A lawsuit filed by Texas state officials against Pfizer alleging the vaccine maker violated the state’s consumer protection laws by misleading the public about its COVID-19 vaccine should be allowed to proceed, Texas Attorney General Ken Paxton told a Texas appeals court this week.
In an appellant brief filed Wednesday in the U.S. Court of Appeals for the 5th Circuit, the state argued that Texas consumer laws are not preempted by the federal liability shield granted to COVID-19 vaccine makers under the federal Public Readiness and Emergency Preparedness Act (PREP Act).
Texas sued Pfizer in state court in November 2023, alleging the company’s “false” and “deceptive” marketing of its COVID-19 vaccine violated the Texas Deceptive Trade Practices Act (DTPA).
In January 2024, Pfizer successfully shifted the case to federal court. The U.S. District Court for the Northern District of Texas, Lubbock Division, dismissed the suit in December 2024. Texas appealed in January.
Texas claims Pfizer capitalized “on Americans’ fear of the unknown” by touting its vaccine “as a miracle cure.” Pfizer’s claims “led Texas consumers to make choices they would not have otherwise made,” while “Pfizer enriched itself based on these misleading statements to the tune of billions of dollars.”
The state also alleges that Pfizer’s misleading statements about its COVID-19 vaccine were coupled with the company’s “censorship of scientists that set the record straight.”
Texas seeks over $10 million in civil penalties and an injunction barring Pfizer from making similar claims about vaccine efficacy in the future.
Pfizer has denied the allegations, telling Reuters in 2023 the case had no merit, and defending its claims about its COVID-19 vaccine as “accurate and science-based.”
Pfizer sought dismissal of the case, arguing that it is immune from liability under the PREP Act, which shields COVID-19 vaccine makers from liability for injuries caused by the vaccines.
Ray Flores, senior outside counsel for Children’s Health Defense (CHD), disputed Pfizer’s claims.
“No COVID-19 vaccine manufacturer blatantly misled the public more than Pfizer,” Flores said today. “Exaggerations of durability, efficacy and safety are expertly spelled out in Paxton’s brief.”
According to Flores, the Texas lawsuit against Pfizer is one of several cases challenging the PREP Act’s liability shield. Under that act, vaccines such as Pfizer’s COVID-19 vaccine, released under emergency use authorization during a public health emergency, are considered “covered countermeasures.”
Other cases include a similar lawsuit filed in Kansas by that state’s attorney general, lawsuits filed by the mother of a child vaccinated at his school without consent in North Carolina and by a vaccine-injured clinical trial participant in Utah.
Flores says these cases have a reasonable chance of success, even though previous legal challenges against the PREP Act have failed.
“The all-consuming reach of the PREP Act’s tentacles is being challenged once again,” Flores said. “I say it over and over again: PREP is public enemy No. 1.”
State consumer protection law supersedes PREP Act, Texas says
In his December 2024 dismissal of Texas’ lawsuit, Senior U.S. District Judge Sam R. Cummings accepted Pfizer’s claim of immunity under the PREP Act and rejected Texas’ argument that Pfizer’s marketing statements about its COVID-19 vaccine were connected to “trade or commerce” or any “consumer transaction.”
But in its brief, Texas argued the PREP Act’s liability shield “only extends to claims ‘for loss’” and does not shield against consumer protection cases filed by the state instead of individual consumers.
According to the brief, in cases brought under the Texas DTPA, the state can sue in cases of alleged “false, misleading, or deceptive conduct in trade or commerce,” when such an action “would be in the public interest.”
The brief also argues that the PREP Act’s liability shield blocks only those claims involving the “administration” of a covered product to “an individual” and does not extend to “sovereign consumer protection suits.”
Texas also argued that the immunity shield “cannot plausibly be read to cover governmental suits for misrepresentations.”
Flores criticized the lower court’s dismissal and said Texas has presented a “strong” case that a federal appeals court must consider.
“The Texas District Court’s one-page dismissal is a prime example of the outmoded knee-jerk reaction that anything goes under PREP,” Flores said. “Whether the state attorney general has the authority — which he obviously does — to protect its citizens must now be considered and ruled upon by the 5th Circuit.”
Flores agreed with Texas’ argument that state consumer protection law falls outside the scope of the PREP Act.
