OPIOIDS ON TRIALWILL LITIGATION STEM THE EPIDEMIC?

_____

GREGORY CURFMAN, MDHARVARD MEDICAL SCHOOL

PETRIE-FLOM CENTER HEALTH LAW P/REVIEW

HARVARD LAW SCHOOL

DECEMBER 12, 2017

OPIOIDXThe Opioid Crisis in America

AN ONLINE COURSE Learn about the epidemic:

causes, effects, and treatment13,000 registrants

www.health.harvard.edu/opioidX

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”)

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 AmeetSarpatwari, J.D., Ph.D.1,5

1 Harvard Medical School, Boston, MA2 Northeastern University School of Law

3 Bouve ́ College of Health Sciences, Northeastern University4 University of California San Diego School of Medicine

5 Brigham and Women’s Hospital

*Posted 12/11/17 at: https://jamanetwork.com/journals/jamainternalmedicine

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.

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

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

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

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?

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

COLLABORATORS

Abbe Gluck1

Ashley Hall1Ameet Sarpatwari2,4

Leo Beletsky3

Catherine Finn4

1Yale Law School2Brigham and Women’s Hospital

3Northeastern University School of Law and Bouve School of Health Sciences

4Harvard Medical School