Plaintiff appeals from orders entered by Judge Pratt in the Eastern District of New York dismissing plaintiff's malpractice and drug products liability suit against defendants Parke-Davis Co., Dow Chemical Corp., Dr. Jack Sherman, the County of Nassau and Meadowbrook Hospital. Dismissal of the claims brought against the County of Nassau, Meadowbrook Hospital, and Dow Chemical Corp. affirmed; new trial ordered with respect to the claims brought against Parke-Davis Co. and Dr. Sherman.
Before Lumbard, Moore and Feinberg, Circuit Judges.
In this diversity action, plaintiff appeals from orders entered by Judge Pratt in the Eastern District of New York on July 15, 1977 and March 6, 1978 dismissing at the close of plaintiff's case her medical malpractice and drug products liability suit against defendants Parke-Davis Company, Dow Chemical Company, Dr. Jack Sherman, the County of Nassau, and Meadowbrook Hospital. We affirm the dismissal of the claims brought against the County of Nassau, Meadowbrook Hospital, and Dow Chemical Company. With respect to the claims brought against Parke-Davis Company and Dr. Sherman, we reverse and remand for a new trial.
The infant decedent Mark Ezagui was born to the plaintiff Elaine Ezagui on September 11, 1960. Defendant Sherman vaccinated Mark, at that time healthy in body and mind, with either Quadrigen, manufactured by Parke-Davis, or Compligen, manufactured by Dow, on January 18, 1961. On January 23, 1961, Mark was admitted to Nassau County's Meadowbrook Hospital with a very high fever later measured at 108o and subsequently diagnosed as post-vaccinal encephalopathy ("PVE"), which is known to cause brain damage, convulsive seizures, blindness, deafness, paralysis, mental retardation, and possibly death. Mark was discharged from Meadowbrook Hospital on February 2, 1961. Thereafter, until his death on April 26, 1970, Mark was under the care of various medical personnel, among them Dr. Sherman. The diagnosis of PVE resulting from the inoculation was repeatedly confirmed.
Plaintiff Elaine Ezagui, suing for herself and as the administratrix of the estate of Mark Ezagui, initiated this action by service of a notice of claim on the County of Nassau on January 28, 1969, and by service of summonses and complaints on the other defendants beginning in October, 1969. Basing her claim on New York law, which the parties concede controls this case, plaintiff demanded damages for personal injuries suffered by the decedent and for his wrongful death, and on her own behalf, for loss of services and medical expenses, all allegedly sustained as the result of the January 18, 1961 vaccination. Plaintiff's amended complaint against drug manufacturers Dow and Parke-Davis alleged (1) failure to warn of a known defect with respect to the drugs Compligen and Quadrigen, (2) breach of warranty of merchantability and fitness for use with respect to the same drugs, and (3) negligence. Plaintiff's complaint against Dr. Sherman alleged (1) lack of informed consent and (2) negligence. Plaintiff further alleged that these breaches of defendant's duties to plaintiff proximately caused the personal injuries and wrongful death of Mark Ezagui.
On July 7, 1977, the district court denied plaintiffs' application to estop collaterally Parke-Davis from denying that Quadrigen was a defective product as determined in Tinnerholm v. Parke-Davis Company, 411 F.2d 48 (2d Cir. 1969) and in Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969). On July 13, 1977, the district court dismissed the complaint against defendants County of Nassau and Meadowbrook Hospital on the ground that the claim was untimely. On January 27, 1978, the trial began.
On February 2, 1978, the district court dismissed the complaint against all of the remaining defendants, on the ground that plaintiff had failed to make out a prima facie case against any. With respect to Dr. Sherman, the district court found that plaintiff had not introduced sufficient evidence to support a finding of medical malpractice. With respect to Dow and Parke-Davis, the district court found that plaintiff had not introduced sufficient evidence to support a finding either that Compligen or Quadrigen was defective or that one of them had proximately caused injury to Mark Ezagui. Our review of the record, however, persuades us that plaintiff did make out a prima facie case against Parke-Davis and against Dr. Sherman.
Parke-Davis developed Quadrigen during the 1950's as a quadruple antigen product, combining diphtheria toxoids, tetanus toxoids, Salk polio vaccine, and pertussis (whooping cough) vaccine. Vaccines confer protection against diseases by introducing antigens into the body which stimulate the production of immunizing antibodies. This process occurs when lymphocytes, cells contained in the lymph glands, absorb the antigens and produce an antitoxin against the particular disease. With some infectious diseases, such as diphtheria and tetanus, it has been possible to isolate the soluble toxin or poison excreted by these bacteria and to inactivate this toxin with formaldehyde, thereby converting the toxin into what is called a toxoid. This toxoid helps immunize the body against disease by stimulating the production of antibodies, but the toxoid will not cause disease because it has lost its poisonous qualities.
By contrast, the bacterial organism which causes pertussis is so complex as to make impossible the isolation and deactivation of the toxin or poison. Since the ingredient in the pertussis bacteria which stimulates the production of protective antibodies has not been isolated, Parke-Davis and other drug companies have manufactured pertussis vaccine consisting of whole pertussis bacteria, treated to reduce their propensity to cause the disease. Because this treatment cannot completely deactivate the relevant toxin, reactions to pertussis vaccine are more frequent than are reactions to other vaccines.
