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Gregory Curfman, "Response to the Opioid Epidemic"

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December 12, 2017

The Sixth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/sixth-annual-health-law-year-in-p-review

Published in: Health & Medicine
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Gregory Curfman, "Response to the Opioid Epidemic"

  1. 1. OPIOIDS ON TRIAL WILL LITIGATION STEM THE EPIDEMIC? _____ GREGORY CURFMAN, MD HARVARD MEDICAL SCHOOL PETRIE-FLOM CENTER HEALTH LAW P/REVIEW HARVARD LAW SCHOOL DECEMBER 12, 2017
  2. 2. OPIOIDX The Opioid Crisis in America AN ONLINE COURSE Learn about the epidemic: causes, effects, and treatment 13,000 registrants www.health.harvard.edu/opioidX
  3. 3. THE HISTORY OF OXYCONTIN • Oxycodone, the active ingredient, developed in Germany in 1917 • OxyContin (Purdue), extended-release form, FDA-approved 1995 • Was the patent on OxyContin obvious? Oxycodone and Contin developed years earlier • 1996-2001: $2.8 billion in sales | 2008-2017: >$2 billion/yr in sales • Patents’ expiration dates approach: Purdue developed abuse- deterrent formulation • FDA approved AD formulation in 2010 | New patents • Purdue ceased to manufacture original formulation • Citizen petition blocked generic market for original (“unsafe”)
  4. 4. Benefits, Limitations, and Value of Abuse-Deterrent Opioids * Gregory D. Curfman, M.D.1,2 Leo Beletsky, J.D., M.P.H.2,3, 4 Ameet Sarpatwari, J.D., Ph.D.1,5 1 Harvard Medical School, Boston, MA 2 Northeastern University School of Law 3 Bouvé College of Health Sciences, Northeastern University 4 University of California San Diego School of Medicine 5 Brigham and Women’s Hospital *Posted 12/11/17 at: https://jamanetwork.com/journals/jamainternalmedicine
  5. 5. Abuse-Deterrent (AD) Opioids: Benefits, Limitations, and Value • Selective use of AD opioids may mitigate opioid abuse and diversion. • AD use may promote switching to more dangerous opioids (heroin). • There is no evidence that AD use reduces overdose death. • Universal substitution would be cost prohibitive. • Greater investment in alternative interventions would be more useful.
  6. 6. OPIOID LITIGATION – THE FIRST WAVE • 2000-2007 • Plaintiffs: Individual citizens, class actions, state attorneys general • Individual cases often unsuccessful: Stigma • Class actions: Difficult to establish commonality • Attorneys general: More successful • 2007: Pivotal case against Purdue Pharma • Purdue settled for fines of $600 million to federal govt. and $20 million to states
  7. 7. OPIOID LITIGATION – THE SECOND WAVE • 2014 – present: Dozens of cases in total • Plaintiffs: State attorneys general, counties, cities, Cherokee Nation, individual towns (communities) • Defendants: Pharma companies (Purdue, Janssen, Endo); distributors (Cardinal Health, AmerisourceBergen, McKesson); retail pharmacies (CVS, Rite Aid, Walgreen’s, Walmart) • Causes of action: Negligent (aggressive) marketing; fraudulent advertising; failure to warn; public nuisance • Role of private law firms: Contingency
  8. 8. 13 TOBACCO LITIGATION VS. OPIOID LITIGATION • Tobacco: Master Settlement Agreement (MSA) of 1998 • Payment of $250 billion over 25 years to 46 states • Mike Moore, MSA attorney, also involved with opioids • Important distinctions between tobacco and opioids • Tobacco: Intended use | Opioids: Misuse • Tobacco: No medical benefit | Opioids: Medical benefit • Promotion: Tobacco to consumers | Opioids to doctors • Tobacco: No FDA regulation | Opioids: FDA regulation • Federal pre-emption of state action | Wyeth v. Levine
  9. 9. LATEST DEVELOPMENT: MULTIDISTRICT LITIGATION (MDL) • On Nov. 30, the U.S. Judicial Panel on Multidistrict Litigation heard arguments from the parties in opioid lawsuits. • Panel consolidated 66 lawsuits nationwide in MDL • Assigned to U.S. District Judge Dan A. Polster in Northern District of Ohio (Cleveland) • With the consolidation of cases in MDL, prescription opioid litigation has entered a new phase. • MDL may lead to settlements?
  10. 10. OBJECTIVES OF OPIOID LITIGATION • Recover financial losses for medical expenditures • Deterrence: Mitigate over-promotion, aggressive distribution, and over-prescription of opioids • Incentivize research and development for novel non-opioid analgesics • Retributive vs. restorative justice • But, litigation will be challenging due to long chain of causation
  11. 11. COLLABORATORS Abbe Gluck1 Ashley Hall1 Ameet Sarpatwari2,4 Leo Beletsky3 Catherine Finn4 1Yale Law School 2Brigham and Women’s Hospital 3Northeastern University School of Law and Bouve School of Health Sciences 4Harvard Medical School

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