United States: Double Preemption Win In Amiodarone Litigation

Last Updated: October 18 2017
Article by James Beck

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents. Still, that's no reason not to praise good results. Recently, the manufacturers of generic amiodarone scored two big wins on the same day. Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330 (D.S.C. Sept. 29, 2017). Moore, which is headed for F. Supp. publication, is the more comprehensive case, so we'll start with it.

The plaintiffs' pitch, such as it is, in these cases is that the generic defendants either piggybacked on the branded manufacturer's earlier off-label promotion or else engaged in such promotion themselves. Secondarily, they claim that they didn't receive the medication guide that the FDA requires manufacturers of this product to provide to prescribing physicians. Somehow, the failure of the prescriber to pass along this pamphlet is the manufacturer's fault.

Didn't work (mostly) in Moore. As for the off-label promotion allegations, they were barred – as other information-related claims involving generic products are barred – because "the generic drug manufacturer could not change its labeling without violating FDA regulations." Moore, 2017 WL 4365162, at *3 (citing Mensing). Further, the entire concept of "off-label" is derived from the FDA-approved label, and thus from the Food, Drug & Cosmetic Act ("FDCA"). Id. at*7. Plaintiff's attempt to gin up a state-law negligence claim based on this alleged conduct ran straight into a quirk of Kentucky law that we've blogged about before: Kentucky, by statute, prohibits negligence per se claims based on violations of federal law.

The Kentucky Supreme Court's holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky. 2006) offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.

* * * *

Under Kentucky law and the Kentucky Supreme Court's analysis of KRS 446.070, which codifies the doctrine of negligence per se, . . . the statute "did not intend for KRS 446.070 to ... confer a private civil remedy for" violations of federal law.

Moore, 2017 WL 4365162, at *7-8. Aside from the off-label aspect, all warning claims were preempted under Mensing. Id. at *8-9. Plaintiff did not allege design- or manufacturing-related claims. Id. at *8.

As for the purported failure to supply the FDA-mandated medication guide, that was something that the plaintiff simply made up. Kentucky, like every other state, follows the learned intermediary rule. Id. at *6. The manufacturer thus has no obligation, "non-delegable" or otherwise, to communicate warnings directly to a patient who has been prescribed a drug. Id. Because there is no such state-law duty, any obligation to supply medication guides was imposed solely by the FDCA. The FDCA, however, "leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance." Id. at *5 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001)).

Since [plaintiff's] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA and it is the FDA, not [plaintiff], that "has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration."

Id. (again quoting Buckman, 531 U.S. at 349).

Implied warranty claims were preempted for the same reasons as negligence and strict liability claims. Id. at *9. Express warranty claims failed because there was nothing the "explicitly warranted" the drug's safety for the off-label use in question. Id. at *10. Without any express language, the warranty claim was simply a doomed repackaging of plaintiff's preempted warning claim. Id. at *11.

The only claim that could conceivably survive preemption in Moore was a fraud claim based on false off-label promotion. As we've seen numerous times in PMA preemption, while every other aspect of off-label promotion was protected by preemption, an allegation that was both false and an FDCA violation could survive – if a plaintiff ever properly pleaded it. The plaintiff in Moore didn't come close:

The majority of the complaint fails to specify actions undertaken by [defendant] and instead conflates accusations of wrongdoing against the two originally named "Defendants." Instead of providing specific details concerning when the wrongful conduct took place, the Complaint alleges that the "Defendants' scheme in the past involved and continues to involve a calculated and deceitful sales campaign. . . ."

Id. at 12. The complaint was such a mess that "it is unclear whether providing [plaintiff] with an opportunity to amend her complaint would be futile." Id. The court decided to give her one more shot. Id.

The second preemption win, Bean, 2017 WL 4348330, was mostly along the same lines, except that, being from South Carolina, the Kentucky quirk on negligence per se wasn't at issue. The plaintiff made same the allegations about off-label promotion and medication guides. Id. at *1-4. The court was even firmer about preemption, not allowing any loophole for "fraudulent" off-label promotion:

Plaintiff's "off-label" promotion claims are due to be dismissed as preempted under Mensing and Bartlett. . . . The basis for Plaintiff's "off-label" marketing claim is that Defendants, by virtue of their marketing of [the drug off-label], rendered the manufacturer's warning inadequate. Defendants are prohibited by the FDCA and FDA regulations from adding or strengthening any warnings for [the drug] to address any risks associated with off-label use. If successful, Plaintiff's "off-label" promotion claims would necessarily require Defendants to either: 1) change the warning label or disseminate additional warnings to reflect the alleged additional dangers associated with the "off-label" use of amiodarone for atrial fibrillation; 2) accept state tort liability; or 3) exit the market place. . . . [S]uch a result requires preemption under Mensing and Bartlett. Plaintiff's "off-label" promotion claims, whether sounding in fraud or negligence, are preempted by the FDCA.

Id. at *5.

Also, as in Moore, the medication guide allegations were preempted as private FDCA enforcement under Buckman. 2017 WL 4348330, at *6-7. Plaintiff didn't even respond to Buckman, which the court found particularly "telling. Id.; see id. at *7 ("the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations"). The learned intermediary rule, which South Carolina follows, precluded any state-law liability for failing to provide warnings directly to a patient . Id. at *8. Buckman also did in the off-label promotion claims, because the court found no state-law obligation to avoid off-label promotion. "[T]he duties Plaintiff alleges Defendants breached regarding 'off-label' promotion exist solely under the FDCA." Id. at *7.

The court in Bean was particularly unhappy with both plaintiffs' allegations and with her counsel. The allegations were inherently inconsistent, because by alleging that the medication guide contained "adequate and sufficient" warnings, the plaintiff necessarily defeated her own allegations. "Plaintiff does not allege that the prescribing physician did not receive the Medication Guide, was unaware of its contents, or the risk [the guide discussed]." Id. at *8. These allegations weren't "plausible on [their] face" under TwIqbal, because the prescriber received "adequate" warnings. Id. As for counsel:

Plaintiff's failure to respond to the learned intermediary argument is striking because Plaintiff's counsel has been involved in several other amiodarone cases that were dismissed in part pursuant to the learned intermediary doctrine.

Id. at *7 n.4 (string citation omitted). Thus, the plaintiff in Bean, unlike the plaintiff in Moore, didn't deserve – and didn't get – any chance to replead. Id. at *8.

One thing that Moore and Bean exemplify to us is how preemption principles cut across product lines. As we've chronicled, much of the favorable law as to off-label promotion was developed in the context of PMA preemption. Buckman, of course, was an implied preemption case involving a 510(k) medical device. Both Moore and Bean employed this precedent to dismiss claims involving generic drugs. In view of this cross-pollination of defense arguments in preemption cases, we offer one final opportunity for improvement. As we blogged about at length here, there is an additional Mensing/Bartlett preemption argument whenever off-label warning claims are asserted. Only the FDA can require warnings about off-label uses.

A specific warning relating to a use not provided for under the "Indications and Usage" section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added). See also 21 C.F.R. §201.80(e). Thus, regardless of anything else, a manufacturer cannot add or alter warnings related to off-label uses without first getting the go ahead from the FDA. In and of itself, that requires preemption of off-label warning claims under Mensing/Bartlett. For more details, see the other post.

A defense win anywhere helps defendants everywhere. Keep winning.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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