Big Pharma, big lawsuits

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.

Few changes

This is not the first time manufacturers have faced off against states over opioids. A decade ago, Purdue was sued over its aggressive marketing of OxyContin, but very little changed after the company settled.

“The settlements weren’t significant enough,” Chase says. “It didn’t change the behavior. In fact, these issues accelerated after that round of litigation.”

In that case, the lawsuits focused on Purdue’s branding of OxyContin as a less-addictive alternative because of its extended release formulation.

“But that was the least of what Purdue did,” Kolodny says. “What caused the epidemic was the campaign to change the culture of opioid prescribing. The settlement didn’t focus on what they had really done, so they were able to keep doing it.”

Purdue and three executives paid more than $630 million in federal fines, and the executives were convicted of criminal charges—each sentenced to three years probation and 400 hours of community service. It is estimated that Purdue’s OxyContin business has generated more than $31 billion in revenue.

There are already other settlements in the works, but most of these lawsuits have only been filed within the past few months.

“The problem is that there are so many lawsuits with such big exposure, the cases aren’t easily settled,” Babcock says. “That’s especially true with companies like Purdue, whose whole settlement posture is in a great deal of flux.”

Galen BioPharma recently agreed to pay $7.55 million to resolve federal claims that it had paid kickbacks to doctors to increase prescribing of its fentanyl-based Abstral product. The company also used a patient registry study to induce additional prescribing. McKesson, a drug distributor, paid $150 million penalty to the federal government after being accused of violating federal drug law related after failing to report suspicious orders in Kentucky.

Suits could generate changes

While a settlement might help counties cover the cost of services related to treating a staggering number of individuals with opioid addiction—including those who have turned to illegal substances such as heroin—advocates hope to see comprehensive changes as a result of the lawsuits.

“From a county official perspective, these lawsuits are less about money and more about behavioral change,” says NACO’s Chase. “We’re seeing through our jails, through child protective services and through foster care, dramatic increases in our caseloads. And ultimately we’re seeing huge increases in the workload of our coroners. Our number-one priority is behavioral change around the way these drugs are prescribed.”

Kolodny says the best result might be an end to what he calls the false marketing of opioids as safe and effective for long-term use. For example, Pfizer settled in two instances by agreeing to stop funding advocacy groups that promote the use of opioids. Pfizer also agreed to provide other documents and evidence to the city of Chicago that might be helpful in its suit against other manufacturers.

It’s important because some of the manufacturers are continuing to fund groups that block efforts to change prescription practices. The American Pain Foundation, the Pain Care Forum and the American Academy of Pain Management (now the Academy of Integrative Pain Management), for example, received millions in contributions from drug makers and have been accused of presenting deceptive information to physicians.

In addition, the Associated Press and Center for Public Integrity found that drug makers and allied advocacy groups were bankrolling an average of 1,350 lobbyists annually across the country from 2006 to 2015 to delay state efforts to limit opioid prescriptions.

Chase says counties want to see a change in federal policy that alters incentives for physicians, accelerates education for providers, and reaches out to consumers so that they are better aware of the risks of the medication.

“We can reduce demand and change incentives,” Chase says. “That’s really the key, in addition to penalties. If pharmaceutical companies are still making tremendous profits off of this, they are going to keep flooding the market.”

Funding treatment

If there are substantial settlement funds available, the experts have a number of ideas for the best use of that money. Treatment is at the top of the list.

“We have a significant backlog and a lack of professional treatment options, particularly in rural areas,” Chase says. “There’s an enormous demand for treatment. As law enforcement officials say, there’s no way we’re going to arrest our way out of this crisis. These pain pills are so addictive that it takes professional abuse counseling to get folks off of them.”

The approach to the crisis should also be smarter.

Eric Sun, MD, PhD, of the Department of anesthesiology, perioperative and pain medicine at the Stanford University School of Medicine, has conducted a number of studies on the distribution of chronic opioid users. According to a recent study his team conducted, published online September 12 in the Annals of Internal Medicine, three-quarters of all opioid prescriptions are prescribed to 10% of patients, and 59% of all prescriptions go to just 5% of patients. Broad approaches that make it harder for all patients to obtain painkillers penalize some while not effectively addressing the minority of chronic users.

