Amanda Watts v. Maryland CVS Pharmacy, LLC

142 F.4th 233
Court of Appeals for the Fourth Circuit·Decided July 1, 2025·No. 23-2025·Published·Cited by 1 cases

Opinion

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 23-2025

AMANDA WATTS, Plaintiff - Appellant,

v.

MARYLAND CVS PHARMACY, LLC, Defendant - Appellee.

Appeal from the United States District Court for the District of Maryland, at Baltimore. Julie R. Rubin, District Judge. (1:21-cv-00589-JRR)

Argued: March 20, 2025 Decided: July 1, 2025

Before DIAZ, Chief Judge, and HARRIS and BERNER, Circuit Judges.

Affirmed by published opinion. Judge Harris wrote the opinion, in which Chief Judge Diaz and Judge Berner joined.

ARGUED: Lindsey Nicole McCulley, SALSBURY STRINGER MCCULLEY, LLC, Baltimore, Maryland, for Appellant. Katherine Herr Solomon, MAURO LILLING NAPARTY, Woodbury, New York, for Appellee. ON BRIEF: Kevin P. Sullivan, SALSBURY SULLIVAN, LLC, Baltimore, Maryland, for Appellant. Scott Patrick Burns, TYDINGS & ROSENBERG, LLP, Baltimore, Maryland; Matthew W. Naparty, MAURO LILLING NAPARTY, Woodbury, New York, for Appellee.

PAMELA HARRIS, Circuit Judge:

At a CVS Pharmacy in 2017, Amanda Watts was given two shots, one with the Pneumovax 23 vaccine and one with the Boostrix vaccine. According to Watts, both vaccines were negligently administered, in the same improper location in her arm. Watts was eventually diagnosed with a chronic pain condition that can result from nerve injury, which she attributes to CVS’s negligence.

But CVS is immune from suit for its administration of Boostrix under the federal National Childhood Vaccine Injury Act of 1986. Accordingly, Watts’s complaint against CVS alleged only that it was negligent in its administration of Pneumovax. The district court granted summary judgment to CVS because Watts presented no evidence from which a jury could find that it was CVS’s administration of the Pneumovax vaccine, rather than the Boostrix vaccine, that caused her injury. We agree with the district court and affirm its judgment.

I.

This case involves the back-to-back administration of two vaccines, Pneumovax 23 and Boostrix, in the same spot on Amanda Watts’s arm. CVS is immunized under federal law for its administration of one vaccine – Boostrix – but not the other. Because that immunity plays a central role in this litigation, we begin with an overview of the relevant federal law. We turn then to the facts and proceedings in this case.

A.

The National Childhood Vaccine Injury Act of 1986 established a National Vaccine Injury Compensation Program (“VIC Program”) as an alternative to traditional civil litigation for resolving certain vaccine-related claims. See 42 U.S.C. § 300aa-10 et seq. Boostrix, which protects against tetanus, diphtheria, and pertussis, is a covered vaccine under the Act. Id. § 300aa-14(a); 42 C.F.R. § 100.3(a). Pneumovax 23, which protects against pneumococcal disease, is not. See 42 C.F.R. § 100.3(a).

Under the Vaccine Act, a person seeking damages of more than $1,000 for an alleged injury resulting from the administration of a covered vaccine must exhaust their remedies under the VIC Program before suing a vaccine administrator, like CVS, in state or federal court. 42 U.S.C. § 300aa-11(a)(2)(A). To proceed under the VIC Program, a claimant files a petition with the United States Court of Federal Claims. Id. § 300aa- 11(a)(1). As relevant here, petitions alleging injury but not death must be filed within three years after the first symptom of the alleged injury. Id. § 300aa-16(a)(2).

The plaintiff in this case, Amanda Watts, did not exhaust her remedies under the VIC Program for any injury stemming from the Boostrix shot she received at CVS in 2017. That has important consequences for this case. Even if CVS was negligent in its administration of Watts’s Boostrix shot, Watts may not recover damages for that negligence. Instead, CVS is effectively immune from suit for its administration of Boostrix, and Watts may hold CVS liable only for injury caused by CVS’s allegedly improper administration of Pneumovax.

B.

In December 2017, a pharmacist at a CVS in Maryland gave Watts two vaccine shots, one with Boostrix and one with Pneumovax. According to Watts, both shots went into her left arm in nearly the exact same spot, leaving only one visible puncture mark. That location, Watts alleges, was incorrect: The vaccines should have been injected into her deltoid muscle, but were instead injected several centimeters below that. Watts would later testify that after the first injection, she told the pharmacist that she felt pain and that “something was wrong.” J.A. 415. She also felt pain after the second injection. Watts does not know, and the record does not indicate, the order in which the two vaccines were administered.

Watts alleges that after she left the CVS, the area around the injection site turned red, and her arm began to swell. Over the next two days, she later testified, the pain increased to the point that she was unable to move her arm. Watts sought emergency medical care twice in the week after the injections. The nurse practitioner who treated her later testified that she observed the presence of only one puncture hole and that the area around it was inflamed.

Watts alleges that eventually the redness and pain from her arm spread to other parts of her body, including her shoulders, back, and legs, becoming at some points so painful that Watts was unable to move at all. She was seen and treated by multiple doctors over the next few years. One of those doctors, Dr. Akhil Chhatre, diagnosed Watts with Complex Regional Pain Syndrome (“CRPS”), a chronic health condition that can occur after a nerve injury and cause long-lasting pain.

C.

In December 2020, Watts filed a complaint against CVS asserting a single count of negligence. 1 Watts alleged that as “a direct and proximate cause” of the negligent administration of Pneumovax, she suffered “painful and permanent injuries,” including CRPS. J.A. 11. Although Watts’s complaint noted that she had received two vaccines at the same time, it did not mention Boostrix by name, and it sought to hold CVS liable only for the improper administration of Pneumovax.

During discovery, the parties introduced experts to opine on both the standard of care for vaccine administration and the cause of Watts’s injuries. Causation was especially critical, given CVS’s partial immunity under federal law. Watts allegedly received two vaccine shots at the same time and in the same location on her arm. And under the Vaccine Act, the effects of those two shots needed to be separated out: CVS could be held liable for injuries caused by an improperly administered Pneumovax shot, but not for injuries caused by the Boostrix shot.

Watts designated Karen Ryle, a practicing pharmacist, as her standard of care expert. As to standard of care, Ryle opined in her report that CVS failed to observe governing standards by improperly injecting Pneumovax below the deltoid muscle. But Ryle also went on to address causation, opining that this faulty injection of Pneumovax caused Watts’s injuries. Ryle’s report did not address Boostrix or attempt to differentiate

1

Watts filed her complaint in Maryland state court. CVS removed the case to the United States District Court for the District of Maryland.

the effect of that shot because, at the time her report was prepared, Ryle was unaware that Watts had received a Boostrix shot along with her Pneumovax shot.

By the time Ms. Ryle was deposed, however, she knew about the Boostrix injection.

And when asked why she believed it was the Pneumovax shot and not the Boostrix shot that led to Watts’s CRPS, she had no answer. Instead, Ryle said that she would amend her previously submitted report, to reflect “that it would be either the Boostrix or the Pneumovax” that caused Watts’s injury, and that she did not “know for certain which one it was.” J.A. 98. She did suggest that based on Watts’s testimony, it would have been “the first shot,” J.A. 108, but as noted above, there is no record evidence as to which that was.

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Amanda Watts v. Maryland CVS Pharmacy, LLC, 142 F.4th 233 (4th Cir. 2025).

142 F.4th 233 (Amanda Watts v. Maryland CVS Pharmacy, LLC) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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