State attorneys general, politicians, and plaintiffs’ counsel are increasingly filing lawsuits against pharmaceutical manufacturers and distributors
The growing number of lawsuits related to prescription opioid abuse has placed the pharmaceutical industry on alert, as many states and other governmental entities seek to shift the burden of responsibility onto companies involved in the opioid supply chain.
State attorneys general, politicians, and plaintiffs’ counsel are increasingly filing lawsuits against pharmaceutical manufacturers and distributors, claiming they share responsibility for the rise in opioid addiction. The lawsuits blame these parties for rising governmental agency spending on healthcare, addiction treatment, criminal justice, and other costs related to opioid abuse.
Some are comparing this to the legal strategy employed against Big Tobacco, in which 46 states forced tobacco companies to pay certain public healthcare costs for patients with smoking-related illnesses. While the theories and facts of the current litigation are distinguishable from the prior tobacco litigation, pharmaceutical manufacturers and distributors should be working now to determine their potential liability exposure, and carefully evaluate their company’s previous practices and circumstances surrounding the issues in dispute.
Some Key Considerations
Issues opioid defendant companies and their counsel may consider include:
1. Supremacy Clause. The Supremacy Clause of the U.S. Constitution mandates that federal law preempts state law. Among other reasons, given the role of the Food and Drug Administration (FDA) in reviewing and approving pharmaceutical drugs, there will likely be questions about whether these issues should be litigated as federal versus state issues.
2. Pain Management Alternatives. Another consideration is whether there were pain management alternatives, and if so, how the safety, efficacy, and physician preference compared to the subject drugs. The opioid crisis has prompted patients and physicians to seek alternative therapies. But it remains unclear if other prescription drug classes, over-the-counter options, acupuncture, massage, aqua therapy, or other pain-reducing methods have the same level of effectiveness.
3. Statistical Analysis. As part of new drug applications for products with the potential for abuse, the FDA requires pharmaceutical companies to submit information on the analysis of studies or information related to abuse of the drug. To the extent actual experience differed from these estimates, statistical analysis can be used to quantify the statistical difference between the anticipated abuse rates and those actually experienced. Additional investigation and analysis into which factors are influencing these variances may isolate causes unrelated to the actions of opioid defendant companies.
4. Reasons for Growth. The sale of prescription opioids has nearly quadrupled over the past decade according to the Centers for Disease Control. The question is: what are the key factors that have caused this increase? The parties may seek to identify and differentiate general demographic and market factors affecting demand including the aging U.S. population, increased diagnosis of conditions requiring on-going pain management, and the significant rise in orthopedic procedures (e.g., hip and knee replacements, spinal repair, rotator cuff surgeries, etc.) and other similar operations.
5. Healthcare Spending. States and local governmental entities filing lawsuits generally cite rising opioid addiction rates. How does the increase in opioid use compare with the increase in relevant healthcare spending? The Medicare and Medicaid cost data may be instructive to analyze the historical correlation between opioid prescriptions, opioid addictions, and the relative amount of public money spent on healthcare.
Questions about managing the growing opioid litigation? Connect with us at OLM@navigant.com
For more on the scale and impact of opioid litigation, read our opioid litigation report.