The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured Measles, Mumps, and Rubella (MMR) vaccine administered in 1999. In addition to Merck & Co., the suit named various federal government defendants: the Health and Human Services (“HHS”), HHS Secretary Thomas Price, FDA Commissioner Scott Gottlieb, and the United States of America. Plaintiff claimed violation of the National Childhood Vaccine Act of 1986 (the “Vaccine Act” or the “Act”), fraud, and conspiracy to commit fraud, and sought compensatory damages for personal injury, as well as declaratory and injunctive relief.
Failure to file a petition in the Vaccine Court precluded claims in District Court
Noting that “administratively exhausting” the claim in the Vaccine Court is a prerequisite to seeking relief in a traditional tort suit, the E.D.N.Y. found that it lacked jurisdiction. In the Vaccine Court plaintiff alleged that his autistic disorder was caused by mercury in thimerosal-containing vaccines (“TCVs”). In fact, Doe was selected as a test case in “the largest omnibus proceeding in the history of the Vaccine Act,” designed to determine whether there is a causal link between mercury in TCVs and autism, which is partly why it took 20 years for plaintiff to obtain a District Court decision. In contrast, in the present action the claimed cause of autism was the MMR vaccine. In addition, because plaintiff could have, but failed, to allege in the Vaccine Court that the MMR vaccine caused his autism, his present claim is barred by claim preclusion (res judicata).
Claims against the federal defendants were held barred by sovereign immunity. Under the Vaccine Act, sovereign immunity would not apply to the HHS Secretary where there is an alleged failure to perform a duty, but plaintiff failed to allege any particular duty in which the Secretary was derelict. Plaintiff allegations also failed to form a valid fraud claim. Since Merck’s allegedly fraudulent actions postdated plaintiff’s 1999 vaccination, plaintiff cannot prove reliance. As to the request to revoke Merck’s license for distributing its MMR vaccine, the court held that the proper body to consider license revocation is the FDA via an administrative petition. The remaining claims in the patently defective complaint were also dismissed.
The Act was enacted in the setting of increased vaccine-related litigation, out of concern that increased liability would drive vaccine manufacturers out of the market. This decision is particularly pertinent in the face of the current measles outbreak. Per the CDC, from January 1 to March 28, 2019, 387 cases of measles have been confirmed in 15 states – the second-greatest number of cases reported in the U.S. since measles was eliminated in 2000.
National Childhood Vaccine Act of 1986
In 2011, the United States Supreme Court discussed the Vaccine Act’s no-fault compensation scheme for those claiming a vaccine-related injury, and weighed in on the potentially competing considerations of vaccine safety and recovery for vaccine-related injuries (Bruesewitz v. Wyeth LLC). The Vaccine Act permits “significant tort-liability protections for vaccine manufacturers” and “expressly eliminates liability for a vaccine's unavoidable, adverse side effects.”
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
The High Court held in a split decision that the Act preempts design defect claims against vaccine manufacturers.
Unlike in tort suits, claimants under the Act are not required to show that the administered vaccine was defectively manufactured, labeled or designed. No showing of causation is necessary for those injuries listed in the Act's Vaccine Injury Table.
Procedurally, a petition must first be filed with the United States Court of Federal Claims, where claims are adjudicated by the congressionally created Office of Special Masters (colloquially known as the Vaccine Court). The Court of Federal Claims must review objections to the special master's decision and issue a judgment before a claim is permitted to be filed against the vaccine manufacturer in a traditional tort suit for damages.