We’re old enough that we remember the pre-Daubert Bendectin litigation.  Bendectin was the only FDA-approved drug indicated for nausea and vomiting from pregnancy.  Yellow journalism (the National Enquirer) and scientific fraud (deliberately falsified scientific data) fanned a birth defect scare, which led to an avalanche of factually baseless litigation – Daubert was

We light up a cigar maybe once a month. Of course, they’re no damned good for us. If we had any doubts, the headache and swamp-breath the next day would remove them. Still, a spirit of convivial dissipation tells us to smoke’em if we’ve got’em. No need to warn us off cigars, or the inevitable

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.

Continue Reading Preemption (and Other Things) Defanging Depakote Claims

We’ve covered a lot of topics since we started DDLaw in late 2006.  One that we haven’t addressed in any real fashion is overwarning – except for an unusual allegation made by a plaintiff that a defendant was “hiding” a warning among too many other warnings.  Cf. Kendall v. Hoffmann-La Roche, Inc., 2010 WL 3034453, at *22 (N.J. Super. App. Div. Aug. 5, 2010) (plaintiff complained that a drug’s warnings focused “predominantly” on birth defects and suicide but only “alluded to” about her condition (“abdominal and bowel problems”) in a “less conspicuous or pointed manner”).

We remedy that today.

Usually, the concept of overwarning is asserted by a defendant – that the plaintiff is threatening the usefulness of warnings about serious, relatively frequent risks by demanding that a defendant include a plethora of warnings about less serious and/or less frequent risks, or otherwise seeks to clutter up the defendant’s warnings with details of one sort or another.  As the Supreme Court observed, albeit not in the product liability context, “[m]eaningful disclosure does not mean more disclosure.  Rather, it describes a balance between competing considerations of complete disclosure and the need to avoid informational overload.”  Ford Motor Credit Co. v. Milhollin, 444 U.S. 555, 568 (1980) (citation and quotation marks omitted).  A typical critique of the problem of overwarning in the general (non-drug/device) product liability context occurred in Liriano v Hobart Corp., in consideration of the “open and obvious” limitation on the duty to warn:

[W]hen a warning would have added nothing to the user’s appreciation of the danger, no duty to warn exists as no benefit would be gained by requiring a warning. . . .  This is particularly important because requiring a manufacturer to warn against obvious dangers could greatly increase the number of warnings accompanying certain products. . . .  Requiring too many warnings trivializes and undermines the entire purpose of the rule, drowning out cautions against latent dangers of which a user might not otherwise be aware.  Such a requirement would neutralize the effectiveness of warnings as an inexpensive way to allow consumers to adjust their behavior based on knowledge of a product’s inherent dangers.

700 N.E.2d 303, 308 (N.Y. 1998) (citation omitted) (emphasis added).  Here’s another:

[T]he proliferation of label detail threatens to undermine the effectiveness of warnings altogether.  As manufacturers append line after line onto product labels in the quest for the best possible warning, it is easy to lose sight of the label’s communicative value as a whole.  Well-meaning attempts to warn of every possible accident lead over time to voluminous yet impenetrable labels-too prolix to read and too technical to understand.

Continue Reading On Overwarning

Over ten years ago, Lars Noah (now on the faculty of the University of Florida College of Law) wrote on the subject of product warnings. In his article, he noted that it was theoretically possible for a plaintiff to sue a defendant not just for failing to warn, but for the opposite — for over-warning.