779 F.2d 1429 (9th Cir. 1986), 84-3906, Toner for Toner v. Lederle Laboratories, Div. of American Cyanamid Co.

Docket Nº:84-3906.
Citation:779 F.2d 1429
Party Name: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.
Case Date:January 07, 1986
Court:United States Courts of Appeals, Court of Appeals for the Ninth Circuit

Page 1429

779 F.2d 1429 (9th Cir. 1986)

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.

No. 84-3906.

United States Court of Appeals, Ninth Circuit

January 7, 1986

Argued and Submitted April 4, 1985.

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.

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