Vaccine Injury Suit Dismissed Over Records

In December 2017, a patient received 2 vaccinations—diphtheria-tetanus-pertussis booster (Tdap, Boostrix; GSK) and pneumococcal polysaccharide vaccine (Pneumovax 23; Merck)—at a national chain pharmacy. The vaccinations were received sequentially and administered so close to the same spot that there was only 1 visible skin puncture.

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Upon administration of the first vaccination, the patient told the pharmacist that she felt pain and that “something was wrong.” During the next 2 days, the patient experienced increased inflammation and pain in her shoulder. The patient sought medical follow-up and was diagnosed with complex regional pain syndrome. Initially, it was alleged through expert testimony that the administration of the pneumococcal vaccine was outside the standard of care, and another expert concluded that the pneumococcal vaccine administration led to a nerve injury. There is no documentation or witness recollection regarding which vaccination was administered first. Once the experts became aware of sequential vaccine administration, the assertion of the vaccination causing the injury became less conclusive.

The sequence of vaccine administration is a critical factor in this case. In 1986, the National Childhood Vaccine Injury Act was passed to create a vaccine injury compensation (VIC) program for specific vaccine-related injury claims. The claims must be made directly to the program and within 3 years of the onset of symptoms. The VIC program covers injuries related to the Tdap booster but does not cover injuries related to the pneumococcal polysaccharide vaccine. Accordingly, if the injury is caused by the Tdap booster, then the pharmacy is not liable to the patient due to the national VIC program.

LEGAL PROCESS AND PRACTICE IMPLICATIONS

In December 2020, the patient filed a lawsuit against the pharmacy alleging that negligent administration of the pneumococcal vaccine led to “painful and permanent” nerve injuries. Because the patient had not made a claim to the VIC program and there was ambiguity over the causative agent, the trial court judge ruled in favor of summary judgment dismissal of the lawsuit. The reasoning was that no evidence was available from which a jury could find the injury was caused by the pneumococcal vaccine and not caused by Tdap. The trial court judge indicated the jury essentially would be asked to guess.

The patient appealed the trial court order for summary judgment. In July 2025, the US Court of Appeals for the Fourth Circuit upheld the trial court’s grant of summary judgment for the pharmacy. The Fourth Circuit acknowledged that the decision created a difficult position for the patient; however, the lack of evidence on a causative agent does not allow the case to go forward to a jury.

This case demonstrates the legal system’s complexity in balancing fairness to plaintiffs seeking relief and fairness to defendants in determining their responsibility. Regardless of perspectives on the outcome, a pharmacist taking a moment to document even 1 sentence could make all the difference.

REFERENCE

Amanda Watts v Maryland CVS Pharmacy, LLC, No. 23-2025 (4th Cir 2025).