March 4, 1999
COURT OF APPEALS UPHOLDS CONTEMPT ORDER IN ANIMAL DRUG CASE
On February 5, 1999, the U.S. Court of Appeals for the Third Circuit affirmed an order of civil contempt entered by the District Court requiring Frank Lampley to stop promoting and distributing unapproved new animal drugs. Lampley manufactures and sells unapproved new animal drugs. In 1992, FDA received information that Lampley was distributing unapproved animal drugs in violation of the Federal Food, Drug, and Cosmetic Act, and sought an injunction against him in the U.S. District Court for the Eastern District of Pennsylvania. Several months later, the District Court issued a permanent injunction prohibiting Lampley from distributing unapproved new animal drugs in interstate commerce.
In 1996, FDA learned that Lampley once again was distributing unapproved animal drugs as he made claims that his products could cure, treat, or prevent diseases in horses and cows. FDA filed a motion for an order to show cause, asking that Lampley be held in civil contempt. At a hearing held March 13, 1998, the District Court held Lampley in contempt of the 1992 order. The Court asked Lampley to cooperate with FDA, and agree to a plan to cure his past violations within 30 days. After the parties were unable to reach an agreement, Lampley sent a letter to his customers saying that the Court takes the position that his products are unapproved new animal drugs, and that "...the FDA, U.S. Attorney, and Judge ...are ignor[ing] the law and just do what they want to."
The District Court held a second hearing on June 3, 1998. At that hearing, FDA presented evidence that since the March 13 hearing, Lampley had continued to promote his products as drugs. The Court ordered the parties to propose a final contempt order. After the parties again failed to reach an agreement, the Court ordered Lampley to (1) mail a letter to his customers stating that his products have not been approved by FDA for any drug claims; (2) withdraw all advertising and promotional material for his product that directly or indirectly made drug claims for those products; and (3) destroy all existing labeling, advertising, and promotional materials for his products.
Lampley then appealed the District Court's order to the Third Circuit arguing that the District Court abused its discretion in ordering him to send letters to his customers informing them of the court's ruling, and that the contempt order violated his First Amendment rights under the commercial speech doctrine. The Court of Appeals found that the District Court had not abused its discretion in entering the order since Lampley repeatedly violated the District Court's 1992 injunction. The Court of Appeals also found that Lampley's First Amendment rights were not violated because his drug claims promote unlawful activity -- the sale and purchase of unapproved animal drugs. In addition, the Court of Appeals held that Lampley's products did not fit within the exemptions created by the Dietary Supplement Health Education Act of 1994 (DSHEA). The Court of Appeals found that the DSHEA does not apply to claims that a particular product will cure, prevent, treat, or mitigate disease. Furthermore, the Court stated that it appears that the DSHEA does not apply to dietary supplements intended for veterinary use. The Court of Appeals affirmed the contempt order entered by the District Court.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
|
||||||
 |
||||||
|
||||||