United States: Utah Federal Court Dismisses Birth Defect Failure To Warn Claim

Last Updated: December 5 2017
Article by Stephen J. McConnell

Today Time Magazine announces its Person of the Year. The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an interview and a major photo shoot. We said "probably" is no good and took a pass. Thanks anyway!

[None of that actually happened. You might even call it fake news.]

Still, we can see why this blog would receive a major award for its literary achievements. We admit that we are not quite on the same level as, say, James Joyce's Ulysses, which 84 years ago on this date was found by an SDNY judge not to be obscene. We also must ruefully acknowledge that our case analyses are not as funny and transgressive as Lolita, which Vladimir Nabokov completed 64 years ago on this date. But we have occasionally encountered preemption issues as mystifying as Ulysses and plaintiff pseudo-experts who made the unhinged Humbert Humbert character in Lolita seem rational.

If there is a product liability issue that lends itself to literary invention, it is the issue of warnings. All that even a minimally creative plaintiff lawyer needs to do is parse an existing warning, then dream up some specification or adjective that would frighten doctors or patients just a tiny bit more. Stephen King is a fine writer, and odds are that he could do a splendid job of boosting terror in both warning labels and failure to warn claims. Of course, let's remember that we are talking about fiction.

It is not fictional that there are many assorted asinine warning labels out there based on fear of lawsuits. A hairdryer bears a warning against use by folks "while sleeping." A tag on an iron helpfully advises against ironing clothes while worn on the body. A bag of peanuts cautions us that the product ... contains nuts. The instructions for a chainsaw counsel against trying to stop the chain with one's hands. An over-the-counter bottle of sleeping pills lists possible side effects, including ... drowsiness.

There is more than a little fiction at work in the failure to warn claim in Cerveny v. Aventis, Inc., 2017 U.S. Dist. LEXIS 197194 (D. Utah Nov. 29, 2017). You may remember the name Cerveny. This litigation has already produced one of the best decisions of 2017. The crux of this latest Cerveny decision was the fiction that the plaintiffs' proposed warning would pertain to the plaintiffs. The court ultimately arrives at a sensible ruling on inapplicability of a warning about a risk to a population group that did not contain the plaintiffs. The court also makes clear that in fraud/negligent misrepresentation claims, a contraindication is not intended to induce reliance.

The plaintiffs in Cerveny were the parents and their child, who was born with certain physical defects. The mother had taken a prescription fertility drug before pregnancy, but not during the pregnancy. That rather obvious and fundamental temporal fact is central to the case. The FDA at one point proposed a warning of possible fetal harm when the drug is taken during pregnancy. That warning was not on the medicine when taken by the mother in this case, and one of the claims was that it should have been. The failure to warn claim was essentially that the future mother would not have taken the medicine before pregnancy if she knew that taking it during pregnancy could cause birth defects.

Courts all too often are all too tolerant of plaintiff failure to warn theories. Those claims all contain a dose of speculation, but some are speculative to the point of implausibility. It might be tempting for the court to pass the question, no matter how absurd, to the jury. Not the Cerveny court: "When a proposed warning does not apply to the plaintiff, she cannot prove defect or inadequacy." The Cerveny court quotes from Rivera v. Wyeth-Ayerst Labs, 283 F.3d 315, 321 (5th Cir. 2002), which rejected as "absurd," and "too speculative to establish Article III standing" a claim based on an allegation that an "extra warning, though inapplicable to [the plaintiff] might have scared her and her doctor" from using the drug. Cerveny and Rivera recognize that there must be a limitation to how speculative a failure to warn theory can be, and that Article III standing must actually mean something. Accordingly, the Cerveny plaintiffs cannot prevail on a cause of action based on a failure to warn about the risk of a medicine used during pregnancy when the use in the case was only prior to pregnancy. That is a notable result. We already have a post collecting opinions that likewise reject warning claims based on inapplicable risks.

There was another ground for rejecting the failure to warn claim. The label for the drug might not have contained an express warning, but it did contain a contraindication vs. use during pregnancy. So if that is what the plaintiffs claim needed to be said, it was said in the contraindication section, and that is enough.

What about the plaintiffs' misrepresentation claims? The contraindication discussed above also said that "no causative evidence of a deleterious effect" of the medicine on the human fetus had been seen. The plaintiffs contended that the "no causative evidence" language was false. But even if that is so, the contraindication was not directed to the plaintiff, and it was not intended to induce her to take the medication. The purpose of the contraindication was to inform doctors that their pregnant patients should not take the medicine. The plaintiff was simply not in that category. The failure to warn theory conjured up by the plaintiff lawyers was clever and creative, but it was also wrong.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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