TENNEY, District Judge.
This is an appeal and cross-appeal from a final judgment of the United States District Court for the Southern District of New York, Sprizzo, Judge, entered upon interrogatory
Lederle appeals from the district court's final judgment as well as its rulings and orders denying Lederle's motions for summary judgment, judgment notwithstanding the verdict, or a new trial. Plummer cross-appeals from the district court's order directing a second trial on the issue of proximate causation and refusing to award him interest from the date of the first jury's verdict. We vacate the district court's judgment and remand for entry of judgment notwithstanding the verdict. The cross-appeal is rejected in all respects.
This products liability action involves Orimune, a polio vaccine manufactured by Lederle. All agree that the development of vaccines against poliomyelitis has been a major achievement of modern preventive medicine. Ironically, the very success of the polio vaccines underlies the charge of negligence in this action.
At the outset, it should be noted that there are two different types of polio vaccine. Oral polio vaccine, technically referred to as poliovirus vaccine, live, oral, trivalent ("OPV"), developed by Dr. Albert Sabin, contains three live but weakened strains of virus that nonetheless provoke the vaccinee's immune system to respond and develop antibodies effective against the wild strain of the virus. Injected polio virus ("IPV"), developed by Dr. Jonas Salk, contains killed, or inactivated strains of virus. The Salk IPV vaccine was developed first and the Sabin OPV vaccine became available shortly thereafter. Orimune is the trade name for the OPV vaccine manufactured by Lederle. Both vaccines aided in greatly reducing the incidence of polio in the United States.
Notwithstanding certain inherent risks, OPV became the vaccine of choice in the United States and most of the world for a number of reasons. First, because OPV is administered orally, commonly on a sugar cube, it is far easier to distribute than IPV which must be injected with a hypodermic needle. Second, the interaction of the live virus in OPV with the immunological system confers lifetime immunity. IPV, in contrast, requires periodic readministration in the form of "booster shots" to maintain immunity. Third, the oral administration of OPV stimulates production of antibodies in the gastrointestinal tract as well as in the bloodstream, thus producing bowel immunity which interrupts the method of transmitting the wild strain of the virus. Over time, the interruption of the virus' transmission path is expected to eradicate the wild strain. Finally, persons vaccinated with OPV shed vaccine viruses through feces and saliva to nonvaccinated persons, thereby conferring immunity on them as well.
To understand the risks inherent in OPV, it is necessary to comprehend the immunization process. The live but weakened viruses of OPV grow in the intestinal tract of the vaccinee. The growing viruses trigger the vaccinee's immune system to produce antibodies which render the vaccinee immune to the disease after 30 days. Rarely, but at a statistically predictable rate, the virus reproduced in the vaccinee's intestinal tract reverts to the virulent form. When this occurs, the vaccinee or persons coming in close contact with the vaccinee during the 30-day period may contract polio. Unvaccinated adults can take two precautions to avoid the risk of "contact polio": (i) alternative vaccination with IPV prior to contact with the vaccinee; and (ii) avoidance of contact with the vaccinee for one month, during which time live polio viruses
In November 1979, Orimune was prescribed and administered to Plummer's infant granddaughter, Mavis Lyster, by Dr. Abby Cohen. Dr. Cohen did not convey any warnings to Mavis' mother. Plummer thereafter contracted a condition diagnosed as paralytic poliomyelitis. It is undisputed for the purposes of this appeal that Plummer had never been vaccinated and contracted polio through contact with his granddaughter.
In a deposition, Dr. Cohen stated that his education and training had informed him that there was a slight risk in administering OPV inasmuch as the vaccinee or those coming in contact with the vaccinee could potentially develop paralytic disease. His reading of professional journals confirmed that polio could be transmitted via "secretions from the mouth, but much more commonly by way of stool." Joint Appendix ("JA") 184. He described the risk of contact polio as "small," admitting that he "probably did not know [the statistics on its occurrence]." He also indicated he was aware that both the 1977 package insert for Orimune and articles in professional journals recommended that doctors warn patients concerning the risks of OPV. However, he expressed his view concerning the necessity of conveying warnings as follows:
The Warnings at Issue
Under established law, the sellers of dangerous products may be required to include on containers of these products directions or warnings as to their use. Restatement (Second) of Torts, § 402A comment j (1965). It is undisputed that certain types of drugs, such as polio vaccines, are dangerous. Id., comment k. Therefore, in assessing the potential liability of prescription drug manufacturers, it is essential to review the informational inserts provided with the drugs.
