Melissa Cloer, MD v. Secretary of Health & Human Services Amici Curiae

Summary of the Argument

Congress’ primary purpose in establishing the Vaccine Program2 was to promote the nation’s health by protecting its current supply of vaccines and by encouraging the development of new vaccines. See H.R. Rep. No. 99-908, 99th Cong., 2nd. Sess. (1986). This goal would be furthered, Congress decided, by prohibiting civil lawsuits against vaccine manufacturers for vaccine-related injuries until claimants had first processed their claims through the Vaccine Program. Due to the “no fault,” informal and generous nature of the Program, Congress believed that most, if not all, claims for vaccine-related injuries would be resolved in the Program without resort to civil litigation. Congress also provided, however, that a dissatisfied petitioner could reject the Program’s ultimate decision and then file a civil lawsuit with certain limitations. See §§ 21-23.

The question presented by this case is regarding § 16(a)(2).3 The legislative history of the Vaccine Act itself is silent as to whether a “discovery rule” or “equitable tolling” is applicable to § 16(a)(2). This is significant, the government argues, because the Vaccine Program is a waiver of sovereign immunity and must be strictly construed. In other words, the government says, unless the statute expressly permits the “discovery rule” and “equitable tolling,” they are not available to petitioners. However, petitions in the Vaccine Program are not entering lawsuits against the federal government. For this reason, the Vaccine Program is not a waiver of sovereign immunity. Instead, it is a remedial insurance program administered by the Secretary of Health and Human Services. It is not funded by the general treasury, but by a special excise tax on vaccines, which directly funds the Vaccine Trust Fund. Indeed, in light of the Act’s clearly stated goals of an inclusive Vaccine Program, one intended to divert injured persons away from civil litigation, both a “discovery rule” and “equitable tolling” must be available to petitioners. Any other interpretation, leaving civil litigation as the sole available remedy,4 would undoubtedly frustrate Congressional intent.

In Brice, Judge Newman stated that the majority’s patent refusal to permit equitable tolling with respect to § 16(a)(2) no matter how worthy the petitioner or how compelling the petition was “neither a necessary interpretation of the Vaccine Act, nor a tolerable one.” Brice, 240 F.3d at 1374 (dissenting opinion). Surely, Judge Newman will agree, the “discovery rule” should also be available to petitioners, as it “opens the door to a petitioner upon whom the door should not be shut.” Id. Any other interpretation of the statute serves only to undermine Congressional intent.

Finally, in the view of amici, the circumstances of this particular case support an equitable tolling of § 16(a)(2). Dr. Melissa Cloer (“Dr. Cloer”) exercised due diligence in presenting her claim once she became aware of the cause of her injury.

2 The Vaccine Act, which established the Vaccine Injury Compensation Program, is located at 42 U.S.C. §§ 300aa-1 et seq. For convenience, future references will be to the “Vaccine Act,” the “Act” or the “Vaccine Program.” Individual sections to the Act will include only the section number.

3 “[I]f a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset. . .of such injury.” § 16(a)(2).

4 In Brice v. Sec’y of HHS, the Federal Circuit observed, “We need not decide in this case whether a petitioner who fails to file a timely petition under the Program may still pursue traditional tort remedies.” 240 F.3d at 1368. However, the answer to this question is both relevant and important. Certainly, vaccine manufacturers may argue that untimely filings by children and adults in the Program cut off traditional state tort remedies. Indeed, one of the purposes of the Vaccine Act is to shield vaccine manufacturers from lawsuits. However, most states toll statutes of limitations for minors and for brain-damaged individuals. It is inconceivable that Congress would have intended such a sweeping preemption of the rights of children and mentally handicapped persons without a single word in the statute. The Vaccine Act expressly states that, except as otherwise provided, “State law shall apply to a civil action brought for a vaccine-related injury or death.” § 22(a). The Vaccine Act does not provide that untimely petitioners in the Program forfeit all rights to civil litigation. Indeed, such an interpretation is incongruous with Congressional intent, will be firmly rejected by state courts, and, should be rejected by this Court.

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