Opioid Epidemic and Overdose Deaths Blamed on Pharma in Ohio Lawsuit

At the National Mall in September 2016, family members of those who died of opioid overdoses attend a "Fed Up!" rally to end the epidemic. Ohio Attorney General Mike DeWine has filed a lawsuit against pharmaceutical companies he believes are implicated in the epidemic. John Moore/Getty Images

Updated | Ohio Attorney General Mike DeWine filed a lawsuit Wednesday against at least five pharmaceutical companies considered central to the nation's opioid epidemic. The filing is not the first legal action against painkiller manufacturers, but its inclusion of five large drug manufacturers makes it one of the most sweeping. And Ohio is the first state in the U.S. to file such a suit.

The lawsuit alleges that these companies engaged in fraudulent marketing practices that "helped unleash a healthcare crisis that has had far-reaching financial, social and deadly consequences for the state of Ohio." The drugs in question include brand names, such as OxyContin and Percocet, as well as generics, such as oxycodone. The pharmaceutical companies named as defendants include Johnson & Johnson, its subsidiary Janssen Pharmaceuticals, Purdue Pharma and Cephalon Inc.

These companies, says the lawsuit, violated the Ohio Consumer Sales Practices Act and distributed misleading information about the risks and benefits of the opioids they sell. DeWine is seeking public acknowledgment of culpability from the drugmakers, an injunction against further dissemination of allegedly deceitful marketing materials, damages for money spent by the state of Ohio on both the opioids and their addictive fallout, and reimbursement to consumers who were led to believe the pills would relieve chronic pain.

The opioid epidemic has a frightening grip on Ohio. According to the Centers for Disease Control and Prevention, 3,310 Ohioans died due to overdose in 2015, an increase of 21.5 percent from 2014, putting the state among the top five for overdose deaths in the country. Prescription opioids, as well as heroin and fentanyl, were implicated in those deaths.

The crisis there has been accompanied by wrenching reports of parents dying in cars with their children in the backseat and other disturbing events. Earlier this year, one Ohio county resorted to using a "mobile morgue" to store dead bodies due to an overflow at the actual morgue.

Public health experts support the attorney general's approach. "The point of legal action against manufacturers is not just to hold them accountable," says Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, "but also to deter future marketing and promotion that overstates the safety of these products."

Alexander says the lawsuit sends a powerful message to the pharmaceutical industry "that the marketing and promotion of opioids has to line up with the scientific evidence."

Pharmaceutical manufacturers named in the lawsuit have been quick to speak out against the action. "We firmly believe the allegations in the lawsuit are both legally and factually unfounded," says Jessica Castles Smith, spokeswoman for Janssen Pharmaceuticals. She says the company "has acted appropriately, responsibly and in the best interests of patients regarding our opioid pain medications, which are FDA-approved and carry FDA-mandated warnings about the known risks of the medications on every product label."

In a statement, Purdue Pharma said that Oxycontin accounts for less than 2 percent of opioid analgesic prescriptions and that the company is leading the development of abuse-deterrent technology.

Broader efforts also are underway. Earlier this year, U.S. Senator Claire McCaskill and the Homeland Security and Governmental Affairs Committee launched an investigation of drug companies that manufacture opioids. "We have received a substantial number of documents and continue to work with the companies involved in order to ensure the committee receives all the information it requested," says Drew Pusateri, spokesman for McCaskill.

Whether any of these actions will help stop the epidemic, of course, remains to be seen.

The lawsuit provides a compelling history of the opioid epidemic. Initially opioids were intended for short-term use or end-of-life care only. But, the document states, "by the late 1990s, and continuing today, each Defendant began a marketing scheme designed to persuade doctors and patients that opioids can and should be used for chronic pain, a far broader group of patients much more likely to become addicted and suffer other adverse events from the long-term use of opioids."

Drug companies have spent millions of dollars on promotional activities and marketing materials that dismiss the risks tied to opioids, the plaintiffs assert. And pharmaceutical practices used across the industry, such as identifying key opinion leaders, better known as KOLs, and sponsoring medical education materials have enabled opioid manufacturers to increase sales by influencing the doctors who prescribe these drugs.

According to the lawsuit, opioids are now the most prescribed class of drugs, with $11 billion in annual revnue in 2014 alone.

Ohio has paid its more than fair share. In 2012, more than 790 million doses of opioids were prescribed to patients in Ohio, "enough to supply every man, woman and child in the state with 68 pills each." In 2016, 2.3 million people in Ohio were prescribed an opioid; that's 20 percent of the state's entire population. At the moment, overdose deaths, which have been skyrocketing since 2003, are continuing to rise.

This story has been updated to include additional details about the lawsuit and to note that Ohio is the first U.S. state to file an opioid lawsuit against the pharmaceutical industry.