Posts tagged as:

off-label

October 12 roundup

by Walter Olson on October 12, 2009

  • Speech-curbing proposals continue to get polite academic reception: NYU’s Jeremy Waldron, big advocate of laws to curb “hate speech”, delivered Holmes Lectures at Harvard this past week [HLS, schedule]
  • Lawsuit over collectible baseball hit into stands by Phillies’ Ryan Howard, his 200th career homer [Howard Wasserman, PrawfsBlawg; NJLRA]
  • Orchid-importer prosecution a poster case for the evils of overcriminalization? Maybe not [Ken at Popehat]
  • Texas State Fair and city of Dallas don’t have to allow evangelist to distribute religious tracts inside the fair, judge rules after three years [Dallas Observer blog]
  • Drug maker: FDA’s curbs on truthful promotion of off-label uses impair our First Amendment speech rights [Beck and Herrmann and more, Point of Law and more]
  • Did plaintiff Eolas Technologies go to unusual lengths to ensure Eastern District of Texas venue for its patent litigation? [Joe Mullin, IP Law and Business via Alison Frankel, AmLaw]
  • Update: “Lesbian Denied Infertility Treatment Settles Lawsuit” [San Diego 6, earlier]
  • Even in the Ninth Circuit, “psychological injury resulting from a legitimate personnel action” is not compensable [Volokh]

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May 21 at AEI: Off-Label Uses of Approved Drugs: Medicine, Law, and Policy

by Ted Frank on May 12, 2008

An important all-day conference at AEI next week:

In the last several years, nearly every major pharmaceutical company has paid hundreds of millions of dollars to settle allegations of illegal “off-label” marketing of drugs. There has been a growing trend of actions by federal prosecutors, state attorneys general, and cooperating trial lawyers to litigate against pharmaceutical manufacturers for allegedly doing too much to promote off-label use of prescription products. Citing recent legal changes mandating exclusion from federal programs after a conviction, many manufacturers say they are forced to settle rather than risk defending themselves–even as prosecutions against individual executives have foundered in front of juries.

At this AEI Legal Center event, experts on both law and health care will present papers on the law, economics, medicine, and public policy of off-label marketing, discussing everything from the abuse of class action mechanisms to implications for the First Amendment and medical malpractice. Speakers include former Food and Drug Administration chief counsel Daniel Troy; former Cephalon general counsel John Osborn; former deputy attorney general George Terwilliger; principal deputy assistant attorney general and acting assistant attorney general for the Civil Division Jeffrey Bucholtz; attorneys Brian Anderson, James Beck, Mark Herrmann, Richard Samp, and Kyle Sampson; law professor Margaret Johns; and AEI scholars John E. Calfee, Theodore H. Frank, and Scott Gottlieb.

Panel I: Off-Label Marketing, R&D, and Medical Practice

Panel II: The Legal Environment from Federal Regulation and Enforcement

Panel III: Distortions from State and Private Enforcement

Panel IV: Legal Implications for Commercial Speech and Medical Practice

Register here. Earlier discussion on POL: Feb. 1; Feb. 19; Mar. 24; Dec. 17; Aug. 31; Aug. 22 (Richard Epstein); Aug. 1, 2006 (state AGs); Mar. 19 (InterMune indictment).

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