Toner for Toner v. Lederle Laboratories, Div. of American Cyanamid Co., No. 84-3906
| Court | United States Courts of Appeals. United States Court of Appeals (9th Circuit) |
| Writing for the Court | Before WRIGHT, KENNEDY, and ANDERSON; KENNEDY |
| Citation | 779 F.2d 1429 |
| Parties | Prod.Liab.Rep.(CCH)P 10,831 David TONER, Guardian ad litem for Kevin TONER, an infant child, and David Toner and Susan Toner, husband and wife, individually, Plaintiffs-Appellees, v. LEDERLE LABORATORIES, a DIVISION OF AMERICAN CYANAMID CO., a corporation, Defendant-Appellant. |
| Decision Date | 07 January 1986 |
| Docket Number | No. 84-3906 |
Page 1429
child, and David Toner and Susan Toner, husband
and wife, individually, Plaintiffs-Appellees,
v.
LEDERLE LABORATORIES, a DIVISION OF AMERICAN CYANAMID CO., a
corporation, Defendant-Appellant.
Ninth Circuit.
Decided Jan. 7, 1986.
Kenneth L. Pederson, Twin Falls, Idaho, for plaintiffs-appellees.
Robert J. Koontz, Elam, Burke, Evans, Boyd, & Koontz, Boise, Idaho, for defendant-appellant.
Page 1430
Appeal from the United States District Court for the District of idaho.
Before WRIGHT, KENNEDY, and ANDERSON, Circuit Judges.
KENNEDY, Circuit Judge:
This products liability action involves Tri-Immunol, appellant Lederle Laboratories' triple antigen vaccine used to immunize children against diphtheria, pertussis, and tetanus (DPT). Lederle, the only American distributor of the vaccine, contends that the evidence presented to the jury was insufficient to support a finding that it was negligent in the design, manufacture, and distribution of the vaccine. Resolution of this appeal requires us to address unsettled questions of Idaho law, and we deem it appropriate to permit the judicial system of that state to address those matters. We therefore defer decision of this case and certify four questions raising state law issues to the Idaho Supreme Court. See Idaho App.R. 12.1 (Supp.1985).
In 1979, Kevin Toner, then a three-month-old infant, was vaccinated with Tri-Immunol and suffered a rare condition of the spine known as transverse myelitis, the cause of which is unknown. As a result of the affliction, Kevin is permanently paralyzed from the waist down. His parents commenced litigation in Idaho state court, and appellant removed the case to federal court on the basis of diversity of citizenship. 28 U.S.C. Sec. 1441 (1982). The suit was tried to the jury on theories of strict liability, negligence, breach of warranty of merchantability, and failure to warn. Appellees withdrew the failure to warn claim before the case was submitted to the jury. The jury found that the pertussis component of the vaccine had caused Kevin's paralysis; although in a special verdict the jury rejected the strict liability and breach of warranty claims, it found appellant negligent and assessed damages of $1,131,200.
In the early years of this century, pertussis was one of the leading causes of death in children. In recent years, however, the widespread availability of vaccines such as that marketed by defendant has virtually eradicated the disease. An instructive, brief description of common vaccines is found in an opinion by the Second Circuit, Ezagui v. Dow Chemical Corp., 598 F.2d 727, 731 (2d Cir.1979), and we rely upon that description for the following background explanation.
By introducing an antigenic factor into the body, vaccines stimulate the production of antibodies that protect against disease. Some infectious organisms, such as those causing diphtheria and tetanus, excrete soluble toxins insolable by medical research. The toxin is inactivated with formaldehyde and transformed into a toxoid. The toxoid is then used in a vaccine, as it can immunize against disease by stimulating the production of antibodies in the recipient, even though it has lost its own poisonous qualities.
This is not the case, however, with vaccines such as Tri-Immunol. Tri-Immunol is a so-called whole cell vaccine because it contains whole killed pertussis organisms. The whole organism is used because the pertussis organism contains fifteen or sixteen different antigens, and medical science has yet to isolate the one that stimulates protection against the disease. See Tinnerholm v. Parke, Davis & Co., 411 F.2d 48, 50 (2d Cir.1969). Courts that have addressed the issue of liability for adverse reactions to the DPT vaccine have commented that "the bacterial organism which causes pertussis is so complex as to make impossible the isolation and deactivation of the toxin or poison." Ezagui, 598 F.2d at 731; accord Tinnerholm, 411 F.2d at 50. Because of this difficulty, at the time of Kevin Toner's vaccination, the whole cell pertussis vaccine was the only pertussis vaccine licensed by the Food and Drug Administration (FDA) for use in the United States. It remains the only licensed vaccine today.
The whole cell pertussis vaccine is neurotoxic and can cause adverse reactions. These reactions are of two types: local and severe. Local reactions include swelling, fever, irritability, and crying spells. Severe
Page 1431
reactions include encephalopathy, paralysis, and even death. The expected rate of severe reactions ranges between one in 100,000 and one in 310,000 doses. Prior to this incident, there had been only one case of transverse myelitis reported in connection with a DPT vaccine.During the 1950's, the Eli Lilly Company developed a fractionated cell pertussis vaccine called Tri-Solgen that was prepared by treating whole killed pertussis cells with salt. Early studies indicated that this method of preparation resulted in a less toxic vaccine, and following its approval by the FDA in 1967, Tri-Solgen occupied a substantial share of the market. Lilly withdrew from the vaccine business in 1975 and stopped producing Tri-Solgen. Lilly sold the right to produce Tri-Solgen to Wyeth Laboratories; however, the FDA has refused to relicense the vaccine.
Lederle was aware of the neurotoxicity of Tri-Immunol as early as the 1950's and since that time has received occasional reports of severe adverse reactions to the vaccine. Following FDA approval of Tri-Solgen, Lederle conducted an internal study comparing Tri-Immunol with Tri-Solgen in an effort to determine whether to develop its own fractionated cell product. The study found fewer local reactions associated with Tri-Solgen, but it noted no severe reactions in either cohort due to the restricted number of subjects studied. At trial, Dr. Frank Cano, the Manager of Biologics at Lederle, testified that the differences observed in the study lacked statistical significance. Lederle only experimented with the production of a fractionated cell product until 1975. Since then, Japan has developed a pertussis toxoid vaccine, and Lederle's research efforts to achieve that...
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