IN RE SABIN ORAL POLIO VACCINE PROD. LIABILITY LIT.
| Decision Date | 18 April 1991 |
| Docket Number | No. MDL 780.,MDL 780. |
| Citation | 763 F. Supp. 811 |
| Parties | In re SABIN ORAL POLIO VACCINE PRODUCTS LIABILITY LITIGATION. |
| Court | U.S. District Court — District of Maryland |
Stanley P. Kops, Adler & Kops, Philadelphia, Pa., and Marc S. Moller, Kreindler & Kreindler, New York City, for plaintiffs.
Rupert M. Mitsch, Julie Zatz and Ann Wion, Torts Branch, Civil Div., U.S. Dept. of Justice, Washington, D.C., for defendant.
These seven cases, which have been transferred to the District of Maryland pursuant to 28 U.S.C. § 1407 (1988), are brought against the United States under the Federal Tort Claims Act, 28 U.S.C. §§ 2671-80 (1988). Plaintiffs (or persons whom they represent) contracted poliomyelitis, allegedly as a result of the administration of doses of oral polio vaccine ("OPV") manufactured by Lederle Laboratories, Inc. Plaintiffs contend that the Division of Biologic Standards of the National Institutes of Health ("DBS") was negligent in various respects in approving release to the public of the vaccine allegedly giving rise to their injuries.1
On July 12, 1990, I issued an opinion denying a motion for summary judgment filed by plaintiffs and granting in part and denying in part a similar motion filed by the United States. 743 F.Supp. 410. Broadly stated, I sustained the Government's "discretionary function" defense as to plaintiffs' claims relating to the establishment of the OPV program but rejected it as to actions taken by DBS in implementing the program. The parties then consented to my trying in a consolidated proceeding the liability issues left open by my earlier opinion which were common to all of the cases. A fifteen-day trial ended on March 27, 1991. This opinion constitutes my findings of fact and conclusions of law under Fed.R.Civ.P. 52(a).
I have concluded that over the years DBS has, in violation of 42 C.F.R. § 73.114(b)(1)(iii), approved for release type 3 polio vaccine, knowing that it is more neurovirulent than type 1 polio vaccine, which is mandated by regulation as the reference standard.2 I have also concluded that, in violation of 42 C.F.R. § 73.113(b), DBS has released lots of vaccine, including the lots involved in two of the pending cases, which were more than five tissue culture passages from the original strain from which they were derived. There are, however, two observations which I would like to make at the outset.
First, although I find DBS to have been negligent in the eyes of the law, I do not find DBS officials and consultants to have been derelict in the performance of their duties. To the contrary, the scientists who established and implemented the OPV program were (and are) extraordinarily able professionals who consistently acted in the public interest as they reasonably perceived it to be. They made judgments on extremely difficult questions which, strictly from the standpoint of public health, appear to have been entirely proper. We are fortunate to have persons like Bennett Elisberg, Ruth Kirschstein and Joseph Melnick dedicate themselves to public service, and it was a privilege to have them testify before me.
Second, my finding that regulatory violations occurred does not imply that the public health is or has been endangered in any respect. According to the undisputed record, the OPV used in the United States has always been "state of the art" vaccine and the OPV program has resulted in the virtual eradication of wild poliovirus in the Western Hemisphere. I might add that the irony that I am finding what is perhaps the most successful public health program in history to have been implemented "negligently" is not lost upon me. However, that finding is one to which my understanding of the law and my perception of the facts have inexorably led.
Poliomyelitis is a disease of the central nervous system. It is of three types. Type 1 can be contracted only from a type 1 virus, type 2 only from a type 2 virus and type 3 only from a type 3 virus. Each of the plaintiffs here suffers from the third type of the disease.
In 1955 a vaccine against each type of polio, developed by Dr. Jonas Salk, was licensed for production and use in the United States. This vaccine was an inactivated polio vaccine ("IPV") derived from a virus which had been killed. The use of the Salk vaccine dramatically decreased the incidence of polio but did not eradicate it. Between 1958 and 1961, there were nearly 19,000 cases of the disease in the United States. Thirteen thousand people were paralyzed and over 1,000 people died.
