Makers hid opioids' dangers, lawsuits filed in Arkansas claim

2 cases key on marketing, doctor lobbying

Two lawsuits filed in separate state courts this month say opioid-makers lied about the risks and benefits associated with their addictive painkillers through a deceitful marketing scheme for years.

Both suits blame opioid-makers' advertising practices and lobbying efforts for the flood of pain pills in the state, where opioid prescriptions outnumbered people in 47 out of 75 counties in 2016.

Officials and lawyers involved in the cases say the swell of prescriptions over nearly two decades jeopardized Arkansans' health and burdened taxpayers.

"Drug companies should never place their desire for profits above the health and well-being of customers or the communities where the customers live," state Attorney General Leslie Rutledge said at a Thursday news conference announcing the filing of a state lawsuit.

"In short, these manufacturers lied ... and helped to unleash a health care crisis that has had far-reaching financial, social and deadly consequences in Arkansas and across the nation," she said.

Both suits seek punitive monetary damages. The state's suit also seeks an injunction to stop what it calls deceptive marketing practices.

The suit filed by Rutledge in Pulaski County Circuit Court on Thursday targets three companies -- Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson -- which she said manufacture the most-used opioids in the state.

A coalition of Arkansas jurisdictions made up of 87 counties and cities filed a similar lawsuit in Crittenden County Circuit Court on March 19 against 52 opioid manufacturers, including Purdue, Endo and Johnson & Johnson. That effort is led by the Association of Arkansas Counties and the Arkansas Municipal League.

Both complaints pinpoint the same methods they claim the sued companies used to mislead patients and doctors.

Opioid manufacturers encouraged doctors to prescribe more painkillers, even when patients showed signs of addiction, for instance.

The concept of "pseudo-addiction" -- that addictive behaviors aren't warnings, just indicators of undertreated pain -- was pushed to physicians who would later write opioid scripts via webinars and other Purdue-sponsored programs, the suits allege. The doctor who popularized this idea was also paid by Purdue, Endo and Janssen, a pharmaceutical company owned by Johnson & Johnson, court records stated.

The newspaper wasn't able to immediately reach any of the manufacturers for comment.

On Purdue's website, an undated letter says the company supports measures to limit first-time opioid prescriptions and recommends that physicians check their states' prescription drug monitoring database to make sure that patients aren't doctor-shopping to get more pain pills.

"As we continue to fight the prescription opioid and illicit substance abuse crisis, we are applying our resources and our best scientific minds to discover and develop new, non-opioid pain medicines for patients," the letter reads. "No one solution will end the crisis, but multiple, overlapping efforts will. ... This is our fight, too."

The two lawsuits also alleged that the drug companies paid physicians to participate in "speaker bureaus" that promoted a particular opioid during forums attended by other doctors.

"These speakers give the false impression that they are providing unbiased and medically accurate presentations when they are, in fact, presenting a script prepared by [manufacturers]," the county association and municipal league's suit said.

Selected speaker-doctors and opioid-makers also worked with "front groups" claiming to be independent patient advocacy organizations to change how doctors, patients and officials perceive painkillers, the suits said.

One such group, the American Pain Foundation, had financial ties to Purdue, Endo and Janssen. The foundation's board was composed of speaker-doctors, and it also received more than $10 million from opioid companies, with Endo providing at least $5 million, the suits said.

While receiving money from opioid-makers, the foundation released educational guides for patients, journalists and policymakers that "touted the benefits of opioids for chronic pain and trivialized their risks, particularly the risk of addiction," according to Rutledge's suit.

Other similar organizations that received contributions from the opioid-makers drafted treatment guidelines that recommended the use of painkillers for chronic pain, even though the same companies were aware of the risks that came with prolonged use of such narcotic drugs, both suits said.

In the state suit, Rutledge said that the "guidelines have been a particularly effective channel of deception," influencing physicians and the "body of scientific evidence on opioids," having been cited 732 times in academic literature and reprinted in The Journal of Pain.

Both suits call into question how opioids were branded online and in medical journal advertising.

A video on Forbes.com introduced Hyslinga, Purdue's newer brand-name hydrocodone, and implied that undertreated pain patients could be driven to suicide, Rutledge's suit stated. Other examples are seen in ads by Endo and Purdue, where chronic pain patients' function is improved by opioid use.

The attorney general's suit differs from the county-led one in that it claims that companies violated deceptive-trade laws by "knowingly making false representations" of the drugs' characteristics and advertising their use under false pretenses.

Rutledge also argued that the companies committed Medicaid fraud, since the state wouldn't have reimbursed claims for these prescriptions if the opioid-makers hadn't lied about the drugs' effectiveness in chronic-pain patients.

Between 1999 and 2017, the state's Medicaid program reimbursed pharmacies at least $6.2 million for prescriptions for opioids made by the three companies, according to federal data. Medicaid covered more than 670,000 individual prescriptions for those companies' opioids during those years.

The other circuit court suit argued that opioid-makers were grossly negligent and endangered the public health, welfare and safety of Arkansans.

Manufacturers also broke the state's Uniform Narcotic Drug Act because they failed to "maintain effective controls against opioid diversion," according to the suit. The law outlines how controlled substances may be sold and used.

"Prescription opioid diversion and the corresponding increase in abuse, addiction, and criminal activity has placed an insurmountable demand on County and City resources," the suit stated.

A third Arkansas opioid lawsuit, filed in federal court, argued that opioid manufacturers and distributors should pay for the costs related to local opioid misuse. That suit is now part of an effort called the National Prescription Opiate Litigation, which was transferred to the Northern District of Ohio last year.

The group litigation combines more than 150 separate suits involving municipalities from Alabama, California, Illinois, Kentucky, Ohio, Washington and West Virginia. In the past month, jurisdictions from additional states filed paperwork to join the litagation.

Rutledge wants to keep the state's lawsuit separate. A representative from her office said that she "determined that an individual lawsuit focused on the disproportionate harm to Arkansas and Arkansans was the best way to proceed on behalf of the citizens."

Richard Wroten, executive vice president of the Arkansas Medical Society, said it was too early to comment on either lawsuit and that the issue may come up during the group's next board meeting in May.

In December, the board unanimously approved regulations limiting how doctors prescribed opioids to most patients.

Metro on 03/31/2018

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