The Orimune package insert describes in detail the risks of administering OPV. The "Adverse Reactions" section of the June 1979 package insert, the principal warning at issue here, states in pertinent part:
Thus, the 1979 package insert advises that unvaccinated individuals may avoid the risk of contracting contact polio from Orimune vaccinees by receiving an IPV vaccination prior to contact.
The 1977 Orimune package insert
Dr. Darrell Salk, son of the doctor who discovered IPV, testified as an expert witness for the plaintiff. He stated that in his opinion Lederle's warnings inaccurately estimated the number of occurrences of contact polio per doses distributed as one in 6 million, and misleadingly failed to compare the risk of contracting contact polio relative to the risk of contracting wild polio. However, he admitted that Lederle's method of stating the risk is also used by most medical authorities in the United States, including the United States Public Health Service Advisory Committee on Immunization Practice (JA 298, 304; 314-19) and Centers for Disease Control (JA 334-35), the Committee on Infectious Diseases of the American Academy of Pediatrics (JA 308), and an Institute of Medicine Study of Poliovirus vaccines (JA 334-38).
The Centers for Disease Control provided the data in the 1979 insert stating the risk of contact polio per doses distributed. JA 334-336; Brief for Appellant, at 39. The insert was approved by the Bureau of Biologics (presently the Office of Biologics Research and Review) of the Food and Drug Administration in June, 1979, as required by 21 C.F.R. §§ 600-601 (1986).
Although Plummer's complaint originally alleged several theories of liability, the case did not proceed to trial on all of them. After the completion of discovery, Lederle moved for summary judgment on the grounds that (i) its warnings were adequate as a matter of law and (ii) there was
The district court rendered an oral ruling denying Lederle's pre-trial motion for summary judgment but substantially narrowing the issues to be tried. In accordance with this ruling, the parties prepared a Joint Pre-Trial Order dated May 4, 1984 which reflected the district court's view that the only issues remaining to be tried, as a matter of law, were (i) whether Lederle had a duty adequately to advise the reasonable physician of precautions to be taken in connection with the prescription and administration of Orimune; (ii) whether Lederle satisfied such a duty; (iii) assuming that Lederle did not satisfy its duty, whether that failure was the proximate cause of plaintiff's damages.
The case proceeded to trial. The jury returned a verdict that Lederle was liable to Plummer for damages in the amount of $3.2 million, finding that the 1977 insert was inadequate because it did not include general precautions or either of the two specified precautions for avoiding the risk and the 1979 insert was inadequate because it did not include general precautions or the second specified precaution, although it was adequate in recommending the first specified precaution, alternative administration of IPV. The jury further found that Lederle had used reasonable efforts in distributing the 1979 insert and that it had been received by Dr. Cohen. The jury concluded that Lederle's inadequate warnings were a proximate cause of plaintiff's injury and Dr. Cohen's failure to warn was not the sole cause of plaintiff's injury.
Lederle moved for judgment notwithstanding the verdict or a new trial, contending that its warnings were adequate as a matter of law and that the charge on proximate causation was erroneous. The district court ordered a new trial limited to the issue of proximate cause, reasoning that the jury might have been misled by an erroneous supplemental instruction which failed to point out that the defendant could be exonerated not only by the doctor's negligence but also by the patient's contributory negligence. The judge ruled over Lederle's objection that it would allow Plummer to introduce evidence at the second trial concerning his theory that the package inserts "minimized the risk" of contact polio.
The second jury answered seven questions. In response to questions 1 and 2, the jury agreed that the defendant's package
Lederle again moved for a new trial, on the ground that the second jury's answers to questions 6 and 7 were irreconcilably inconsistent. Lederle claimed that questions 6 and 7 were redundant, and therefore the jury could not simultaneously conclude: (i) that the 1979 insert was inadequate in failing to recommend as a specified precaution avoidance of contact with the vaccinee for one month (response to question 6) and (ii) that the insert adequately recommended general precautions (response to question 7). Lederle's motion was denied in an order dated July 24, 1986.
