Specific Practice & Industry Groups Details:
Statement of Practice Summary:
Regulation of food, drug, cosmetic and medical device products; Advertising; Intellectual Property and Biotechnology.
Documents by Lawyers at this office
Government Agencies Cannot Amend Their Rules Through Litigation Settlements
Douglas J. Behr,Arthur S. Garrett,Robert S. Niemann,Jacquelyn L. Thompson, May 23, 2013
A federal appellate court recently ruled that government agencies cannot change agency rules through litigation settlements, thereby avoiding notice and comment rulemaking. The court's decision, if followed by other courts, will limit government agencies' flexibility in settling legal challenges to...
California's Green Chemistry Initiative/Safer Consumer Products Regulations
Herbert Estreicher,Devon Wm. Hill,Leslie T. Krasny,Sheila A. Millar, April 24, 2013
California Assembly Bill 1879 (Cal. Health and Safety Code sec. 25252, et seq.), an important statutory basis for California's Green Chemistry Initiative, attempts to reduce or eliminate the use of hazardous materials through an all-inclusive approach that considers how hazardous substances can be...
FDA's Strict Criminal Liability Standard has Far-Reaching Consequences
Melvin S. Drozen,Leslie T. Krasny,Daniel C. Rubenstein, April 22, 2013
The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 imposes a strict standard of criminal liability that has been affirmed and expanded upon by the courts since its passage. Notably, courts have held that corporate officers may be found strictly liable for the criminal actions of others...
Year Established: 1962