JURIST Guest Columnist Lauren A. Rousseau of the Western Michigan University Cooley Law School discusses the impact that the onslaught of litigation against the pharmaceutical industry could have on the opioid epidemic…

According to the federal Centers for Disease Control, over 63,600 people died of drug overdose in the United States in 2016 – an average of 174 deaths per day. This was a 21% increase compared to 2015, and more than three times the number of such deaths in 1999. The annual number of overdose deaths has been steadily rising over the last fifteen years, leading many to refer to our current drug problem as an epidemic. And this epidemic has been driven largely by addiction to opioid drugs. In 2016, more than 42,000 overdose deaths, or 72%, were related to opioids, which includes prescription painkillers such as Vicodin, Lortab, Percocet, and OxyContin, as well as illicit drugs such as heroin and fentanyl. In October 2017, President Trump formally declared our country’s drug problem a public health emergency.

Much media attention has been given to the role pharmaceutical companies have played in creating the opioid epidemic. In the mid-1990s, the medical community’s conclusion that pain was undertreated converged with Purdue Pharma’s introduction of its new, extended-release opioid drug OxyContin, setting the stage for a sea change in how opioids were used and prescribed. Prior to this, opioids had been viewed as dangerously addictive and were prescribed only under limited circumstances, but Purdue claimed that OxyContin was virtually non-addictive when prescribed for pain and aggressively marketed it for long-term use. Its marketing strategy was wildly successful; sales of OxyContin exploded from $45 million in 1996 to $3 billion in 2012. Other opioid drug manufacturers jumped on the bandwagon, with the result that opioid prescriptions in this country nearly quadrupled from 1999 to 2010. By 2012, more than 259 million opioid prescriptions were written – enough for every American adult to have his or her own bottle of pills.

We are all now painfully aware that opioid drugs are extremely addictive. Opioid overdose deaths have risen in tandem with the increase in opioid prescriptions. Prescription pills also served as a gateway to heroin use. Heroin is a stronger and cheaper opioid, and once a person becomes addicted to prescription pills, cost and difficulty obtaining pills often drive the person to heroin. According to the American Society of Addiction Medicine, four out of five heroin users start with prescription pills.

The drug epidemic has been extremely costly to our country, in terms of both human life and dollars. Over 500,000 people have lost their lives since 2000 due to drug overdose, and it is estimated that another 500,000 will die from this cause by 2027. The cost to our society, in terms of lost wages, productivity, and tax revenue, as well as increased spending on health care, social services, education, and criminal justice, is estimated to have exceeded $1 trillion from 2001 to 2017. Increasingly, state and local governments are looking to the pharmaceutical industry to cover these costs.

Purdue Pharma has been repeatedly sued based on its misrepresentations concerning the addictive nature of its opioid drugs. The company pled guilty in 2007 to criminal charges of misbranding OxyContin with the intent to defraud and mislead the public, and paid $635 million in fees and fines. Other drug companies have also paid millions of dollars in civil penalties and fines in connection with their opioid drugs.

In September 2017, the attorneys general of 41 states announced that they were banding together to investigate opioid manufacturers and distributors to determine their role in creating the opioid epidemic. And in the past year and a half, hundreds of lawsuits have been filed by cities, counties, and states in both state and federal courts against opioid drug manufacturers and distributors, alleging misleading marketing and failure to monitor, detect, investigate, and report suspicious orders of opioid drugs.

In December 2017, 64 opioid lawsuits filed in federal courts in Alabama, California, Illinois, Kentucky, Ohio, Washington, and West Virginia were consolidated by the federal Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Ohio under Judge Dan Polster. Since then, the litigation has grown to include more than 250 lawsuits, and is known as the National Prescription Opiate Litigation, MDL #2804. Ohio was chosen as the venue because it has the second highest overdose death rate in the nation (second only to West Virginia), is geographically central and accessible to the parties, and is home to one of the largest wholesale drug distributors.

The opioid litigation has been compared to the tobacco litigation of the 1990s, which resulted in the largest civil settlement in our nation’s history. In those cases, 46 state attorneys general claimed that the tobacco companies were liable for the costs of treating smoking-related illnesses. The settlement exceeded $200 billion, with the companies agreeing to make annual payments to the states to fund smoking prevention campaigns and other health programs. Unfortunately, much of that settlement money has been diverted by the states for purposes unrelated to smoking.

