Our first reaction upon reading Metz v. Wyeth, 2012 U.S. Dist. Lexis 42432 (M.D. Fla. March 28, 2012), is boy, this case has a little of everything! After it was over, the plaintiffs must have felt a little like the French after they went to war against the Prussians in 1870.
First, Metz has a little Conte (for the uninitiated, that’s shorthand for the branded liability in generic cases controversy), although only a little – the court notes (at *2 n.1) that it previously dismissed the claims against the non-manufacturing branded drugmaker. See Metz v. Wyeth, Inc., ___ F. Supp.2d ___, 2011 WL 5826005, at *1-3 (M.D. Fla. Nov. 18, 2011). That moves Metz onto our list of one-two punch cases that combine product identification with Mensing preemption. It’s the seventh suit to achieve this distinction that we know of.
Second, as you might have guessed, Metz has Mensing/generic drug preemption issues all over it. The court held that most of the plaintiff’s claims against the manufacturer of the generic drugs she took were preempted. Those were: (1) negligence claims, except for (possibly, the court used “may” and never definitively decided the point) allegations that the defendant could have “take[n] additional steps to warn doctors and/or consumers of information already appearing in, or recently added to, the label.” Metz, 2012 U.S. Dist. Lexis 42432, at *8; (2) the defendant’s failure to “inform itself” of alleged risks, id. at *10; (3) all strict liability claims, including design defect and failure to withdraw the drug from the market, id. at *11-13; (4) warranty claims (unless based on the “additional steps” theory), id. at *13-15; and (5) misrepresentation/fraud. Id. at *15-17.
In addition to Mensing-based preemption, the court invoked Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), in holding that claims “that [defendant] failed to supply relevant information to the FDA” were also preempted. 2012 U.S. Dist. Lexis 42432, at *17 n.6.
Third, the court addressed another of our pet peeves, negligence per se claims based on alleged allegations of Food, Drug and Cosmetic Act (“FDCA”) violations. As a matter of state law, Metz held that Florida did not recognize such an animal. Only statutes that the legislature (Congress, in the case of the FDCA) intended be privately enforced could give rise to negligence per se. Id. at *17-19. Furthermore, “failure to comply with administrative regulations rather than substantive regulations establishing a specific standard of care” also cannot be the basis of an negligence per se claim. Id. at 19 n.8. These are two of the grounds covered in our comprehensive negligence per se post on state-law defenses.
Fourth, the court noted the plaintiff’s improperly vague pleading at two points in the first half of the Metz opinion. No facts concerning manufacturing defect were pleaded, leading to a dismissal under TwIqbal. 2012 U.S. Dist. Lexis 42432, at *11 n.4 . Plaintiff’s misrepresentation claims – mostly concerning post-marketing pharmacovigilance – failed the particularity requirements of Rule 9(b). Id. at *16.
Fifth, all non-preempted claims failed on summary judgment under the learned intermediary rule because the labeling, specifically warning against long-term use, was adequate as a matter of law:
[T]he product label . . . contained the accurate, clear, and unambiguous warning that “[t]herapy should not exceed 12 weeks in duration.” This warning, which was available both in the package insert and on the internet . . .. satisfied [defendant’s] duty to provide Plaintiff’s treating physician with adequate information about the risks associated with [the drug’s] use (including the FDA indicated prohibition on long term use).
Metz, 2012 U.S. Dist. Lexis 42432, at *23 (footnote omitted).
The warning discussion in Metz also accepted a couple other noteworthy propositions. (1) Once an adequate warning is given, “[w]hether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant.” Id. at *22. “This is true even if [defendant] knew or should have known that the medical profession was not warning patients of allegedly known harmful side effects.” Id. at *23 n.12. Also, (2) “there is no duty to communicate an inadequate warning,” so the plaintiff cannot claim liability for not changing to a warning that they still allege is inadequate. Id. at 23 n.11. It would a good idea to save these quotes somewhere. Both of these points are worth remembering for future cases.
Thus, the Metz case featured Conte, preemption, negligence per se, TwIqbal, and the learned intermediary rule – and the defendant won on all of them. That’s what we call putting it all together.