Vincent v. Thompson

• Decision Date: 22 December 1975
• Citation: 50 A.D.2d 211,377 N.Y.S.2d 118
• Parties: Janet VINCENT et al., Respondents, v. Ralph Bernard THOMPSON et al., Appellants.
• Court: New York Supreme Court — Appellate Division

Page 118

377 N.Y.S.2d 118

50 A.D.2d 211

Janet VINCENT et al., Respondents, v. Ralph Bernard THOMPSON et al., Appellants.

Supreme Court, Appellate Division, Second Department.

Dec. 22, 1975.

Davis Polk & Wardwell, New York City (Lawrence E. Walsh, Guy Miller Struve and Richard J. Cunningham, New York City, of counsel), and D'Amato, Costello & Shea, New York City (Joseph M. Costello and Richard C. Browne, New York City, of counsel), for appellant Parke, Davis & Co.

Martin, Clearwater & Bell, New York City (William F. Martin, New York City, of counsel), for appellant Thompson.

Meyer, English & Cianciulli, P.C., Mineola (Bernard S. Meyer and James Oliviero, Mineola, on the brief), and Joseph T. Mirabel, Huntington (Walter Wortman, Huntington, on the brief), for respondents.

Before RABIN, Acting P.J., and HOPKINS, MUNDER and SHAPIRO, JJ.

SHAPIRO, Justice.

Defendants Ralph Bernard Thompson and Parke, Davis & Company (Parke, Davis) appeal from a judgment of the Supreme Court, Nassau County, entered upon a jury verdict, which, Inter alia, awarded plaintiff Janet Vincent damages in the amount of $300,000 for personal injuries allegedly sustained by her as the result of the administration by Dr. Thompson of a quadruple vaccine called Quadrigen, manufactured by Parke, Davis. The action has been settled as against Dr. Thompson. ¹ We reverse the judgment as to Parke, Davis, on the law, and grant a new trial as against it.

In Tinnerholm v. Parke, Davis & Co., D.C., 285 F.Supp. 432, affd. 2 Cir., 411 F.2d 48, the District Court, as the trier of the facts, found that 'Quadrigen was defective and that the defect was the proximate cause of the injury sustained by Eric Tinnerholm', the infant plaintiff therein (see 411 F.2d, at p. 53). In this case, at the outset of the trial, the plaintiffs moved for a determination that the decision in the Tinnerholm case acts as a collateral estoppel against Parke, Davis as to the defectiveness of Quadrigen. The trial court granted the plaintiffs' motion and instructed the jury--at the very commencement of the trial and before any proof had been taken--that it should consider the following facts as established against Parke, Davis:

'One. The vaccine, 'Quadrigen', which is manufactured by the defendant Parke, Davis, was released to the public market without 'Two. The vaccine 'Quadrigen', was defective as a product in view of the leakage of toxins from within the pertussis component of the vaccine, which leakage was caused by this preservative 'phemerol'.'

adequate prior testing in the face of evidence that the vaccine was unstable. ²

We are of the opinion that, because of the basic difference between the facts in this case and those in Tinnerholm, the trial court erred in applying the doctrine of collateral estoppel.

THE FACTS HERE

On June 27, 1960 Dr. Thompson was called by Mrs. Gaylord E. Smith, who told him that her daughter, Janet, then 13 years of age, had stepped on a nail with her left foot the previous day. Dr. Thompson testified that he took some tetanus toxoid, some duracillin and some polio vaccine with him to the Smith home because Janet hadn't had the latter since the previous August. He injected this mixture into Janet's shoulder. He denied having injected Janet with Quadrigen. That drug is Parke, Davis' name for the four-in-one shot which combines 'diphtheria and tetanus toxoids into a triple antigent product (colloquially known as 'DTP')' (Tinnerholm v. Parke, Davis & Co., supra, p. 50). The next morning he received a call from the Smiths informing him that Janet was weak, could not sit up and had trouble moving her right leg. He visited Janet immediately after the call and diagnosed her illness as between a myelitis and polio, although he thought it was an atypical polio. He had her admitted to Meadowbrook Hospital. The final diagnosis of Janet's illness made in Meadowbrook Hospital was that she had 'transverse myelitis, etiology unknown'. In August, Janet was sent from Meadowbrook Hospital to the Rusk Institute for rehabilitation. The records there state that 'attempts were made to clarify the etiology of the illness without any definite results.' So far as the medical records and the testimony disclose, Janet never had an abnormal fever reading at any time after the injection.

Although Dr. Thompson denied that he had injected Janet with Quadrigen, there is sufficient other testimony in the record to sustain a contrary finding.

