Johnson v. American Cyanamid Co.

Prager, J.,

dissenting: I respectfully dissent. By this decision, the majority has denied to the plaintiff his right to trial by jury and has substituted its judgment for that of the jury and the trial judge who heard the testimony of the witnesses and determined the case. I have no quarrel with the general principles of law stated in the majority opinion which govern the liability of a drug manufacturer. I agree that where a manufacturer produces a highly beneficial product which is unavoidably unsafe to certain users of the product, the rules set forth in comment k of § 402A of the Restatement (Second) of Torts (1963) should be applied in determining the manufacturer’s liability.

Where a product creates a danger that cannot be eliminated, but its utility is so great that it should be manufactured without subjecting the manufacturer to strict liability, it may be marketed provided the user is made aware of the danger and is given the opportunity to make an informed decision whether to expose himself or herself to it. This principle is universally applied by the courts in such situations. The liability of the manufacturer in such cases is not based upon strict liability but is based upon the negligent failure to provide an adequate warning to an injured user of the product.

The law requires that the warning be communicated to the user of the product who may be injured by the use of the product. In situations where a product is sold and delivered to a treating physician, who then administers the product to the patient, the law requires that the manufacturer of the drug provide information and a sufficient warning to the physician who in turn is required to advise the patient or user of the drug of its dangers so *292that the ultimate user may make an informed decision whether to expose himself or herself to it. In the present case, the evidence is undisputed that the defendant, Dr. Vernon L. Branson, the treating physician, never at any time conveyed to the plaintiff, Emil E. Johnson, any warning whatsoever that the use of Orimune by Mr. Johnson’s daughter could transmit paralytic polio either to the child or to Mr. Johnson as the parent and custodian of the child. Both Dr. Branson and Mr. Johnson testified without equivocation that no warning was ever given by the doctor to Johnson.

The evidence was likewise undisputed that some information about the drug and a warning were given by the defendants, American Cyanamid Company and Lederle Laboratories, to Dr. Branson. The primary issue presented to the jury was whether or not the warning was adequate to inform Dr. Branson of the nature of the drug, its dangers, and the possibility of using less dangerous alternatives.

In determining this case, this court must first consider the nature and scope of the warning requirement in mass inoculation cases. In this regard, the cases generally agree that an adequate warning in mass inoculation cases requires that vaccinees be directly informed in clear and simple terms by the drug manufacturer of (1) the reasonably foreseeable risk inherent in the product; (2) reasonable available alternative products and the reasonably foreseeable risks posed by such alternatives; and perhaps — in appropriate cases — (3) the reasonably foreseeable results of remaining untreated. Petty v. United States, 740 F.2d 1428, 1436-37 (8th Cir. 1984) (adequacy of swine flu vaccine warnings); Unthank v. United States, 732 F.2d 1517, 1521 (10th Cir. 1984); Comment, Informed Consent to Immunization: The Risks and Benefits of Individual Autonomy, 65 Cal. L. Rev. 1286, 1295-99, 1307-11 (1977); see also Cobbs v. Grant, 8 Cal. 3d 229, 241-45, 104 Cal. Rptr. 505, 502 P.2d 1 (1972); cf., Britain, Product Honesty is the Best Policy: A Comparison of Doctors’ and Manufacturers’ Duty to Disclose Drug Risks and the Importance of Consumer Expectations in Determining Product Defect, 79 Nw. U.L. Rev. 342 (1984).

This rule is recognized and applied in Kearl v. Lederle Laboratories, 172 Cal. App. 3d 812, 218 Cal. Rptr. 453 (1985), which the majority opinion quotes from in depth. In Kearl, the package *293of OPV polio vaccine which was sold and delivered by Lederle to the doctor in 1978 contained a one-page warning insert which was described by the Kearl court as follows:

“ ‘IMPORTANT INFORMATION ABOUT POLIO AND POLIO VACCINE. 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. (Italics 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.’ (Italics 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. 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.’ (Italics added.)” pp. 818-19.