A federal court sitting in diversity must follow the law directed by the Supreme Court of the state whose law is found to be applicable, and if there is no direct decision by the highest court of that state, the federal court should determine what it believes that state's highest court would find if the issue were before it. See Meredith v. Winter Haven, 320 U.S. 228, 234-37, 64 S.Ct. 7, 10-12, 88 L.Ed. 9 (1943). Plaintiff is a California resident, his granddaughter was inoculated with Orimune in California, and he developed polio in California, as well. Thus, New York's choice of law rules, which apply to this action by virtue of the holding in Klaxon Co. v. Stentor Elec. Mfg., 313 U.S. 487, 496, 61 S.Ct. 1020, 1021-22, 85 L.Ed. 1477 (1941), dictate that California substantive law applies because that is the place where plaintiff's injury occurred. Fort Howard Paper Co. v. William D. Witter, Inc., 787 F.2d 784, 795 (2d Cir.1986); Wright v. Carter Prod., Inc., 244 F.2d 53, 56-57 (2d Cir.1957).
Issue of the Adequacy of the Warnings
It is undisputed that polio vaccines are inherently dangerous drugs. The seller of such a product may be required to give directions or warning as to use on the product's container. Restatement (Second) of Torts, § 402A comment j (1965).
Thus, drug manufacturers are obligated by law to provide doctors and/or consumers with adequate knowledge of the hazards of the drugs they manufacture. If they do so, they are held not to a strict liability standard for the consequences attending the use of the product, but to a negligence standard. Brown v. Superior Court, 182 Cal.App.3d 1125, 227 Cal.Rptr. 768 (1 Dist.), petition for review granted, 229 Cal.Rptr. 663, 723 P.2d 1248 (1986). In a negligence action, the adequacy of warnings is determined based on their "reasonableness." Finn v. G.D. Searle & Co., 35 Cal.3d 691, 700, 200 Cal.Rptr. 870, 875, 677 P.2d 1147, 1152 (1984). If the drug is given under clinic-type conditions the manufacturer is obliged to warn consumers directly. In the case of prescription drugs dispensed by physicians, the obligation is to warn the physician. This "prescription drug rule" has been followed by the courts of California. See Fogo v. Cutter Laboratories, Inc., 68 Cal.App.3d 744, 754, 137 Cal.Rptr. 417, 423 (1 Dist.1977); Magee v. Wyeth Laboratories, Inc., 214 Cal.App.2d 340, 348, 29 Cal.Rptr. 322, 328 (2 Dist.1963). The rule was explained in Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974), as follows:
498 F.2d at 1276.
The parties do not seriously dispute that in the present case we are considering Lederle's
The second jury agreed with Plummer's claims that the warnings issued by Lederle regarding Orimune improperly (i) minimized the risk of contact polio and (ii) failed to specify precautions that could be taken to avoid these risks. On this appeal, we must determine whether the district court properly construed California law applicable to this action as allowing Lederle to be found liable to Plummer if inadequacies of this nature were present in Lederle's warnings. Lederle contends that such inadequacies are, as a matter of law, insufficient to support the jury's verdict.
With regard to the issue of alleged minimization of the risk in product warnings, the California authority most closely analogous to the instant case is Kearl v. Lederle Laboratories, 172 Cal.App.3d 812, 218 Cal.Rptr. 453 (1 Dist.1985). The facts underlying Kearl differ in only two ways from those in the present case: (i) contact polio was not involved (i.e., the vaccinee herself contracted the disease from the administration of Orimune); and (ii) the vaccine was administered in a clinic-type setting so the court was required to review manufacturer warnings transmitted directly to the patient, rather than through a "learned intermediary" such as a doctor. The claims regarding the adequacy of the warnings in Kearl are almost identical to those asserted by Plummer in the present case. The Kearl court noted that Lederle had warned the patient directly of the risk of contracting polio from the vaccine, and mentioned the alternative vaccine, IPV. The court concluded that this warning adequately informed plaintiff of the foreseeable risks. It rejected plaintiff's contention that the warning was inadequate for failing to state precisely the exact known risks of contracting polio from OPV relative to contracting it from wild polio viruses (i.e., without being vaccinated). The court concluded: "whatever duty a manufacturer may have to inform of risks associated with nonuse of a product, such a duty most certainly cannot be imposed when the relationship between use and nonuse is statistically close (and quite possibly immeasurable) and the probability of injury from either course is extremely remote." 172 Cal.App.3d at 835, 218 Cal.Rptr. at 468. The court held the warning to be adequate as a matter of law.
