Opinion ID: 1189000
Heading Depth: 1
Heading Rank: 3

Heading: strict tort liability may be imposed even if merck's interpretation of comment k were accepted

Text: This court rejects the idea of freeing drug manufacturers from liability for defective drugs simply because they claim that the drugs are reasonably or unavoidably dangerous. However, even if, like the dissenting justice, we were to accept Merck's interpretation of comment k in this case, Thomas and his mother would still be entitled to a trial. A factfinder could find in this case that the product here, if not defective or dangerous per se, was unreasonably dangerous as marketed. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir.1974). Reyes noted that [i]n terms of the user's interests, a product is `unreasonably dangerous' only when it is `dangerous to an extent beyond that contemplated by the ordinary consumer.' [11] Id. (quoting Restatement (Second) of Torts § 402A cmt. i (1965)). Citing to comment k, the Reyes court thus held that even an unavoidably unsafe vaccine may be defective if marketed without an adequate warning. Id. at 1274-78. Accordingly, under the Reyes rationale, even under the broadly exculpatory interpretation of comment k espoused by Merck, liability cannot be avoided by a drug manufacturer and distributor in the marketing of a vaccine unless the vaccine is accompanied by proper directions and warning. Id. at 1274 (quoting Restatement (Second) of Torts § 402A cmt. k (1965)). [12] It would appear that a factfinder in this case could reasonably conclude that the vaccine given to Thomas Allison was not accompanied by a proper warning. [13] Although Merck does not admit that this vaccine can cause disastrous central nervous system disorders, it announces in its MMR II package circular (which is not distributed to vaccinees) that significant central nervous system reactions such as encephalitis and encephalopathy occurring within 30 days after vaccination, have been temporally associated with measles vaccine approximately once for every million doses. (Emphasis added.) In dealing with the mass consumers of the vaccine, the Health District revised this information when it issued its Important Information (not a Warning) flyer prepared by the Center for Disease Control (CDC). The Important Information flyer is a revision of Merck's package circular, and it contains a much less dissuading statement, namely, that, [a]lthough experts are not sure, there might be a very remote possibilitya chance in a millionthat takers of the vaccine may have a more serious reaction, such as inflammation of the brain (encephalitis). The gist of the faulty warning aspect of liability in this case is that none of the prospective vacinees was warned of the actual possibility of permanent brain damage. Rashes, yes; sore throats, yes; inflammation of the brain, yes; but permanent blindness, deafness, and mental retardation, no. [14] Further, there is evidence in the record that Merck underestimated the incidence of serious central nervous system involvement caused by or temporally associated with the vaccine. [15] Whether the incidence data be true or not, the information that was ultimately conveyed to Jo Ann Allison could be seen by a factfinder as being slanted and insufficient; and the only information that was actually made available to Ms. Allison was that there was a one in one million [not four in one million] chance that her son may have a more serious reaction to the vaccine such as inflammation of the brain. At no time was Ms. Allison ever made aware that the vaccine might result in her son's becoming an invalid. Accordingly, there is certainly an issue of fact as to whether the warning in this case was proper; and, in fact, there appears to be substantial evidence in this case from which a jury could find that the vaccine in question was not `accompanied by proper directions and warning,' Reyes 498 F.2d at 1274 (quoting Restatement (Second) of Torts § 402A cmt. k (1965)), especially when that evidence is viewed in the favorable light required on appeal from summary judgment. Consequently, even if we were to accept Merck's version of comment k, the Allisons would still be entitled to a trial on the merits. [16]