Thanks to the development and distribution of lifesaving vaccines, we are on a path to defeat a once-in-a-century pandemic. As the rollout continues, the knowledge that not only vaccines, but various medications and treatments, go through a rigorous review and approval process boosts our confidence in them. We saw this play out with the recent pause and then reinstatement of the Johnson & Johnson Covid-19 vaccine by U.S. regulators due to blood clot concerns.
Recent polling even demonstrates that Americans are more likely to trust the vaccine because the Food and Drug Administration and the Centers for Disease Control and Prevention are willing to step in and re-evaluate if and when necessary.
But there’s a problem. Some state courts issue rulings that impose liability on pharmaceutical companies that go beyond, and even contradict, the regulatory processes of the expert federal agencies that determine whether treatments are safe and effective for the public.
State Law and Federal Regulatory System in Conflict
It’s easy to see how allowing state courts to add additional regulatory burdens that are inconsistent with federal law will effectively hamper innovation and ultimately impact patient safety. The reality is that the conflict between state law and a federal regulatory system established by Congress poses a serious threat to public health.
The U.S. Supreme Court has an opportunity to review a case (Janssen Pharmaceuticals v. A.Y.) in which Pennsylvania’s courts did just this. The Supreme Court can and should decide to review this important case in order to re-establish the supremacy of federal law and rein in state courts that disregard the rule of law.
When a federal agency, in this case the FDA, prohibits unilateral changes to warnings in a medication’s package insert, state courts should not then hold liable product manufacturers who merely followed federal guidelines.
The Philadelphia Court of Common Pleas held Janssen Pharmaceuticals liable for not adding warnings about specific risks of off-label use associated with one of its pharmaceutical products. The Pennsylvania Supreme Court refused to review the decision.
Such rulings ignore the fact that the FDA prevents companies from unilaterally making changes to product labels once they’re approved by the FDA, including warning of risks of off-label use. If state courts are permitted to second guess the FDA, the agency’s authority and expertise will be severely undercut. This would potentially add 50 layers of regulatory uncertainty for companies that operate nationwide.
Pharmaceutical products go through a rigorous federal approval process and must adhere to strict guidelines to protect consumers. That process includes an ongoing requirement to report side effects, adverse impacts, and more. The FDA has the power and statutory obligation to ensure that prescription medicine labels appropriately communicate risks from off-label uses. FDA experts know how to best convey the information without diluting the labeling by including speculative or scientifically unfounded warnings.
As a practical matter, a state court holding the manufacturer of an FDA-approved product liable for not changing a mandated warning has the effect of overruling federal law. If allowed to stand, it would, we believe, violate the Supremacy Clause of the U.S. Constitution.
Creating this level of legal inconsistency and unpredictable liability will no doubt impair innovation and investment in the development of new treatments. It exposes businesses to 50 different state regulatory and liability structures, making it next to impossible to plan ahead financially when faced with such unpredictable legal environments that could result in billions of dollars in legal fees.
The unfortunate result is fewer resources for the research and development of potentially life-saving medicines, harming the very patients these expansive liability theories profess to benefit.
The remarkable vaccines now being administered demonstrate the importance of ensuring that the process for determining approval and use of lifesaving treatments and medications is not subject to the inherent uncertainties of individual state court decisions. We can be confident in receiving these vaccinations because extensive testing, and the ongoing analysis we’ve witnessed, show us they’re both safe and effective. We know the benefits of taking these approved products outweigh the risks that may arise. This includes disclosure of side-effects that are detected after a product is approved.
The Supreme Court has a chance to spur innovation, help protect Americans’ lives, and reestablish the supremacy of federal law. Moreover, the court can prioritize public health by reviewing Janssen and make clear that state courts cannot hold any party liable for simply following guidelines set forth by federal agencies.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
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Tiger Joyce is president of the American Tort Reform Association.