The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic manufacturers on the basis of preemption and other defenses we like.  It certainly does those things, and that’s good.  But we see decisions like that almost every week.  What Wagner does, however, is add to the quality of those decisions, not just their quantify.  Its opinion is clear and unhesitating.  It takes on Mensing and Bartlett preemption and the non-existence of failure-to-update claims in barely more than three crisp pages.  And, along the way, it provides uncomplicated and convincing passages that all of us can use in our future briefing.

Wagner is a hormone therapy (synthetic progestin) case in which the plaintiff sued both generic and brand manufacturers using the usual claims, and some not so usual claims.  The generic manufacturers moved for judgment on the pleadings.  From there, the court went to work.  It described Mensing and Bartlett in the simplest of terms:

In Mensing, the Supreme Court held that the FDCA preempts any state law that would require companies to improve generic drug labels.  Mensing, 131 S. Ct. at 2577-78.  The Court reasoned that it would be impossible for those companies to both change the generic drug label and maintain sameness with the corresponding brand-name drug label.  Id.  In Bartlett, the Court extended the principles in Mensing to cover state defective-design laws.  Bartlett, 133 S. Ct. at 2470.  To comply with the defective-design tort law, the Court determined that generic drug companies would have to either change the drug’s formula or change its label.  Id. at 2474.  Alternatively, generic drug companies could choose to stop selling the generic drug.  Id. at 2477. The Court held that the first two options were impossible because of the FDCA and the last option, withdrawal of the product from the market, was unreasonable. Id. at 2470. Thus, under Mensing and Bartlett, where a generic company faces only these three options to satisfy a state law duty and avoid liability, that state law is preempted by the FDCA.

Id. at *7-8.

Simple enough, and the court didn’t back away from any of it in the face of plaintiff’s claims.  Plaintiff’s state law claims were numerous: “varieties of negligence; strict products liability; misrepresentation; breach of warranty; consumer fraud; assault and battery; and infliction of emotional distress.”  But they all attacked labeling or design, and the court saw that:

The factual allegations underlying each of Wagner’s claims are that the Generic Defendants should have either improved the safety of MPA by changing the formula or strengthened the warnings on the label.  But the Generic Defendants could not comply with the FDCA and avoid liability under Wagner’s state-law theories.  These claims are thus preempted by the FDCA because the Generic Defendants cannot change the formula or the label of MPA without violating federal law.

Id. at *8-9.
The court held all these claims preempted.

The court was equally succinct in taking down plaintiff’s claim that the generic defendants failed to update their products’ labels to match changes made to the labels of the brand-name drugs.  Id. at *10.  Generic manufacturers’ obligations to update labels come from the FDCA, not from state law.  But the FDCA does not authorize private plaintiffs to enforce its provisions:

[T]the FDCA does not provide a private cause of action for its enforcement.  21 U.S.C. § 337(a); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001)).  The FDA exclusively, not private citizens, has the authority to enforce the FDCA labeling requirement on generic drugs.  As mentioned above, the question of whether Wagner could use state tort law to effect the same enforcement result to her private benefit is not entirely settled, but most courts that have addressed the issue have decided against allowing it.  See, e.g. Morris, 713 F.3d at 777.

Id. at *11-12.
In other words, plaintiff’s failure-to-update claim had no basis in law.

The court believed that it had no basis in logic either.  In her claims against the brand-name manufacturers, plaintiff alleged that labels for those drugs were deficient.  Yet her failure-to-update claim alleged that the generic manufacturers should have adopted those (supposedly deficient) labels.  That logic leaves a hole big enough for causation to fall through:

[E]ven if her private claim were not barred, [alleging that the generic manufacturers should have matched the brand-name drug labels] is inconsistent with Wagner’s theory of the case.  Wagner alleges that the brand-name labels are themselves inadequate.  Thus, even if the Generic Defendants had timely updated their labels, Wagner would not have been adequately warned of the dangers of the drugs she was taking.  Under Wagner’s own theory of the case, the Generic Defendants’ failure to timely update their labels to a different but still deficient form could not be a cause of Wagner’s injuries.

Id. at *12.  The court dismissed plaintiff’s failure-to-update claims.

More opinions should be written this clearly and succinctly.