Developments in Medical Device and Drug Litigation

June 18, 2024

In this alert, David Graham highlights three significant litigation trends that have emerged over the last year. The disregard and assessment of current doctrines, as well as the targeting of over-the-counter medications are key focuses in 2024. Read below for some highlights or watch David’s recent presentation on these topics.

1. Disregard of Established Doctrines

First, State courts could be ignoring time honored doctrines such as the learned intermediary doctrine and FDA arbitors of drug approvals and safety to find liability under state consumer protection standards. In State ex. Rel. Shikada v. Bristol Meyers Squibb, the Hawaii Supreme court held that Bristol Meyers violated Hawaii’s UDAP statute when in failed to conduct further research on the efficacy of Plavix (anti-clotting drug) in persons with a certain genetic mutation which limits uptake of the medicine. It also stated that Bristol Meyers should have warned patients of possible lower efficacy for certain patients with the genetic mutation. It did not seem to matter to the court that FDA approved the medicine and that physicians usually decide what is the best therapy for patients. Finally, the court ignored testimony Hawaii state purchasers of Plavix that it probably would have paid for the medicine even if it knew more about the efficacy issue for certain patients.

2. Plaintiffs Target OTC Medications

Second, plaintiff lawyers are turning their sights on OTC medications in class action lawsuits such as those against Acteminophen productrs and Zantac. It is easier to file suit in cases related to OTC drugs because there are fewer factual and legal obstacles, including the learned intermediary doctrine and expert prescriber issues. Much of this litigation focuses on a particular allegedly harmful ingredient or efficacy claims that plaintiffs believe are inaccurate. It is often funded by litigation funds and “independent laboratories” are used to find defects upon which plaintiffs might base a lawsuit.

3. The Future of the Chevron Doctrine

Third, the United States Supreme Court is considering changes to or the elimination of the Chevron Doctrine. That Doctrine allows judges to defer to agencies’ reasonable interpretations of ambiguous laws in litigation. If a court determines that a law is ambiguous and the agencies interpretation is reasonable, that interpretation should be followed by the court.

If the Court does not eliminate the doctrine, the Court could better define what is reasonable, make sure the agency is acting with the force of law, ask courts to look more closely for statutory indications that Chevron may not apply, instruct courts on how to deal with statutory silence, say that there is no deference unless there is consistent agency interpretation over time, or some combination of these possible changes.

Expert legal guidance is essential to navigate the evolving landscape of these types of litigation. Additionally, as more of these lawsuits arise, adept legal counsel can provide invaluable assistance in addressing the nuanced legal and factual challenges inherent in such cases. Gardner Law has extensive experience with these types of cases and can assist companies of all sizes. If you have questions, the team at Gardner Law can help.