Court Opinion

ID: 9621983
Source: CourtListenerOpinion
Date Created: 2023-08-22 06:10:44.129553+00
Date Added: 2024-06-11T18:05:12.033302
License: Public Domain

HOWE, Associate Chief Justice:
(dissenting).
I dissent. I would limit the comment k exception to its literal wording as advocated by Justice Stewart. I would apply it only to a narrow class of prescription drugs which have lifesaving potential, drugs which have attendant risks but which are administered because they have the potential of saving the life of a person who is probably doomed to death by a disease, an epidemic, or a fatal condition. I believe that is what is meant by “unavoidably” unsafe. The exception would thus apply only to a small number of drugs — not the full gambit of drugs approved by the FDA. While I recognize the problem associated with a case-by-case application, I do not think the problem would be as great as portrayed by the majority opinion since only a relatively small number of drugs would fall into the class entitled to the exemption.
The Supreme Court of Wisconsin in Collins v. Eli Lilly Co., 116 Wis.2d 166, 342 N.W.2d 37 (1984), adopted a narrow application of comment k:
Drug companies like other sellers or manufacturers, have a duty to produce and market reasonably safe products. We recognize in some exigent circumstances it may be necessary to place a drug on the market before adequate testing may be done. Insofar as these circumstances exist, we agree with the comment [k] that strict liability should not be imposed. However, we find no exigent circumstances which would excuse DES producers or marketers from adequately testing DES before it was placed on the market. Although there was a societal interest in preventing miscarriages in pregnancy, alternative treatment was available and the problem did not approach epidemic proportions.
A similar view was expressed by United States District Judge J. Thomas Greene in Patten v. Lederle Laboratories, 676 F.Supp. 233 (D.C.Utah 1987), where he wrote:
[A]s this court sees it, comment k does not provide blanket immunity to all prescription drugs. The language of the comment indicates it is to apply to only ‘some’ products.... The court considers that extending comment k protection to an entire class of products would be unwise in light of the requirements comment k specifies as prerequisite to its application.
*100As to all prescription drugs which do not fall within the exempted class but which have been approved by the FDA, I would accord them only a rebuttable presumption of being of safe design.