The national opioid epidemic has morphed into a national crisis
The national opioid epidemic has morphed into a national crisis that has drawn the attention of policymakers at all levels of the government. Funding for opioid treatment was discussed as a component of recent legislation to reopen the federal government. Attorney General Jeff Sessions also recently rolled out new enforcement policies to pursue criminal charges against fraudulent schemes to distribute opioids. This legislation and recent law enforcement actions in response to the opioid abuse and overdose epidemic follow in the wake of increasing efforts by local, state, and federal authorities to recover the costs associated with the opioid crisis. These governmental responses raise the issue of the civil liability of pharmaceutical companies for their role in this public health emergency.
Understanding the Scope of the Opioid Crisis
The harm caused by the excessive distribution of oxycodone (Oxycodone®), hydrocodone (Vicodin®), fentanyl, and other opioids has exacted an enormous human and financial toll throughout the country. Opioids claim the lives of over 115 people every day in the U.S. according to the National Institute on Drug Abuse. Some estimates by public health officials place the number of fatalities in America related to opioids at 300,000 people since the late 90s. Further, the number of opioid prescriptions and overdoses have quadrupled since that time.
The economic impact of opioid abuse is estimated at a staggering $78.5 billion per year according to the Centers for Disease Control and Prevention (CDC). These expenses include increased costs associated with drug treatment programs, healthcare, lost productivity, law enforcement, incarceration, and criminal justice.
State & Local Lawsuits against Pharmaceutical Companies That Manufacturer Opioids
Because the opioid epidemic has had a particularly devastating impact on certain regions of the country, a growing number of government entities have been pursuing lawsuits against the distributors of opioids, which include pharmaceutical companies. For example, Ohio leads the country in fatal overdoses. An article published by The Atlantic in 2017 reported that paramedics in the state were increasingly devoting their time to overdoses, and coroners’ offices were running out of space for bodies. In one 12-month period, 793 million opioid pills were prescribed, which was sufficient to supply every single person in the state (regardless of age) with 69 pills.
Although the opioid crisis has impacted the entire country, certain states have been hit hardest. The national average for opioid overdoses stands at 10 per 100,000, but the rate is significantly higher in certain states:
- Pennsylvania 10.5
- Kentucky: 20
- Ohio: 22
- West Virginia 35
While President Trump has deemed the opioid crisis to be a national public health emergency, government agencies have successfully been using litigation to hold pharmaceutical companies accountable for the harm associated with their products. The Ohio Attorney General, for example, filed a lawsuit against several pharmaceutical companies that include Johnson & Johnson, Purdue Pharma, and Teva Pharmaceuticals.
Many other jurisdictions have joined in filing lawsuits against “big pharma” to combat the devastating impact of opioid addiction and abuse while forcing the drug manufacturers to bear the increased public costs created by their product. Lawsuits like the one in Ohio have been filed in jurisdictions across the U.S. that include but are not limited to Orange and Santa Clara County in California, Mississippi, Illinois, the Cherokee Nation, the city of Everett, Washington, and several counties in New York.
Legal Theories in Lawsuits Brought Against Pharmaceutical Companies
The allegations in the lawsuit filed by the Ohio AG alleges that the drug companies “trivialized the risk of opioids” while exaggerating the benefits associated with using the drugs to treat chronic pain. These types of allegations that focus on misleading marketing provide frequent grounds for recovery in defective pharmaceutical lawsuits brought by parties suffering harm that range from patients to public entities.
While many of the lawsuits being filed against pharmaceutical companies allege similar allegations, the Everett, WA lawsuit goes further alleging that Purdue Pharma, the manufacturer of OxyContin, knew the drug would find its way into the black market but failed to take steps to prevent this outcome. The argument essentially is that the pharmaceutical company knew the drug would be misused and traded on the street because of the massive levels at which the drug was distributed in certain geographic areas.
The marketing of opioids has been a common target of lawsuits based on deceptive marketing to healthcare professionals and patients. The Los Angeles Times, for example, reported that Purdue Pharma marketed OxyContin as offering 12-hour pain relief although the company knew the drug’s effects would wear off sooner. Patients taking the drug suffered withdrawal ultimately leading to addiction.
Some attorney generals and other parties filing lawsuits to hold drug companies accountable point to the tobacco litigation as a precedent. The civil lawsuit brought against the tobacco industry in 1998 by 46 states and six other jurisdictions constituted the largest settlement of civil litigation in the history of the U.S. The settlement forced the tobacco companies to assume the burden of the costs associated with the harm caused by their product. The manufacturers agreed to permanent annual payments to states to pay for anti-smoking and public-health programs.
Some of the other legal theories asserted in complaints filed against pharmaceutical companies include:
- Federal RICO violations
- Misrepresentation
- State law corrupt practices violations
- Public nuisance
Government officials that have pursued lawsuits against opioid manufacturers have alleged multiple forms of unlawful conduct:
- Failure to deny, detect, or report orders for opioids that were unusually large in size or suspicious on some other basis
- Circulating medical literature that misleadingly suggested opioids posed a minimal risk of addiction.
Although a litany of examples of drug companies disregarding obvious red flags exists, the most prominent example might be the case of Kermit, West Virginia. The entire population of the city was 392 people, but the town received an average of 4.5 million pills per year over a two-year period.
While litigation against pharmaceutical companies brought for harm caused by their products is still in the early stages, large settlements between government entities and drug companies offer prospects for success:
- Mallinckrodt PLLC settled for $35 million in 2017 based on its failure to report suspicious opioid orders.
- In 2017, Cardinal Health, Inc. settled for $20 million over the distribution of oxycodone and hydrocodone pills in West Virginia. The company was responsible for the distribution of 780 million of these types of pills over a six-year period, which amounted to 433 pills per state resident.
- McKeeson Corporation paid a civil penalty in 2017 in the amount of $150 million for failure to report abnormal orders for opioids based on pattern, frequency, and size.
- Cardinal Health, Inc settled in 2016 for $44 million for failing to report suspicious opioid orders by pharmacies in New York, Florida, and Maryland.
- In 2015, Purdue Pharmaceutical settled with Kentucky in the amount of $24 million for misleading marketing regarding the risk of addiction associated with OxyContin.
Multiple State Attorney Generals Announce Massive Opioid Investigation
A group of 41 attorney generals recently announced a collective effort to investigate pharmaceutical companies that manufacture and distribute opioids. Several large pharmaceutical companies were served with subpoenas, including Purdue Pharmaceuticals, Endo International, Teva Pharmaceutical, and Janssen Pharmaceuticals. The AGs also requested that McKesson, Cardinal Health, and AmericsourceBergen provide information. The coalition of AGs indicated that they are seeking evidence that the pharmaceutical companies misrepresented the effectiveness of opioids despite knowledge of the drugs high risk of addiction.
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