Kearl v. Lederle Laboratories

• Court: California Court of Appeals
• Writing for the Court: SABRAW; POCHE, Acting P.J., and CHANNELL
• Citation: 172 Cal.App.3d 812,218 Cal.Rptr. 453
• Parties: , 54 USLW 2232 Elizabeth KEARL, a minor By and Through the Guardian Ad Litem, Dean KEARL, and Dean Kearl, Individually, Plaintiffs and Respondents, v. LEDERLE LABORATORIES, et al., Defendants and Appellants. AO16034.
• Decision Date: 27 September 1985

Page 453

218 Cal.Rptr. 453 172 Cal.App.3d 812, 54 USLW 2232 Elizabeth KEARL, a minor By and Through the Guardian Ad Litem, Dean KEARL, and Dean Kearl, Individually, Plaintiffs and Respondents,
v.
LEDERLE LABORATORIES, et al., Defendants and Appellants. AO16034. Court of Appeal, First District, Division 4, California. Sept. 27, 1985.
As Modified Oct. 2, 1985.

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[172 Cal.App.3d 816] Eugene E. White, Law Offices of White & White, Sacramento, and Michael C. Scranton, Pleasant Hill, for plaintiffs and respondents.

W.W. Gudmundson, Richard J. Siggins, William S. Ginsburg, Raymond L. Morocco, Gudmunson, Siggins & Stone, San Francisco, for defendants and appellants.

Skadden, Arps, Slate, Meagher & Flom, Malcolm E. Wheeler, Hughes Hubbard & Reed, Los Angeles, for amicus curiae Pharmaceutical Manufacturers Ass'n.

[172 Cal.App.3d 817] SABRAW, Associate Justice.

Defendant, Lederle Laboratories, appeals from a judgment for plaintiff after a jury determined defendant's polio vaccine was defective and caused plaintiff to contract that disease. We reverse the judgment.

Although defendant raises numerous grounds for reversal--erroneous evidentiary rulings, misconduct on the part of the trial judge, inconsistency of verdicts, denial of due process, and erroneous application of strict products liability law to the facts of this case--we need address only the latter issue here. We hold that although in standard products liability litigation a plaintiff may utilize a strict liability design defect theory, such a strict liability cause of action must be prohibited for public policy reasons if the court determines, after taking evidence, that the product complained of is "unavoidably dangerous"; in such special cases, a plaintiff may proceed on a design defect theory only on the basis of negligence. Furthermore, we will explain that although unavoidably dangerous products--like all other products--are subject to strict liability for manufacturing defects, such products are subject merely to negligence liability for warning defects.

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I. Background and Procedure

In the early 1950s polio was a crippler of many in this country and throughout the world. In the same decade Dr. Jonas Salk developed an injected killed polio virus vaccine. The virus was grown in a tissue culture and chemically "killed" to make it incapable of causing the disease, but able to act as an antigen to stimulate production of antibodies and thus repel any wild polio virus that entered the body. (Comment, Mass Immunization Cases: Drug Manufacturers' Liability for Failure to Warn (1976) 29 Vand.L.Rev. 235, 237.) Later in the decade Dr. Albert Sabin developed an oral vaccine consisting of living (but attenuated or "weakened") polio virus. The attenuated virus particles are generally incapable of causing the disease itself, but are strong enough to produce antibodies to repel wild polio virus and confer lifetime immunity. (Id., at 238.) At trial and in the briefs, these two discoveries are referred to as the "Salk" and "Sabin" vaccines. As defendant points out, however, neither vaccine retains the exact formulation it contained when first introduced by its respective inventor. We will thus refer to the two vaccines by their current generic terms: injected "killed" polio vaccine (IPV) (i.e., Salk) and oral "live" polio vaccine (OPV) (i.e., Sabin).

In the early 1960s this country's public health officials selected OPV over IPV as the vaccine of choice for mass immunization. (Franklin & Mais, Tort Law and Mass Immunization Programs: Lessons from the Polio and [172 Cal.App.3d 818] Flu Episodes (1977) 65 Cal.L.Rev. 754, 765.) OPV was preferred because it would: (1) be more acceptable to the public since it could be taken orally rather than by injection; (2) produce lifetime immunity in most persons without need for periodic booster shots as required by IPV; (3) prevent an immunized person from being a "carrier" of the disease, in contrast to the mere systemic immunity conferred by IPV; and (4) better eradicate wild polio virus from the environment because unlike IPV, OPV suppresses the wild virus from the intestinal tract. (Boffey, Polio: Salk Challenges Safety of Sabin's Live-Virus Vaccine (April 1977) 196 Science 35.) Soon thereafter, OPV associated cases of polio began to be reported. (J. Paul (1971) A History of Poliomyelitis 465.) In 1964, a Public Health Service special advisory committee report concluded that some cases of polio were in fact caused by the OPV vaccine, but emphasized the need to continue mass immunization at full speed. (Comment, supra, 29 Vand.L.Rev. at pp. 239-240, citing Special Advisory Committee on Oral Poliomyelitis Vaccine, Report to the Surgeon General of the Public Health Service (1964) at pp. 5-6.)

