Court Opinion

ID: 9539073
Source: CourtListenerOpinion
Date Created: 2023-08-07 07:46:21.307189+00
Date Added: 2024-06-11T14:58:26.197799
License: Public Domain

HUNTLEY, Justice,
concurring specially.
I concur in the majority opinion and write further to address two points.
POINT I: All who read this opinion and that of the 9th Circuit at 779 F.2d 1429, should be aware that Lederle and the Amicus Curiae Pharmaceutical Manufacturers Association, in seeking to engraft comment k into negligence law, are proposing something far more revolutionary in its effect than most would realize.
They seek by the device of engrafting comment k into negligence law to actually abolish negligence causes of action in this field and substitute the Food and Drug Administration for the jury.
The parties and Amicus were all in agreement in their presentations to this Court that not one state as yet has ruled that comment k applies to negligence causes of action.
Perhaps the reason that no state has done so is that no state supreme court has yet become convinced that the FDA has either adequate staffing, expertise, or data base to warrant its being substituted for the judicial system.
The full implications of the Pharmaceutical Manufacturers proposal can be more fully realized upon consideration of the partial transcript of the oral argument before this Court of attorney Robert Koontz, arguing for Lederle, attached hereto as Appendix A and the entire transcript of attorney Malcolm Wheeler, arguing for the Pharmaceutical Manufacturers Association, attached hereto as Appendix B.
I fear the day when any supreme court can be convinced that an agency such as the FDA, no matter how well-intentioned, can supplant the American judicial system.
POINT II: There are two statements in the 9th Circuit opinion which trouble me as running counter to FDA procedures as I understand them:
Lilly sold the right to produce Tri-Solgen to Wyeth Laboratories; however, the FDA has refused to relicense the vaccine.
However, in 1972, a review panel within the Bureau of Biologies of the FDA refused to certify Tri-Solgen as “safe and effective” although it did so certify the whole cell vaccines. Because the FDA has refused to relicense Tri-Solgen or any other fractionated cell product, the manufacture and sale of such a vaccine by Lederle, or any other pharmaceutical company, would constitute a criminal offense under the Food, Drug and Cosmetic Act. See 21 U.S.C. §§ 331(d), 333(a), 355(a) (1982).
The foregoing statements seem to suggest that the fractionated vaccine Tri-Solgen is disapproved by the FDA.
It is my understanding that the FDA does not license a medication in a “vacuum.” That is, a medication is licensed only to a specific manufacturer presenting a specific product which has undergone specific testing, with adequate data having been presented to the FDA. The FDA does not, for example, issue generalized approval for anyone who wishes to manufacture a specific medication.
Thus, the fact that a fractionated cell vaccine is not now licensed does not mean it is disapproved — it merely means either that no manufacturer has sought and obtained approval or that, in the instance of the 1972 refusal by a review panel of the Bureau of Biologies, the application therein failed to make an adequate showing of safety or efficacy, which is not to say that another manufacturer could not have made a successful application.