Dunn v. Lederele Laboratories

• Decision Date: 24 January 1983
• Docket Number: Docket No. 60229
• Parties: Betty DUNN and Thomas Dunn, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, a Division of American Cyanamid Co., a foreign corporation, Defendant-Appellee.
• Court: Court of Appeal of Michigan — District of US

Page 576

328 N.W.2d 576

121 Mich.App. 73

Betty DUNN and Thomas Dunn, Plaintiffs-Appellants, v. LEDERLE LABORATORIES, a Division of American Cyanamid Co., a foreign corporation, Defendant-Appellee.

Docket No. 60229.

Court of Appeals of Michigan.

Submitted Aug. 4, 1982.

Decided Nov. 3, 1982.

Rehearing Denied Jan. 13, 1983.

Released for Publication Jan. 24, 1983.

Charfoos, Christensen, Gilbert & Archer, P.C. (by Adrienne G. Southgate and Harriet Morman), Detroit, for plaintiffs-appellants.

James S. Goulding, Detroit, for defendant-appellee.

Before KAUFMAN, P.J., and WAHLS and CLEMENTS ^*, JJ.

KAUFMAN, Presiding Judge.

In 1974 plaintiffs, Betty and Thomas Dunn, ¹ took their daughter Stephanie to a doctor for her baby shots. The doctor gave Stephanie, Orimune, the Sabin vaccine manufactured by defendant Lederle Laboratories, a division of American Cyanamid Company. Soon after, Mrs. Dunn became ill. Polio was diagnosed.

The Dunns sued the doctor and Lederle for failure to warn of the hazards of contact polio. After the doctor testified at trial, plaintiffs settled their case against him. The case against Lederle proceeded, and a Wayne County Circuit Court jury found for the defendant Lederle. Plaintiffs' motion for judgment notwithstanding the verdict or, in the alternative, new trial was denied. Plaintiffs appeal from this denial.

Lederle admitted at trial that it knew of contact polio as early as 1966. Lederle also admitted that Mrs. Dunn was infected with polio as a result of contact with her daughter. The primary defense was that, even if its warnings were inadequate, the failure to adequately warn was not the proximate cause of Mrs. Dunn's disease. We conclude that the jury could reasonably find for the defendant on this theory. The trial judge therefore did not abuse his discretion by denying the motion for judgment notwithstanding the verdict or new trial.

I.

Poliomyelitis, or polio, is caused by a virus which enters the body orally and reproduces rapidly in the intestinal tract. The virus then spreads to the spinal column, damaging the nervous system and causing muscular paralysis. ² In 1952, before a vaccine was developed and marketed, there were 57,879 reported polio cases in the United States. Crippling paralysis resulted in 21,269 cases. ³

In 1949 a Harvard doctor, Enders, discovered a process for creating a tissue culture of the virus. This was a major step in the development of a vaccine. By reproducing the virus, chemically killing it, and injecting the killed virus into the human body, another doctor, Salk, invented a vaccine. This vaccine, the "Salk" vaccine, came into common usage around 1955. ⁴

In time a live virus vaccine was invented by another doctor, Sabin. The live, or "Sabin", vaccine was preferred over the Salk vaccine for several reasons. First, the Salk vaccine was administered by injection; the Sabin vaccine is taken orally as a drop in a sugar cube. Second, the Salk vaccine required three separate shots followed by booster shots. The trivalent type Sabin vaccine requires only one administration, and no boosters, to combat all varieties of the polio virus. ⁵ Third, the Salk vaccine did not attack the virus in the intestinal tract, where it reproduces rapidly. As a result, the disease could still easily spread from vaccinated persons to nonimmune persons. The Sabin vaccine, on the other hand, provides intestinal immunity; it kills the virus where it breeds. Coupled with the lack of need for booster shots, permanent immunity is provided. These differences, among others, made the Sabin vaccine more compatible with the nationwide effort to immunize the masses and stop polio. ⁶

The Sabin vaccine involves introducing a weakened, but live, virus into the body. The presence of the virus triggers the natural production of antibodies which destroy the weakened virus. These antibodies then immunize the body to naturally-occurring wild polio viruses. ⁷ This use of a live virus led to a controversial finding: the vaccine itself could cause polio. ⁸ In the 1960s, several people developed polio within 30 days of immunization. A special committee of the United States Public Health Service determined that some of these cases might have been caused by the vaccine. ⁹ A plausible theory is that these persons lacked the immunity system needed to ward off the virus introduced. Additionally, "contact-type" polio was diagnosed among other patients. Because the live virus vaccine operates in the intestinal tract, some virus is expelled in the feces. Unvaccinated persons coming in contact with the feces of recently-vaccinated persons--generally from handling diapers--could develop the disease. ¹⁰

