Class Action and Product Insights for Your Business
April 18, 2022 - FDA, Drug & Medical Device, Product Liability

Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

Pleading and Preemption: Immunization Against Vaccine Products Liability Claims

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM), 2022 WL 788669 (D. Conn., Mar. 15, 2022). This ruling shows that plaintiffs making vague allegations of injury will not satisfy Iqbal and Twombly.


Approved by the Food and Drug Administration (“FDA”) in 2006, Merck’s Gardasil vaccine helps protect individuals against human papillomavirus infection, a viral infection associated with cervical cancer. With her mother’s consent, the plaintiff in Herlth received the first two doses of the vaccine at the age of 15. The plaintiff allegedly experienced side effects. She was diagnosed with various disorders, including chronic fatigue syndrome and postural orthostatic tachycardia syndrome, a condition that affects the body’s ability to adjust the heart rate and regulate blood flow. The plaintiff filed a petition for compensation in the “Vaccine Court” (i.e., the Office of the Special Masters of the U.S. Court of Federal Claims)—a prerequisite for bringing a civil action. Only after receiving an unfavorable outcome at the Vaccine Court may an individual sue the manufacturer. Here, the Vaccine Court dismissed the plaintiff’s claim for insufficient proof. The plaintiff then sued in federal court, alleging state law failure to warn, manufacturing defect, negligence, and common law fraud claims. The crux of the plaintiff’s complaint was her failure to warn claim. She alleged that her mother believed the vaccine was safe based on Gardasil television advertisements and other marketing material.

The District Court’s Decision

In granting Merck’s motion to dismiss, the court concluded that all claims were either preempted or inadequately pled. Federal law preempted the failure to warn claim, the plaintiff failed to plausibly plead a manufacturing defect, the plaintiff failed to plead fraud with particularity, and federal law preempted the fraud on the FDA claim.

With respect to the failure to warn claim, the court held that the Food, Drug, and Cosmetic Act (“FDCA”) preempts a state law failure to warn claim against a drug manufacturer. FDA approves the text of vaccine labels. Manufacturers may change the label only with FDA approval, unless the changes reflect “newly acquired information” about warnings or adverse reactions, among other things. 21 CFR §601.12(f)(2)(i). A unilateral label change requires reasonable evidence of a causal link between the newly acquired information and the adverse reaction at issue. 21 CFR §201.57(c)(6)(i). Under this standard, the plaintiff had to sufficiently plead that Merck had newly acquired information (i.e., information received after the FDA’s approval of Gardasil) related to the plaintiff’s alleged injuries that justified a label change.

Here, the plaintiff failed to meet her burden. She relied on conclusory allegations about risks of Gardasil that bore no concrete relationship to her alleged injuries. Her complaint also referred to scientific studies and news articles linking Gardasil to her alleged injuries without explaining how the studies supported her allegations. Even worse, many of the studies were published well after the plaintiff received her vaccine. Merck could not have relied on them to effect a label change before the plaintiff was allegedly injured.

The court also rejected the plaintiff’s argument that drug labeling preemption principles apply only to design defect claims and not failure to warn claims. The plaintiff based this argument on the Vaccine Act’s express preemption of state law design defect claims against vaccine manufacturers. In rejecting this argument, the court reasoned that Congress did not intend to make it more difficult to bring design defect claims, while also, opening the “floodgates” for failure to warn claims. The court thus found that the Vaccine Act preempts both state law design defect and failure to warn claims.

As to the manufacturing defect claim, the court found that the design defect claim was in fact a “dressed up” manufacturing defect claim; the plaintiff did not allege a mistake or flaw in the manufacturing process.

The rest of the plaintiff’s claims failed for similar reasons. Under her negligence claim, the plaintiff lumped together various disparate theories that sounded in fraud, which requires a heightened pleading standard. The plaintiff failed to meet her burden. For instance, the plaintiff’s references to Merck’s advertisements merely described the advertisements. She did not point to specific statements in the advertisements made with knowing falsity.

Finally, even if the plaintiff could have satisfied pleading standards for her fraud on the FDA claim, Buckman preemption applied, barring state law claims alleging fraud on the FDA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). As the court noted, the Second Circuit further clarified that the FDCA preempts state tort law claims only when the cause of action assigns liability “solely on the basis” of fraud against the FDA. Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006). Since the plaintiff sought to assign liability “solely on the basis” of purported fraud against the FDA, the FDCA preempted her fraud on the FDA claim.


This ruling is one of the first major vaccine preemption decisions since FDA authorized the COVID-19 vaccines, which spurred much public attention and discussion around vaccines. Herlth makes clear that there is a high bar for successfully pleading vaccine products liability claims. Under Twombly and Iqbal, showing that a vaccine manufacturer acquired new information regarding possible side effects requires more than vague and conclusory allegations.