Toner v. Lederle Laboratories, a Division of American Cyanamid Co.

• Decision Date: 04 February 1987
• Docket Number: No. 16453,16453
• Citation: 112 Idaho 328,732 P.2d 297
• Parties: , 55 USLW 2456, Prod.Liab.Rep. (CCH) P 11,284 David TONER, guardian ad litem for Kevin Toner, an infant child, and David Toner and Susan Toner, husband and wife, individually, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., Defendant- Respondent.
• Court: Idaho Supreme Court

Page 297

732 P.2d 297

112 Idaho 328, 55 USLW 2456, Prod.Liab.Rep. (CCH) P 11,284

David TONER, guardian ad litem for Kevin Toner, an infant child, and David Toner and Susan Toner, husband and wife, individually, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., Defendant- Respondent.

No. 16453.

Supreme Court of Idaho.

Feb. 4, 1987.

[112 Idaho 329] Kenneth L. Pedersen (argued) and Curtis Webb, Twin Falls, for plaintiffs-appellants.

Robert J. Koontz (argued), William J. Batt and Catherine A. King, Boise, for Lederle Laboratories.

Phillip M. Barber, Boise and Malcolm E. Wheeler (argued), Los Angeles, CA, for amicus curiae, Pharmaceutical Manufacturers Association.

BISTLINE, Justice

In 1979, plaintiff child Kevin Toner, then three months old, received a vaccination of Tri-Immunol, a drug manufactured by defendant Lederle Laboratories and designed to immunize children against diphtheria, pertussis, and tetanus. Thereafter, Kevin suffered a rare condition of the spine known as transverse myelitis. The affliction permanently paralyzed Kevin from the waist down. Plaintiffs brought suit against Lederle in Idaho state court, but the suit was removed to federal district court on the basis of diversity jurisdiction. At trial, the jury found that Lederle's vaccine has caused Kevin's paralysis and found Lederle negligent, although it rejected plaintiffs' strict liability and breach of warranty claims. Lederle appealed the judgment to the United States Court of Appeals for the Ninth Circuit. Rather than render a decision, pursuant to I.A.R. 12.1 (Supp.1986) the Court of Appeals certified and this Court accepted two controlling questions of Idaho law. These questions center on the role in Idaho strict liability and negligence law of the so-called "unavoidably unsafe" product doctrine, as described in comment k of Restatement (Second) of Torts § 402A (1965) (quoted infra, p. 12).

I. BACKGROUND

Toner found much with which to disagree in the Court of Appeals' summary of the facts. Two of the points of contention Toner raised we will set out in footnotes to our quotation of the Court of Appeals' opinion. As we do not have the trial record before us, we must use the Court of Appeals' summary as background to our decision. However, as we will explain below, the posture of the case, which includes a standing jury verdict that Lederle was negligent but that the vaccine was not in a "defective condition unreasonably dangerous to persons," requires certain factual presumptions regardless of the Court of Appeals' recitation.

The Court of Appeals states the facts as follows:

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. § 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 insoluble 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 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 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.

                [112 Idaho 331]  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
                

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.[ ¹

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 objective may reach fruition within the next few years.

The principal thrust of appellees' negligence argument at trial concerned Lederle's failure to develop a fractionated cell product. In support of this theory, appellees contend that Tri-Solgen was shown to be a safe yet equally efficacious pertussis vaccine. Appellees' experts testified that the whole cell vaccine was five times more reactive than the fractionated cell product, and that early studies indicated that Tri-Solgen caused fewer local reactions than the whole cell vaccine. The studies did not establish, however, that Tri-Solgen caused fewer severe reactions than the whole cell vaccine.[ ² With regard to efficacy, appellees produced four studies that found that fractionated cell products produced As noted, Toner vigorously disputes this characterization of the facts. Without the trial record (other than the proposed and given jury instructions) before us, we cannot make an independent assessment. However, until it is determined otherwise, we must presume that sufficient evidence supported the jury's verdict that Lederle was negligent. See Glovatorium, v. N.C.R. Corp., 684 F.2d 658, 660 (9th Cir.1982) ("This court will not disturb a jury verdict unless the evidence is such 'that no reasonable [person] would accept it as adequate to establish the existence of each fact essential to the liability.' Kunz v. Utah Power & Light Co., 526 F.2d 500, 504 (9th Cir.1975)....").

[112 Idaho 332] an immune response to pertussis. However, in 1972, a review panel within the Bureau of Biologics of the FDA refused to certify Tri-Solgen as "safe and effective" although it did so certify the whole cell vaccines. Because the FDA has refused to relicense Tri-Solgen or any other fractionated cell product, the manufacture and sale of such a vaccine by Lederle, or any other pharmaceutical company, would constitute a criminal offense under the Food, Drug and Cosmetic Act. See 21 U.S.C. §§ 331(d), 333(a), 355(a) (1982). Toner v. Lederle Laboratories, 779 F.2d 1429, 1430-31 (9th Cir.1986) (footnotes added).

By examining the allegations, the jury instructions, and the jury verdicts, we can further narrow that which we must presume. Lederle's standard of care relevant to the allegations of negligence was most specifically addressed in the following jury instruction, requested by Lederle and given by the trial court:

INSTRUCTION NO. 27: A manufacturer of vaccines has the duty to exercise...