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healthlawyers

  1. Thank you to all faculty and planners of the FDLI/AHLA Program on the Intersecting Worlds of Drug, Device, Biologics and Health Law.
  2. Fascin discussion on whether govt. focus on offlabel has resulted in "overchill." Kracov - need to define boundaries, perhaps thru litig
  3. Bloom's response on scientific exchange: Maybe industry paying for egregious examples in past. Distinction tween FDA and DOJ enforcem action
  4. Kracov: How can have scientific exchange about a drug without running risk of doing off market promotion or even enforcement?
  5. Last session of FDLI/AHLA prog: Off Label Promotion with Klasenmeier, Bloom and Kracov. Discussing vast govtmntal pwer to force settlemnt.
  6. Boozang: Can you get release from employee that will not file FCA claim? Mixed cases. Ct may ignore release if govt not know of wrong.
  7. Boozang:Lawyer can try to serve as qui tam relator when reveals ongoing or future crime/fraud. Exception to model rules of prof conduct
  8. FCA does not preclude atty from being qui tam relator. But may violate Rules of Prof. Conduct if reveal confidential information.
  9. Boozang - lesson of Synthes. Evolving theories of liability to make those with most authority take notice of prosecutorial efforts.
  10. Synthes case - produces bone cement. Not clinically trialed for spinal surgery. Three patients died after spinal surg. Execs got prison time
  11. Stndards for exclusion under RCOD - Is conduct a pattern; what is harm to beneficiaries; what is defendants role in conduct? Complex analys
  12. Boozang on Respons Corp Officer Doctrine (RCOD) - OIG excluded Purdue/Phrma execs from fedl hlth progs for 12 years. Appeals been unsuc.
  13. Class actions - two clear legal theories, but buried potential claims in allegations: kickback, insurance fraud, consumer protec claims.
  14. Class action allegation - co-pay subsidies designed to impose additional costs on plans because steer members to more expensive manuf drugs.
  15. Patient Support Initiatives session - reviewing class action lawsuits filed by self insured union plans on copayment assistance programs.
  16. Constitutional debate on ACA so good that AHLA will try to post audio on web for AHLA members as soon as can edit it.
  17. Terrific session on constitutionality of ACA between S. Ct. counsel Michael Carvin and Professor Martin Redish. Intellectual clash of titans
  18. Ferrari taking audience through practical case study in determining FMV for hiring oncologist as key opin. leader. Interesting.
  19. Ferrari - cons of outside valuator - cost; not neces to estab. valuation; raised expectation that will avoid investigation.
  20. Ferrari-Outside valuator pros - independence, evidence of lack of intent, more expertise, savings in long run if investig., helps deal.