In the early 1940's, drug manufacturers developed a method for combining pertussis vaccine with diphtheria and tetanus toxoids in a three-way antigen product known as "DTP" and marketed by Parke-Davis under the trade name "Triogen". This combination allowed one shot to do the work of three and was regarded as an important advance. This three-in-one combination produced no apparent increase in toxicity or reactivity.
In 1953 Dr. Jonas Salk developed a polio vaccine. Following commercial development of the Salk Vaccine, Parke-Davis decided to add the new polio vaccine to its "Triogen" product in order to develop a four-way antigen product, whereby one shot would protect against polio as well as diphtheria, tetanus, and pertussis. This new product Parke-Davis marketed under the trade name Quadrigen, beginning in July, 1959.
Combining the older Triogen product with the new Salk polio vaccine, however, required a change in preservative which many investigators later believed caused the marked increase in adverse medical reactions experienced with the use of Quadrigen. All vaccines packed in multidose vials require a preservative to maintain their sterility. Prior to the development of the Salk polio vaccine, the universal preservative was merthiolate. Although originally intended to maintain sterility, merthiolate was later shown to act as a stabilizer of the vaccine, decreasing toxity but maintaining potency. Merthiolate, however, adversely affected the polio vaccine. Accordingly, Parke-Davis selected a different preservative for use in Quadrigen. This preservative was benzethonium chloride, or Phemerol, which was Parke-Davis' trade name for this product. Later research, however, indicated that use of Phemerol caused certain endotoxins in the pertussis vaccine to leak out from the bacterial cell into the fluid which was injected. One of these endotoxins, the lipopolysaccharide, was known to cause a fever which could lead to convulsions and brain damage, as occurred in this case. From the time when they first began to investigate the marked increase in adverse reactions reported by doctors using Quadrigen, until very recently, Parke-Davis research personnel have been on record as believing that the leakage of these endotoxins was responsible for the measured increase in adverse medical reactions associated with Quadrigen, an increase which finally led to the withdrawal of Quadrigen from the market in November, 1962. (The return in 1962 to the older three-in-one product, administered with a separate polio vaccine, reduced the incidence of adverse medical reactions to their pre-Quadrigen levels).
Two earlier cases explicitly relied upon this "Phemerol causes leakage" theory in affirming judgments against Parke-Davis involving Quadrigen vaccinations which allegedly caused severe personal injuries to the infants vaccinated. See Tinnerholm v. Parke-Davis & Co., 411 F.2d 48 (2d Cir. 1969), Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969). These cases both found a defect in Quadrigen because of this leakage problem and found that this defect proximately caused injuries to the plaintiffs involved. Plaintiff in this case argued before trial that these cases should collaterally estop Parke-Davis from denying that Quadrigen was defective. The district court, however, denied plaintiff's application for collateral estoppel on the ground that new scientific evidence cast doubt on the "Phemerol causes leakage" theory. In so denying plaintiff's application, the district court clearly followed the requirements of New York law. In Vincent v. Thompson, 50 A.D.2d 211, 377 N.Y.S.2d 118 (2d Dept. 1975), another Quadrigen case, the Appellate Division denied collateral estoppel based on the Tinnerholm case partially because of the purported "discovery" of the same new scientific evidence at issue here.
The Appellate Division's ruling, properly construed, disallows collateral estoppel as to chemical defect whenever the plaintiff relies solely on cases where the "Phemerol causes leakage" theory was an essential step in the court's finding of chemical defect. Accordingly, plaintiff cannot invoke collateral estoppel as to chemical defect on the basis of Stromsodt, Supra, because that case also relied upon the "Phemerol causes leakage" theory in affirming a finding of chemical defect. Nor can plaintiff rely upon the collateral estoppel order affirmed in Grant v. Parke-Davis & Co., 544 F.2d 521 (7th Cir. 1976) (reported in full in Commerce Clearing House, Products Liability Reporter, P 7848), inasmuch as the collateral estoppel order in that case was grounded on the findings of chemical defect in Tinnerholm, Supra, and Stromsodt, Supra.
Plaintiff, however, sought collateral estoppel not only as to chemical defect, but also as to the inadequacy of the warnings which accompanied the product, relying on Stromsodt, Supra and other Quadrigen cases. In Stromsodt, the Eighth Circuit affirmed a district court finding that the package inserts accompanying Quadrigen were inadequate in light of the known risks of harm associated with normal use of the product, risks which had been repeatedly brought to Parke-Davis' attention. The package insert at issue in both Stromsodt and in this case, as well as in the other Quadrigen cases (where they were also found to be inadequate), states that the incidence of "local and systemic reactions following the administration of Quadrigen are usually mild . . . (and) is usually no greater than is normally experienced with trivalent vaccine." According to Judge Mehaffy of the Eighth Circuit:
"To tell the practitioner who had successfully used Triogen that reactions from Quadrigen are usually no greater than normally experienced with Triogen simply does not comport with the record facts in this case and the knowledge of the medical experts associated with Parke-Davis and others. . . . Parke-Davis had knowledge that many doctors would not use the product, that other doctors reported to it prior to the inoculation of plaintiff that they were having more severe ...