The court in Kearl considered this warning and held as a matter of law that it was an adequate warning, using the following language:

“As related above defendant directly warned plaintiff in plain and explicit terms about the risk of contracting polio from the vaccine. It described the alternative vaccine, IPV, and stated that vaccine carried no risk of causing polio, that it was available, and that most polio experts feel it is not as effective as OPV in controlling polio nationwide — an objective statement of fact clearly borne out by the literature. The reader was specifically invited to inquire further about IPV and was generally invited to ask questions about polio and polio vaccination. We conclude this warning adequately informed plaintiff of the reasonably foreseeable risks associated with OPV and with the alternative product, IPV.” p. 834. (Emphasis supplied.)

Compare the warning in Kearl with the warning inserted in the package delivered to the physician, Dr. Branson, in the present case. It was as follows:

“ADVERSE REACTIONS
“Individual patients have at times attributed symptoms or conditions to the *294vaccine by reason of time relationship, but these in general have been minor and apparently unrelated.
“Expert opinion is in agreement that the administration of live oral poliovirus vaccines is generally an effective and safe method of protecting populations against the natural disease. Paralytic disease following the ingestion of live poliovirus vaccines has been reported in individuals receiving the vaccine, and in some instances, in persons who were in close contact with subjects who had been given live oral poliovirus vaccine. Fortunately, such occurrences are rare, but considering the epidemiological evidence developed with respect to the total group of 'vaccine related cases’ it is believed by some that at least some of the cases were caused by the vaccine.
“The estimated risk of vaccine-induced paralytic disease occurring in vaccinees or those in close contact with vaccinees is extremely low. A total of approximately 30 of such cases were reported for the 8 year period covering 1963 to 1970, during which time about 147,000,000 doses of the vaccine were distributed nationally. Even though this risk is low, it should always be a source of consideration.” (Emphasis supplied.)

In considering the adequacy or inadequacy of the warning in this case, the language should be carefully analyzed. The first paragraph gives the impression that the symptoms or conditions suffered by patients from use of the vaccine have been minor and apparently unrelated. In paragraph two, although it is stated that paralytic disease following the ingestion of live poliovirus vaccines has been reported in individuals receiving the vaccine and in persons who were in close contact with persons who have been given oral vaccine, fortunately, such occurrences are rare, but it is believed by some that some of the cases were caused by the vaccines. This would indicate that the relationship between use of the live oral vaccine and paralysis suffered by patients or persons in contact with patients is questionable, because it is only believed by some that the cases were caused by the vaccines. This statement is contrary to the undisputed testimony of the defendants’ experts which was presented at the trial.

One of defendants’ experts, Dr. Vincent L. Fulginiti, testified by deposition that, as early as 1960, the manufacturers of the live polio vaccine knew that a certain number of people would get paralytic polio by coming in contact with a recipient of Orimune. In the present case, the vaccine was administered to plaintiffs daughter in 1975, fifteen years after the defendants became fully aware that the administration of Orimune could cause paralytic polio either to the user or to a person in close contact with a user. Would a reasonable person reading paragraph two of the insert *295warning given in this case reach that conclusion from the subdued language used in paragraph two?

It seems to me that, from.a reading of the warning given in this case, a reasonable person might conclude that the danger of total paralysis is not emphasized with the same intensity which is present in the warning which was found adequate in Kearl v. Lederle Laboratories, mentioned heretofore. It must also be emphasized that the warning in the present case did not in any way convey to Dr. Branson the fact that there was a reasonably available alternative product and the reasonable risks posed by such alternative product. This element of an adequate warning was considered as essential by the court in Kearl.

The majority opinion cites as authority Wooderson v.Ortho Pharmaceutical Corp., 235 Kan. 387, 681 P.2d 1038, cert. denied 469 U.S. 965 (1984). The duty to warn is discussed on pages 399-411 of the Wooderson opinion. If we follow Wooderson, I do not believe that this court could hold that a reasonable person could not reach the conclusion that the warning given in this case was not adequate.