OPV has remained the vaccine of choice for more than two decades. As defendant observes, it continues to be recommended over IPV by, inter alia, the United States Public Health Service Advisory Committee on Immunization Practice, the Public Health Service Centers for Disease Control and the California State Public Health Service. It is also the vaccine of choice for every concerned medical advisory organization in the United States, including the Committee on Infectious Diseases of the American Academy of Pediatrics and the National Academy of Science. Moreover, the choice of OPV over IPV has been subject to periodic reconsideration. For example, after reviewing available information in 1977, the Institute of Medicine, National Academy of Sciences, recommended that OPV continue to be the principal vaccine against polio. During the same time IPV has been used only sporadically in this country, and is currently not made in the United States, ¹ although it is still available here.

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In November 1978 a physician advised Mrs. Kearl that her four-month-old daughter, Elizabeth, should be vaccinated. About two weeks later she took Elizabeth to a Contra Costa County clinic where she read a one page warning entitled "IMPORTANT INFORMATION ABOUT POLIO AND POLIO VACCINE. [172 Cal.App.3d 819] Please read this carefully." The information sheet briefly described polio, stated that the risk of contracting it is very low "[e]ven for someone who is not vaccinated," and explained inter alia that oral live polio vaccine is "one of the best ways to prevent polio" in young children. (Emphasis added.) It provided: "POSSIBLE SIDE EFFECTS FROM THE VACCINE: Oral live polio vaccine rarely produces side effects. However, once in about every 4 million vaccinations, persons who have been vaccinated or who come in close contact with those who have recently been vaccinated are permanently crippled and may die. Even though these risks are very low, they should be recognized. The risk of side effects from the vaccine must be balanced against the risk of the disease, both now and in the future." (Emphasis added.) The information sheet suggested that pregnant women should consult a physician before taking the vaccine, and listed other persons who should not take the vaccine without consulting a doctor. ² It then informed the prospective vaccinee of the alternative vaccine: "NOTE ON INJECTABLE (KILLED) POLIO VACCINE: Besides the oral polio vaccine, there is also a killed polio vaccine given by injection which protects against polio after several shots. It has no known risk of causing paralysis. Most polio experts do not feel it is as effective as the oral vaccine for controlling polio in the United States. It is recommended for persons needing polio vaccination who have low resistance to infections (or those who live with them) and for unprotected adults traveling to a place where polio is common. It is not widely used in this country at the present time, but it is available. If you would like to know more about this type of polio vaccine, please ask us." (Emphasis added.)

The information sheet concluded: "QUESTIONS: If you have any questions about polio or polio vaccination, please ask us now or call your doctor or health department before you sign this form," and cautioned the reader to report any adverse reactions occurring within four weeks of taking the vaccine. Mrs. Kearl later testified she understood from the warning that there was a slight chance her daughter would get polio from the vaccine, and consciously considered that risk when she signed a consent form ³ and allowed her child to be vaccinated.

[172 Cal.App.3d 820] About four weeks after the vaccination Elizabeth began to develop paralysis. Plaintiff sued both defendant and Contra Costa County and at trial--over defendant's objection--was allowed to put on strict products liability design defect evidence. Dr. Lawrence Steinman testified for plaintiff that OPV is defective in design because (i) contrary to the ordinary consumer's expectations it can cause polio, and because (ii) IPV is superior to OPV. Dr. Steinman also testified that the warning

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quoted above is inadequate because it fails to state that "OPV is the best way to get polio."

Although the trial court allowed Dr. Steinman's strict products liability design defect testimony over defendant's objections, when it came time to cross examine plaintiff's expert the court apparently reconsidered and thought better of allowing such evidence. It informed defendant that comparisons of the two vaccines would not be allowed and that no further evidence on that theory would be taken--even as rebuttal to, or impeachment of, Dr. Steinman's design defect testimony. The court, however, refused defendant's requests to admonish the jury not to consider such design defect evidence, and to exclude further testimony on that theory of defect. Similarly, when defendant attempted to introduce evidence to rebut Dr. Steinman's testimony that the predominant cause of polio in 1978 was OPV, the court routinely barred such proof as irrelevant.

Defendant suffered other seemingly erroneous evidentiary rulings during presentation...