Ms. Staples v. HHS - IPV/Polio, paralytic polio (1994)

Ms. Staples of Houston, Texas, filed a petition seeking compensation under the National Childhood Vaccine Injury Act of 1986 for paralytic polio she contracted in 1955 as a result of the so-called Cutter Incident — the first mass vaccination disaster in American history.

On April 18, 1955, Ms. Staples purchased several vials of inactivated polio vaccine (IPV) manufactured by Cutter Pharmaceutical from her local pharmacy and brought them to her physician, Dr.

Greer, who administered the initial dose to her two children. Ten days later, on April 28, 1955, a radio broadcast announced that the Cutter IPV was being recalled because it had not been properly inactivated — the vials contained live, infectious poliovirus.

Ms. Staples checked her remaining vials, confirmed they were Cutter product, and returned them to her pharmacy as instructed by the U.S.

Public Health Department. Between May 4 and May 7, both Ms.

Staples and her husband fell ill with diarrhea, vomiting, elevated temperatures, and an inability to rise from bed unaided. Ms.

Staples additionally suffered severe headaches and neck and shoulder pain. Her physician examined her on May 9 and concluded she had contracted paralytic polio from contact with her children.

She was admitted to Hedgecroft Hospital, a polio treatment center. The following day she suffered respiratory failure and was placed in an iron lung.

On May 11 she required an emergency tracheotomy and lapsed into a four-month coma. She remained hospitalized until May 1956.

At the time of the litigation, respondent's expert Dr. Lee testified that Ms.

Staples suffered from post-polio syndrome: diminished respiratory capacity, increased fatigue, difficulty sleeping, arthralgia of the knees and ankles, and severe scoliosis. She was required to spend between fourteen and sixteen hours each day in her iron lung.

The sole legal question was whether the Vaccine Act authorized compensation for community contact polio cases arising from a defective IPV rather than an oral polio vaccine (OPV). The Vaccine Injury Table (Section III) provides compensation for paralytic polio in "a vaccine-associated community case" involving "Polio Vaccines (other than Inactivated Polio Vaccine)." Ms.

Staples argued that the Cutter vaccine was not truly inactivated — it was literally "other than inactivated" — and that the Table's use of the plural "vaccines" demonstrated Congress contemplated more than just OPV. She contended the conflict between the Table's language and the petition requirements of Sections 11(c) and 13(a) — which specifically require contact with a recipient of "an oral polio vaccine" — justified resort to the Act's liberal compensatory purpose.

Respondent argued that Sections 11(c) and 13(a) unambiguously require OPV contact; that the Table's phrase "other than Inactivated Polio Vaccine" simply distinguished Section III (OPV injuries) from Section IV (IPV injuries); and that the plural "vaccines" referred to the multiple types of OPV then available — monovalent Types 1, 2, and 3, and the combined trivalent vaccine — not to defective IPV. Chief Special Master Golkiewicz dismissed the claim on August 16, 1993, concluding that while petitioner's argument was "not unreasonable," there was "not a scintilla of evidence" that Congress intended to compensate IPV contact cases.

Ms. Staples moved for review.

Judge Yock, writing for the Court of Federal Claims on January 26, 1994, agreed that the Table's language created an ambiguity justifying resort to legislative history, but found that history decisively against the petitioner. From 1980 onward, every relevant congressional report and OTA study discussed only OPV community contact risk; none mentioned IPV contact cases.

Congress had in fact held extensive hearings on the Cutter Incident in May and June 1955 — and was fully aware that IPV had caused 166 contact polio cases — yet when it enacted the 1986 Vaccine Act thirty-one years later, made no mention of compensating past IPV contact victims. A 1986 House Report expressly stated that "no serious side effects of currently available IPV have been documented," reflecting Congress's belief that another Cutter-type event would not recur and that past victims were not within the Act's scope.

The court further resolved the plural "vaccines" question by observing that FDA regulations at the time of enactment recognized four distinct oral polio vaccines — monovalent Type 1, Type 2, and Type 3, plus the trivalent combination — which explained the plural usage without any need to include defective IPV. Reading Sections 11(c) and the Table in harmony, both required OPV contact in community cases.

Because the Vaccine Act is a waiver of sovereign immunity, compensation required a clear and unambiguous congressional intent that was simply absent. The court affirmed the dismissal.

The court expressed explicit sympathy: "Undeniably, the petitioner and her family have suffered a great tragedy." It noted, however, that it lacked authority to rewrite the statute, and that the proper forum for relief was Congress. This case served as the lead decision for five companion cases dismissed the same day: Beard (No. 91-157V), Welsh (No. 91-759V), Connone (No. 90-1709V), McNutt (No. 91-608V), and Hanson (No. 90-3422V).