User:EF1007/FDA preemption

FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). FDA preemption does not apply to every product approved by the Food Drug and Cosmetic Act, and may not apply under every circumstance, given the Supreme Court's evolving interpretation of the issue. FDA preemption applies to many vaccine manufacturers, however, since Congress expressly preempted lawsuits against vaccine manufacturers when it established the Vaccine Injury Compensation Program in 1988.

It has been a highly-contentious issue. In general, FDA preemption deprives injured people of their day in court, so some consumers are against it. Pharmaceutical manufacturers and pharmaceutical lobby groups are in favor of exemptions, arguing that the FDA should set both the floor and the ceiling for drug regulation, and that these regulations should preempt all state laws, whether they are stricter or more relaxed,.

Federal Preemption Generally
Under the United States Constitution, federal law is the "supreme Law of the Land" and thus overrides any state laws that conflict with it. There are three ways that federal preemption may occur: (1) express preemption; (2) implied preemption; and (3) conflict preemption. Express preemption occurs when Congress clearly states that state laws are superseded by the federal law. Implied preemption occurs when the "structure and purpose" of the federal law demonstrates Congress' intent to override conflicting state law. Conflict preemption occurs when it is impossible to obey both the federal and state law, and thus the federal law prevails.

Legislators may preempt, or protect, certain product manufacturers from lawsuits to advance policy goals. For example, vaccine manufacturers are often shielded from lawsuits because Congress decided that vaccinating the public is an important policy goal. Additionally, the federal government has wholly preempted state regulation of medical devices, meaning that states must follow the federal guidelines and cannot implement stricter guidelines for medical devices. The federal government has also preempted state HIPAA laws by setting a minimum privacy standard for patient health information; any state law that conflicts with or is less strict than HIPAA is preempted.

History of Food and Drug Preemption
The United States began regulating food and drugs in 1906 when Congress passed the Pure Food and Drug Act (PFDA) to combat unsafe drug production, labeling, and distribution. The PFDA faced numerous challenges at the Supreme Court, so Congress increased food and drug regulation authority by passing the Federal Food Drug and Cosmetic Act and thus creating the Food and Drug Administration (FDA).

The FDA is "responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, [and] cosmetics." Its Federal Register is the sole method of seeking approval for, and tracking, drugs in the U.S. The FDA also solely approves and manages food and drug labeling rules, record keeping requirements, investigations, and adverse food and drug events. The FDA must approve drug labels that include directions for use, warnings, and instructions for adverse events. Failure to use the Federal Register to report about, or seek approval for, food and drugs in the U.S. could result in monetary penalties or even prison time.

The FDA has long held that its drug labeling requirements should be the "floor and ceiling" of regulating drugs, and expressly preempt any state law regarding the same. The FDA approves drugs based on a cost-benefit analysis: if the potential therapeutic benefits of a drug outweigh the risks, it will be deemed "safe" and thus approved. Many drugs come with significant risks, however, but the FDA maintains that "a requirement that a drug be safe under all circumstances would deprive a number of patients of beneficial drugs."

U.S. Courts have invalidated drug manufacturers' claims of preemption in many circumstances. Medtronic Inc. v. Lohr was considered a leading case on the scope of express FDA preemption. There, a woman's pacemaker failed and caused her serious injuries, so she sued Medtronic. Medtronic argued that FDA preemption shielded them from suit. The Supreme Court held that medical device manufacturers are not completely immune from suit, and reasoning that there was no evidence that Congress intended to preempt standard common law duties, like making safe products.

In Motus v. Pfizer, as another example, the plaintiff claimed that Pfizer failed to warn of increased suicidal thoughts associated with an antidepressant. The California Central District Court held that the plaintiff's claim was not preempted by federal law, because state failure-to-warn laws advanced Congress' goal of promoting drug safety. The Ninth Circuit Court of Appeals heard the case and declined to decide the preemption issue, instead ruling in favor of Pfizer on the issue of whether the failure to warn actually caused the plaintiff's injury. The FDA used this case as an opportunity to clarify the federal government's position on preemption, by listing various types of claims in its brief that drug manufacturers cannot be sued for.

Wyeth v. Levine was considered a seminole case on FDA preemption for about a decade. In Wyeth, the FDA approved a manufacturer's drug application and its warning label. The label did not warn doctors to use an intravenous (IV) drip method, so a woman developed gangrene and lost her hand when the doctor simply injected the medication into her arm. The Supreme Court again protected the injured party, holding that FDA label approval does not preempt plaintiffs from suing under state tort law. The Court stated that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."

The Supreme Court's interpretation of FDA preemption changed in ''Mutual Pharma. Co. v. Bartlett''. In that case, the patient was prescribed an anti-inflammatory drug for shoulder pain, and it caused her to developed toxic epidermal necrolysis - a death of skin tissues; the patient became permanently disfigured and almost completely blind. The following year, the FDA changed the drug's label to warn of that very condition; the injured woman sued. The Supreme Court held that the plaintiff's case was preempted, because it would have been impossible for the drug manufacturer to comply with the state law requiring updated labels, and the FDA's rule prohibiting label updates without their express approval. The manufacturer was also not required to stop selling the drug, despite its knowledge of side effects not warned of on the label, because of FDA rules; the state rule would have required the manufacturer to stop the sale of the drug. Mutual Pharma Co. v. Bartlett is the current ruling case on FDA preemption - it was upheld when the Supreme Court considered the same issue in 2019, in Merck Sharp & Dohme Corp. v. Albrecht. The case expanded FDA preemption, and significantly restricted the ability to sue drug manufacturers.

Vaccine Injury Compensation Programs (VICP)
Compensation programs are frequently developed to compensate victims of food and drug injuries. In the 1980s, Congress expressly preempted vaccine manufacturers from civil lawsuits for injuries caused by vaccines. However, for about three decades thereafter, courts allowed exemptions to federal preemption. In 1994, the Supreme Court of Nevada held that tort claims for vaccine injuries are not automatically preempted by the Act, but rather that the compensation fund was optional, and individuals could still pursue their own lawsuits; that injured party won $750,000. They were allowed to sue under the theory that the vaccine was defective and unsafe, and that the manufacturer failed to warn of side effects; failure to warn is not preempted and thus not protected.

As a result of the federal protection for drug manufacturers, injured parties typically cannot sue for adverse reactions to vaccines under traditional or state tort law, but the U.S. federal government offered an alternative to lawsuits: compensation programs. Under the Vaccine Injury Compensation Program, injured claimants can file a complaint against the Secretary of the Department of Health and Human Services (HHS), and the department will determine whether the injury was likely caused by a covered vaccine, and thus whether it qualifies for compensation. Compensation programs provide financial assistance to injured parties, without a finding that a vaccine actually caused the injury. They are "no-fault alternatives" to traditional lawsuits. There are twelve covered vaccines, including MMR, polio, and influenza.

The Covid-19 vaccines are the newest vaccines to be covered by the VICP. As of March 1, 2023 there have been 11,765 claims filed and 1,136 decided, 61 of which were found eligible for compensation.