Plummer v. Lederle Laboratories, Div. of American Cyanamid Co.

Decision Date19 May 1987
Docket Number1366,Nos. 692,D,s. 692
Citation819 F.2d 349
PartiesProd.Liab.Rep.(CCH)P 11,422 Harry PLUMMER, Plaintiff-Appellee, Cross-Appellant, v. LEDERLE LABORATORIES, DIVISION OF AMERICAN CYANAMID COMPANY, Defendant-Appellant, Cross-Appellee. ockets 86-7768, 86-7798.
CourtU.S. Court of Appeals — Second Circuit

David Jaroslawicz, New York City (Alfred S. Julien, Stuart A. Schlesinger, Edward J. Sanocki, Jr., Julien & Schlesinger, New York City, on the brief), for plaintiff-appellee, cross-appellant.

J. Peter Coll, Jr., New York City (Charles W. Gerdts, III, Laurie J. Gentile, Donovan, Leisure, Newton & Irvine, New York City, on the brief), for defendant-appellant, cross-appellee.

Before PRATT and MINER, Circuit Judges, and TENNEY, District Judge. *

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 answers following two jury trials. The first trial commenced on October 1, 1984, and at the conclusion thereof the jury answered special interrogatories and returned a general verdict for plaintiff Harry Plummer of $3.2 million. The district court reserved decision on the motion of defendant Lederle Laboratories ("Lederle") to set aside the verdict, and ordered a second trial limited to the issue of proximate causation. The second trial commenced on June 2, 1986, and at the conclusion thereof, the jury returned interrogatory answers in favor of Plummer. A final judgment awarding $3.2 million in damages to Plummer was entered on August 13, 1986.

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.

BACKGROUND

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 are being shed from the intestinal tract of the vaccinee via the saliva and feces.

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:

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....

JA 182-83.

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, Sec. 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:

Paralytic disease following the ingestion of live poliovirus vaccines has been, on rare occasion, reported in individuals receiving the vaccine, as well as in persons who were in close contact with vaccinees. Most reports of paralytic disease following ingestion of the vaccine or contact with a recent vaccinee are based on epidemiological analysis and temporal association between vaccination or contact and the onset of symptoms. Most authorities believe that a causal relationship exists.

The Center for Disease Control reports [the number of doses distributed for certain years and the number of occurrences of contact polio and vaccine-associated polio]....

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. When the attenuated vaccine strains are to be introduced into a household with adults who have never been vaccinated, some physicians may choose to give these adults at least two doses of IPV a month apart ... before the children receive ORIMUNE. The benefit of being protected against polio is believed to greatly outweigh any risk from polio 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 1 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 "[t]he 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...

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