gillum Ferguson (argued), Office of the United States Attorney, Chicago, IL; Douglas N. Letter, Appellate Litigation Counsel, Civil Division, U.S. Department of Justice, Washington, DC, Scott R. McIntosh, Special Counsel, Appellate Staff, Civil Division, U.S. Department of Justice, Washington, DC, Eugene M. Thirolf, Director, Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, Daniel K. Crane-Hirsch, Attorney, Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, on the brief, for Plaintiff-Appellee., Marc W. Martin (argued), Chicago, IL, Samuel Rosenthal (argued), Curtis, Mallet-Prevost, Colt & Mosle, Daniel J. Popeo, Washington Legal Foundation, Arnon D. Siegel, Washington, DC, for Defendants-Appellants.