“Unlike a claim for loss due to the administration of a covered vaccine, the attorney general’s allegations of violations of the Texas Deceptive Trade Practices Act fall outside of the purview of the PREP Act,” Flores said.
Kansas lawsuit alleges Pfizer violated previous agreements with the state
A similar lawsuit filed by Kansas Attorney General Kris Kobach also challenges Pfizer’s claims about the safety and efficacy of its COVID-19 vaccine. According to Flores, the Kansas case is one of several “important PREP challenges” nationwide and is “stronger” than Texas’ case.
Kobach filed the lawsuit in state court in June 2024, alleging Pfizer made misleading claims about the safety and effectiveness of its vaccine and used “denial and delay” tactics, confidentiality agreements and an “extended study timeline” to conceal “significant safety concerns” and “critical data” about the vaccine.
“Pfizer must be held accountable for falsely representing the benefits of its COVID-19 vaccine while concealing and suppressing the truth about its vaccine’s safety risks, waning effectiveness, and inability to prevent transmission,” the lawsuit states.
According to the lawsuit, Pfizer’s misrepresentations also run afoul of three consent judgments — agreements between Pfizer and the state of Kansas in 2008, 2012 and 2014 stemming from previous cases in which the company agreed not to make misleading claims about its products in the future.
For example, as part of the 2008 consent judgment, Pfizer agreed it would “not make any written or oral claim that is false, misleading or deceptive regarding any FDA-approved Pfizer product” through any medium. Pfizer made similar promises in the 2012 and 2014 judgments.
According to Flores, the previous consent judgments form the centerpiece of Kansas’ case against Pfizer. He rejected Pfizer’s claims that the PREP Act supersedes those agreements.
“Kansas v. Pfizer has an extra added benefit of three consent judgments, where Pfizer promised not to mislead the citizens of Kansas,” Flores said. “Astonishingly, Pfizer claims these three consent judgments entered more than a decade ago are unrelated settlements that did not involve a vaccine subject to the PREP Act. I don’t buy it.”
As it did with the Texas lawsuit, Pfizer successfully removed the Kansas lawsuit to federal court in July 2024. According to Flores, Pfizer has sought to affirm immunity under the PREP Act and subsequent dismissal of these cases in federal court.
In a September 2024 motion, Kansas asked for the case to be remanded to state court. Pfizer filed an opposing motion in October 2024. A ruling is pending.
According to Flores, if the Kansas lawsuit is remanded to state court and is ultimately successful, it might still have national ramifications.
“A remand to state court is still a ruling by the federal District Court,” Flores said. “That would embolden other states that have expressed interest to also sue Pfizer under their respective state consumer protection laws.”
Similar lawsuits in Utah, North Carolina challenge PREP Act liability shield
Flores said the Kansas lawsuit is similar to a lawsuit challenging AstraZeneca for breach of contract after the company reneged on a promise to provide medical treatment to a clinical trial participant who sustained serious injuries after receiving the company’s vaccine.
Brianne Dressen sued AstraZeneca in May 2024, alleging she was disabled by the company’s COVID-19 vaccine in 2020. According to the complaint, AstraZeneca’s consent form for trial participants promised medical treatment for illness or injury suffered during the study, but the company reneged on this promise.
AstraZeneca argued it was immune under the provisions of the PREP Act. But in November 2024, a federal court ruled that the act’s liability shield does not extend to breach-of-contract claims. According to the ruling, Dressen’s claim is based on “a broken promise, not a countermeasure.”
“There is a breach of contract element reminiscent of (the so-far successful) Dressen v. AstraZeneca,” Flores said, adding that AstraZeneca faces an “uphill battle” in that case.
According to Flores, another case that might successfully overcome the PREP Act’s liability shield is a North Carolina lawsuit filed in state court in 2022 by the mother of a 14-year-old boy who was administered a COVID-19 vaccine at his school without his — or his family’s — consent.
Last month, the Supreme Court of North Carolina overturned the decisions of two lower courts, ruling the case can proceed because the PREP Act does not preempt state law requiring parental consent for vaccination. The court also ruled that the PREP Act does preempt injury claims filed under tort law.
That case will now return to the North Carolina Court of Appeals to address questions relating to state law and the state Constitution. In July 2024, CHD filed an amicus brief urging the Supreme Court of North Carolina to overturn the lower courts’ dismissal of the case.
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