In recent years America has seen an increasing number of opioid-involved deaths and is currently experiencing what the Center for Disease Control (“CDC”) describes as an “opioid epidemic.” This crisis has been devastating to many communities and individuals, and States are feeling the effect, too. State, county and municipal governments have faced mounting costs in battling this crisis, and some are now taking the fight to the manufacturers and distributors of these drugs.
On September 19, 2017, the Attorneys General of 41 States announced the formation of a coalition created to investigate the potentially unlawful marketing and distribution practices of major opioid manufacturers and distributors. They served subpoenas on manufacturers Endo Intentional, Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Allergan, Inc. and Purdue Pharma, and demanded documents from distributors AmerisourceBergen, Cardinal Health and McKesson. This investigation is being led by the New York Attorney General’s office.
Additionally, several States – including Missouri, Ohio, New Mexico and West Virginia – have filed lawsuits against some of the major players in the pharmaceutical industry. These States are looking to recoup some of the costs they have incurred in response to the rising number of opioid-related deaths and overdoses. These costs are claimed to stem from a massive increase in social services related to opioid use, such as increased expenses for prosecuting opioid-relate crimes, toxicology and autopsy reports, costs for placing children of opioid-users in custody of the state, and opioid-related jail costs. County governments in several states and the City of Chicago have filed similar suits.
These investigations and lawsuits are premised on claims that these opioid manufacturers and distributors have wrongly contributed to the widespread opioid epidemic. Although individual State claims differ, they generally allege that the companies have deliberately engaged in efforts to deceive doctors and consumers about the risks of prescribing and taking opioids. Illustratively, Missouri Attorney General Josh Hawley stated in a news conference announcing the Missouri action that these companies have “. . . used bogus front organizations and fake research; they used fraudulent advertising and deceptive trade practices, and they repeatedly lied about the true risks of the drugs they sold.”
Missouri’s Petition, filed in the plaintiff-friendly City of St. Louis, joins Purdue, Endo, Janssen and Johnson & Johnson as defendants. It alleges that a widespread medical consensus existed that opioids should not be used to treat chronic pain because of the “extraordinary risk of addiction, dependence and overdose,” and that the defendants, individually and in concert, “created a sprawling campaign of misinformation and deception to convince doctors and consumers that opioids pose little risk of addiction, and that such risks can be easily identified and mitigated.” To do so, it says, they communicated directly to doctors and consumers; created and controlled third party organizations including the American Pain Foundation and Academy of Pain Medicine; and engaged highly credentialed medical professionals such as Dr. Russell Portno (who stirred controversy by advocating use of opioids for chronic pain), and Dr. Lynn Russell (who was investigated by the Drug Enforcement Administration for overdose deaths at his Lifetree Pain Clinic).
Missouri pleads claims for alleged violations of the Missouri Merchandising Practices Act, and a claim for recovery of Medicaid payments made based on “false statements and false representations regarding opioids and regarding medical alternatives to opioids.” Recovery is sought for compensatory and punitive damages, civil penalties and other relief.
These claims will face strong industry opposition. The opioids at issue have been approved and are regulated by the Food and Drug Administration, and must bear FDA-approved warning labels. Individual doctors play an integral part in assessing the risks and benefits of opioids and prescribing them for patients. Proving misrepresentation and deception will not be an easy task. State efforts to hold the industry responsible for the opioid crisis will face a major and, likely, lengthy battle. Time will tell to what extent they may succeed.