While Dr. Salk had been developing his inactive vaccine, other scientists, including Dr. Albert Sabin, had been working on an oral poliovirus vaccine. OPV is produced from a live virus attenuated but not killed during the production process. Scientists perceived that OPV might have several advantages over IPV.4 It was relatively less costly and, as its name reflects, could be taken orally whereas IPV required three initial inoculations followed by a least one subsequent booster shot. Moreover, OPV is preferable to IPV because persons who are immunized with IPV can still be linked in the chain of infection; although immunized themselves against the disease, they can serve as carriers of the wild polio virus and pass it on to others. Of course, despite these advantages, there is an inherent risk in the use of OPV. Like other live virus vaccines (such as those used for smallpox and yellow fever), OPV stimulates immunity by inducing a mild infection in vaccinees. Thus, a person vaccinated with OPV or a person who comes into close contact with the vaccine's virus (usually by exposure to a vaccinated person) may develop polio.5
On June 30, 1958, the Surgeon General of the United States appointed an ad hoc committee to consider whether, in light of the continued incidence of polio after the institution of the IPV program, an effective OPV program could and should be developed. There were six members of the committee. The director of DBS chaired the committee; the five other members were academicians who had been actively involved in research on polio and polio vaccines. The purposes of the committee were to (1) assist in the selection of the virus strains to use in the manufacture of an OPV, (2) evaluate data pertaining to the efficacy and safety of vaccines produced from the selected strains and (3) develop regulations for governing the licensing and manufacturing of OPV.
During 1958 and 1959 twenty field trials involving the use of OPV were conducted throughout the world. The most extensive trials, in which vaccines derived from the strains developed by Dr. Sabin were used, were conducted in Eastern Europe and the Soviet Union. By the end of 1959 over 15 million persons had been vaccinated in the Soviet Union alone. Dr. Dorothy Horstmann, an internationally respected epidemiologist, spent two months in the Soviet Union and Eastern Europe under the auspices of the World Health Organization ("WHO"), conducting her own review of the methodology and results of the Soviet tests. After completing her studies, she reported to the ad hoc committee her conclusion that the tests had been properly conducted and that vaccines derived from the Sabin strains were safe and effective. The same conclusion was confirmed by other laboratory and field tests, which were subjected to critical scrutiny at a series of international conferences in which members of the ad hoc committee participated. After reviewing all of the information available to it, the committee recommended to the Surgeon General without qualification that the Sabin type 1 and type 2 strains be used. Although the committee noted a concern that the Sabin type 3 strain had "less than optimum immunogenic capacity and shows a tendency to change its neurovirulence characteristics after passage in serum," it stated that the strain was "satisfactory from the point of view of neurovirulence" and recommended its use.
On August 24, 1960, the Surgeon General, acting upon the recommendation of the ad hoc committee, declared that OPV was suitable for use in the United States and released the committee's recommendations concerning the use of the Sabin strain. In March 1961 DBS adopted regulations, along lines recommended by the ad hoc committee, governing the issuance of manufacturing licenses and the approval and release of vaccine.
Lederle was an early pioneer in the development of OPV. A Lederle employee, Dr. Harold Cox, had developed one of the strains which competed with the Sabin strain in the clinical field trials. Lederle also lent support to Dr. Hilary Koprowski, the developer of the other major strain used in the clinical field trials. When the Surgeon General's ad hoc committee selected the Sabin strain over the Cox and Koprowski strains for use in the United States, Lederle quickly purchased Sabin strain material from which to derive its own seeds and manufacture its own vaccine. It tested its vaccine lots in the summer of 1961 and submitted the test results to DBS in late December of that year.
Lederle's vaccine had to pass a monkey neurovirulence test in order to qualify for licensure. 42 C.F.R. § 73.114(b)(1)(iii) provides, in part, that a "virus pool under test is satisfactory for poliovirus vaccine only ... if a comparative analysis of the test results demonstrate that the neurovirulence of the test virus pool does not exceed that of the Reference Attenuated Poliovirus." Since type 1 vaccine had proven to be the safest in the clinical field trials, type 1 was selected as the reference virus. See 42 C.F.R. § 73.111. Thus, in order to obtain a license for its type 3 vaccine, Lederle had to demonstrate, inter alia, that the results of the monkey neurovirulence tests which it performed on its licensing lots of type 3 vaccine did not exceed the results of similar tests which it...
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