Photo of Bexis

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

For a few months, in 2004-05, plaintiffs alleged that the generic defendants did not include the latest of a number of FDA-approved labeling revisions. Id. at *3. This period overlapped briefly with the allegedly injured plaintiff’s 2005-09 use of the drug. Id. at *4. So there is a short period where it is temporally possible that a prescribing physician could have acted on the basis of un-updated labels.

Temporality of use is not enough to establish causation, particularly in a case that turns on information, and that’s exactly what happened. Plaintiff’s own allegations were incompatible with causation, because the doctor in question didn’t even prescribe generic metoclopramide. Instead, the doctor’s prescription was for the branded drug, and generic substitution came later. Id. at *9.

In the instant case, [plaintiff’s] doctors prescribed her the brand name drug . . . – not the generic drug metoclopramide – from 2005 to 2009. The labels for [the branded product] already contained the 2004 warnings at the time that [plaintiff’s] doctors prescribed. . . . Thus, [plaintiff’s] doctors had already gleaned “substantially the same” knowledge about the effects of using [the drug] from the 2004 updates to the [branded] label that they would have gained from an identical update to the labels of the generic version of the drug.

Id. (emphasis added). The opinion pointed out that exactly the same result has been reached in other update-related cases. Id. (citing Fullington v. Pfizer, Inc., 720 F.3d 739, 747 (8th Cir. 2013); Bell v. Pfizer, Inc., 716 F.3d 1087, 1097 (8th Cir. 2013)). Why are we not surprised?

Allegations of failure to update imply that something else needed updating, and that something was the branded label. Thus, the adequacy of the branded label, for a doctor who prescribed the branded product, defeat causation. We’ve seen in other cases how plaintiffs complain about pharmacies and generic substitution. Whether or not such complaints have merit in other contexts, they certainly kill causation in failure-to-update cases. Where the prescriber never even prescribed the defendant’s product, how could s/he have relied on the defendant’s warnings?

[B]ecause [plaintiff’s] physicians prescribed her [the branded drug], not generic metoclopramide, [she] has not shown that her physicians relied on the labeling of generic metoclopramide.

*          *          *          *

[Plaintiff] does not allege that her physicians prescribed [the branded drug] because of any labeling or representations made by the generic defendants.

Woods, 2016 WL 1719550, at *9-10 (emphasis original). Of course plaintiff did not. That’s the opposite of what plaintiffs normally allege, particularly in Alabama, where for a few months the courts imposed innovator liability before the legislature put a stop to it. Indeed, “[plaintiff] has not alleged that her physicians ever saw the package inserts or labeling for the generic drug . . ., much less that they relied on those labels.” Id. at *10.

Oh, and for the sake of completeness, two plaintiffs’ other claims – failure to add warnings and failure to send reminder “Dear Doctor” letters (“consistent with” FDA-mandated labeling) – were preempted. Woods, 2016 WL 1719550, at *4-6. The final claim, fraud, wasn’t pleaded with specificity under Fed. R. Civ. P. 9(b), id. at *10-11, a conclusion that was a fortiori from the just-discussed analysis of how failure-to-warn lacked evidence of causation.

Woods is further confirmation that the other side’s duty-to-update ruse to avoid preemption is hardly worth the candle. Even if they beat preemption, the claim itself is worthless. Most doctors never see generic labeling at all, particularly those who prescribe the branded product subject to pharmacy substitution. As we’ve discussed at great length, failure to read the allegedly inadequate label is fatal to causation in a warning case.