THE FACTS IN TINNERHOLM

On the basis of substantial evidence the trial court found that at about noon on Saturday, November 28, 1959, the infant plaintiff, Eric Tinnerholm, then sound and healthy, was inoculated by a Dr. Feinberg with Quadrigen. On Tuesday morning, December 1, 1959, at about 4:00 A.M., the child was found tangled up in his bedclothes and whimpering; upon being picked up and patted, he quieted down and presumably went back to sleep. There was no indication of temperature at that time. Sometime later, between 6:30 and 7:00 A.M., the child's mother found him huddled under the covers, lethargic and bathed in perspiration. His temperature at that time was 108 , he was very white, his lips were blue and he was limp. Dr. Feinberg was summoned, and he had the baby admitted to Huntington Hospital at 8:45 A.M., where the infant remained until December 18, 1959. During that time he developed recurrent convulsive seizures and paralysis of the right arm and leg. At the time of trial he was, and will remain, mentally retarded (with a mental age of five months) to a degree classified within the idiot-imbecile range; he is paralyzed in both right limbs and still suffers occasional seizures (Tinnerholm v. Parke, Davis & Co., 411 F.2d 48, 50).

The Court of Appeals noted in Tinnerholm (p. 51):

'The findings of the court below in support of its conclusion that Parke, Davis is liable to plaintiffs-appellees may be summarized as follows:

1. '* * * by manufacturing Quadrigen in the method chosen by defendant, the chances of contracting an encephalopathy were enhanced,' because:

2. '* * * the effect of the use of benzethonium chloride was to release the endotoxin from the bacteria cell into the fluid that was injected. One such endotoxin, the lipopolysaccharide, causes fever * * *'; and

3. '* * * the release of the endotoxin into the fluid injected into the infant plaintiff was the cause of the unusually high fever which, in turn, caused the severe and permanent brain damage."

THE BACKGROUND OF QUADRIGEN

In order to understand the nature of the defect in Quadrigen, and its causal relationship to the injuries sued for in Tinnerholm, it is necessary to examine the origin and composition of that compound. In affirming the judgment below in Tinnerholm, the United States Court of Appeals, in its opinion, set forth that background (pp. 50--51) Quadrigen was developed by Parke, Davis as a quadruple antigen product, combining pertussis (whooping cough) vaccine, with diphtheria and tetanus toxoids and with the Salk polio vaccine. In the early 1970's, a method of combining pertussis vaccine with diphtheria and tetanus toxoids into a triple antigent product (colloquially known as 'DTP') had been developed. The Parke, Davis DTP was marketed under the trade name 'Triogen.'

'Vaccines are intended to stimulate the production of antibodies in order to confer protection against disease by introducing an antigenic factor into the body of the recipient. In developing a vaccine in the cases of some infectious organisms, notably diphtheria and tetanus, it has been possible to isolate a soluble toxin or poison excreted by the bodies of these bacteria, and to inactivate this toxin with formaldehyde, thereby converting a toxin into what is called a toxoid. A toxoid preserves the ability to immunize against the disease by stimulating the production of antibodies in the recipient, although it has lost its own poisonous qualities.

'In contrast, the bacterial organism which causes pertussis is so complex that it has been impossible to isolate and inactivate the toxin or poison. Since the ingredient in the pertussis bacteria which stimulates the production of protective antibodies has not been isolated, pertussis vaccine consists of whole pertussis bacteria, treated to remove their propensity to cause the disease, while preserving their ability to stimulate the production of rpotective antibodies.

'Some fifteen or sixteen different antigens have been described in the pertussis organism, including an exotoxin, an endotoxin, a protective antigen, etc. One or more of these antigens confers protective ability; no one knows which one or what it is. In the production of the pertussis vaccine, the exotoxin is destroyed by heat, but the endotoxins inside the cell survive such treatment. Because of the complex nature of the pertussis bacteria and the inability to isolate the toxin in order to inactivate it, reactions to pertussis vaccine are not uncommon. There may be local reaction, such as soreness or tenderness at the site of the injection and systemic (attacking the entire body) reaction such as fever and general discomfiture. Rarely, reactions associated with the disease itself, such as convulsions, high fever, or even brain hemorrhage and mental retardation occur.

'All vaccines require a preservative to keep them sterile; and one of the problems confronting Parke, Davis in the development of Quadrigen was the selection of an appropriate preservative to protect the final product from contamination. In the development of pertussis vaccines and indeed all other vaccines, up until the development of polio vaccine (licensed for distribution in 1956), the preservative universally used was merthiolate. The preservative used in Parke, Davis' Triogen had been merthiolate, but because

merthiolate had a deleterious effect upon the polio virus in the Salk vaccine, a new preservative had to be chosen. The preservative ultimately selected by Parke, Davis (and according to Parke,...