Wooderson stands for the following legal propositions:

(1) The manufacturer of ethical or prescription drugs has a duty to give timely and adequate warnings to the medical profession of any dangerous side effects produced by its drugs of which it knows, or has reason to know.

(2) The duty to warn must be commensurate with the seriousness of the danger. The greater the danger, the greater the duty.

(3) Although the duty of the ethical drug manufacturer is ordinarily to warn the doctor rather than the patient, the manufacturer is directly liable to the patient for a breach of such duty.

(4) In the case of drug manufacturers, the standard of constructive knowledge is that of an expert in that particular field.

(5) Recause a manufacturer cannot be required to warn of a risk unknown to science, the knowledge chargeable to the manufacturer of an ethical drug must be limited to that of the period during which the plaintiff was using the product in question.

(6) The duty to warn is a continuous one, requiring the manufacturer to keep abreast of the current state of knowledge relevant to its products as gained through research, adverse reaction reports, scientific literature, and other available methods.

(7) An adequate warning is one reasonable under the circumstances.

*296In Wooderson, this court refused to hold that the warning was adequate as a matter of law and held that it was a jury question. We refused to substitute our judgment for that of the jury.

The law is clear that, in determining the adequacy of the warning on a dangerous product, the testimony of experts in the field should properly be considered. In this regard see Siruta v. Hesston Corp., 232 Kan. 664, 659 P.2d 799 (1983). The rule is generally followed throughout this country that expert or opinion evidence is admissible to be considered by the jury in determining the adequacy of the warning provided by a manufacturer to a user of a product. See the annotation on the subject at 26 A.L.R. 4th 377.

Let us now consider the evidence presented in the record in this case which supports the plaintiffs position that the warning provided by the defendants, as manufacturers, was inadequate and did not satisfy the requirements of law discussed earlier in this dissent. The evidence was undisputed that Emil E. Johnson, who is now totally incapacitated by permanent paralysis of his upper trunk, was never given any warning whatsoever by anyone as to the dangers of Orimune or the alternative use of a less dangerous vaccine. As early as 1960, it was known that live polio vaccine will cause some persons to get paralytic polio. Despite this knowledge, American Cyanamid and Lederle Laboratories decided to manufacture Orimune and make it available to the medical profession. I have no quarrel with that decision, provided warnings were provided to the medical community to protect the patients and persons in contact with them.

The evidence was undisputed that on June 28, 1968, Dr. Russell F. Cahoon, an employee in Lederle’s Medical Controls Branch, sent a memorandum to his superior, Dr. Eugene Swanzey, complaining that the warning contained in the package insert was not adequate. Dr. Cahoon suggested that all of the facts then known, which emphasized the risk involved, should be included in the package insert to advise the physicians, so that they could give proper warnings to their patients. Dr. Cahoon recognized that many prospective vaccinees or their relatives might be less likely to accept and receive the vaccine and this might reflect in reduced sales. Dr. Swanzey stated that he did not remember receiving the memorandum but, if he did, he threw it in the wastebasket. Dr. Swanzey did not see fit to *297discuss it with his superiors. Why has the majority rejected this testimony as a matter of law?

Dr. Branson was called as a witness. He testified without equivocation that the 1975 insert involved in this case did not tell him enough. He testified that he would have liked to have known as a practicing physician that Lederle was expecting a certain number of contacts to get polio from the vaccine he was giving to his babies. If he had known about it, he would have passed the information on to Emil Johnson. He did not consider the warning adequate, because it was not made clear that the vaccine would cause paralytic disease. Dr. Branson testified that, since he has learned about the use of IPV vaccine, he has used it in his practice, and, if Lederle had told him about IPV vaccine in 1975, he would have done so then. Dr. Branson, a competent Kansas physician, clearly testified that the warning provided by the defendants was inadequate. Why has the majority rejected his testimony as a matter of law?

