Recovering drug user Elizabeth Brooks takes a drug test with case manager Chrystal Orndorff in Big Stone Gap, Va. (Melina Mara/The Washington Post)

Major opioid manufacturers have asked a judge to throw out the first test case of whether they must pay for the nation’s drug crisis, arguing that two Ohio counties cannot prove the drug companies’ actions were responsible for overdose deaths or other harms, newly unsealed court documents show.

Lawyers for Purdue Pharma, Mallinckrodt Pharmaceuticals and other drug companies contend that Cuyahoga and Summit counties cannot sufficiently connect the tens of billions of legal painkillers the companies produced to fatalities and addiction. Nor can the counties show that drug company sales calls caused doctors to overprescribe the medications, they said.

The Ohio counties “have no evidence that their alleged injuries were proximately caused by the collective ‘manufacturers’ . . . rather than by criminal cartels trafficking in deadly street drugs,” the manufacturers argued in criticizing expert testimony presented by lawyers for the two counties.

The request that federal judge Dan Polster toss out the lawsuit is a common pretrial tactic in civil litigation. More significantly, it is the first full public airing of the legal defense manufacturers are likely to offer in the landmark lawsuit brought by nearly 2,000 cities, counties and other groups across the country, the largest civil case in U.S. history. Polster has urged all sides to settle the case.

The drug producers’ motion targets the two counties because they are scheduled to go to trial first, in October, as a test case in the enormous lawsuit.

With plaintiffs trying to prove the drug companies engaged in a civil racketeering enterprise, “it seems the fight is about how granular you have to be when you’re proving these types of . . . claims,” said Elizabeth Chamblee Burch, a law professor at the University of Georgia. “There’s kind of an inherent tension there, because [racketeering] is about proving an aggregate wrong,” she said. “It’s the tension between proving a [racketeering] claim, which requires aggregate proof, versus what you can pin on these particular defendants.”


Remote mountain towns of southwestern Virginia’s coal country, where fog settles along Route 58 between the hills, received millions of prescription opioid pills between 2006 and 2012. (Melina Mara/The Washington Post)

A person with knowledge of the defense strategy said the plaintiffs need to show that the companies were conspiring with one another and acting in concert. That’s difficult to do because the companies are fierce competitors, said this person, who spoke on the condition of anonymity because Polster has warned people associated with the case not to comment on it. The idea that the defendants conspired is not consistent with the reality of their business.

The person said the plaintiffs have not been able to tie alleged false or misleading promotion by drug companies to harm in communities and are relying on statistical data that the defendants believe is poorly modeled.

The defendants’ motion was unsealed late Tuesday night, after an appellate court ordered Polster to make some material in the case public.

As yet, the unsealed court records do not include arguments from the major drug distributors and retail chains, which are also defendants in the case.

Defense attorneys listed in the court papers did not return telephone calls seeking comment Wednesday. A public relations representative for the plaintiffs did not return an email seeking comment.

The municipalities are seeking billions of dollars to help pay for the costs of treatment, emergency aid and law enforcement in an epidemic they claim started when drug companies ignored clear signs that opioids were being diverted to the black market.

More than 200,000 people have died of overdoses from legal painkillers in the last two decades. A similar number have succumbed to heroin and illicit fentanyl in the second and third waves of the epidemic.

The municipalities’ claims against drug producers, distributors and retailers were made public Friday. They argued that some of the biggest and best-known companies in the United States participated in what amounts to a civil racketeering enterprise when they sold vast quantities of drugs that devastated communities across the country. Cuyahoga and Summit also argue that drug distributors created a “public nuisance” that endangered the health of their residents — a problem those companies must pay to help abate.

The Washington Post also revealed a previously undisclosed database maintained by the Drug Enforcement Administration last week. It shows that the drug industry inundated consumers with 76 billion opioids between 2006 and 2012, many more than experts had previously believed.

But in court, the question will be whether the two counties, and future plaintiffs, can meet the legal standards necessary to prove the drug companies’ regulated commerce in painkillers was so excessive that it caused the counties harm. In their newly revealed court filing, the manufacturers argued forcefully that the plaintiffs fall far short of proving their case.

They said the counties have not proved even some of the basic elements required by Polster: that the manufacturers deceptively promoted opioids to sell more than was medically necessary; that the excess drugs were diverted to the black market; and that the counties had to spend money to stop the flow of drugs and clean up the damage.

The defense argued that one of the counties’ consultants, Meredith Rosenthal, a professor at Harvard University’s T.H. Chan School of Public Health, “made no attempt to measure the effect of the alleged misconduct.” Rosenthal did not separate lawful sales visits to doctors — known in the drug trade as “detailing” — from allegedly illegal promotional activities, they said.

Her testimony “would provide no evidence about whether and to what extent any alleged deceptive marketing can be causally linked to plaintiffs’ alleged losses,” the defendants wrote.

Rosenthal did not return an email seeking comment. In her March 25 report, unsealed Friday, she concluded that “promotion caused a large share of the sales of opioids nationally and in the [two counties] during the damage period.” But the numbers that support her conclusions are blacked out in the publicly released documents.

Another, consultant, David Cutler, compared shipments of prescription opioids to deaths from all types of opioids, the defendants contend.

“There is no legal or factual basis for holding manufacturer defendants liable for harms caused by illicit drugs,” they wrote. Nor can Cutler pin culpability on any individual manufacturer, they said.

Cutler, a Harvard economics professor, declined to comment . But his March 25 report, also unsealed Friday, shows that he calculated the impact of prescription opioid shipments on deaths, the crime rate, juvenile protection and other services that counties pay for.

After 2010, he wrote, “the share of licit mortality attributable to defendants’ misconduct increased from 26.3 percent to 44.6 percent.” However, much of the data behind his conclusions is redacted.

Other data offered by the plaintiffs measures shipments between wholesale drug distributors — the middlemen in the supply chain — and pharmacies, and therefore does not prove any wrongdoing by manufacturers, the defendants alleged. Manufacturers sit at the top of the supply chain and send drugs to distributors, who bring them to pharmacies and other places where they are purchased and consumed.

In addition, the drug producers claimed, the analysis does not take into account many other factors that could influence the final data on harm, including the impact doctors and criminal drug dealers might have had.

Steven Rich contributed to this report.