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Big Pharma, big lawsuits

November 22, 2017
by Brian Albright
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Dozens of lawsuits filed by counties, cities and states against opioid manufacturers aim to hold the big drug companies accountable for the opioid crisis one way or another. The suits, citing fraud and consumer protection laws, have been filed by large cities like Chicago and smaller towns like Bridgeport, Conn.; by states led by Republican and Democratic governors; and from nearly every region of the country.

“Almost all of [the lawsuits] are claiming that the marketing of the products was fraudulent and misrepresented to the general public and to the physician constituency,” says Chip Babcock, an attorney with the Austin, Texas-based law firm Jackson Walker L.L.P.

In Florida, former Representative Gwen Graham has made a potential lawsuit against pharma companies part of her platform as she runs for governor. In other states, people affected by addiction have begun suing drug manufacturers as well as individual physicians. Thirty-six states have also filed an anti-trust lawsuit against the makers of Suboxone (buprenorphine naloxone).

In Ohio, the suit filed by Attorney General Mike DeWine is considered one of the strongest and exemplifies the types of charges made by other claimants. Ohio alleges that drug company efforts to overstate the benefits of prescription opioids while downplaying addiction risks directly led to the current addiction and overdose crisis. The suit claims that the drug companies have triggered a public nuisance under the Ohio Product Liability Act and that marketing practices violated the Ohio Consumer Sales Practices Act, the state’s Medicaid fraud statute and the Corrupt Practices Act.

“The United States is the largest consumer of painkillers by far,” says Matthew Chase, executive director of the National Association of Counties (NACo). “There were aggressive attempts to push out these pharmaceuticals.”

In September, a West Virginia attorney filed to have 66 similar cases consolidated. In addition, 41 state attorneys general have teamed up to investigate drug company marketing and sales practices, issuing subpoenas to Endo, Johnson & Johnson, Allergan, Teva, AmerisourceBergen, Cardinal Health, McKesson and Purdue Pharma. These could be the first steps toward a universal settlement, similar to the $206 billion agreement reach by 46 states and “Big Tobacco” in 1998.

The claimants in most of the prescription-opioid cases want to see an end to what they characterize as aggressive and misleading opioid marketing as well as help in shouldering the enormous cost to states, counties and cities now dealing with rising levels of addiction and overdose deaths. According to a study by the Centers for Disease Control and Prevention’s (CDC’s) National Center for Injury Prevention and Control, the economic burden of overdose, abuse and dependence in the United States topped $78.5 billion in 2013.

Even if the Big Tobacco settlement serves as a precedent, communities will continue to wonder if the legal action will make any impact on the opioid crisis.

 

Decades of aggressive marketing

“This is an epidemic that began in 1996, and the CDC has been very clear about why,” says Andrew Kolodny, MD, co-director of the Opioid Policy Research at the Heller School for Social Policy and Management, and executive director of Physicians for Responsible Opioid Prescribing. “As the medical community began to prescribe opioids more aggressively, the rates of addiction and overdose deaths went up.”

Just as the lawsuits assert, Kolodny says that drug company marketing practices drove a rapid increase in prescriptions.

“The messaging—and most of it came from the drug companies—was that patients were suffering needlessly, the risk of addiction had been overblown, opioids were safe and effective for long-term use, and we should be using them for many more people with pain,” he says.

Pharmaceutical manufacturers funded professional societies, specialists within their own speaker’s bureaus, according to some media reports, in order to push the message that more patients needed lengthier prescriptions for opioids in order to handle pain that had previously been treated using alternative methods.

Another Big Tobacco?

Babcock says that while the scope of the lawsuits and the speed at which they are proliferating are similar to the landmark case against Big Tobacco, there are some details that make the Big Pharma cases unique.

“Tobacco never enjoyed a government endorsement, and in fact, the government actively warned that tobacco was harmful to human health,” Babcock says. “In contrast, the FDA has approved opioid drugs as safe, and highly trained medical professionals have prescribed the drugs for their patients. Because there is a federal regulatory scheme in place, the pharmaceutical companies are claiming that federal law pre-empts the state laws. These consumer protection statutes would have to give way to federal interests in regulating the sale, marketing and supply of drugs.”

In addition to the FDA’s authority providing some defense to pharma companies, there are also other stakeholders in the healthcare system that are culpable. State pharmaceutical boards, distributors, hospitals, large pharmacy chains like CVS and Walgreens, and individual physicians have also played a role, and in some cases have already been held liable and fined by the federal government.

 

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