Dr. Branson called as a witness Dr. Russell A. Nelson, a board certified pediatrician and a professor of pediatrics at the KU Medical Center. Dr. Nelson testified that if he had been adequately informed of the dangers of the live vaccine, the existence of the safe alternative Salk killed vaccine, and the fact that the killed vaccine was available to protect a vaccinee’s family, he would have passed that information on to Mr. Johnson, who was getting his daughter vaccinated. He felt that if he had had knowledge about the Salk killed vaccine, he would have given Mr. Johnson the opportunity to use either one. A reading of Dr. Nelson’s testimony could lead a reasonable person to the conclusion that the warning contained in the 1975 insert was not sufficient to advise a pediatrician of the danger involved in using live polio vaccine or of the other less dangerous alternative vaccine available. Why has the majority rejected his testimony as a matter of law?

Dr. Darrell J. Salk, a pediatrician on the faculty at the University of Washington, was called as a witness in the case by the plaintiff. His father is Jonas Salk, one of the developers of the inactivated killed polio vaccine which carries his name. Dr. Salk explained in great detail why the Orimune or live vaccine insert in this case was inadequate or misleading. In his testimony, Dr. *298Salk was specifically asked these questions and gave these answers:

“Q. Now, I want to tie this to the defendant’s package insert, that’s where I’m going, Doctor. Do you have an opinion to a reasonable medical probability as to whether or not the package insert for Orimune in 1975 was misleading in regard to the way in which they presented the risk of contact and recipient polio?
“A. Yes.
“Q. And what is that opinion?
“A. It’s my opinion that it’s misleading.”

Why has the majority rejected his testimony as a matter of law?

At the close of the evidence, the defendants contended that their warning was adequate as a matter of law. The trial court overruled that motion, holding that the adequacy of the warning was a question of fact for the jury. The case was submitted to the jury, which obviously found the warning to be inadequate. Twelve Kansas citizens on the jury, the trial judge, and three members of this court have concluded that the adequacy of the warning was a fact issue.

The rules to be used by an appellate court in reviewing the trial evidence, when challenged as to its sufficiency to support a verdict, are well stated in Cantrell v. R. D. Werner Co., 226 Kan. 681, 684, 602 P.2d 1326 (1979), an opinion by Justice Holmes. There he said:

“It has long been the rule that when a verdict is attacked for insufficiency of the evidence, ‘the duty of the appellate court extends only to a search of the record for the purpose of determining whether there is any competent substantial evidence to support the findings. The appellate court will not weigh the evidence or pass upon the credibility of the witnesses. Under these circumstances, the reviewing court must review the evidence in the light most favorable to the party prevailing below.’ Craig v. Hamilton, 221 Kan. 311, 313, 559 P.2d 796 (1977).”

This rule was approved by Justice Miller in his opinion in Wooderson v. Ortho Pharmaceutical Corp., 235 Kan. at 393.

Similarly, in Timsah v. General Motors Corp., 225 Kan. 305, 591 P.2d 154 (1979), the rules are concisely stated in Syllabus ¶ 1:

“When a verdict is attacked on the ground it is contrary to the evidence, it is not the function of this court on appeal to weigh the evidence or pass on the credibility of the witnesses. If the evidence with all reasonable inferences to be drawn therefrom, when considered in a light most favorable to the successful party below, will support the verdict this court should not intervene.”

In Wooderson, 235 Kan. at 393, Justice Miller defined “substantial evidence” as evidence which possesses both relevance *299and substance and which furnishes a substantial basis of fact from which the issues can reasonably be resolved. Stated in another way, “substantial evidence” is such legal and relevant evidence as a reasonable person might accept as being sufficient to support a conclusion.

I respectfully question how the four-person majority can hold, from the evidence in this case, that no reasonable person could conclude that the warning failed to meet the standard required by law for the protection of the American people. In my judgment, a legitimate fact issue was presented in the case which was for the jury to determine.

