Wednesday, July 25, 2012

Lyman: Branded Out; Generic Waist Deep In Big Muddy

We’ve just read Lyman v. Pfizer, Inc., 2012 WL 2970627 (D. Vt. July 20, 2012).  Frankly, we expected it to be worse than it was.  Regular readers are no doubt familiar with Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt.  2010), in which the same court (we would say in violation of Erie principles of federalism) predicted that Vermont would follow the controversial holding of Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal. App. 2008), in the absence of any Vermont precedent for doing so.  We were steeling ourselves in Lyman for more of the same.

Didn’t happen.

The court used remote causation to clip Conte’s wings significantly.  We were muttering about the same concept well before we got to the court’s holding.  The facts delved well back into the product liability equivalent of deep time − while the plaintiff only started using the product (metoclopramide) in 2003, the discussion of the branded manufacturer’s conduct went back at least to 1980, when the FDA approved the original Reglan branded version of the product.  Lyman, 2012 WL 2970627, at *4.  Predictably, plaintiff alleged fraud on the FDA with respect to the 1980 approval.  Id. at *5.  The fact that the opinion saw fit to mention these ancient, and blatantly-preempted allegations filled us with foreboding.

Other facts, thankfully, turned out to have more relevance.  These were:  (1) the drug was only approved for gastrointestinal reflux, (2) it was never approved for long-term use; (3) after losing its patent protection, the branded manufacturer sold all of its rights to the drug to an unaffiliated company in 2001; and (4) plaintiff never used the branded version.  Lyman, 2012 WL 2970627, at *2, 4-5.

The branded defendants − the original manufacturer and its 2001 purchaser − sought summary judgment, arguing that even under a Conte rationale, plaintiff didn’t have a case.

They were right.

The most important reason that the Conte theory of causation failed was that it relied upon events that occurred decades before plaintiff’s alleged injury.  The causal chain was simply too remote.  Activity that occurred years, even decades, before the plaintiff ever began taking (a different manufacturer’s version of) the product “ha[d] so far spent itself as to be too small for the law’s notice.”  Lyman, 2012 WL 2970627, at *17. As to warnings:

[Defendant’s] alleged negligent actions are too remote to constitute a proximate cause of [plaintiff’s] injury.  [The] development, testing, labeling and promotional activity had ceased entirely by the end of 2001, long before [plaintiff’s] first consumption of a dose of [the drug].  In fact, much of the misconduct attributed to [defendant’s predecessor] occurred in the 1980s.

Id.  Similar reasoning was also fatal to the plaintiff’s fraud claim − reliance on anything the original branded manufacturer had done years ago, before the labeling had been changed, was simply not justifiable:

[Plaintiff’s prescribers] derived their impressions from a variety of sources.  Those sources could conceivably be traceable back to statements made by [defendant], but from a time well before [plaintiff] began taking [the drug].  [Defendant] stopped manufacturing [the drug] and ceased having responsibility for its label in December 2001, and there is no evidence that it made any statements regarding [the drug] after that time. . . .  [T]he new NDA holder . . . had revised the label three times, and an inquiry into the current information . . . would have revealed . . . that therapy should not exceed twelve weeks. . . .  [A]ny prescriber’s reliance on [earlier] statements . . . was not justifiable.

Id. at *18.  Lyman thus cut off the perpetual tail of liability that Conte (which was willing to look at what a doctor had reviewed while still in training) had permitted.  Thus, the only court ever to follow Conte ultimately couldn’t stomach the temporally-infinite cause of action that Conte had described.  That’s a big deal − especially since Conte involved the same drug and thus identical hisorical facts.  Lyman demonstrates, once again, how radical Conte’s departure from established law actually was.

Legal cause as to the branded defendants in Lyman also failed for another reason − the defendant’s alleged negligence related to another condition, not the off-label use for which the plaintiff was taking the drug:

[Plaintiff] received [the drug] for the off-label use of controlling migraine-related nausea.  [The branded defendants’] development, testing and promotional efforts were directed toward treatment of gastrointestinal conditions, not [plaintiff’s] condition. . . .  Under these circumstances the negligent conduct alleged bears no causal connection to the injury suffered.

