What is being called the “biggest civil trial in U.S. history” is about to begin – unless it settles.
The case, one of more than 2,000 that have been consolidated in the National Prescription Opiate Litigation brought against drug companies for the opioid epidemic, is set to get underway in October in the Ohio counties of Cuyahoga and Summit. According to Drug Enforcement Administration (DEA) data, drug companies distributed 267,109,356 oxycodone and hydrocodone tablets between 2006 and 2012 in Cuyahoga County, Ohio, an equivalent of 29 pills per person per year during that time.
But in response to a landmark $572 million ruling handled down in by an Oklahoma judge against opioid drug maker Johnson & Johnson on August 27, Purdue Pharma, Johnson & Johnson, Endo International, and Allergen are now reportedly trying to resolve the thousands of opioid lawsuits currently pending in Ohio federal court. The companies are said to be in talks with government representatives and Judge Dan Polster, who is overseeing the Ohio trial. Endo and Allergan may have already reached tentative deals, according to a recent National Public Radio (NPR) report.
The Automation of Reports and Consolidated Orders System (ARCOS), a pain pill database maintained by the DEA and recently made public by the Washington Post, reported that only six companies dispensed 75% of the opioids in the U.S. from 2006 to 2012: McKesson, Walgreens, Cardinal Health, AmerisourceBergen, CVS and Wal-Mart. McKesson held the largest share of the market at 18.4%. Just three manufacturers made about 88% of the opioids in that period: Mallinckrodt subsidiary SpecGx, Actavis Pharma and Endo Pharmaceuticals unit Par Pharmaceutical. These companies allegedly saturated the nation with 76 billion pain pills during those years, leading to nearly 100,000 deaths.
During those years, the highest death rates related to opioids were in rural communities in West Virginia, Kentucky and Virginia, where fatalities were triple the national rate. But no part of the country has escaped the opioid epidemic, and many think the blame lies with the pharmaceutical industry, which allegedly boosted the volume of pills distributed from 8.4 billion in 2006 to 12.6 billion in 2012, a 51% increase.
In The United States of Opioids: A Prescription for Liberating a Nation in Pain, author and healthcare attorney Harry Nelson writes, “The opioid crisis is unique among public health disasters and mass casualty events insofar as it was caused by multiple points of failure in our health system. Opioid manufacturers need to address their unique role in triggering the rising opioid overdose death toll by promoting misleading information to physicians and patients about their drugs.”
Not surprisingly, the opioid drug companies deny they have any legal duties or causal role in the harms caused. Collectively, they blame the FDA, physicians and consumers, claiming that local governments have no legal standing to pursue claims in their own right. However, opioid drugs have a limited therapeutic benefit, and because they are highly addictive and too often lead to overdoses, experts say they should only be prescribed for short, specific durations in medically monitored settings.
“Too frequently, opioids kill people instead of pain,” said attorney Jeffrey Simon of Simon Greenstone Panatier, one of the leaders of a Texas opioid case. “Even with that knowledge, several drug companies manufactured, promoted, distributed, and dispensed opioids for long-term consumption by millions of Americans. That over-supply of opioids led foreseeably to vast human misery and large taxpayer expense.”
Despite the billions of dollars that drug makers and distributors have reserved to pay off settlements, it will likely not be enough. A wide variety of plaintiffs – cities, counties, Native American tribes, and others – are demanding compensation for diverse types of harm are expected, pushing the settlement amount over a trillion dollars for the first time in history, likely bankrupting multiple defendants. At least one drug manufacturer, Insys Therapeutics, has already filed for chapter 11 reorganization.
Legal experts have compared the opioid lawsuits to the nation’s tobacco litigation of the 1990s that resulted in a $246 billion settlement spread over 25 years between four of the largest tobacco companies in the U.S. and 46 state attorneys general, five U.S. territories, and the District of Columbia. Thomas O’Toole, president of Sound Jury Consulting LLC in Seattle, sees the similarities between the two.
“The tactic used by the plaintiff attorneys in the tobacco litigation was to make the states the plaintiffs, rather than the individual smokers,” he said. “Before that, when the plaintiffs were individual smokers, it was too easy for the tobacco companies to point the finger at the user and say that it was their choice to smoke. Those kinds of appeals to personal responsibility work well, but having the states as the plaintiffs significantly limited the tobacco companies’ ability to do that. It was hard to place any critical focus on the states, which is so important in jury trials. It’s no coincidence that the same has happened here.”
Regarding the possibility of settlement, O’Toole said it’s anybody’s guess. “Settlements are difficult to predict. I have seen so many cases that should have settled that did not, and so many cases get taken to trial that should have settled long before trial . . . Some companies do not seem to mind the exposure,” he said. “For example, Johnson & Johnson seems to take a pummeling in some courtroom across the country on the same types of cases nearly every week, but keeps trying them. Regardless, I would suspect that some of the defendants want to at least test the waters with a trial or two.”
Should this first case proceed to trial, how might a jury approach it? “We have some data that suggests that people want to see some responsibility at the level of the doctors as well,” said O’Toole, who recently conducted national survey research of jury-eligible citizens on the issues involved in the opioid litigation. “It seems to stem from larger frustration with the state of health care in the country because many people see opioids as an easy alternative to doctors taking the time to truly understand what’s going on with a patient. A lot of people think too many doctors rush through patient care and resort to opioids as a way of making them happy and being able to move quickly on to the next patient,” he said.
According to Simon, the litigation will have a positive impact on the nation’s opioid epidemic, regardless of whether it settles or goes to trial. “The litigation is already having the effect of causing some drug manufacturers to stop promoting these drugs, and to stop hawking them to healthcare providers and consumers with misinformation as to their safety and effectiveness. The litigation and publicity surrounding it is also helping more prescribers and consumers better understand why, in most instances, longer-term consumption of opioid drugs is more dangerous than therapeutic,” he added.
“While only part of a solution, the civil justice system is an essential means to hold these drug companies financially accountable for the harm they’ve done,” said Simon. “They need to provide communities with the resources they need to provide the medical treatments and education necessary to reduce the size and scope of the opioid epidemic.”