Thursday, December 01, 2022

painful vaccination is injury for NY GBL purposes

DeCostanzo v. GlaxoSmithKline PLC, 2022 WL 17338047, No. 21-CV-4869 (GRB)(AYS) (E.D.N.Y. Nov. 29, 2022)

DeCostanzo’s putative class action alleged that GSK’s ad campaign for the whooping cough vaccine Boostrix misled consumers into believing the vaccine would help prevent transmission of the disease to infants when in fact it increases the risk of unwittingly transmitting the disease (because Boostrix-vaccinated people may acquire and transmit whooping cough despite being asymptomatic). She brought claims under NY GBL §§ 349, 350, state consumer protection statutes, the Magnuson-Moss Warranty Act, breach of express warranty, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, unjust enrichment, fraud, and negligent misrepresentation. The court dismissed the unjust enrichment claim as duplicative but otherwise denied GSK’s motion to dismiss.

First, accepting that she was required to exhaust administrative remedies in vaccine court under the National Childhood Vaccine Injury Act of 1986, she’d done so (this basically just requires submitting a petition, waiting 240 days, and withdrawing the petition, a workaround approved by previous court cases). Nor did the primary jurisdiction doctrine apply, even though the FDA found Boostrix “safe and effective” when approving the vaccine and the CDC recommends adults get a Tdap vaccine, especially if they are around infants.

Whether GSK engaged in a deceptive practice or false advertising was “well within the conventional experience of judges and only indirectly involves technical matters regarding vaccine efficacy which are within the ambit of the agency’s expertise.” The claims turned on GSK’s marketing of Boostrix, not the FDA or CDC’s licensing or promotion of the vaccine. There was also no substantial danger of inconsistent rulings “since the FDA has already found that acellular pertussis vaccines such as Boostrix do not prevent transmission.”

Did plaintiff allege cognizable injury? She didn’t pay for the vaccination, which was covered by insurance. She alleged injury because the vaccine created “a defective immunity to pertussis that will last the remainder of [her] li[fe],” she received a “painful injection of various substances” she would not have otherwise received, she “expend[ed] time and resources to seek out and obtain Boostrix, paying, directly or indirectly, in whole or in part, for Boostrix,” and she has suffered the emotional injury of fearing she will spread the whooping cough because “the product has actually rendered [her] more likely to spread pertussis.”

The court accepted that “a painful vaccine shot in the arm which she would not have received but for GSK’s allegedly misleading ad campaign” was a cognizable injury. However, a price premium theory was unavailable since she didn't pay, and the deception itself couldn't satisfy the injury requirement. Although the risk of transmitting whooping cough to others was arguably too speculative, another alleged injury was “the defective immunity which currently renders her vulnerable to asymptomatic infection, which “is a cognizable injury because it is a biologically disadvantageous condition.”

I don't quite get the defective immunity theory. If she hadn't gotten the shot, wouldn't she have had an equally defective non-boosted immune system? I guess the idea is that if she wasn't boosted and got sick, she'd be symptomatic and know it--but that's not really the same as having a presently defective immune system.

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