Plummer v. Lederle Labs - brief

Case brief: template

Case name:	Plummer v. Lederle Labs.
Court:	UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT
Citation; Date:	819 F.2d 349; 1987

PROCEDURAL HISTORY
Trial court:		Appeal court (for appeal cases only):
Plaintiff:	Plummer	Appellant:
Defendant:		Respondent:	Plummer

Facts of the case:
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. 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. "My feeling . . . was that there is an extremely minute percentage of people who will have the complications from the drug. I felt that, again, because I had never experienced [other practicing physicians] giving these warnings, it . . . wasn't necessary for me to do it; and . . . I felt . . . that giving the warning . . . could scare off parents from bringing children in for future vaccinations, which to me were much more important than the warning itself for the few number of people who are going to contract disease . . . . " The Orimune package insert describes in detail the risks of administering OPV. [Per CDC]: The risk is estimated to be one case in a recipient for every 20 million doses of vaccine distributed and one case in a contact for every 6 million doses distributed. The risk of vaccine-associated paralysis is extremely small for vaccinees, susceptible family members and other close personal contacts. However, the responsible physician should convey or specifically direct personnel acting under his authority to convey the warnings to the vaccinee [or] parent . . . of the possibility of vaccine-associated paralysis prior to administration of the vaccine. 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 was also introduced into evidence and it varies from the 1979 insert by stating that "expert opinion is in agreement that the administration of [OPV] is generally an effective and safe method of protecting populations against the natural disease", and that "the estimated risk of vaccine-induced paralytic disease occurring in vaccinees or those in close contact with vaccinees is extremely low." It did not give a breakdown of the estimated number of cases of contact polio, as the 1979 warning did. Also, it did not advise physicians to consider administering IPV to previously unvaccinated individuals

Remedy sought:	Appeal and cross-appeal from a judgment of the United States District Court for the Southern District of New York after jury trials before John E. Sprizzo, Judge, awarding plaintiff $ 3,200,000.00 on his products liability claim against the manufacturer of an oral polio vaccine.

Court opinion (including key issues and arguments):
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. ... The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. 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. ... In a negligence action, the adequacy of warnings is determined based on their "reasonableness." .... 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. The parties do not seriously dispute that in the present case we are considering Lederle's duty to direct warnings to the prescribing physician and the medical profession in general, rather than to the patient. The parties' primary dispute is over the type of warnings required to be given to meet the manufacturer's duty under California law. 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. 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. 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.... This contention is not supportable. ... The California courts have not yet addressed the question of whether precautions must be specified as a matter of law in prescription drug cases. 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. 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. 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. Dr. Cohen testified that he knew of the information plaintiff claimed should have been in the insert -- that an unimmunized person should avoid contact with the vaccinee for 30 days -- but still did not warn Plummer's daughter. ...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. ...

Disposition of case:
Vacated and remanded for entry of judgment dismissing the action against defendant.

ECONOMIC ANALYSIS OF THE CASE