In a sharp rebuke to the federal judge overseeing the multidistrict litigation over the opioid crisis, a panel of the U.S. Court of Appeals for the Sixth Circuit said a pretrial ruling by U.S. District Judge Dan Polster was a "clear abuse of discretion."

The panel overturned Polster's decision in advance of a trial—scheduled to take place Nov. 9, 2020 with a dozen pharmacies as defendants—to allow plaintiffs to add new claims more than a year after a deadline to do so.

The pharmacies, which include CVS and Walgreens, had petitioned the Sixth Circuit to overturn Polster's ruling, dated Nov. 19, 2019, along with two subsequent decisions, insisting that he had violated the Federal Rules of Civil Procedure. On Wednesday, the circuit agreed with the pharmacies, granting their petition for writ of mandamus.

"Not a circuit court in the country, so far as we can tell, would allow a district court to amend its scheduling order under these circumstances," wrote Circuit Judge Raymond Kethledge. "Respectfully, the district court's mistake was to think it had authority to disregard the rules' requirements in the pharmacies' cases in favor of enhancing the efficiency of the MDL as a whole."

MDLs, Kethledge wrote, "are not some kind of judicial border country, where the rules are few and the law rarely makes an appearance."

One of the defendant pharmacies applauded the ruling as defending the rule of law in litigation.

"We were pleased with the Sixth Circuit's decision today, which recognized the importance of the rule of law applying to all litigation and to all parties," said Walgreens spokesman Phil Caruso. "Walgreens never manufactured or marketed any opioid medications. Our pharmacists only dispensed FDA-approved opioid medications when presented with a prescription written by a physician with a valid DEA license for a legitimate medical need."

The other defendant pharmacies, including Rite Aid, Discount Drug Mart, and Giant Eagle's HBC Service Co., did not respond to requests for comment.

"This 6th Circuit decision is a procedural ruling related to a single bellwether case involving Ohio counties, Cuyahoga and Summit, and did not consider or decide the merits of the dispensing claims against the pharmacy defendants," wrote plaintiffs' executive committee co-lead lawyers—Paul Farrell of Farrell Law in Melville, New York, Paul Hanly of Simmons Hanly Conroy in New York City and Joe Rice of Motley Rice in Mount Pleasant, South Carolina—in an email. "The distribution claims against the pharmacy defendants remain."

Polster, a federal judge in the Northern District of Ohio, provided a statement through his judicial assistant, Helen Norton: "Judge Polster will follow the directive of the Sixth Circuit."

Wednesday's decision is the second time the Sixth Circuit has reversed Polster in the opioid MDL, which now includes 2,700 lawsuits filed by cities, counties and other governments alleging that pharmacies, and the distributors and manufacturers, created a public nuisance by filling improper prescriptions for opioid painkillers. On June 20, 2019, the Sixth Circuit found that Polster should have given more weight to the public interest in a federal database of opiate pharmaceutical distributions, rather than limiting access to only the parties in the litigation.

But the Sixth Circuit has rejected numerous other attempts to challenge Polster, including a petition asking him to recuse from the MDL just before a trial originally planned last year between two Ohio counties and three distributor defendants. That case settled on Oct. 21 for $260 million.

Cuyahoga and Summit counties, the two Ohio plaintiffs, sought to amend their case to pursue claims against several pharmacies, which they had asked Polster to sever from the trial. The pharmacies insisted the amendments raised new claims against them as dispensers of opiate pharmaceuticals, not as distributors, and that Polster should not have allowed the Ohio plaintiffs to amend their complaint.

Their petition before the Sixth Circuit got support from the U.S. Chamber of Commerce and Lawyers for Civil Justice, which have pushed for new rules for MDLs.

In a statement on Wednesday, Lawyers for Civil Justice praised the Sixth Circuit's decision.

"This is an enormously important ruling not only for this high-stakes multidistrict litigation, but it also sends a clear signal to all parties in MDLs that they must comply with the Federal Rules of Civil Procedure and that there is no MDL exception loophole," said its executive director, Andrea Looney.

The Sixth Circuit concluded that Polster had inappropriately allowed the Ohio plaintiffs to amend their complaint almost 19 months after his initial 2018 deadline to do so. Polster, in a Feb. 25 response, insisted the move was necessary to make the MDL more efficient.

But the Sixth Circuit said the requirements of Rule 16(b) were "woefully unmet here."

"The district judge in this case is notably conscientious and capable, and we fully recognize the complexity of his task in managing the MDL here," Kethledge wrote. "But the law governs an MDL court's decisions just as it does a court's decisions in any other case."

The pharmacies, he wrote, had "certain procedural rights that the district court was bound to respect."

"The court's attempt nonetheless to inject those claims back into the pharmacies' cases was plainly contrary to the law, in the form of Rule 16(b) — which means that the court's decision to grant the counties leave to amend was a clear abuse of discretion," he wrote.

The Sixth Circuit said the other two rulings—refusing to allow pharmacies to file a motion to dismiss the amended complaint, and ordering the pharmacies to provide data for all prescriptions dating back to 2006—were moot given its decision. The appeals court noted, however, that the district court "may not refuse to adjudicate motions properly filed" under Rule 12(b). Also, while discovery must be limited to the needs of a case, that "does not prevent the MDL court from creating efficiencies in the MDL generally; to the contrary, presumably the very reason the cases were transferred to the MDL court in the first place is that the needs of some cases are the same as those of many others."

The ruling throws another wrench into the planned trial against the pharmacies. Last month, the pharmacies sought a 60-day delay in discovery and deposition deadlines in light of the COVID-19 outbreak.

Circuit Judge Richard Griffin and Senior Judge Eugene Siler Jr. joined Kethledge on the panel.

Kethledge and Griffin were appointed circuit judges by President George W. Bush, and Siler was appointed by President George H.W. Bush. Polster was appointed to the district court by President Bill Clinton.