It has long been the position of the Kansas Supreme Court that the right of trial by jury is a substantial and valuable right. The law favors trial by jury and the right should be carefully guarded against infringements. The State has an interest in the subject of trial by jury as a matter of public right. The State has declared its policy on the subject not only by the decisions of its courts but also through acts of the legislature. In Bourne v. Atchison, T. & S. F. Rly. Co., 209 Kan. 511, 497 P.2d 110 (1972), the court declared:

“The right of trial by jury is provided for in the Constitution of the State of Kansas in Section 5 of the Bill of Rights which declares as follows:
“ ‘§ 5. Trial by jury.
“ ‘The right of trial by jury shall be inviolate.’
“K.S.A. 6-238 provides a statutory right to trial by jury as follows:
“ ‘60-238. Jury trial of right.
‘(a) Right preserved. The right of trial by jury as declared by section 5 of the bill of rights in the Kansas constitution, and as given by a statute of the state shall be preserved to the parties inviolate.’ ” p. 513.

Twenty-one years ago, in Gard v. Sherwood Construction Co., 194 Kan. 541, 400 P.2d 995 (1965), Justice Wertz had this to say about the importance of the right to trial by jury:

“The right of every individual citizen to a trial by jury is of ancient origin, and as now practiced is the result of a long process of development. Having early been regarded as a right, it was in England first guaranteed as such by the Magna Charta. It was introduced in this country by the English colonists who considered it a right under the English law, and is regarded as a basic and fundamental feature of American jurisprudence, and has since the organization of our government been incorporated in the form of expressed guaranties in the constitutions of both state and federal governments. It is a substantial and valuable right and should never be lightly denied. The law favors trial by jury, and the right should be carefully guarded against infringements (50 C.J.S., Juries, § 9, p. 722); and a trial court in the exercise of its prerogatives in determining questions of law, *300only, in these kinds of cases should not usurp the power and function of the jury in weighing evidence and passing upon questions of fact.” p. 549.

The majority of this court in this case, on the basis it is determining a question of law, has usurped the power and function of the jury by weighing evidence and by passing upon the credibility of witnesses. From this action, I must respectfully dissent.

I also dissent from the decision of the majority that, although defendants American Cyanamid Company and Lederle Laboratories are not liable as a matter of law, the verdict of the jury that the defendant physician, Dr. Vernon L. Branson, was without fault should be permitted to stand, with the result that the plaintiff Johnson is completely denied any remedy in the case. The majority has recognized the rule adopted by this court in Turnbull v. Byram, 235 Kan. 891, Syl. ¶ 2, 684 P.2d 429 (1984), which states:

“Where the jury finds a party to an action negligent and the record on appeal discloses as a matter of law that party is not negligent, the negligence of the remaining parties to the action must be redetermined by the factfinder and the percentages of fault of the remaining parties reassigned on retrial.”

The court refuses to apply that holding to the present case on the basis that the jury’s verdict that the defendant Dr. Branson was not at fault concludes the matter, because the plaintiff failed to appeal from the jury’s verdict on that issue. Such a ruling is manifestly unfair. The evidence in the case is absolutely undisputed and, in fact, it is admitted by Dr. Branson that no warning of any kind was given to the plaintiff, Emil E. Johnson, as to the dangers of Orimune and the alternative vaccine available. The cases hold that the ultimate consumer is entitled to this information as a matter of law so he can make an informed decision whether to expose himself to it. The majority opinion does not dispute that principle. If the warning was sufficient as a matter of law to convey the dangers and alternatives involved to the physician, and the physician did not convey that information to the plaintiff, then it would logically follow that the physician is liable for failure to carry out his duty to give the required warning to Mr. Johnson.

The jury in this case was required by the court to determine the adequacy of the warning given by defendants, American Cyanamid Company and Lederle Laboratories, and also to de*301termine whether or not Dr. Branson should be held liable for failure to understand the dangers of the oral live vaccine. The jury squarely placed the causal fault on the drug manufacturer, obviously holding that the warning was so inadequate and inept that Dr. Branson could not have reasonably realized the dangers involved. If the jury had been instructed that the plaintiff was entitled as a matter of law to a warning from Dr. Branson and that Dr. Branson should have known from the package insert the dangers and alternatives involved and should have conveyed that information to Emil E. Johnson so that he could have made an intelligent decision, the jury would have certainly concluded that Dr. Branson failed his duty by failing to give any warning of any kind. If this case is to be reversed on the basis that the drug companies’ warning was adequate as a matter of law, certainly the plaintiff should be entitled to a new trial against Dr. Branson under appropriate instructions from the trial court.

