AG Matt Denn takes on Big Pharma in opioid lawsuit

The state Attorney General's Office is taking on Big Pharma — drug manufacturers, distributors and drugstores — who put powerful, painkilling opioid drugs into the hands of Delawareans, according to a lawsuit filed Friday.

The filing details the ways in which manufacturing companies like Purdue Pharma and Endo Pharmaceuticals knowingly misled doctors and consumers of opioids, saying the drugs are not powerfully addictive and dangerous to the consumer. 

That omission – and the subsequent distribution and prescription of those drugs to the larger population – resulted in the death of 694 Delawareans from 2007 to 2016 specifically from prescription opioid-related overdoses, the lawsuit claims. Of those deaths, 112 were in 2016 alone.

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“Opioid manufacturers misrepresented the addictive nature of their products. They, along with national opioid distributors and national pharmacies, knew that they were shipping quantities of opioids around the country so enormous that they could not possibly all be for legitimate medical purposes, but they failed to take basic steps to ensure that those drugs were going only to legitimate patients,” said state Attorney General Matt Denn. “These companies ignored red flags that opioids were being diverted from legitimate channels of distribution and use to illicit channels. The failure of these corporate defendants to meet their legal obligations has had a devastating impact on Delawareans.”

In addition to the continued loss of life, Delaware also loses about $100 million annually in resources for health care, criminal justice, social services and education – all of which have been impacted by the opioid epidemic, according to the lawsuit. Recovering those dollars is a portion of the "request for relief" in the state's filing.

Nearly all companies named in the state's lawsuit told The News Journal that they are committed to addressing the opioid epidemic and either hope to be a part of the conversation around how to fix it or have already taken steps to address addiction. Some, including Endo Pharmaceuticals and Cardinal Health, added that they deny the allegations and plan to defend themselves in court.

"We operate as part of a multi-faceted and highly regulated healthcare system – we do not promote or prescribe prescription medications to members of the public – and believe everyone in that chain, including us, must do their part, which is ultimately why we believe these copycat lawsuits filed against us are misguided, and do nothing to stem the crisis," Cardinal Health said in a written statement. "We will defend ourselves vigorously in court and at the same time continue to work, alongside regulators, manufacturers, doctors, pharmacists and patients, to fight opioid abuse and addiction."

Besides a trial by jury, Delaware is seeking a cease-and-desist order for the manufacturers and distributors, monetary damages for the increased costs to numerous Delaware systems impacted by the epidemic, penalties for violating Delaware Code and "the cost of lost productivity and lower tax revenue" for the state.

An exact dollar amount is not provided because it depends on the number of false claims and wrongdoings that the state can prove.

Delaware's lawsuit isn't the first of its kind in America to challenge Big Pharma's role in the opioid – and subsequently, heroin – epidemic. But it challenges the role that distributors of these drugs, like McKesson Corp., Cardinal Health Inc., AmerisourceBergen, Anda Pharmaceuticals Inc. and H.D. Smith, along with pharmacies like CVS and Walgreens, played in filling forged prescriptions and not cracking down on the high requests for pills.

Many Americans became addicted to pain pills as doctors began prescribing them more frequently. When law enforcement and federal regulations cracked down on the pills, demand for a substance that would provide the same results skyrocketed.

Because drugs like oxycodone and Percocet have high-dollar values on the street, some turned to heroin, which was far cheaper. The federal Drug Enforcement Administration estimates that one bag of heroin costs $5 to $10 in Delaware, making it cheaper than a beer in some local bars.

Similarly, the illegal use of prescription drugs continues to have an impact. 

According to the lawsuit, 860,000 opioid prescriptions are issued in Delaware each year – almost one prescription per Delaware resident – but "studies suggest that as many as 110,000 of those prescriptions are diverted to non-medical uses."

"In the past few years, Delaware has seen annual distribution exceeding 50 pills per resident and 440 pills per opioid user," according to Drug Enforcement Administration data cited in the filing.