“Opioids are not effective for long-term treatment of pain with the exception of cancer,” Sun says. “What can we do to address [patients] where they are and reduce what they are taking? That’s a clinical issue, not a legislative one. We can identify those patients and reduce their opioid use.”

Prescriber practices also need to be improved, Kolodny says.

“We are still massively overprescribing,” he says. “Doctors have had this drilled into them for more than a decade that they need to prescribe these drugs more frequently.”

Millions of patients have come to rely on long-term opioids for issues like back pain, and it’s difficult to change that trajectory, especially when millions of pain patients are dependent on opioids.

“Even for people who don’t become clearly addicted, the physiological dependence makes it hard to come off of them,” he says.

Kolodny also says that there should be funding for programs directed at correcting the misinformation that led to overprescribing in the first place. He advocates for easier access to treatment with buprenorphine, with a payment system that supports that access.

Costs mount in the meantime

In the meantime, Babcock says that pharmacies may shoulder some liability, as will hospitals and physicians who prescribe opioids.

 “This case cuts across almost every layer of delivery of medical services,” Babcock says. “It continues to escalate in its expense for states and municipalities in order to take care of people who have now become addicted. It is one of the biggest medical crises outside of tobacco we’ve ever faced.”

And the answers can’t come too soon for most communities.

“The private sector is enjoying the profits, and the taxpayers are suffering all of the costs, both in terms of loss of family, loss of communities, and the financial cost,” Kolodny says. “This epidemic has cost counties a tremendous amount of money.”

Behavioral Healthcare Executive reached out to the Pharmaceutical Research and Manufacturers of America for comment on this story. While they declined to comment on legal activities involving specific companies, a spokesperson noted that the industry announced in October a public-private partnership with federal agencies to develop non-addictive pain medicines and create new formulations that support long-term addiction recovery.

Plaintiffs pile on

Below is a list of some of the states, counties, and municipalities that have filed lawsuits against drug manufacturers, distributors and other entities related to the opioid crisis. In addition, a coalition of 41 states attorneys general have also issued joint subpoenas. While this list is not comprehensive, it does reflect the scope of the legal challenges currently underway.

STATES

• Arizona
• Illinois
• Kentucky*
• Louisiana
• Mississippi
• Missouri
• New Hampshire
• New Jersey
• New Mexico
• Ohio
• Oklahoma
• South Carolina
• Washington
• West Virginia*
• The Cherokee Nation

COUNTIES

• California: Orange, Santa Clara
• Kentucky: Boyle, Franklin
• Michigan: Ingham, Oakland, Wayne
• New York: Broome, Dutchess, Erie, Niagara, Rensselaer, Saratoga, Suffolk, Sullivan, Ulster
• North Carolina: Buncombe
• Ohio: Belmont, Brown, Clermont, Cuyahoga, Jackson, Licking, Ross, Summit, Vinton
• Oregon: Multnomah
• Pennsylvania: Beaver, Delaware
• Texas: Bowie, Marion, Upshur
• West Virginia: Cabel, Kanawha
• Wisconsin: Eau Claire, Marthon, Sauk

CITIES

• Birmingham and Gadsden, Ala.
• Phoenix, Ariz.
• Bristol, Bridgeport, New Milford, Naugatuck, Oxford, Roxbury, Waterbury and Wolcott, Conn.
• Miami, Fla.
• Chicago, Ill.
• Indianapolis and Kokomo, Ind.
• Louisville, Ky.
• Portland, Maine
• Greenfield, Mass.
• Newark and Toms River, N.J.
• Cincinnati, Dayton, Elyria, Lorain and Portsmouth, Ohio
• Everett, Seattle and Tacoma, Wash.
• Princeton, W.V.

*Have reached a settlement

Brian Albright is a freelance writer based in Ohio.