RECENT LEGAL DEVELOPMENTS IN RESPONSE TO THE OPIOID CRISIS
February 9, 2018
The opioid crisis is continuing to rage on, shattering lives, families, and communities while placing an unbelievable burden on the healthcare system of the United States. Well over 42,000 people died in 2016 due to opioids overdose, and 40% of those deaths involved a prescription opioid (https://www.cdc.gov/drugoverdose/index.html). Overdoses are now the leading cause of death in the United States, far eclipsing firearms and car accidents. Unfortunately, the figures coming in for 2017 are no better – the problem is escalating and we have yet to turn the tide on the crisis.
There are several strategic responses being employed in both the public and private sectors. These developments raise many legal issues for the healthcare and pharmaceutical industry to consider, including:
Enhanced Federal and State Law Enforcement Efforts
Over the past several months, the Drug Enforcement Administration (DEA), along with other federal, state, and local enforcement and regulatory authorities, have dramatically increased their investigation and enforcement efforts against pharmaceutical manufacturers and distributors and prescribers who are believed to be operating outside of the law. During a press conference on January 30, 2018, U.S. Attorney General Jeff Sessions announced that the DEA is adding 90 additional special agents and 130 Task Force Officers to their already extensive diversion control arsenal deployed across the country. He also highlighted the DEA’s collection and in-depth analysis of the 80 million transaction records it collects every year to identify manufacturers and distributors that are statistical outliers. The Attorney General’s additional efforts include new requirements for all U.S. Attorney’s Offices to designate an “Opioid Coordinator” tasked with developing custom enforcement strategies for each district, additional funding for state and local law enforcement efforts, and deploying FBI resources for investigating opioid sales on the dark web. To be sure, these enforcement efforts and strategies will only increase, putting healthcare providers into direct contact with regulatory and criminal investigations on multiple fronts.
Lawsuits Against the Pharmaceutical Industry
As recently reported in the Washington Post, a dozen states and nearly 270 towns, cities, and counties have filed lawsuits against drug distributors, manufacturers, and chain drugstores alleging that they failed to report suspicious orders and phony prescriptions for the drugs (https://www.washingtonpost.com/world/national-security/dea-launches-new-crackdown-on-pharmacies-and-opioid-over-prescribers/2018/01/30/14cc20be-0600-11e8-94e8-e8b8600ade23_story.html?utm_term=.75aad5c82a77). Hospitals have also joined the fray by filing lawsuits claiming that manufacturers and distributors engaged in deceptive marketing practices and failed to abide by established duties. These trends will continue, creating scores of legal issues and civil actions for years to come.
Enhanced Requirements for Medical Providers
Nationally, licensing Boards continue to crack down on prescribers and dispensers. The DEA is working with state agencies and diversion units of state police forces to investigate prescribers and dispensers. Boards of Medicine and Boards of Pharmacy are more and more likely to investigate and punish those who have not complied with the standard of care or regulatory requirements. State drug control acts are being amended to address the prescribing of opioids, benzodiazepines, and Narcan. The uses of Prescription Drug Monitoring Programs are expanding in scope with some state legislatures now giving the Programs the power to report outliers to the relevant licensing boards for investigation. In short, individual prescribers and dispensers will continue to be subjected to a variety of government investigations.
The increased focus on pharmacies, suppliers, and medical providers will take this fight in a new direction and will undoubtedly have a significant impact on both hospital-owned and retail pharmacies, as well as prescribing professionals. On this front, Hancock Daniel attorney Elizabeth Whalley Buono will be discussing the types of initiatives undertaken across the stakeholder continuum, barriers that have been overcome, and legal and regulatory impediments that have stymied even the most motivated of public servants at the GTCbio Opioid Crisis and Alternatives Conference taking place on May 8-9, 2018, at the Meyer and Renee Luskin Conference Center on the UCLA campus. She will focus on the need for unprecedented inter-agency collaboration in combating the opioid epidemic.
Pharmacies, suppliers, hospitals, or other providers with questions about the DEA’s new enforcement or with related compliance needs may contact one of our qualified team members for further guidance – Healthcare Investigations and Enforcement Actions, Life Sciences, or Health Regulatory Boards.
The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.