Pharma

Earlier this year, with its decision in Bruesewitz v. Wyeth,[1] United States Supreme Court found that the National Childhood Vaccine Injury Act[2] immunizes vaccine manufacturers from liability for claims related to vaccines’ design defects. This decision has the shared effect of protecting vaccine manufacturers and promoting the public’s health.

Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 to establish a no-fault compensation program for individuals who experienced vaccine-related injuries or death and to stabilize the vaccine market. In the early to mid-1980s, concerns arose about associations between the diphtheria, tetanus, and pertussis (DPT) vaccine and physical and mental disabilities in children.

These concerns led to a wave of lawsuits against manufacturers of the DPT vaccine; ultimately two of the three domestic DPT vaccine manufacturers stopped producing the vaccine to avoid the costs associated with DPT vaccine-related litigation. By 1984, parents who sought to vaccinate their children faced vaccine shortages.[3] Other parents were electing not to vaccinate their children at all, to avoid any potential vaccine-related risks.[4]

To allay the fears of parents and vaccine manufacturers, Congress created the Vaccine Injury Compensation Program.  Through this federal program, an individual with a probable vaccine-related injury (or that individual’s legal guardian) can file a petition with the U.S. Court of Federal Claims to request compensation. A court-appointed special master reviews the petition and makes a determination. This is then reviewed by the Court of Federal Claims. The process is aided by the NCVIA’s Vaccine Injury Table, which includes a list of vaccines covered by the NCVIA as well as information about compensable vaccine-related injuries.[5] If an individual’s vaccine-related injury meets the parameters specified by the Vaccine Injury Table, then the individual is compensated without needing to demonstrate causation. Compensation, which is financed via a tax on vaccines and paid by the federal government, may include medical, rehabilitative, and other costs.[6]

Individuals are permitted to reject the determination of the Court of Federal Claims and pursue a lawsuit against the vaccine’s manufacturer.[7] However, these lawsuits face certain limitations, including the requirement that the plaintiff must first present the claim to the federal Vaccine Injury Compensation Program.[8] For the most part, vaccine manufacturers are immunized from lawsuits related to their failure to warn, as long as they have met all relevant regulatory requirements and have given any vaccine-related warning to either the individual who was injured or to that person’s physician.[9] The NCVIA also immunizes vaccine manufacturers from liability due to a vaccine’s “unavoidable, adverse side effects.”[10]

This provision of the NCVIA was at the center of Bruesewitz v. Wyeth. In 1992, shortly after receiving a DPT vaccination, Hannah Bruesewitz began having seizures.[11] She was subsequently diagnosed with a “residual seizure disorder” and “developmental delay.”[12] In 1995, Hannah’s parents filed a claim on Hannah’s behalf with the Vaccine Injury Compensation Program. The Bruesewitzes rejected the Program’s determination, and they brought a lawsuit against the vaccine’s manufacturer, in 2005.  They claimed that the manufacturer should be held liable for their daughter’s disabilities due to the defective design of the DPT vaccine.[13] The Bruesewitzes argued that their claims could be brought under state law, even though the federal NCVIA appeared to prohibit, or preempt, such claims. Specifically, the NCVIA states: “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine . . . if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”[14]

The Court held that the NCVIA does indeed preempt the state laws upon which the Bruesewitzes based their claims, meaning that the Bruesewitzes’ claims were invalidated. In its opinion, the Court noted that the NCVIA includes a sound quid pro quo: “The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries; in exchange they avoid costly tort litigation and the occasional disproportionate jury verdict.”[15] This liability protection has “coax[ed] [vaccine] manufacturers back into the market.”[16]

Bruesewitz v. Wyeth gave the Supreme Court an opportunity to reexamine the delicate balance that has ensured on-going access to vaccines in the United States for nearly 25 years. Like other corporations, vaccine manufacturers seek profits from the sales of their products. If the costs from vaccine-related litigation surpass the revenues from vaccine sales, then vaccine manufacturers will, understandably, stop producing vaccines. Some manufacturers acted on this calculation when they left the vaccine market in the 1980s. While this might be a sound business decision, it is not one that leads to effective public health policy. Vaccines are critical to protecting the public’s health. They have been hailed by the Centers for Disease Control and Prevention as “one of the greatest achievements of biomedical science and public health.”[17] This recognition led the federal government to devise a unique system to provide broad liability protections to vaccine manufacturers.

Recently, scholars have referred to the NCVIA as a “social compact” and “a compromise that safeguards the public’s health.”[18] They have posited that the Supreme Court was correct to “protect” this compromise.¹⁸ Others have noted that “civil litigation [outside the Vaccine Injury Compensation System] could be useful in the rare cases in which a plaintiff was contending that a plausible alternative vaccine design would have prevented the adverse event at issue.”[19] A related point was raised in Justice Sotomayor’s dissent to the Bruesewitz decision. She argued that the text of the NCVIA did not preempt all design-defect claims, because the statute only grants liability protection to vaccine manufacturers for “unavoidable,” as opposed to avoidable, side effects.[20] In the majority opinion, however, the Court suggested that allowing such litigation to proceed would be undesirable, as it could potentially leave vaccine manufacturers to face a “universe of alternative designs . . . limited only by an expert’s imagination.”[21] In other words, the Court endorsed Congress’s decision to protect specific corporations to accomplish the greater goal of protecting the public’s health.

In recent years, the Court has decided several major cases, such as Bruesewitz, involving preemption and public health.  These opinions are often fact-specific, making it difficult to draw generalizations about the Court’s preemption jurisprudence.  From a public health perspective, federal preemption of state and local laws can, at times, promote public health goals. Most public health professionals would favor a strong federal law rather than “a patchwork of weaker or inconsistent state or local laws” to support a public health intervention.[22] Preemption, though, often interferes with public health goals, by preventing states or localities from enacting experimental or innovative laws to address the particular health challenges they face. AsBruesewitz demonstrated, preemption can also prevent state-level lawsuits from proceeding, which may prevent injured parties from receiving compensation for harms they experienced. Although Bruesewitz involved federal preemption, in all likelihood it will ultimately be regarded as a decision that protected the nation’s vaccine supply and, thus, the public’s health.