The law seems to be well settled that on reversing a case, the appellate court will ordinarily direct a new trial if, under the circumstances of the case, this is required to attain justice. Usually, an appellate court will not undertake to render a final judgment in a case where questions of fact are present, even though it may have the power to do so. The necessity for a new trial is deemed to exist whenever a jury verdict might be different from what it was in a trial where errors were committed. 5 Am. Jur. 2d, Appeal and Error § 963, p. 390, and the many cases cited therein.

It is true that in most jurisdictions today a judgment, against multiple tortfeasors may be reversed as to one such defendant without affecting the judgments as to the others. However, even under this rule, the courts will not enter such a partial reversal where substantial justice requires a reversal as to all defendants, as where it appears that a different verdict probably or possibly would have been rendered against the remaining defendant if that defendant had been sued alone or if the jury had realized that the remaining defendant would be solely liable.

Almost all jurisdictions recognize the rule that where the rights of the parties are so intermingled or where the error permeates the entire case the court should reverse as to parties not involved in the appeal. This court in Angell v. Railway Co., 98 Kan. 268, 157 Pac. 1196 (1916), stated that the more reason*302able as well as the more modern rule is that a judgment against joint tortfeasors may be affirmed as to part of them and reversed as to the others but only where no substantial injustice will result from that procedure. In Beachy v. Jones, 108 Kan. 236, 245, 195 Pac. 184 (1921), the court stated that in order to prevent a miscarriage of justice, the new trial granted by the court should be on all of the issues involved and between all the parties to the original action.

This rule is especially important in comparative negligent cases. In Kenneally v. Thurn, 653 S.W. 2d 69 (Tex. Civ. App. 1983), a motorcyclist brought an action for damages from a collision against the motorist, the city, and the property owner. The trial court sustained the motion of the city for a directed verdict. The plaintiff appealed. The appellate court, in reversing, granted a new trial against all defendants, stating:

“We cannot say that reversing the judgment of the trial court only insofar as plaintiffs’ claim against the City of San Antonio is concerned would not produce unfairness to plaintiffs. Because of the doctrine of comparative negligence, plaintiffs are entitled to a comparison of the extent of the causal negligence of all parties to the suit. We cannot say that the error in excluding the City of San Antonio from the process of attributing causal negligence to each party did not affect the jury verdict in this case.” 653 S.W. 2d at 75.

In Sullivan v. Methodist Hospitals of Dallas, 699 S.W. 2d 265 (Tex. Civ. App. 1985), a patient and her husband sued the hospital and doctor for injuries incurred when a sponge was left in her abdomen following a Cesarean section. The appellate court reversed and remanded the entire case for a new trial, because only clearly separable issues should be severed. The court stated that the doctrine of comparative negligence requires reversal and a new trial as to all multiple defendants in an action for damages, even though error has been found only as to one defendant. 699 S.W. 2d at 273-74.

To the same effect are Rose (Betty) v. Whitbeck, 278 Or. 463, 564 P.2d 671 (1977); Kure v. Chevrolet Motor Division, 581 P.2d 603 (Wyo. 1978); and Kuhn v. Kuhn, 301 N.W. 2d 148 (N.D. 1981).

Today the plaintiff, Emil E. Johnson, a Kansas farmer, is totally incapacitated as a result of the effect of the Orimune administered to his daughter. It is unfair to deny him any remedy whatsoever simply because this court has held that the jury was not properly instructed in the case. If this case must be reversed, *303justice and reason require that a new trial be granted Mr. Johnson against the defendant Dr. Vernon L. Rranson.

Herd and Lockett, jj., join in the foregoing dissenting opinion.