It is widely accepted that overly aggressive and deceitful marketing tactics by the companies that make oxycodone, fentanyl and other opioids helped start the opioid crisis in the 1990s. Now, thousands of lawsuits at both the federal and state level have been filed to hold these companies to account.
The story of the current opioid epidemic began about thirty years ago when the federal Food and Drug Administration (FDA) began approving new forms of opioids like morphine-containing MS Contin (1987, first extended-release opioid product), fentanyl-containing Duragesic (1990, first opioid skin patch), and oxycodone-containing OxyContin (1995). At the same time, a sea-change was occurring in how medical professionals thought about pain. The “Pain is the 5th Vital Sign” movement began (p. 2-3) in 1990 with a call to action by Dr. Mitchell Max, then president of the American Pain Society, and culminated in The Joint Commission, which sets healthcare standards, published its Pain Standards in 2001. While the Joint Commission’s standards and the broader pain movement were well-intentioned, the drug companies that made the newly approved opioids took advantage of them. Doctors at the time were well aware of the addictive potential of opioids and would often only prescribe them to cancer patients whose pain was too severe for other medication. The drug companies aggressively marketed to doctors, using their new concern about patient pain and knowingly misleading them about the addictive potential of their new drugs, to ramp up sales. Drug companies’ employees were even directed to lie about patients’ cancer status to health insurance companies to get more sales. Prescriptions and sales of OxyContin and other opioids skyrocketed (p. 5) from 76 million in 1991 to 219 million in 2011, a 188-fold increase.
In 2017, opioid prescribing rates vary from 39.5 per 100 people in California to 74.2 per 100 people in Michigan and 107.2 per 100 people in Alabama (the highest in the country). While prescription rates and overdose deaths from prescription opioids have fallen modestly in recent years, the bell cannot be unrung. The country has experienced drug epidemics before, this current crisis has direct links to the drug companies that made massive profits off of addiction.
United States v. Insys Therapeutics
In June of this year, the company Insys Therapeutics entered into a settlement with the US Department of Justice that made them the first drug company to file for bankruptcy over costs levied against them because of their practices. The US Attorney for the District of Massachusetts, Michael E. Lelling, had charged Insys for using “speaker series”, which were supposed to educate doctors on their fentanyl product Subsys, for exchanging bribes to get doctors to prescribe more of their product. On physician’s assistant from New Hampshire, who had prescribed no Subsys before attending one of these events, wrote 672 Subsys prescriptions after being given over 40,000 dollars from Insys. For this crime, Insys agreed to pay $225 million dollars. Separately, five former Insys executives were convicted of racketeering, the crime of maintaining a continuous illegal operation, in a Boston federal court. Three other executives were convicted of other crimes related to this scheme.
Oklahoma v. Johnson & Johnson
In another major victory, Oklahoma’s Attorney General, Mike Hunter, successfully sued Johnson & Johnson (yes, the baby powder company) in state court. The original lawsuit also included Purdue and Teva pharmaceuticals, both opioid manufacturers, but each company settled for $85 million and $270 million respectively. Johnson & Johnson, which did not settle, ended up being fined $572 million, though Hunter originally sought $17.5 billion. While Johnson & Johnson’s opioid products, sold through their subsidiary Janssen Pharmaceuticals, make up less than 1% of the opioid market in Oklahoma; the company makes and supplies most of the raw ingredients used by other companies to make opioids like OxyContin. While the $572 million fine will likely fund Oklahoma’s opioid response for only a year, Johnson & Johnson has vowed to ask the court to put the fine on hold while they appeal the judge’s decision to the appellate court.
The National Prescription Opioid Litigation
In the US District Court for the Northern District of Ohio, headquartered in Cleveland, over 2000 lawsuits brought against the drug manufacturers, drug distributors, chain pharmacies and doctors that federal, state, tribal and local governments believe perpetuated the opioid epidemic have been consolidated into one proceeding overseen by US District Judge Dan Polster. Judge Polster has selected the suits brought from Summit and Cuyahoga counties in Ohio for a bellwether trial next month, although Ohio Attorney General Dave Yost has asked that the trial be halted. In multidistrict litigations like this, a bellwether trial serves as a test run. Just like in Oklahoma, many companies would rather settle than go through a long, expensive trial. For example, Mallinckrodt, the largest maker of generic oxycodone, settled with the bellwether counties for $30 million. This wasn’t the first settlement Mallinckrodt entered for its practices, either. In 2017, the company agreed to pay $35 million in another settlement with the federal government.
However, the most talked-about settlement related to the National Prescription Opioid Litigation is the one recently entered by Purdue Pharma and its owners, the Sackler family. As part of the $10 billion dollar settlement, if enacted, Purdue would file for bankruptcy and divest from its worldwide pharmaceutical holdings. The company would then reopen under non-Sackler leadership and all future profits from OxyContin would be put into a trust to help communities with their response to the opioid epidemic. The Sackler family will also have to pay $3 billion from their own wealth. This settlement is separate from the $85 million Purdue agreed to pay in the Oklahoma state court case.
Many see the Purdue settlement as a major victory and 26 state attorneys general have indicated that they would take the settlement, attorneys general from the 24 other states and the District of Columbia, like Massachusetts AG Maura Healy and North Carolina AG Josh Stein, have decided to say no to the settlement and go after Purdue and the Sacklers in their own lawsuits.
Despite settlements from Mallinckrodt, Purdue, and others, the National Prescription Opioid Litigation will continue in Cleveland.
Why are governments suing?
Civil litigation has been used by governments before to hold private companies accountable for a public health crisis. In 1998, 46 states, 5 US territories and DC reached a settlement with the largest tobacco companies, known as the Tobacco Master Settlement Agreement (MSA), which requires yearly payments from the companies to states and territories forever. In 2018, MSA payments totaled $27.5 billion. In addition to the payments, the MSA forced tobacco companies to stop certain practices and to make public thousands of documents detailing their deceptive marketing practices. Many parallels can be drawn between MSA and the ongoing opioid litigation, including the reckless practices of both the tobacco and opioid companies.
Lawsuits cannot be the only solution to the opioid epidemic, but addressing the crisis has put significant financial strains on many of our public systems. The government attorneys arguing these lawsuits are trying to get drug companies like Insys and Purdue to pay for the damage they have caused to make their billions.