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So plaintiffs learned in the In re: Gardasil Products Liability Litigation, MDL 3036, 2024 WL 1197919 (W.D.N.C. Mar. 20, 2024).  Try as they did in 550-paragraph and 120-page complaints to muddle their claims, the court cleared away the muck and found what was left was almost all preempted by the Vaccine Act.

While pending motions to dismiss were stayed when the MDL first was created, the court gave defendants permission to file two bellwether Rule 12 motions.  Defendants chose a case under New York law and one under North Carolina law.  Defendants moved to dismiss all design defect and manufacturing defect claims and certain failure to warn and fraud claims.  To put defendants’ preemption claims in context, the court provides a thorough summary of the Vaccine Act.  Most importantly pointing out that the Vaccine Act creates a “no-fault compensation system funded by vaccine manufacturers.”  Individuals who allege injury as a result of a vaccine can file a petition for compensation in Federal Claims court.  The quid pro quo for this compensation system, “is the provision of significant tort-liability protections for vaccine manufacturers.”  Id. at *6.  Those protections include preemption of design defect claims and of direct-to-consumer failure to warn claims.  Id. 

The preemption of design defect claims is so clear cut that plaintiffs did not argue against it.  Rather, they argued that they were not making such claims.  Even going so far as to tell the court at oral argument that they “scrubbed the word “design” from the complaints in response to [defendants’] earlier successful motions to dismiss.”  Id. at *7.  But a global search and replace for the word design wasn’t persuasive for the court.  “[T]he Court must look at the true nature of the allegations, not just how Plaintiffs have self-described their claims.”  Id.  That analysis led the court to find several design defect claims that plaintiffs tried to hide under negligence or manufacturing defect causes of action:

  • Claims that the ingredients in the vaccine are dangerous is a design defect claim.  Because the FDA approved those ingredients, an attack on them is an attack on the design of the product.  Id.
  • Claims that the vaccine was not properly developed or inadequately tested challenge the design of the product.  Inadequate testing is a “not an independent wrong.”  Rather, because the vaccine was approved based on that testing, it is an “attack on the design of the approved vaccine.”  Id. at *8.
  • Allegations that a product is not safe and effective “is effectively an allegation that the entire design of the vaccine is defective.”  Id.

Similarly, in their manufacturing cause of action, plaintiffs alleged, upon information and belief, that the defendants failed to comply with manufacturing specifications and protocols required by the FDA.  Id. at *10.  While that is the technical definition of a manufacturing defect, what plaintiffs allege in support is that the “vaccine recipe itself, not any specific instances of improper manufacturing, is the problem.”  Id.

A claim that all the doses of a vaccine are inherently and unreasonably dangerous when manufactured as intended is not a “manufacturing defect” claim. Rather, it is an allegation of a “design defect,” which is barred by the Vaccine Act.  Id. (emphasis in original).

Therefore, plaintiffs “upon information and belief” manufacturing allegations are contradicted by their own allegations that the dangerous ingredient is in every vaccine on the market.

On failure to warn, the Vaccine Act only allows claims for failure to warn medical providers.  Claims premised on failing to warn plaintiffs, their parents, or the general public, direct-to-consumer claims, are expressly barred.  Id. at *8-9.  The wording of the Act says there is no liability in a civil action “solely due to the manufacturer’s failure to provide direct warnings to the injured party.”  Id. at *9.  Having lost on this issue in every other federal court, this time plaintiffs tried to argue that “solely” meant a direct-to-consumer failure to warn claim could proceed here because plaintiffs were also alleging a failure to warn medical providers.  The court “decline[d] the invitation to reach such an absurd result.”  Id. Plaintiffs’ interpretation would “nullify the prohibition” on direct warning claims.  So, only failure to warn the learned intermediary survives.

The last claim at issue was for fraud.  To the extent plaintiffs’ fraud claims were premised on an alleged failure to warn, they suffer the same fate as plaintiffs’ failure to warn claims—no fraud directed to plaintiff.  Id. at *11.  Plaintiffs tried to argue that the statutory prohibition did not include intentional tort claims, but once again the court found plaintiffs’ interpretation “would significantly undermine, if not fully eliminate” the quid pro quo established by the Act.

With respect to fraud on medical providers, plaintiffs’ complaints fail to meet the heightened pleadings standard of Rule 9.  Plaintiffs conceded they had not pleaded the time, place, or content of any allegedly fraudulent statements made to plaintiffs’ medical providers, but tried to blame that lapse on doctors not liking to talk to plaintiffs’ lawyers.  Neither we nor the court thought much of that excuse. The court found the failure to plead these essential elements “dooms their claims.”  Id. at *12.  That left only plaintiffs’ fraudulent concealment claims which the court determined was to be held to a more lenient pleadings standard.  Further as the discovery on this claim would overlap with the permitted failure to warn medical providers claim, the court sort of a took a no harm, no foul approach leaving for summary judgment the differences of proof needed for the two claims.

The court also denied any leave to amend as pointless given the advance stage of the case.  So, these claims are gone and what remains is a significantly pared down case.