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From Health Law Daily, March 13, 2018

Warnings, labeling for an FDA-approved generic drug preempt state claims

By Jeffrey H. Brochin, J.D.

State tort-law claims based on an alleged failure by a generic drug manufacturer to provide adequate warning labels for a generic drug were preempted by federal drug regulations applicable to generic drug manufacturers, a federal district court in California has ruled. The patient’s claims that the generic heart medication Amiodarone was unaccompanied by proper warnings and that the warnings given did not accurately reflect the severity or duration of side effects were preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604, 608-08 (2011) (PLIVA) and were therefore dismissed with prejudice. However, the patient’s allegations as to failure to provide medication guides, and as to off-label marketing, were dismissed with leave to amend (Collette v. Wyeth Pharmaceuticals, Inc., March 12, 2018, Donato, J.).

Background. A patient who was prescribed the drug Amiodarone (the generic name for the brand-name version, Cordarone) and later developed pulmonary fibrosis, filed suit against both the brand-name drug manufacturer and the generic version manufacturer alleging among other things, a failure to warn and violations of the California Business & Professions Code § 17200 et seq. (Unfair Competition Law or "UCL"), and the California Civil Code § 1750 et seq. (Consumer Legal Remedies Act or "CLRA"). The manufacturers moved to dismiss the claims and the court granted the motions, in part with prejudice and in part with leave to amend.

Gatekeeping preemption. The court first addressed the gatekeeping preemption issues raised by the generic drug manufacturer, noting that all of the patient’s claims were framed under state common law and statutory law. The court looked to several Supreme Court decisions that reviewed state laws for drug labeling, and determined that those decisions mandated the conclusion that claims going to the warnings and labeling for Amiodarone, were preempted under federal law. Relying specifically on PLIVA, the court ruled that because the patient’s drug warning and labeling allegations were preempted by federal law, those allegations were dismissed with prejudice and to be removed from any amended complaint.

Failure to provide medication guides. The patient also alleged that that the manufacturers failed to distribute with the drug the "Medication Guide" as required by the FDA. The court expressed uncertainty as to whether that claim was or was not preempted: on the one hand, state-law fraud-on-the-FDA claims are impliedly preempted by federal law because the federal statutory scheme amply empowers the FDA to punish and deter fraud against the agency. On the other, the California circuit has recognized that claims that assert violations of state-law duties that parallel duties under federal law are not preempted.

Accordingly, the court was unable to resolve the preemption issue at the current stage of proceedings because the claim, in its current form, was too cursory and vague to state a plausible cause of action. The court granted the manufacturers’ motion to dismiss that claim but at the same time, advised the patient that the court had some skepticism that the claim could be successfully re-stated. Despite those doubts, the court granted the patient leave to amend the claim.

Off-label marketing. The patient also alleged that the manufacturers engaged in "off-label" marketing by promoting Cordarone/Amiodarone for the treatment of atrial fibrillation and as a ‘first line anti-arrhythmic therapy,’ even though it had been approved by the FDA only as a drug of last resort for patients suffering from documented, recurrent life-threatening ventricular fibrillation and ventricular tachycardia when those conditions did not respond to other available anti-arrhythmic drugs and therapies. The court found that claim to be the strongest in terms of avoiding federal preemption, finding that there was no question that the manufacturers had a state common law duty not to engage in fraud and deceit in the way that they marketed and sold their drugs. That duty arose wholly separately from federal law and did not necessarily conflict with the manufacturers’ specific labeling and disclosure requirements under the FDA’s regulations.

Pleading fraud with particularity. Although the court found that the off-label marketing allegation stated "the germ of a cognizable legal claim," as an allegation sounding in fraud, it was subject to the heightened pleading standard under Federal Rule of Civil Procedure 9(b), and the patient had failed to so plead with the requisite particularity. The off-label marketing allegations in their current form were too generalized, and needed to be re-iterated with much more about what, specifically, each manufacturer said and did, and how those statements and actions (or lack thereof) related to the patient. The court therefore dismissed those as well, but granted leave to amend.

The case is No. 3:16-cv-010334-JD.

Attorneys: Christopher W. Cantrell (Doyle APC) for Raymond J. Collette. George J. Gigounas (DLA Piper LLP) for Wyeth Pharmaceuticals, Inc. Christiana Jacxsens (Greenberg Traurig, LLP) for Eon Labs, Inc. and Sandoz, Inc.

Companies: Wyeth Pharmaceuticals, Inc.; Eon Labs, Inc.; Sandoz, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews GenericDrugNews LabelingNews PrescriptionDrugNews PLDrugNews SafetyNews

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