Bert W. Rein Wiley Rein LLP
Results 1 to 5 of 11
First Amendment defense prevails against FDA prosecution for off-label marketing *
USA - December 3 2012
In an important 2-1 decision overturning the criminal conviction of a pharmaceutical sales representative, a panel of the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, today reset the legal boundaries between the Food and Drug Administration's (FDA) regulatory authority and pharmaceutical manufacturers’ rights to disseminate “off-label” information about approved drug products.
Co-authors: James N. Czaban.
Coalition for Responsible Regulation v. Environmental Protection Agency - Highly deferential judicial review of agency scientific determinations *
USA - July 9 2012
On June 26, 2012, the Court of Appeals for the D.C. Circuit upheld a series of United States Environmental Protection Agency rules relating to the regulation of greenhouse gases under the Clean Air Act, referred to in the Court's opinion as the Endangerment Finding, the Tailpipe Rule, and the Timing and Tailoring Rules.
Co-authors: Richard L. McConnell, Brendan J. Morrissey.
Christopher v. SmithKline Beecham - a new limit on the deference accorded to an agency's interpretation of its own regulations *
USA - June 20 2012
In a June 18 decision, the Supreme Court of the United States placed an important new limit on the deference courts should accord to a federal administrative agency's interpretation of its own regulations.
Co-authors: Brendan J. Morrissey, Helgi C. Walker, Elbert Lin.
The D.C. Circuit finds the SEC's proxy access rule to be arbitrary and capricious *
USA - August 5 2011
In a widely-publicized decision issued on July 22, 2011, the United States Court of Appeals for the District of Columbia Circuit vacated the Securities and Exchange Commission's (SEC or Commission) "Proxy Access Rule."
Co-authors: Thomas W. Queen.
Court to weigh viability of state suits over generics *
USA - March 14 2011
On March 30, the U.S. Supreme Court will hear argument in three consolidated cases involving injury allegedly caused by generic versions of the prescription drug Reglan (metoclopramide): Pliva v. Mensing, U.S., No. 09-993, Actavis Elizabeth LLC v. Mensing, U.S., No. 09-1039, and Actavis Inc. v. Demahy, U.S., No. 09-1501.
Co-authors: Karyn K. Ablin, James N. Czaban.
Co-authors of Bert W. Rein
Other Wiley Rein LLP authors
- Andrew G. Woodson,
- Brandis L. Zehr,
- Brett A. Shumate,
- Carol A. Laham,
- D. Mark Renaud,
- Daniel P. Graham,
- Jon W. Burd,
- Karen E. Trainer,
- Katherine R. McDonald,
- Kathryn Bucher,
- Laura A. Foggan,
- Michael E. Toner,
- R. Allen Norfleet,
- Ralph J. Caccia,
- Robert L. Walker,
- Samuel B. Gedge,
- Scott D. Delacourt,
- Shane B. Kelly,
- Thomas R. McCarthy,
- Tyler Robinson