In the present case, we similarly hold that the warning was adequate as a matter of law. The first jury found that Lederle took reasonable efforts to disseminate the 1979 package insert to the medical profession. The 1979 insert contained statistics compiled by public health authorities estimating the number of cases of contact polio per doses of vaccine distributed. This method of stating the risk of contact polio is used not only by Lederle, but also by established medical authorities. Even assuming, as the second jury found, that the warnings did minimize the risk of contracting contact polio, the fact remains that the probability of contracting either contact polio or wild polio is extremely remote. The Kearl decision thus establishes that the verdict here cannot be supported by Plummer's theory that Lederle negligently minimized the risks of contracting contact polio in its package inserts.
Plummer further claims that the California Supreme Court has endorsed an approach that requires manufacturers of prescription drugs to give warnings of specific precautions that can be taken to avoid the hazards of its drug, citing Finn, supra. This contention is not supportable. Finn merely recognized in dictum that two types of warnings exist: those which instruct the consumer regarding use of a product and those which inform him regarding risks that may follow from use of a product. 35 Cal.3d at 699, 200 Cal.Rptr. at 875, 677 P.2d at 1152. Nowhere did the court state that a prescription drug manufacturer would be deemed negligent for failing to specify precautions in its package inserts. The California courts have not yet addressed the question of whether precautions
However, Lederle correctly points out that in Dunn v. Lederle Laboratories, 121 Mich.App. 73, 328 N.W.2d 576 (1982), a Michigan appellate court was presented with this same proposed theory of liability in a contact polio case and was asked to reverse judgment in favor of Lederle. The court refused to find a duty to warn of precautions to be taken in connection with prescribing Orimune. That court stated: "[c]onsidering the slight risk of contact polio, the variability of risks of harm (depending on many personal factors, including cleanliness and frequency and type of contact with a recently-vaccinated child), the introduction of individualized medical judgment, and ... other policy reasons ..., we do not accept plaintiffs' invitation to add new requirements to a manufacturer's duty to warn." 121 Mich.App. at 83, 328 N.W.2d at 581 (footnotes omitted).
In the present case, the judgment of the district court rests on the jury's finding that Lederle's warnings were legally inadequate because they failed to specify precautions for avoiding contact polio. We must determine what the California Supreme Court would decide if it were faced with this question. In the absence of any applicable California precedent in the prescription drug context based on a duty to specify precautions, we believe the California Supreme Court would not expand a manufacturer's duty and require that specified precautions be stated, especially where the warnings are being directed to a "learned intermediary" such as a doctor. In short, judgment notwithstanding the verdict should have been directed since there is no duty under California law to specify precautions in the prescription drug context.
The Proximate Causation Issue
The second major issue on appeal relates to the proof of proximate cause. Lederle claims that Plummer failed to make a showing sufficient to establish all the elements essential to his case, thus the motion for judgment notwithstanding the verdict should have been granted. See Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 2554, 91 L.Ed.2d 265 (1986). In particular, Lederle claims Plummer did not prove that inadequacy of the warnings was the proximate cause of his injury, since the testimony established that Dr. Cohen was aware of the risks of contact polio but as a matter of practice, did not convey these warnings to the parents of the patient. Lederle claims that the verdict must be set aside because of this failure of proof of proximate causation.
Plummer responds by arguing that the jury was entitled to discredit Dr. Cohen's testimony and reach its own conclusion on proximate cause. Presumably, Plummer contends that the jury's conclusions in response to the question on minimization of the risk, i.e., that Dr. Cohen was prompted not to warn the patients based on the inadequacies in the warnings to state the true risk, is the substitute for a finding on proximate cause. In support, plaintiff cites Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973), a case which imposed liability on a drug manufacturer because its overpromotion of a dangerous drug to the medical profession was coupled with a gross minimization of the risk of prescribing the drug in the product warnings.
