More than 1,300 suits filed against opioid makers; Mylan included in minor role

MORGANTOWN — Cities and counties across the country are seeking redress from the opioid industry for the public costs of the opioid epidemic.

Because of their similarities, the suits have all been gathered under one judge in the U.S. District Court for the Northern District of Ohio. The U.S. Judicial Panel on Multidistrict Litigation noted on March 28 that 1,396 cases had been filed, staring in 2017, and more have been added since.

They’re collectively called “National Prescription Opiate Litigation.” Along with various damages, the plaintiffs seek a national abatement fund to combat the epidemic.

Locally, Mylan has been named in about 298 cases — the most recent on April 18.

A March case filed by the city of Geneva, N.Y., which will be cited here, names 81 defendants. They include manufacturers such as Purdue Pharma, Endo and Mylan; wholesale distributors such as Cardinal Heath and AmerisourceBergen; and pharmacies such as CVS, Rite Aid and Walgreen’s.

Among the defendants, Purdue is often the chief focus. Its OxyContin constitutes about 30 percent of the opioid market. Mylan is a relatively small player with little involvement in the opioid industry. Those allegations and Mylan’s response will appear after a look at the bigger picture.

Many of the suits top 600 pages, so we’ll cover just some highlights of the charges against the manufacturers, combining entries from the Geneva suit, originally filed March 13, and one from Livingston, Mich., filed April 9.

The Livingston suit prefaces the problem in the dramatic language typical of such suits.

“Across the country, Americans are addicted to prescription drugs, synthetic opioids, and heroin at levels unprecedented in U.S. history. The opioid epidemic has led to carnage and devastation—including the loss of over 33,000 lives annually, the destruction of countless families and homes, and the incarceration of hundreds of thousands of addicts who have turned to crime in order to support their chemical addictions. The United States comprises less than 5 percent of the world’s population, but consumes over 80 percent of the world’s opioid products.”

The suits describe how before the mid-990s, opioids were recognized as suitable for short-term treatment of acute pain, such as after surgeries, and for cancer patients.

“Beginning in the mid-1990s, drug manufacturers aggressively over-promoted highly addictive, dangerous opioid products—falsely telling both the federal government, and the medical community, that the risk of opioid addiction and dependence was rare.” They launched “misinformation campaigns” to promote opioids for long-term chronic pain, underplaying and even denying the drugs’ addictive qualities.

“The misinformation campaign worked.”

The misinformation began, the suits allege, by taking a five-sentence letter from the New England Journal of Medicine. In it, a doctor said he’d seen no evidence of addiction among patients who took opioids during hospital stays.

The plaintiff point out that the letter referred to short-term use for acute pain, not long-term for chronic pain, but it served as the foundation for the campaign. Pro-opioid key opinion leaders (KOLs) such as Russell Portenoy (who later admitted his misuse of the information) used it for pseudo-academic papers, citing each other’s work as evidence.

They pushed this false evidence on doctors at training seminars and through company drug reps trained to convey the company message.

Purdue invited KOLs to training seminars at posh resorts. Doctors who attended seminars wrote twice as any opioid proscriptions as those who didn’t. “In return for their pro-opioid advocacy, Manufacturer Defendants’ KOLs received money, prestige, recognition, research funding, and avenues to publish.”

Manufacturers and KOLs, the suits allege, also formed front groups — the American Pain Foundation (APF), the American Academy of Pain Management and the American Pain Society — to promote their agendas.

They created the concept of “pseudoaddiction” to convince doctors to prescribe ever-higher doses.

The APF publication funded by Purdue, “A Policymaker’s Guide to Understanding Pain & Its Management,” says, “Unfortunately, too many Americans are not getting the pain care they need and deserve. Some common reasons for difficulty in obtaining adequate care include . . . misconceptions about opioid addiction.”

Because of pseudoaddiction, APF said, “the doctor should not assume the patient is addicted even if he persistently asks for a specific drug, seems desperate, hoards medicine, or overindulges in unapproved escalating doses. The doctor treats this patient by prescribing a high-dose, long acting opioid. … Pseudoaddiction can be distinguished from true addiction in that this behavior ceases when pain is effectively treated.”

The defendants also engaged in what the plaintiffs call “diversion enterprises.” By law, the suits say, manufacturers are supposed “maintain effective controls against diversion of their drugs, to design and operate a system to identify suspicious orders of their drugs, to halt unlawful sales of suspicious orders, and to notify the DEA of suspicious orders.”

Instead, the defendants deliberately failed to “to identify, investigate, halt, and report suspicious orders of opioids and diversion of their drugs into the illicit market, in order to unlawfully increase the quotas set by the DEA and allow them to collectively benefit from the unlawful formation of a greater pool of prescription opioids from which to profit.”

Mylan

Mylan produces about 1.1 percent of the world’s opioid products and is the 17th-largest opioid maker in the country. Its products include a generic Suboxone sublingual film; an acetaminophen/codeine phosphate tablet; a fentanyl transdermal patch; a morphine sulfate extended-release tablet; a naloxone hydrochloride injection for reversal of opioid depression and for diagnosis of overdoses; and a tramadol hydrochloride extended release tablet.

Some of the suits naming Mylan allege it marketed and promoted its drugs “through a highly deceptive marketing campaign that it carried out principally through its sales force and recruited physician speakers. Its campaign rested, upon information and belief, on a series of misrepresentations and omissions regarding the risks, benefits, and superiority of opioids, and incorporated each of the types of deceptive messages described herein.

“For example, Mylan, along with the other manufacturing defendants, focused their deceptive marketing, upon information and belief, on primary care doctors, who were more likely to treat chronic pain patients and prescribe them drugs, but were less likely to be educated about treating pain and the risks and benefits of opioids and therefore more likely to accept defendants’ misrepresentations.”

Mylan did not comment on the suit but a review of its recently released Global Social Responsibility report provided information on the topic.

It says, “Over the course of Mylan’s history, we have worked to help address some of the world’s most pressing public health problems. The ongoing opioid crisis is no exception. Mylan fully recognizes the scope of this issue and is committed to doing our part to help in the fight against opioid addiction, abuse and misuse. … Mylan is not promoting or marketing any of its opioid products.”

Mylan’s fentanyl patch incorporates the drug the adhesive layer of the patch, meaning it has no drug reservoir containing fentanyl gel.

“Lawful fentanyl products such as Mylan’s fentanyl transdermal system have been broadly acknowledged by federal authorities as not being responsible for the current fentanyl crisis,” it said.

Regarding payments to third-party advocacy groups and professional societies, Mylan notes that former Sen. Claire McCaskill issued a report in 2018 observing that its participation was minimal, and to only one of the 14 third parties cited in the report. “Moreover, Mylan continues to cooperate with separately disclosed government inquiries that it has received.”

Regarding diversion, Mylan said “We have internal practices designed to detect suspicious orders and prevent the sale of opioid-containing products where there may be a risk of diversion.”

It’s working to develop a new delivery system for non-opioid pain reliever Meloxicam. “We remain dedicated to working with key stakeholders across the spectrum of opioid-related issues to continue to identify avenues to help bring an end to this public health challenge.”

Tweet David Beard @dbeardtdp Email dbeard@dominionpost.com