Happy Star Wars Day. May the Fourth be with you.
If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.
The plaintiff in Flores claimed that the Gardasil vaccine, which fends off Human Papillomavirus, caused her to suffer from postural orthostatic tachycardia syndrome (POTS) and other injuries. She filed a petition with the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program. After judgement was rendered in that forum, the plaintiff filed a lawsuit with claims for negligence, strict liability failure to warn, strict liability manufacturing defect, breach of express warranty, and common law fraud. The defendant moved to dismiss the complaint and won across the board.
The negligence claim was a “poorly disguised” design defect claim, which is barred by the Vaccine Act. The negligence cause of action griped about the defendant’s lack of reasonable care in designing the product. It also suggested that ingredients in the vaccine were unsafe. The Flores court was correct in identifying this as a design defect claim. If the negligence claim was aimed at anything else, it was impossible to figure out what that was. The claim was “lengthy, difficult to follow, and replete with run-on sentences.” The court threw up its hands and told the plaintiff to try again.
The failure to warn claim was also a goner. To the extent the claim addressed a failure to warn the plaintiff and her parents, it was barred by both the Vaccine Act and Nevada’s adoption of the learned intermediary doctrine. To the extent the claim addressed a failure to warn the plaintiff’s doctors, it was marked by vagueness and lack of substance. The complaint alleged that the manufacturer did not disclose the vaccine’s “dangerous propensities” and its “carcinogenic characteristics and autoimmune-inducing characteristics,” but never specified what “propensities” and “characteristics” were not conveyed to the plaintiff’s doctors. Again, the plaintiff needed to try again.
The breach of warranty claim was a “veiled failure to warn claim.” Therefore, the Vaccine Act, Nevada’s learned intermediary doctrine, and the vagueness as to what was hidden from the doctors doomed this cause of action. In addition, the complaint failed to substantiate how the manufacturer’s “representations became part of the basis of the bargain.” Moreover, Nevada statutes require that, prior to bringing a breach of warranty claim, a “plaintiff must first provide the defendant with some type of pre-suit notice.” That didn’t happen here. The Flores court dismissed the warranty claim without prejudice and with leave to amend.
The manufacturing defect claim was as defective as such claims usually are. To the extent this claim took issue with “toxins” present in the FDA approved vaccine formula, the claim was preempted by the Vaccine Act. To the extent this claim alleged that the vaccine deviated from the approved design, it was implausible. The plaintiff asserted that the vaccine violated manufacturing specifications, but then “puzzlingly states that her Gardasil products she received did not ‘have a substantial change in their condition as designed, manufactured, sold, distributed, labeled, and marketed’” by the defendant. That blatant contradiction required dismissal, with the plaintiff afforded an opportunity to do a rewrite.
Finally, it will hardly surprise you that the fraud claim flunked Rule 9(b) specificity. The complaint says that advertisements “duped” the plaintiff’s mother into believing the vaccine was safe and effective, but never specifies when mom saw such ads. The complaint also alludes to fraudulent conduct that misled the general public and doctors, but those allegations “stray even further from Rule 9(b)’s specificity requirements.” Maybe the plaintiff can fix that lack of specificity. Maybe not.
The Flores case demonstrates that it is not impossible to bring a lawsuit against a vaccine, but such a lawsuit must be narrowly and clearly framed. Both the public good and court dockets would benefit if the same restrictions applied to all drug and medical device lawsuits.