What's new about these lawsuits is the naming of pharmacies and their role in getting prescription drugs into the hands of people who, according to the lawsuit, submit forged prescriptions or whose behavior would flag the state's prescription drug monitoring system. 

CVS Pharmacy, which is named in the lawsuit, also partners with the state to distribute the overdose-reversing drug, naloxone. This initiative went into effect late last year, allowing more people to access naloxone in a local pharmacy rather than by attending a community training event.

The company, according to the state's lawsuit, has also paid out millions in settlements for its prescribing practices. 

Mike DeAngelis, senior director of corporate communications for CVS Health, said that though the company had not yet seen or reviewed the complaint, it has already taken extensive measures to combat the diversion of prescription drugs, including training for its pharmacy teams.

"CVS Health is strongly committed to working with the DEA and other regulatory and law enforcement agencies to help reduce prescription drug abuse and diversion while ensuring access to appropriate, effective pain medications for patients who need them," he said. 

Similar to CVS, Walgreens partners with the state for the placement of drug take-back boxes in locations throughout Delaware.

There's been a recent push for lawsuits of this sort, specifically by counties and states most impacted by the heroin and opioid epidemic. Just last month, Cecil County, Maryland, officials announced their intent to also file a lawsuit for the reimbursement of monies lost in fighting the opioid epidemic.

In the past, these pharmaceutical companies have shelled out millions in settlements. Purdue Pharma paid some $600 million after a 2007 ruling against the company, showing they knowingly misled doctors and consumers.

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As recently as August 2017, Purdue settled for more than $20 million with multiple Canadian plaintiffs over claims that "the company failed to warn about the dangers of OxyContin, including its addictive properties," according to the lawsuit.

But as Denn points out in the court filing, it has done little to curb the continued production and distribution of these drugs.

These manufacturing companies "have engaged in a multi-million dollar marketing campaign to minimize and misstate the risks of addiction and abuse when prescription opioids are used to treat chronic pain," according to the state's case.

The complaint cites training that Purdue held in the late 1990s and early 2000s during which addiction was described to doctors as "exquisitely rare" and notes information on the company's website as recently as last year that indicates their own knowledge about the drugs' addictive powers.

A letter posted on the company's website explains how Purdue is looking to fight the opioid epidemic, citing the development of opioids with "abuse-deterrent properties."

"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," according to the letter.

The Healthcare Distribution Alliance – the national trade association representing wholesale distributors – contends that companies merely distributing and delivering these pills to providers shouldn't be included in lawsuits like these because they "don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers," according to a statement from spokesman John Parker.

“Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated," Parker said in a statement.

Already this year, Delaware has lost eight people to suspected drug overdoses – and, as documented by The News Journal, the epidemic's toll of Delaware is nearly impossible to quantify. 

Gov. John Carney mentioned the epidemic in his State of the State address Thursday, noting that though strides have been made, there will be more reforms coming under the oversight of Lt. Gov. Bethany Hall-Long.

"We strengthened oversight of opioid prescriptions, expanded access to substance abuse treatment and better coordinated our efforts to help those battling addiction," Carney said.

But what many refer to as the public health crisis of this generation continues to ravage the state.

"Adverse social outcomes include child neglect, family dysfunction, babies born addicted to opioids, criminal behavior, poverty, property damage, unemployment, and social despair," according to the lawsuit. "As a result, more and more of Delaware’s resources and those of its counties and municipalities are devoted to addiction-related problems.

"Meanwhile, the prescription opioid crisis diminishes Delaware’s available workforce, decreases productivity, increases poverty, and consequently requires greater State and local expenditures."

And, according to the state and many others, the negligence of Big Pharma and the companies that work with them are to blame.

In previous interviews, Denn has pointed to the families of those who have lost their battle with addiction as reasons for undertaking this effort as attorney general.

"No person can meet those people and see that and not feel compelled to try and do something about it," Denn said.

Contact Brittany Horn at (302) 324-2771 or bhorn@delawareonline.com. Follow her on Twitter at @brittanyhorn.