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JONES v. LEDERLE LABS.

February 26, 1992

MELISSA JONES, an infant under the age of 14 years, by her father and natural guardian, RICHARD JONES, Plaintiff, against LEDERLE LABORATORIES, a division of AMERICAN CYANAMID CO., Defendant.


The opinion of the court was delivered by: JACK B. WEINSTEIN

Memorandum, Judgment and Order

 Jack B. Weinstein, District Judge:

 FACTS AND PROCEDURAL HISTORY

 Melissa Jones is a severely retarded twelve-year-old girl. This action, brought on Melissa's behalf by her father, alleges that her condition results from receiving defendant's DTP vaccine at the age of two and one half months. See Jones v. Lederle Laboratories, 695 F. Supp. 700 (E.D.N.Y. 1988). The DTP vaccine is intended to immunize children against diphtheria, tetanus, and pertussis (whooping cough). In this country, the vaccine traditionally has been given to children in a series of five injections at ages two, four, six, and eighteen months, and at five years.

 Shortly before Melissa received her first DTP shot her parents reported that the child experienced intermittent stiffening of the limbs in a manner that suggested seizures. Nevertheless, on June 6, 1979 her pediatrician administered the DTP vaccine. Three days later Melissa had another seizure. On the fourth day after the vaccination she suffered a series of more serious seizures for which she was hospitalized. She subsequently was diagnosed as being severely brain damaged.

 The DTP vaccine given to Melissa is manufactured and sold by the defendant under the name Tri-Immunol. Tri-Immunol includes a "whole cell" pertussis vaccine. The whole cell vaccine consists of pertussis cells which have been killed by heat and thus do not cause whooping cough. when injected into the body, they stimulate the production of antibodies that prevent infection by future exposure to live pertussis cells. The risks associated with this process are disputed. Pertussis cells contain toxins that can cause fever, local swelling and pain in children who are inoculated. whether these toxins also pose a risk of neurological damage is disputed by the parties.

 In light of the vaccine's perceived utility in eliminating whooping cough -- a disease that in the 1940s caused thousands of infant deaths annually in this country -- the federal Food and Drug Administration approved use of the whole cell vaccine in 1943 despite the risks it was then thought to pose.

 In 1980, Melissa's parents brought a malpractice action against the pediatrician for administering the DTP vaccine in a manner contrary to instructions on the vaccine. The suit resulted in a substantial settlement.

 This action was commenced in February 1985 in New York State Supreme Court. Recovery was originally sought on theories of defective design and manufacture, failure to warn, express and implied warranty and negligence. Defendant removed on the basis of diversity jurisdiction.

 The gist of plaintiff's claims is that defendant produced an unreasonably unsafe vaccine that caused Melissa's brain damage. The vaccine is alleged to have been unreasonably unsafe because, according to the plaintiff, an alternative pertussis vaccine could have been produced and sold at the time of Melissa's inoculation that was equally effective and less risky.

 Defendant maintains that its product was not negligently designed or manufactured nor unreasonably unsafe. It claims that there is no evidence that an efficacious alternative vaccine could have been produced commercially in this country in 1979. Defendant also contends that plaintiff cannot prove general or specific causation because current scientific knowledge has not established any causal connection between the whole-cell pertussis vaccine and neurologic disorders. According to the defendant, Melissa Jones' pre-inoculation seizures indicated a neurological disorder present at birth that worsened over time for reasons unrelated to her inoculation.

 In August of 1988, this court issued a memorandum and order in response to defendant's motion for summary judgment. See Jones v. Lederle Laboratories, 695 F. Supp. 700 (E.D.N.Y. 1988). Applying New York law, the court granted summary judgment for defendant with respect to the manufacturing defect, failure to warn and express warranty claims. Id. at 706-09. The court also held that triable issues of fact remained as to the design defect, negligent design and breach of implied warranty claims. Since New York law treats the implied warranty and design defect claims as equivalents, see id. at 709, the substantive issues left for trial were: (1) was the vaccine defectively or negligently designed and (2) did the improper design cause plaintiff's injuries?

 On December 23, 1991 the jury returned a $ 3,250,000 verdict for the plaintiff. Seventy-five percent of the fault was apportioned to the ...


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