II

Unavoidably unsafe products must be properly marketed with adequate warnings of their dangers. See Calabrese v. Trenton State College, 162 N.J.Super. 145, 392 A.2d 600, 604 (1978), aff'd 82 N.J. 321, 413 A.2d 315 (1980) (rabies vaccine). The polio vaccine is an unavoidably unsafe product; there are certain risks inherent in its use, yet its benefits outweigh these risks so greatly that it would be counterproductive to ban the drug. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (CA 5, 1974), cert. den. 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974) (polio vaccine). To maximize safety, then, some kind of warning may be required.

Warnings generally must be calculated to reach the ultimate consumer. An exception exists for drugs dispensed in a manner requiring a physician to weigh the risks and benefits of a drug's use on a particular patient. Smith v. E.R. Squibb & Sons, Inc., 405 Mich. 79, 88, 273 N.W.2d 476 (1979). ¹¹ With these drugs the doctor, and not the patient, must be warned by the manufacturer.

The manufacturer must adequately warn of dangers it knows or has reason to know of. 2 Restatement Torts 2d, Sec. 388, pp. 300-301. ¹² In this respect, the manufacturer is held to the knowledge of an expert and is presumed to know of scientific studies and articles concerning the safety of its products. Borel v. Fibreboard Paper Products Corp., 493 F.2d 1076, 1089 (CA 5, 1973), cert. den. 419 U.S. 869, 95 S.Ct. 127, 42 L.Ed.2d 107 (1974); Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 149 (Mo.1967). Taking this knowledge into consideration, the adequacy of a warning is an issue of reasonableness. Smith v. E R Squibb & Sons, supra, p. 90, 273 N.W.2d 476. Reasonableness is a question of fact.

III

Plaintiffs' first claim on appeal is that the jury could not find Lederle's warning adequate because any warnings given did not disclose how to avoid contact polio. We do not intend to second-guess the jury on the reasonableness of Lederle's warnings. Even if the warnings were inadequate, the jury could find that the failure to warn was not the proximate cause of plaintiff's injury. ¹³ Plaintiffs' argument on the proper scope of warning, however, deserves comment.

Plaintiffs cite no authority for the proposition that a warning must include instructions on how to avoid a danger. Our search of the law also reveals no authority. ¹⁴ This is understandable for many reasons. A danger is often avoided simply by refusing to use the dangerous product. Of course, this option was not available to the plaintiff, her daughter, or her doctor. ¹⁵ Second, a "danger" is many things to different people. Especially with drugs, the danger can vary from person to person. Some people are more sensitive to certain drugs than are others; thus, methods of avoiding the danger may vary depending on the user's susceptibility to danger and the type of reaction suffered. This leads to another reason: sensory overload. Commentators have cautioned that excessive warnings on product labels may be counterproductive. See Twerski, Weinstein, Donaher & Piehler, The Use and Abuse of Warnings in Product Liability--Design Defect Litigation Comes of Age, 61 Cornell L.Rev. 495, 514-517 (1976):

"The unexamined premise that warnings are not costly in risk-utility balancing is, in our considered opinion, highly questionable. Warnings, in order to be effective, must be selective. They must call the consumer's attention to a danger that has a real probability of occurring and whose impact will be significant. One must warn with discrimination since the consumer is being asked to discriminate and to react accordingly. The story of the boy who cried wolf is an analogy worth contemplating when considering the imposition of a warning in a case of rather marginal risk. These considerations are of particular significance when considering whether a warning should be imposed or a design change mandated in a products liability case. Those who argue for warning as the judicial solution to latent defect cases labor under a naive belief that one can warn against all significant risks. The truth is that such a marketing scheme is not feasible. The warning process, in order to have impact, will have to select carefully the items which are to become part of the consumer's mental apparatus while using the product. Making the consumer account mentally for trivia or guard against risks that are not likely to occur imposes a very real societal cost. Even when the risks are significant, one must consider whether the consumer will perceive them as significant. If the only way to ensure that the consumer will consider them significant is to oversell the warning by increasing its intensity, one may again face the problem that all warnings will come into disrepute as overly alarming. This does not mean that warnings do not have a major role to play in the area of product safety. It does mean, however, that there is a real question as to which dangers must be warned against and which dangers should be designed out of products. Furthermore, for every danger that is designed out it may become possible to warn against others that still remain as potentially dangerous.

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"In short, when calculating the burden of precaution which is part of the...