Lawsuits against distributors, pharmacies will rely on `aggregate proof’ too many pills were sold, without any examples of improper prescriptions to show how it happened.

My latest story for Legal Newsline on Forbes:

Plaintiffs in bellwether trials against the opioid industry scheduled to begin next year will try to prove their cases without presenting a single example of pills that were prescribed improperly.

Lawyers for the cities of Cleveland and Akron and their surrounding counties said they will rely “solely on a theory of aggregate proof” under which experts will testify that marketing practices and lax controls over suspicious patterns of drug distribution are to blame for the opioid addiction crisis in northern Ohio.

Defendants, who range from manufacturers like Purdue Pharma to distributors and retail pharmacy chains, won an order earlier this month requiring the plaintiffs to turn over hundreds of prescriptions they regard as improper or illegal, and hundreds more examples of people who became addicted to opioids due to medically unnecessary prescriptions.

The defendants said the plaintiffs must present such evidence to show a causal link between opioid sales and the damages they claim are due to addiction. Cities and counties have prescription data and medical records for thousands of people because they are large employers and also operate  public hospitals and health systems.

But in an order late last week U.S. District Judge Dan Aaron Polster, who is overseeing more than 1,000 cases in the opioid multidistrict litigation, gave the plaintiffs a choice: They could turn over the prescription data or forgo it entirely. In a filing late Wednesday, plaintiffs chose the latter. They did say they might turn over evidence of hundreds of individuals who became addicted to prescription drugs by November 2, but not the underlying prescriptions.

By choosing to rely upon aggregate proof, the plaintiffs are betting on a trend in which judges overseeing mass tort litigation are allowing plaintiffs to skip the once-essential element of tying a specific action by a specific defendant to a specific example of harm. Instead, the plaintiffs will try to prove drug manufacturers and distributions caused the opioid crisis by a pattern of activities that collectively resulted in too many opioid pills being released into the community.

Former Mississippi Attorney General Mike Moore, now a consultant to plaintiff lawyers who hope to earn contingency fees in the opioid litigation, helped develop this approach with tobacco litigation in the 1990s. Instead of suing on behalf of smokers who were sickened by their addiction to tobacco, he sued on behalf of the state seeking compensation for smoking-related medical expenses.

“The kind of causation you show depends upon how you conceive of the legal injury,” said David Noll, an associate professor at Rutgers Law School who studies class actions and mass torts. “The Mike Moore approach is to reconceive the injury in a way that allows specific causation to be shown without showing a connection between any particular bad prescription and an individual injury.”

The plaintiffs said they will base their case on “misrepresentations and omissions of material fact” that led prescribers to maintain patients on excessively high doses of opioids including extended-release pills that manufacturers claimed were less susceptible to abuse. They said they “do not intend to assert, either in expert opinions or factual presentations at trial, that any specific prescription was unauthorized, medically unnecessary, ineffective, or harmful, or that the filling of any specific prescription caused or led to harm.”

Filings in a lawsuit by the Cherokee Nation show how identifying specific prescriptions might hurt their case. In a motion opposing efforts by the Cherokees to have their case remanded to state court in Oklahoma, McKesson Corp. said 23% of the opioid pills it shipped into the Cherokee reservation area were purchased by the federal government and many of them were dispensed through the Indian Health Service, a division of the Department of Health and Human Services.

McKesson cited the data to support a decision by Judge Polster to retain control of the Cherokee lawsuit under rules allowing cases involving actions by federal officers to be heard in federal court.

But the data also undercut claims in more than 1,200 lawsuits by counties, cities and Native American tribes that opioid manufacturers, distributors and pharmacists are to blame for shipping unreasonable numbers of pills and failing to report suspicious orders to the federal government. The federal government was McKesson’s largest single customer in Cherokee country, according to prescription data.

The Cherokees tried to carve out from their complaint any allegations they suffered injuries due to pills distributed by government dispensaries, but Judge Polster rejected that in a September ruling, noting that McKesson distributed pills under the Pharmaceutical Prime Vendor program operated by the Veterans Administration. Any pills illegally diverted into the wrong hands from those orders, the judge noted, would have flowed through a federal warehouse under the control of government employees.

“The Tribes’ claims put all prescription opioids at issue and allege that diversion can occur at any point in the supply chain, including those opioids supplied pursuant to the PPV contract,” Polster wrote. “The issue here is whether McKesson’s drug distribution was performed pursuant to a federal contract, and in this case it was.”

The Cherokee Nation filings include data from the federal ARCOS database maintained by the Drug Enforcement Administration showing exactly how many pills each distributor shipped and the retail pharmacies or government dispensaries they were delivered to. Opioid plaintiffs obtained the ARCOS data under seal this summer. The Cherokees cited some of it in a public filing earlier this month.

Those data show 97 million opioid pills were shipped by McKesson and other wholesale distributors into the 14 counties comprising the Cherokee Nation area in Oklahoma in 2016, or about 96 pills per adult resident. In Cherokee County, which is entirely within the tribal area, 4.9 million pills were shipped, or 128 per adult that year. The number of pills shipped was similar across all 14 counties, ranging from 100 to 131 pills per adult.

In their complaint, the Cherokees say distributors negligently shipped opioids knowing they “were ultimately being consumed by Cherokee Nation citizens for non-medical purposes.” Pharmacists, they said, “regularly filled prescriptions in circumstances where red flags were present.” Centers for Disease Control data show the Eastern Oklahoma, where the Cherokee nation is located, has opioid prescription rates of over 100 prescriptions per 100 residents, among the highest in the nation.

McKesson, citing more granular ARCOS data still technically under seal, said it shipped 376 million opioid pills into the 14-county Cherokee Nation area between 2006 and mid-2018, with 85 million or 23% flowing through the government’s PPV system.

The PPV pills wound up in 23 facilities in the area, including a VA hospital in Muskogee and 13 IHS clinics. The percentage of pills under government control was as high as 63% in Muskogee County and federal PPV facilities comprised the largest single destination for McKesson shipments every year from 2006 to 2018, the company said.

To put the Oklahoma numbers in perspective, one academic study of 4,300 patients found they averaged 3.2-3.9 opioid tablets of varying strength a day over a 90-day period. Continued over a year, each patient would have consumed more than 1,000 pills.

The most recent public ARCOS data, released in July 2018, shows 48.9 million grams of oxycodone were distributed in 2017, with a high of 4.1 million grams in Florida, followed by 3.5 million grams in California. A gram of oxycodone translates roughly into 33 30-milligram pills.

Categories: Opioid crisis