were preventing scientists around the world from producing a better and safer pertussis vaccine. Plaintiff's experts took the view that all of the pieces to the puzzle of a non-whole cell vaccine were available in the 1960s or 1970s. This is a misdescription of the historical facts. It was not until 1979 that the recipe for an effective acellular vaccine was developed in the pioneering efforts of the Japanese. The originality of this work was testified to by experts called by both plaintiff and defendant.
As to the manufacture and marketing of an acellular vaccine, the Japanese first distributed their acellular vaccine in December of 1981. This distribution was predicated on tests and results that would not have complied with strict United States testing standards. Under the less stringent Japanese standards, moreover, the Japanese vaccine was approved only for use in children age two and above. To this day, pediatricians in the United States overwhelmingly recommend administering the first whole cell vaccine at age two months, roughly the time at which Melissa received her shot.
After ten years of testing in Japan, the Japanese vaccine has now been demonstrated to be safe for two year old children. Further tests conducted in this country have satisfied federal regulators that the vaccine will probably be effective when used for children aged 18 months or older. In light of these tests, the FDA recently amended its regulations to allow for use of the Japanese acellular vaccine in the fourth and fifth shots in the DTP vaccination sequence. See 59 Fed. Reg. 63,409 (Dec. 4, 1991); N.Y. Times, Dec. 19, 1991, at B22. Testing of equivalent American acellular vaccines for younger children, developed after 1979, will be conducted in European countries where a control population of infants not yet inoculated with the whole cell vaccine is available.
Thus, even today, years of further development and testing will be required before a more advanced vaccine for two-month-old infants will be available in this country. There was simply no basis for the jury to conclude that, by 1979, the defendant could have developed, produced and proven to the FDA's satisfaction the efficacy and safety of an acellular vaccine for use on Melissa Jones.
The case illustrates some of the strengths and weaknesses of the American system for marketing drugs. Requiring strict proof of safety -- both to comply with FDA regulations and to avoid tort liability -- slows the availability of new products. The result may well be that dangers will be enhanced during the necessarily extended developmental period. But these results are attributable to the way in which scientists usually solve problems -- through incremental, peer reviewed experiments -- and to the regulatory system, not to any delict on the part of this defendant.
The evidence is essentially uncontested that defendant could not have produced and marketed the safer vaccine that plaintiff's experts say would have avoided Melissa Jones's injuries. Once this conclusion is reached, there is nothing left to the case. The warnings were adequate. The production was not defective -- it was in accordance with the design. No safer alternative design was available. The vaccine, with its possible drawbacks, saved far more infant lives than it put at risk.
No basis for liability has been shown. Defendant's motion for judgment as a matter of law is granted. The case is dismissed. No costs or disbursements.
Brooklyn, New York
February 26, 1992
Jack B. Weinstein
United States District Judge
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