The Right to Try Laws in Drug Lawsuits: Would There Still Be Liability?

The issue of a patient’s “right to try” experimental therapies and drugs that haven’t been fully FDA approved is becoming an increasingly pressing issue in our age of advanced medical technologies. Thirty-one states have passed Right to Try (RTT) laws in an effort to allow terminally ill patients access to drugs, biologics and medical appliances the FDA has not vetted and condoned. Nineteen states have proposed RTT legislation and an RTT bill has been introduced into the federal House of Representatives, but no further federal action has been taken to pass the bill.

The issue of the “right to try” is a complex one involving the competing jurisdictions of state and federal law. One of the biggest questions being debated is whether manufacturers and physicians remain liable for adverse outcomes of experimental drugs under RTT legislation.

What Are RTT Laws?

The aim of RTT laws is to allow patients to obtain investigational medicines before the FDA has fully approved the treatment. Generally, the laws allow patient access to these drugs if the patient is terminally ill, the drug is recommended by a physician, the patient consents to the treatment after learning the potential risks and the drug has passed Phase I of the FDA’s clinical trials. Under state RTT laws, the manufacturer of the unapproved treatment and the recommending physician would presumably have protection from liability for damages to a consenting patient’s health.

Federal Preemption Poses a Problem

On a federal level, the Food Drug And Cosmetic Act (FDCA) does not permit the distribution of a treatment until the FDA ensures its safety and efficacy, which is a process that can often take years. RTT laws are designed to undercut and circumvent the FDCA policy, as many terminally ill patients do not have the luxury of waiting for the FDA.

Federal law, however, preempts state law and thus nullifies state-based RTT laws. Federal courts have ruled in favor of the FDA in previous drug-related cases, setting precedents that federal law supersedes and preempts state law in regards to the manufacture and distribution of medicine. This essentially renders well-meaning RTT laws useless under the power of the FDA. Drug manufacturers cannot legally allow patients access to unapproved medicine unless a patient is using the FDA’s expanded access programs.

The Issue of Liability

Despite the preemptive power of federal law, tort liability is a product of state legislation and is not regulated by the FDCA. A “tort” is a civil wrong which causes damage to someone else, and the liability for harm falls to the entity which perpetrated the tortious act. RTT laws offer protection from tort liability to drug manufacturers and physicians. As the FDCA does not specifically control tort liability, courts could potentially conclude that federal legislation does not preempt RTT laws in terms of liability. This means that the liability protection extended to manufacturers and physicians through RTT laws could possibly hold strong in court cases.

The hazard of tort liability has been a major reason why drug manufacturers are reluctant to allow patients access to unapproved treatments. If a precedent is set on protecting manufacturers from liability under RTT laws, manufacturers could be more likely to distribute their unapproved products through the FDA’s expanded access programs.