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

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. 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

7. 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”)

8. 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

9. 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.

11. 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

12. 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

13. 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

14. 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?

15. 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

16. 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