Defending Against Opioid Cases in Louisiana: The Buckman Defense
Many know that opioid addiction and deaths via overdose have skyrocketed over the last few years. In 2016 alone, there were more than 63,000 deaths in the US from drug overdoses, almost all of which involved some form of opioid. Of those deaths, about one-quarter, or about 16,000, are related to prescribed opioids. The remainder are deaths related to illegal use of drugs such as heroin, smuggled fentanyl and fentanyl analogues, cocaine, benzodiazepines, and methamphetamine. Because of this, some commentators have argued that we have a drug overdose crisis, not a prescription drug crisis. See opinion article from The Hill here.
It is inevitable that the opioid crisis will spawn a great deal of litigation. Among the many possible claims will be allegations of violation of statutes and regulations promulgated by the federal Food and Drug Administration. In defending against such claims, skilled defense attorneys will need to marshal all possible defenses including a federal preemption defense based on the reasoning of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).
Defending Against Opioid Cases in Louisiana: Preemption Under Buckman
The Buckman defense is the argument that state common law and statutory claims are preempted by federal law and by regulations and decisions made by the Food and Drug Administration (“FDA”). In Buckman, the plaintiffs claimed to be injured by orthopedic bone screws. They sued the manufacturer’s regulatory consultant under state tort law claiming negligence and claiming that the consultant had obtained approval for the screws from the FDA by making fraudulent representations in various applications to the FDA. The US Supreme Court held that these fraud-on-the-FDA claims were preempted. The court noted that the FDA is tasked by Congress with achieving a “delicate balance” of protecting the health and safety of consumers and ensuring that helpful and needed drugs and medical devices reach the marketplace. As the court phrased it: “… the FDA is charged with the difficult task of regulating the marketing and distribution of medical devices without intruding upon decisions statutorily committed to the discretion of health care professionals.” The court held that the FDA’s balancing would be disrupted by allowing fraud-on-the-FDA claims under state law tort and negligence claims.
Defending Against Opioid Cases in Louisiana: Policy Justifications Underlying Buckman
Essentially, Buckman supports the idea that the FDA regulations are and should be enforced pursuant to a regulatory regime, rather than through civil litigation. There are many policy justifications supporting this idea including:
- Uniform national enforcement by the FDA rather than a patchwork of varying laws and precedents
- Consistency among regulations and enforcement is easier to obtain from one centralized regulatory agency
- Regulatory enforcement reinforces FDA’s efforts to strike that “delicate balance”
- Enhanced predictability
- FDA staff has relevant expertise and training helping to avoid disregard for accepted state of scientific research
- Emotions and passion can be tempered during the enforcement process
- Adversarial process may unfairly prey on jury biases and prejudices
- Cost efficiencies for the regulated industry gained by centralized administration
Defending Against Opioid Cases in Louisiana: Larger Applicability of Buckman’s Reasoning
Aside from providing a potential basis for having state law tort and negligence claims dismissed, the reasoning underlying Buckman has many applications. Buckman specifically involved medical devices and various FDA applications. The FDA regulations apply more widely than use-approval of medical devices. By analogy, the Buckman reasoning can apply to any and all FDA regulations. With respect to opioid prescriptions, this line of reasoning might be very helpful for any allegations related to “off-label” use of prescribed opioids.
Defending Against Opioid Cases in Louisiana
If you are interested in further information about opioid defense doctrines or need legal help or advice, you should reach out to an experienced Louisiana attorney as soon as possible.
The author may be contacted at:
Kristin M. Lausten
This article is provided as an educational service for general informational purposes only. The material does not constitute legal advice or rendering of professional services.