We always keep our eyes open while researching.  Earlier this week, while researching prescriber failure to read cases, our search (which was necessarily overbroad), turned up Zeneca Inc. v. Shalala, 1999 WL 728104 (D. Md. Aug. 11, 1999), aff’d on other grounds, 213 F.3d 161 (4th Cir. 2000).  It was an administrative law case, completely irrelevant to our intended topic at the time.  Worse, it involved the incessant wars between innovator and generic manufacturers (something we religiously stay away from, since we try to support both in the product liability context).

One issue in Zeneca caught our eyes (and also our search terms).  The plaintiff challenged the formatting of certain warnings in the defendant’s ANDA application. We’ve seen product liability plaintiffs do that, too, and recently there’s been increased use of the preemption defense against these unusual formatting-related claims.

Even though Zeneca is not a preemption-related case, the court’s rejection of the administrative plaintiff’s formatting-based label challenge relies upon the same types of considerations that, in a state-law action, support preemption:

The Court finds curious [plaintiff’s] related argument that the warnings are ineffective to render [defendant’s] product safe because physicians will ignore those warnings.  Regulations related to the labeling and
packaging of drugs are a fundamental part of FDA’s regulatory scheme
.  To assume that health care providers would either fail to read or ignore clear warnings would call into question that entire scheme. [Plaintiff] has provided no support for this remarkable assertion.  As to [plaintiff’s] claim that the warnings are not sufficiently clear, that they should be printed in a bolder print or a different color, that is precisely the kind of specialized determination about which this Court cannot substitute its judgment for that of the regulatory agency.  See Henley v. FDA, 873 F. Supp. 776, 782 (E.D.N.Y.1995) (“It is this Court’s view that the FDA’s determination of what labeling best reflects current scientific information . . . involves a high degree of expert scientific analysis”), aff’d, 77 F.3d 616 (2d Cir.1996).

Zeneca, 1999 WL 728104, at *9 (emphasis added).

Sounds like a preemption – or alternatively, a primary jurisdiction – rationale to us.  We pass it along for the good of the order, with this reminder:  always keep your eyes open during research, because you might find something of potential value, even if you weren’t looking for it to start with.