The opioid litigation plaintiffs face challenges that the tobacco plaintiffs did not. In the tobacco cases, smokers weren’t misusing the products, but got sick anyway; with opioids, users who develop addiction inevitably take more of the drug than is prescribed, and often engage in criminal behavior such as doctor-shopping, forging prescriptions, or stealing pills. These behaviors make it harder to hold pharmaceutical companies liable for the consequences of opioid use. Historically, courts have laid blame for drug misuse on the individual user, not on pharmaceutical companies. Moreover, in the tobacco cases, the companies were marketing directly to consumers, making it easier to link tobacco use to the companies’ actions; with opioids, pharmaceutical companies directed their marketing campaigns at doctors, who then prescribed the drugs to their patients. The companies can point to doctors as an intervening cause, alleging that they overprescribed and should have recognized signs of addiction in their patients.

Despite the challenges, it is clear that the pharmaceutical industry is facing significant potential liability. Judge Polster has indicated that he would like to see these cases resolved through settlement before trial. In February, he invited representatives of all the parties to begin settlement discussions, and included representatives of state court opioid lawsuits, the state attorneys general who banded together to investigate the industry, the federal Drug Enforcement Agency, the Food and Drug Administration, and insurance companies. By all appearances, Judge Polster is working to craft a global resolution designed to turn the tide on the opioid crisis.

However the lawsuits are resolved, they will surely have a positive impact on health policy and community attitudes towards addiction. The hundreds of filings publicly demonstrate the pervasiveness of the disease, showing that it hits all communities, all socioeconomic classes, and all ages and ethnicities. This helps to reduce the stigma associated with addiction that so often is a barrier to treatment and recovery. The lawsuits have shown a spotlight on the deceptive marketing practices of the pharmaceutical industry, to the benefit of both doctors and patients, many of whom will now take more care in how they deal with medications. The lawsuits also provide support for government regulation that is clearly needed to curb excessive prescribing by doctors, misleading marketing behaviors of pharmaceutical companies, and irresponsible drug distribution. In a possible harbinger of things to come, Purdue Pharma announced on February 10th that it will voluntarily stop marketing its opioid drugs to doctors.

A large monetary settlement of these cases could make a significant difference in reversing the upward trend in overdose deaths and addiction. There is a serious shortage of treatment beds, facilities, and trained personnel to treat addiction, and funding could alleviate these problems. Money is also needed for prevention efforts in schools, education and awareness campaigns, health care reimbursement costs, addiction treatment in the jails, first responder training, and supplies of the overdose reversal drug naloxone. Taking a lesson from the failures of the tobacco settlement, any opioid litigation settlement should include provisions to ensure that states are using the money for its intended purpose, and not diverting it to other uses.

Concern has been raised by some that the pendulum may swing too far, and that patients with legitimate pain may be denied needed medication. This is a legitimate issue. However, scientific studies have demonstrated that long-term opioid therapy for chronic pain is not as effective as once thought, and that non-opioid pain relievers can provide comparable relief. Furthermore, the liability and addiction issues surrounding opioid drugs are spurring research into alternative pain therapies that are safer and equally effective.

In conclusion, the avalanche of lawsuits filed by cities, counties, and states against the pharmaceutical industry holds promise as a significant step forward in combatting the opioid epidemic. Lives literally hang in the balance as Judge Polster works with the parties to craft a settlement that could finally turn the tide on this scourge that is devastating our nation.

Lauren A. Rousseau is a professor of law at Western Michigan University Thomas M. Cooley Law School. She is President of the Northwest Wayne County Chapter of Families Against Narcotics, and has spoken and written extensively on the subject of addiction and the opioid epidemic. In 2016, she was honored as one of Michigan Lawyers Weekly’s 2016 Women in the Law in recognition of the work she has done in the area of addiction treatment, education, and advocacy.

Suggested citation: Lauren A. Rousseau, Lawsuits for the Opioid Epidemic, JURIST – Academic Commentary, Mar. 12, 2018, http://jurist.org/forum/2018/03/Lauren-Rousseau-opioid-epidemic.php