[Drug and Device Law] Not The End Of Weeks But A Start
It feels like we have been talking about Weeks for years. Two slightly different versions of the same decision have allowed the “innovator liability” theory of recovery to survive in Alabama against manufacturers of drugs that the plaintiff did not take. Each appeared on our bottom ten list over the last two years. Too many posts to link have discussed how Weeks is on the wrong side of the weight of authority on what started with Conte years ago. In the first five months after its feeble re-do, we did not see cases considering whether to extend Weeks. We now have, with Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073 (N.D. Ala. Jan. 14, 2015). And that led us to find an older Weeks case that took a while to appear in “print,” Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014). So, we present an end-of-the-week two-fer on Weeks from the federal judges in the northern part of this southern state.
Both cases involve plaintiffs who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, and who sued various manufacturers, including the company that brought the branded drug to market long before the plaintiff got the generic. Both cases also involve other issues we often discuss, like TwIqbal, preemption, and the learned intermediary doctrine, but we are not discussing those issues here. Instead, we are limiting ourselves to how these cases limit Weeks and do not allow the plaintiffs to proceed against the branded manufacturer on the allegation that it owed a duty to each plaintiff to provide him with the Medication Guide that would have made clear that his physician was prescribing the drug off-label and that it had various risks. (If we were talking about the risk of these cases, we might talk about how little apparent connection there seems to be between the information gap alleged with each brief prescription and the remote injuries.) Amiodarone was originally approved as a “special needs” drug to be used as “a last resort,” and has a regulatory history with a fair amount of back-and-forth on discouraging (and not encouraging) physicians from prescribing it as first or second line therapy. Plaintiffs apparently did not contend that the Medication Guide hid the ball on the drug’s indication or risks.
As the courts saw it, this was a critical difference from Weeks. In Allain, the plaintiff took amiodarone from two generic manufacturers, but never the innovator’s product. The call to Weeks was not enough to create a duty for the innovator: In Weeks, the Alabama Supreme Court held 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." Id. at *23 (emphasis added). However, unlike the plaintiff in Wyeth, Plaintiff does not allege that the Medication Guide was false or deceptive. In fact, Plaintiff in his reply brief states that the "Medication Guide clearly and unequivocally states that 'off-label' and non-'drug of last resort' use of amiodarone should not occur and provides a clear warning of the dangers of death and severe injury." Plaintiff instead faults Wyeth for failing to ensure that Mr. Dreher received the Medication Guide. Thus, Plaintiff does not challenge the sufficiency of the warning but only that Mr. Dreher was not provided a Medication Guide. As such, Weeks does not control the case at hand.
2015 U.S. Dist. LEXIS 4073, *12 (internal record citations omitted). With Weeks relegated, there was no basis for finding a duty the innovator could have breached. Id. at *13. After all, Medication Guides are to be provided to distributors of the drug, not to patients, let alone to patients who take some other company’s drug.
Stephens took a similarly narrow view of Weeks, rejecting that could create duties for the innovator for any of the claims that plaintiff had asserted with sufficient detail. These claims were, at their core, failure to warn claims (that also ignored the learned intermediary doctrine). Weeks does not apply to such claims:
Unlike the facts before the court in Wyeth, Inc., v. Weeks, 2014 Ala. LEXIS 109, 2014 WL 4055813 (Ala.2014), the plaintiffs here do not allege that the defendants "falsely and deceptively misrepresented or knowingly suppressed facts about [the medication] such that [the treating] physician, when he prescribed the drug [], was materially misinformed and misled about the likelihood that the drug would cause dyskinensia and related movement disorders." 2014 Ala. LEXIS 109, [WL] at * 2. Plaintiffs allege only that defendants failed to warn them, not Mr. Stephens' doctor. Plaintiffs fail to allege that defendants misrepresented anything to Mr. Stephens' doctor. Put simply, the plaintiffs fail to allege that but for defendants' misrepresentations or suppressions about amiodarone, Larry Stephens' doctor would not have prescribed this medication. Similarly, while plaintiffs allege "Larry was not aware that his use of the medication was for an 'off-label' use," the relevant inquiry is whether his physician was aware of this.
* * *
In Count II, the plaintiffs allege that amiodarone was unreasonably dangerous and given its inherent dangerousness, did not contain adequate warnings. The plaintiffs continue that had amiodarone contained adequate warnings, Mr. Stephens would not have taken the drug. SAC, ¶ 105. This is again a failure to warn claim, despite plaintiff's attempts to make it otherwise. See e.g, Wyeth v. Weeks, 2014 Ala. LEXIS 109, 2014 WL 4055813, * 4 (Ala.2014) (holding fraudulent misrepresentation concerning the dangers of a medication is not a claim that the drug ingested was defective, but rather a claim that defendant suppressed information about the manner it was to be taken, removing it from the realm of products-liability actions). Plaintiffs do not assert that amiodarone should have never come to the marketplace because of inherent dangerousness, or that there was a reasonable, safer alternative to the medication. Rather, plaintiffs assert that defendants failed to warn Mr. Stephens that amiodarone was a medication of last resort for ventricular fibrillation and that his doctor's prescribing the same for atrial fibrillation was an "off label" use.
2014 U.S. Dist. LEXIS 180568, **14 & 17-18. Ignoring that plaintiffs ignored the learned intermediary in their allegations, these are pretty run-of-the-mill product liability allegations. If Weeks does not allow innovators to be tagged for such 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.
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Posted By Eric Alexander to Drug and Device Law at 1/30/2015 04:48:00 PM --
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