Opioid makers face hundreds of lawsuits for misleading doctors about drug’s addictive nature

Jerry Mitchell | The (Jackson, Miss.) Clarion Ledger

Show Caption Hide Caption Opioids and the FDA The country is in the midst of an opioid epidemic. Did the FDA play a role in how we got here?

JACKSON, Miss. — The federal judge overseeing about 200 lawsuits against opioid makers would rather curb the opioid epidemic than referee the litigation.

“About 150 Americans are going to die today, just today, while we’re meeting,” U.S. District Judge Dan Polster of Cleveland, Ohio, told the parties earlier this month. “And in my humble opinion, everyone shares some of the responsibility, and no one has done enough to abate it.”

He sees no value in depositions and trials, he said. “People aren’t interested in figuring out the answer to interesting legal questions like pre-emption and learning intermediary, or unraveling complicated conspiracy theories.”

Instead, “my objective is to do something meaningful to abate this crisis and to do it in 2018,” the judge said. “I’m confident we can do something to dramatically reduce the number of opioids that are being disseminated, manufactured and distributed. Just dramatically reduce the quantity and make sure that the pills that are manufactured and distributed go to the right people and no one else.”

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Opioid litigation, which started as a trickle, reached a flood last year when about 250 cities, counties and states sued opioid makers, wholesalers, distributors and marketers.

The lawsuits accuse the companies of misleading health care professionals and the public by marketing opioids as rarely addictive and a safe substitute for non-addictive pain medications, such as ibuprofen.

The companies deny the claims and say litigation should be halted until the Food and Drug Administration-ordered studies on the long-term risks and benefits of opioids are completed.

Experts say the sheer number of opioid lawsuits could lead some companies to settle.

"The litigation costs must be killing them," said Richard Ausness, a professor at the University of Kentucky college of law. "The problem is that a settlement with some plaintiffs will only cause more plaintiffs to sue."

Only a global settlement could prevent this, he said. "I am not sure that this would be feasible, although the Florida Legislature did it in connection with lawsuits against gun manufacturers."

Bloomberg has reported that Purdue Pharma, whose drug OxyContin jump-started the opioid epidemic, is proposing a global settlement in an attempt to end litigation. Purdue would not comment.

A new wave of litigation from Detroit and other Michigan cities and counties accuses companies of violating the Racketeer Influenced and Corrupt Organizations Act, a law created to fight the mob and organized crime.

The litigation alleges Purdue and other opioid makers “pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction.”

“We are deeply troubled by the opioid crisis, and we are dedicated to being part of the solution,” Purdue responded in a statement. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Paul Hanly, whose New York law firm, Simmons Hanly Conroy, is involved in 150 lawsuits, said governments “are learning that litigation may be the only avenue for them to recover some of the massive increased expenses related to the epidemic,” including the costs connected to emergency medical services, mental health, the judicial system, law enforcement, child services and rehabilitation.

With each new lawsuit, governments that have not sued are “taking a hard look at their rights and their obligations to their taxpayers,” he said.

Some hospitals are suing, too.

Hospital officials say they have been forced to treat patients for opioid addiction and overdoses as well as babies born with opioid addiction — treatment that is often lengthy and uncompensated.

In the latest wrinkle, several West Virginia cities have filed litigation against the Joint Commission, which accredits and certifies health care organizations and programs in the United States, alleging the nonprofit spread “misinformation” to health care professionals about the risks of opioid addiction.

In 2001, the commission began requiring hospitals to assess all patients for pain on a scale of 1 to 10, which some said caused more doctors to prescribe opioids.

Purdue gave the commission a grant to produce a pain assessment and management manual, which told health care providers, “There is no evidence that addiction is a significant issue when persons are given opioids for pain control.”

Commission officials have denied that change encouraged doctors to prescribe more opioids, blaming drug trafficking as well as diversion and abuse by individuals.

Earlier this month, the commission released new pain management standards, which require hospitals to have leaders responsible for “pain management and safe opioid prescribing.” Those hospitals also must identify high-risk patients and make prescription drug monitoring programs available to those prescribing opioids.

In addition to litigation, congressional investigations are underway, examining such questions as how drug wholesalers sold more than 780 million painkiller pills in six years to a single pharmacy in Kermit, W.Va., where fewer than 400 people live.

Every state attorney general has either filed a lawsuit against opioid makers or is involved in investigating whether these drugmakers misled health care providers about the addictiveness to opioids. Their offices have issued subpoenas for records from those companies.

On Oct. 26 — the same day President Trump declared that the opioid epidemic was a public health emergency — Justice Department officials announced the arrest of John Kapoor, the founder of Insys Therapeutics.

They accused him of using kickbacks to get doctors to prescribe Subsys, a fentanyl spray for cancer patients suffering from excruciating pain, to patients who didn’t have cancer.

Ausness, who has written about the opioids litigation, said the growing problem of overdose deaths and the publicity surrounding them “may be increasing public concern and thereby putting pressure on state and local officials to do something about it.

“Lawsuits, as presently underwritten by personal injury lawyers, are a cheap response and, if successful, may provide some extra funding for drug treatment programs at the state and local level.”

He believes lawyers are hoping for a repeat of the litigation against cigarette makers, which ended with a $206 billion settlement in 1998.

Ausness pointed out that “compliance with safety standards is only evidence that the product is not defective. It is not conclusive; however, some states have enacted laws that create a presumption that prescription drugs that are approved by the FDA are not defective.”

Those types of claims usually apply to warnings and design claims, he said. (The label for OxyContin declared, “ ‘Addiction’ to opioids legitimately used in the management of pain is very rare.”)

He doubts that FDA approval would provide much protection against fraud claims or negligent marketing claims based on failure to monitor distributors and retail sellers.

He also doubts any lawsuit against the FDA, which approved the drugs, would succeed because the drug approval process falls “within the ‘discretionary function’ exception to the Federal Tort Claims Act, which insulates decisions by federal officials that involve elements of judgment or choice.”

Follow Jerry Mitchell on Twitter: @JMitchellNews