Court Opinion

ID: 6761392
Source: CourtListenerOpinion
Date Created: 2022-07-21 00:31:57.340859+00
Date Added: 2024-06-11T16:02:35.927860
License: Public Domain

Douglas, J.,
concurring in part and dissenting in part. I concur in the majority’s syllabus because I agree with the majority that a prescription drug, vaccine, or like product is not “unavoidably unsafe” per se. Whether such a product is “unavoidably unsafe” must be determined on a case-by-case basis.
However, I must dissent from the majority’s finding that Wyeth’s DTP whole cell pertussis vaccine was “unavoidably unsafe.” In 2 Restatement of the Law 2d, Torts (1965) 353, Section 402A, Comment k, we find that products are “unavoidably unsafe” if, “* * * in the present state *399of human knowledge, [they] are quite incapable of being made safe for their intended and ordinary use.”
It is my judgment that Wyeth’s DTP whole cell pertussis vaccine was not unavoidably unsafe but avoidably unsafe because Lilly’s DTP fractionated cell pertussis vaccine was safer than Wyeth’s whole cell pertussis vaccine. Thus, I think Wyeth should be strictly liable for injuries to Tyler White caused by Wyeth’s DTP vaccine. Wyeth’s vaccine simply does not fit within the exception to strict liability for injuries caused by defective products expressed in Comment k to Section 402A.
The majority finds that the “* * * evidence that DTP containing a fractionated cell * * * vaccine would be both effective and safer than DTP made with a whole cell pertussis vaccine * * * [is] speculative at best.” Therefore, the majority does not believe that, given the then state of knowledge, the whole cell pertussis vaccine could have been made safer. The majority refers to studies that compared DTP vaccine to DT vaccine and found that the only difference between the effects of the two vaccines is that DTP more frequently caused minor reactions. However, the reference to these studies confuses the issue, which is whether the DTP fractionated cell pertussis vaccine was safer than the whole cell pertussis vaccine.
A 1978 internal Wyeth memo, not referred to by the majority, discussed a conversation with Dr. Baraff, Assistant Professor of Pediatrics who practiced at the Emergency Medical Center of the UCLA Hospital and Clinic. Dr. Baraff was involved in a large-scale test of the DTP whole cell pertussis vaccine. Eighty percent of the doses the doctor administered were licensed Wyeth DTP whole cell vaccines. The' doctor found the local, generalized and systemic reaction rate to the whole cell vaccine to be “unacceptable.” The memo claimed that Dr. Baraff stated that “his feelings are reinforced by phone calls and letters which he receives constantly from practitioners, clinic doctors, and pediatricians in the California area who are equally convinced that the whole virus [sic] vaccine is highly reactogenic. * * *” The memo continues that “* * * [t]his is in opposition to prior experience in the pediatric community with the solubilized antigen [i.e., Lilly’s Trisolgen vaccine, also referred to in the majority opinion as a DTP fractionated cell pertussis vaccine].”
Thus, contrary to the majority’s opinion, there is non-speculative evidence in the record that the DTP fractionated cell pertussis vaccine was safer than the whole cell pertussis vaccine.
The majority then contends that there is no evidence that Wyeth could have marketed a DTP fractionated cell pertussis vaccine. However, the record shows otherwise. According to the record, Wyeth acquired rights to Lilly’s Trisolgen vaccine, but Wyeth substituted its own bacterial strains into the Lilly “recipe” for the vaccine. Wyeth then attempted to license this vaccine, but the FDA did not grant the license. The FDA suggested changes Wyeth would have to make in this vaccine in order for the FDA to approve it. However, Wyeth made no further attempts to license the vaccine. Thus, the majority’s finding that Wyeth could not have marketed a safer design for DTP flies in the face of the evidence.
Wyeth itself, which chose not to produce the Lilly fractionated cell pertussis vaccine even though it had the technical knowledge and legal right to make it, uses the fact that it did not *400market it as proof that it could not have produced the safer vaccine. The majority concurs with this conclusion that a drug company’s marketing decisions are equivalent to its technical knowledge. However, this is not only factually inaccurate but is bad public policy because it places drug manufacturers that are, understandably, in the business of making and selling products for the profits involved, in charge of determining the quality of the drugs on the market.
Furthermore, the hands-off posture of the majority, which defers to the marketing decisions of drug manufacturers, exists alongside the hands-off attitude of the FDA at the time Tyler White was inoculated. Prior to 1986 and Congress’ enactment of the National Childhood Vaccine Injury Act of 1986, Section 300aa-l et seq., Title 42, U.S. Code, the FDA played a passive role in licensing vaccines. If a drug manufacturer had come to the FDA with an improved drug, the FDA would have decided whether to license it. However, if a drug manufacturer had elected not to improve its drug, the FDA would not have required that the drug manufacturer attempt to make it safer.
Fortunately, Congress awoke to the fact that drug manufacturers were determining the quality of the vaccines in the United States and passed the National Childhood Vaccine Injury Act. Section 2127(a) of this Act requires the Secretary of Health and Human Services to “* * * promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market * * (Section 300aa-27, Title 42, U.S. Code.)
Whatever the future success in obtaining safer vaccines as a result of the 1986 Act, I think it is important that this court adopt a position which will encourage drug manufacturers to improve their drugs. I regret to say that the majority, by its decision today, has not done so.
Accordingly, although I concur with the majority’s syllabus, I respectfully dissent from the majority’s judgment. I would reverse the court of appeals’ decision that Wyeth is not liable for Tyler White’s injuries and reinstate the jury’s damages award to White.
Sweeney, J., concurs in the foregoing opinion.