[Drug and Device Law] The Elephant in the Room in Alabama
Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else. The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff. Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.” Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.
Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug. Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015). Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability. Id. at *13. We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”
Allain is back, this time on motions by the generic defendants and the innovator defendant to dismiss the amended complaint. Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 83676 (N.D. Ala. June 29, 2015). While we are pleased with how the court handled most of the issues—not just because the defendants won—the treatment of the purported claim against the innovator defendant for “off-label promotion” leaves us befuddled. It is hard to imagine an analysis of whether a claim has been pleaded without looking to some authority that says there is such a claim and what its elements are. However, the Allain analysis of the pleading of this non-claim cites no Alabama authority. It does not even cite Weeks, which is the only reason there is innovator liability in Alabama for any claim. The failure to analyze whether Weeks suggests there should be claim against an innovator for promoting its drug (not taken by the plaintiff’s decedent) off-label is the—you guessed it—elephant in the room in this case. We say this not just because the University of Alabama has had an incongruous elephant mascot for its Crimson Tide since 1930. [Our resident baseball historian and our resident Bay Area blogger could probably go on about the more venerable white elephant mascot of the Athletics baseball team.] And not just because elephants are awesome and we are hoping that transgenic woolly mammoths are coming. No, say this because it is an apropos metaphor for something so obvious that was ignored and because we already put it in the title of this post. Rather than jump right to the pachyderm problem—the consensus seems to be that adult elephants cannot jump anyway—we will roll through what the rest of the opinion addressed. As those with elephantine memories will recall, Allain involves a suit by the estate of a plaintiff who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, against both the generic manufacturers and the company that brought the branded drug to market long before the decedent got the generic. As to the generic manufacturers, plaintiff did not assert that the label or Medication Guide provided inadequate warnings, but the court correctly noted that such a claim would have been preempted by Mensing anyway. Id. at **11-12. Plaintiff also claimed the generic manufacturers should be liable because they did not ensure that the pharmacy where the decedent got his drug had a Medication Guide to put in his hands. Rather than just laugh at the implausibility of this claim, the court found two grounds to shut it down. First, because this claim is premised on a violation of a federal regulation, it was preempted under Buckman and 21 U.S.C. § 337(a), which provides that the United States is supposed to enforce violations of the FDCA. Id. at **21-22. Second, Alabama law requires prescription drug companies to warn physicians, not pharmacies or patients through pharmacies. Id. at **22-23. For what Alabama law provides, two cases were cited, one of which was Weeks. Ironically, the analysis we just described for the generic defendants was really for all the defendants together, without any additional consideration of whether the branded manufacturer had any duty to provide Medication Guides for the branded drug to a pharmacy so that it could hand them out when dispensing the generic. This is so even while the court was citing Weeks for Alabama’s adoption of the learned intermediary doctrine—itself premised on the primacy of relationship between the patient and the medical professional who prescribes a drug over the lack of direct interaction between the patient and the company that makes the drug the patient takes.
It is not like the defendants were always treated together. In evaluating plaintiff’s purported claim that the defendants should be liable for fraudulent off-label promotion of the branded and generic versions of the drug, it was noted that “the specific factual allegations Mr. Allain asserts against the Generic Defendants vary greatly from the allegations against” the branded manufacturer. Id. at **12-13. The allegations against the generic defendants were “woefully deficient and satisfy neither Rule 8 [n]or Rule 9” because they did not alleged specific acts by each defendant, included only general allegations with the buzzword “off-label” in them, and did not include any of the specifics required for pleading fraud. Id. at **14-18. What was not addressed in dismissing the final claim against the generic defendants was whether there could be a claim under Alabama law for off-label promotion, no matter how detailed the pleading. While the court noted that it was punting on whether this was really just a re-cast failure to warn claim that should be preempted by Mensing—“none of the parties point to any binding precedent addressing the impact of Mensing on claims premised on a generic manufacturer’s promotion of its generic drug for off-label use,” id. at *13-14 (emphasis in original)—it broke another rule of nature by putting the cart before the horse. Before a state law claim can be preempted, it first has to exist. Even when the plaintiff takes the drug that was promoted for off-label use, there still needs to be more—like a failure to warn of the risk of the condition that allegedly hurt the plaintiff or his decedent—before there can be an actionable tort. Even if the court had felt like the plaintiff deserved a chance at a third strike on adequate pleading, the dismissal here should have been with prejudice because you cannot adequately plead a non-existent claim.
This brings us to the very large cousin of the little hyrax crammed into its own fancy room. (We are not sure whether to picture this elephant like the bespectacled and wise Prime Minister Cornelius or the young and clownish Arthur, but (s)he surely looks like one of the Babar elephants.) The “allegations of off-label promotion” by the branded defendant are “vague” and mostly “unrelated to the promotion of Cordarone.” There were “a few . . . relevant” allegations of off-label promotion of the branded drug up until the generic drugs came on the market more than a dozen years before plaintiff’s decedent was prescribed them. Ignoring the remote timing alleged and that relevance depends on the legal requirements of the claim, the court found “Mr. Allain has articulated a specific method of how [the branded defendant] promoted Cordarone to physicians for off-label use.” Id. at *20. Then, while recognizing that there should be some allegation about causation, the “vague and dubious” allegations that one of the decedent’s two prescribing physicians was a “victim” of the promotion in general and her decision to prescribe was “greatly affected” by the promotion in general were enough to get by. Id. at **20-21. Thus, the motion to dismiss was denied “[b]ecause his claim against [the branded defendant] is plausible.” Id. at *21. An asserted claim can only be plausible if it sets out the elements of a recognized legal claim (and does not walk right into a recognized legal defense). How could this dreck be considered plausible without considering whether Alabama law condoned it? Such an analysis would have had to consider Weeks—bad, old, disavowed Weeks. About five months earlier, the same court in the same case had come to the correct conclusion that liability on the manufacturer of a drug the plaintiff’s decedent did not take could not be extended past the bounds of Weeks. Weeks is not based on off-label promotion. It does not discuss off-label promotion. There is no indication in Weeks or in any Alabama law before or after it that would allow liability based solely on off-label promotion of a branded drug a dozen years before a patient was given a prescription for a generic version of that drug. As we have said many times, federal courts sitting in diversity are not supposed to expand state law, especially without identifying clear state supporting authority not identified here. There is plenty of authority and common sense, as the Alabama legislature recognized in abolishing innovator liability, behind imposing product liability only on the seller of the drug that allegedly hurt the plaintiff and not on one of its competitors. But, nope, there was no analysis of any of that in the latest Allain decision. There is just a big gap in reasoning that, along with the gap left by the timing of the law trumping Weeks, leaves enough room for an elephant. This mess may get cleaned up later, like once discovery shows the lack of connection between branded promotion in the 1990s and generic prescriptions in 2011, but this claim really should not have gotten by a motion to dismiss. Cleaning up the mess left by an elephant does not sound fun.
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Posted By Eric Alexander to Drug and Device Law at 7/10/2015 07:30:00 AM --
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