Stevens is distinguishable because in the present case there is no evidence that Lederle overpromoted Orimune, nor is there proof that Lederle grossly minimized the risk. At best, Lederle understated a small risk to make it appear even smaller. Furthermore, as Lederle notes, the plaintiff failed to prove that a proper warning would have altered the doctor's conduct.
According to Plummer, Dr. Cohen's testimony that he had a practice of failing to warn his patients of the risk of contact polio should not be credited because he was an interested witness. It may be true that Dr. Cohen was an interested witness, but his was the only testimony on the issue of proximate cause. Even if the jury failed to credit him, Plummer has not proven an essential element of his case. Furthermore, even if the warnings had been stronger, a reasonable jury could not have concluded that Dr. Cohen would have warned the vaccinee's mother. Thus, judgment notwithstanding the verdict should be entered for Lederle because a reasonable jury could not have found proximate cause. See Dunn, 121 Mich.App. at 85, 328 N.W.2d at 582; Stanback v. Parke, Davis & Co., 657 F.2d 642, 646 (4th Cir.1981) (doctor testified he knew of risk but had practice of not informing patients about it); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 92 (2d Cir.1980) ("no one needs notice of that which he already knows").
On Lederle's appeal, we vacate the judgment of the district court and remand for entry of judgment notwithstanding the verdict. Thus, it is not necessary to address Lederle's claims that various evidentiary rulings and instructions to the jury were erroneous, and that the second jury's answers to certain questions were inconsistent.
In view of our decision that judgment notwithstanding the verdict should be granted, Plummer's cross-appeal is denied in all respects.
The estimated risk of vaccine-induced paralytic disease occurring in vaccinees or those in close contact with vaccinees is extremely low. However, the "risk" should be considered by the physician and such information should be conveyed to the parent(s) at the time of vaccination. Those parents of a vaccinee who have not had previous polio vaccination should probably be considered among those adults as subject to increased risk of exposure and in this special situation, in the judgement of the physician responsible, protection may be needed for these intimate contacts.
1. Do you find that the ... [1977 insert] ... failed to advise a reasonably prudent private physician that [an unimmunized adult should be given an IPV inoculation?]
2. Do you find that the ... [1977 insert] ... failed to advise that unimmunized adults should [avoid contact with OPV-vaccinated infant for one month]?
3. Do you find that the ... [1977 insert] ... failed to advise a reasonably prudent private physician of the necessary precautions to be taken to avoid contact with any individual immunized with [OPV]?
4. [Same as question (1), with respect to 1979 insert]
5. [Same as question (2), with respect to 1979 insert]
6. [Same as question (3), with respect to 1979 insert]
7. Do you find ... that the 1979 insert ... was disseminated in a reasonable manner to the medical profession prior to November 3, 1979?
8. Do you find ... that Dr. Cohen received the 1979 insert ... prior to November 3, 1979?
9. If the answer to any one of questions # 1 through # 6 is "Yes" do you find ... that the inadequacy of defendant's warning was a proximate cause of the plaintiff's injury?
10. Do you find ... that the plaintiff's injury was caused solely by the independent decision of Dr. Cohen to administer [OPV] to the plaintiff's grandchild without informing the plaintiff's daughter of the risks incident thereto and the precautions to be taken in that regard?
All of the questions except numbers 4 and 10 were answered affirmatively. JA 54-57.
1. Do you find ... that the manner in which the defendant described the risk of vaccine associated contact polio in the package insert minimized that risk?
2. If [yes to the above], did that description influence Dr. Cohen to not give any warnings?
3. Do you find ... that the defendant's failure to advise [physician in 1977 insert] that a program of IPV inoculation for unimmunized adults should be considered was a legal cause of the plaintiff's injury?
4. Do you find ... that the defendant's failure [to advise physician in 1977 insert] that unimmunized adults should not come in contact with [OPV-vaccinated infant] for approximately one month was a legal cause of plaintiff's injury?
5. Do you find ... that the defendant's failure [to advise physician in 1977 insert] of the necessary precautions to be taken to avoid contact with [OPV-vaccinated infant] was a legal cause of plaintiff's injury?
6. Same as question (4), with respect to 1979 insert.
7. Same as question (5), with respect to 1979 insert.
All of the questions except number 7 were answered affirmatively. JA 133-34.