COVID-19 Misleading Advertising Campaign Lawsuit Against Pfizer Challenges PREP Act Liability Shield
- by Carolyn Hendler, JD
- Published
- Federal & State Courts
A United States district judge has remanded a lawsuit filed by the state of Kansas against Pfizer, Inc. back to state court. This move may prevent the Public Readiness and Preparedness (PREP) Act from shielding the pharmaceutical giant from liability for Its misleading advertising campaign promoting its mRNA COVID-19 shot (Comirnaty).1
The Kansas attorney general, Kris Kobach, JD, filed a lawsuit against Pfizer in June 2024 under the Kansas Consumer Protection Act. The lawsuit alleges that the pharmaceutical company promoted its Comirnaty COVID biologic using “false, misleading and deceptive” advertising that constituted a “misinformation campaign.”2 The attorney general argues that Pfizer claimed the product was safe for pregnant women and had no risk of myocarditis or pericarditis, which was contrary to evidence revealed in Pfizer’s own internally conducted studies on the mRNA biologic and violated the state’s Consumer Protection Act.3 4
The PREP Act, which went into effect in 2005, was part of a series of federal laws passed by Congress after 9-11 that gave expanded authority to public health officials and expanded liability protection to companies manufacturing and individuals administering vaccines during a public health emergency declaration.5 The PREP Act states that when the Secretary of Health and Human Services declares that a disease, health condition or threat to public health or threat of same constitutes an emergency, the Secretary may recommend the use of one or more countermeasures.6
The PREP Act also provides immunity from liability to “certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures, except for claims involving “willful misconduct”.7
PREP Act Doesn’t Shield All Liability
While it provides extensive liability coverage to covered persons for injuries and deaths caused by covered countermeasures, the PREP Act has not proven to be a complete blanket liability shield for pharmaceutical companies. A recent North Carolina Supreme Court found that the PREP Act liability shield is limited to tort claims only and does not necessarily extend to constitutional claims. The court relied on the plain language of the PREP Act to limit its scope because it only covers “claims for losses”.8
A Utah federal court in 2024 upheld a breach of contract claim by a clinical trial participant against the pharmaceutical company, AstraZeneca plc. The court concluded that the case involved a “broken promise, not a countermeasure.”9 10
Pfizer Fails to Move Case to Federal Court
Pfizer attempted to move the false advertising case from state court to federal court, where it would attempt to rely on the PREP Act as a liability shield. Judge Daniel D. Crabtree denied all three of Pfizer’s arguments to remove the case to federal court, effectively blocking Pfizer’s attempt to skirt the state court.11
Pfizer argued that the PREP Act completely preempted state law requiring the case to be moved to federal court. The court rejected this claim and explained that the PREP Act creates two remedies for violations. There is a federal cause of action against covered persons who caused death or serious injury due to willful misconduct, which is a stricter standard compared to negligence. For injuries resulting from actions or inactions other than willful misconduct, the PREP Act establishes a “Covered Countermeasure Process Fund” for “compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration.”12
Pfizer argues that the only viable argument for the plaintiffs is the “willful misconduct” claim. The court disagreed and found that plaintiff’s claims were based on deceptive marketing rather than physical injuries or death.
The court concluded:
Plaintiff’s claims aren’t based on any physical injuries or death. They’re based on deceptive marketing, and that point alone ends the debate.13
The PREP Act’s willful misconduct cause of action does not, “vindicate the same basic interest or right that would be vindicated under state law.” Accordingly, removing the case to federal court under the PREP Act would not sufficiently address plaintiff’s claims, therefore, state law is not preempted.14
Commenting on the state court ruling, Ray Flores, senior counsel for Children’s Health Defense, concluded:
This first-of-its-kind ruling declares Pfizer’s deceptions aren’t afforded carte blanche treatment. This decision is important because it creates a viable path for Pfizer to potentially be held accountable for its wrongdoing on a massive scale.15
Attorney General Kobach said:
This victory is the first step in bringing justice to the Kansans who were misled by the false statements made by Pfizer regarding the health risks of its COVID vaccine. The case will now proceed in state court, which is where a claim under the Kansas Consumer Protection Act belongs.16
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