Opioid defendants say plaintiffs stonewalling them on crucial evidence

By: Daniel Fisher

A looming showdown over evidence could determine the future path of more than 1,000 opioid lawsuits concentrated in federal court in Ohio, as defendants accuse the plaintiffs of refusing to turn over prescription records and other information they say is necessary to defend themselves against claims they caused the nationwide addiction crisis.

Defense lawyers and private attorneys representing the cities of Akron and Cleveland and their surrounding counties are scheduled to discuss the impasse at a meeting November 15 as both sides prepare for bellwether trials planned for next September. The defendants have filed motions to dismiss claims for money damages attributed to medically unnecessary prescriptions, saying plaintiffs have refused to comply with a July deadline to supply evidence of specific patients who received improper prescriptions and subsequently became addicted to opioids.

The plaintiff municipalities – represented by private lawyers seeking a percentage of anything they win – say the motions to dismiss should be denied because they have complied with the discovery order. The two sides still disagree on the fundamental question of what “comply” means, however.

For the plaintiffs, apparently, it means turning over some examples of suspect prescriptions but not the medical records showing why doctors prescribed those opioids. The defendants say without that level of data, the plaintiffs can’t make the necessary cause-and-effect connection between their marketing practices and addiction.

The back-and-forth escalated earlier this month as the plaintiffs approached a November 2 deadline to comply with a revised discovery order requiring them to supply at least 500 suspect prescriptions and 300 patients who became addicted, along with detailed prescription and medical data. Judge Polster gave the plaintiffs a second option of withholding the information, but only if they abandoned any plans to present evidence of individual opioid patients at trial. That could be a significant handicap, since trial lawyers generally try to use the evidence of individual trauma to elicit sympathy from jurors.

On October 29, defendants filed a motion to comply, predicting plaintiffs wouldn’t supply the information. On November 7 Judge Polster rejected the defendants’ motion, saying it was premature because it came several days before the November 2 deadline. A person familiar with the defense case said nearly two weeks later, plaintiffs still haven’t provided the information they are seeking, including medical records showing why patients were prescribed opioids and the connection between those prescriptions and their subsequent addiction.

Plaintiff lawyers, in a November 12 filing, said they don’t need to supply that level of information because they aren’t suing to recover money spent on unnecessary prescriptions. That argument seems to reference previous litigation most of these private lawyers were involved in, over off-label use of prescription drugs. In one of their most successful cases, those lawyers won a favorable court ruling allowing them to sue for off-label prescriptions for Neurontin, an anti-epilepsy drug that doctors prescribed for a number of other uses.

The plaintiffs did comply with the case management order, lawyers argued in their filing this week. They did so when they “notified defense counsel that [they] would forego reimbursement for medically unnecessary or medically inappropriate opioid prescriptions.”

Manufacturers and distributors say that argument is irrelevant in the opioid litigation. Since opioid painkillers are approved by the Food and Drug Administration for treating pain, the plaintiffs can’t argue, as they did with Neurontin and other cases, that the manufacturers improperly marketed their products to physicians for off-label use, defendants say.

Instead, the plaintiffs must show the manufacturers and distributors fraudulently induced physicians to prescribe their products in excessive amounts, or for the wrong patients, or sold them to pharmacies they knew or should have known were dispensing too many, defendants say.

A central claim by the plaintiffs is opioid manufacturers fraudulently advertised their extended-release pills as being non-addictive when they knew otherwise. The plaintiffs accuse distributors like McKesson and AmerisourceBergen of assisting the fraud by closing their eyes to excessive shipments of opioid pills.

In an October 6 order, Special Master David Cohen, who is assisting Judge Polster with case management, seemed to agree with the defense that more information is needed. In that order, Cohen said plaintiffs must identify at least 300 people who became addicted to opioids along with data showing why they were prescribed the drugs, their underlying medical conditions, and “the allegedly false, misleading, or deceptive statement or omission that purportedly caused the healthcare provider to write the prescription.”

Judge Polster modified Cohen’s order to say the plaintiffs could skip providing this and other evidence if they commit to presenting their case entirely on “aggregate proof.” That proof would presumably come in the form of testimony from experts who would use statistical evidence to show how many medically justified prescriptions should have been issued to a given population, versus how many pills actually were prescribed.

The defendants say this approach leaves them at a disadvantage unless they know how the plaintiff experts will distinguish medically necessary from unnecessary prescriptions. The plaintiff cities and counties have detailed medical records for tens of thousands of municipal employees that could show the path from prescription to addiction, the defendants say, as well as similar, if less detailed data about patients treated for addiction in public health facilities.

Lawyers for distributors and pharmacists, in another filing this week, made similar complaints about plaintiff strategies. The plaintiffs thus far have provided general information about how their experts will identify “suspicious” orders distributors and pharmacies should have reported to the government or blocked, the defendants say. But based on the information plaintiffs have supplied thus far, they say, there’s no way for the defense to determine what plaintiffs will argue is suspicious. In the case of one distributor in Ohio, using different methods results in a calculation of excessive shipments ranging from “a little,” they say, to “a lot.”

The defendants also say plaintiffs must show how reporting “suspicious” shipments to the government would have protected them from their losses. The Drug Enforcement Administration is the only entity that possessed complete knowledge of where ever pill was shipped, distributors argue, so it is difficult to see how notifying the DEA of suspicious orders would provide it with more information than it already had.