Lyman, 2012 WL 2970627, at *17.  This rationale also has potentially broad application to other cases involving disparate off-label uses.

The generic manufacturer in Lyman stayed in the case, notwithstanding preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  This ruling (which was on the pleadings; not on summary judgment) had two bases, only one of which we find particularly objectionable.  The relatively unobjectionable ground is that the generic defendant didn’t update its labeling after the FDA approved a labeling change.  Lyman, 2012 WL 2970627, at *9.  Assuming that happened, and assuming it was causal (two big ifs), we don’t have a preemption-based beef with that result.  Mensing was based on impossibility, and it was not impossible (indeed it was probably mandatory) to make that particular change.

The preemption ruling in Lyman that we don’t like tried to split warning hairs that we don’t think are splittable under Mensing.  The opinion allows some sort of claim based on an failure to communicate warnings retroactively, instead of on the inadequacy of the existing warnings:

[T]he amended complaint states that the FDA required the addition of the black box warning [in 2009] as a result of the inadequate warnings provided to consumers and the medical community, indicating that it is the failure to communicate the updated warnings adequately or at all, rather than the inadequacy of the updated warnings themselves, that is at the heart of this failure-to-warn claim against the generic manufacturing defendants.

Lyman, 2012 WL 2970627, at *10.  Sorry, we don’t see the distinction.  This claim is still an attack on the adequacy of the generic drug’s FDA-required warnings, which is preempted under Mensing.  Look at it this way − if those pre-2009 warnings hadn’t been inadequate, there wouldn’t have been any need to communicate later warnings.  Plaintiffs are simply using the 2009 warning change (which should be an inadmissible subsequent remedial measure) to impugn the adequacy of the prior warnings, and Mensing says you can’t do that.  The whole warning swamp is off-limits as preempted; plaintiffs should not be allowed into it.

Otherwise, Lyman isn’t bad for the generics either.  The court wasn’t snowed by plaintiff’s novel (meaning desperate) attempt to repackage preempted warning claims as defective packaging claims.  Allegations that the generic defendants “failed to incorporate . . . package designs that would discourage long-term use” were simply a “nonverbal failure-to-warn claim.”  Lyman, 2012 WL 2970627, at *11; see id. (“unit of use packaging” claim preempted because it was a form of “stronger warning” against long term use) . The packaging allegations also failed under TwIqbal:

Subtracting the legal conclusions, it amounts to a suggestion that certain unspecified types of packaging designs might have discouraged long-term use of the drug, which might have prevented the harm to [plaintiff].  This is an example of an allegation that does not permit the court to infer more than the mere possibility of misconduct.


The plaintiff’s “design” claim was also preempted as a disguised warning claim.  After all, the only thing plaintiff claimed was wrong with the design was unsuitability for long term use − exactly what the challenged warning was about:

The only “defect” that arguably can be gleaned from the pleading is that the drug is unsafe for long-term use. This is simply another way of presenting a failure-to-warn claim.

Lyman, 2012 WL 2970627, at *12.

Plaintiff’s warranty claims also failed.  Off-label use of the product − intended to treat gastrointestinal conditions − for “headache-induced nausea” simply couldn’t be considered an “ordinary use” of the product as required by the Vermont UCC.  Id. at *15.  The lack of any communication between plaintiff’s prescriber and the defendant about plaintiff’s treatment similarly doomed a claim for breach of the implied warranty for a particular purpose.  Id. at *16.

Finally, one of the two generic manufacturers was dismissed on medical causation grounds.  Apparently, there is no support for causation where use of the drug is “intermittent.”  The manufacturer, whose product was only consumed intermittently, thus got out.  Id. at *14.

All in all, a much better result than we had anticipated when we first learned of the decision.