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From Health Law Daily, June 30, 2015

Estate sufficiently alleged manufacturer’s off-label use promotional activities affected physicians

By Mary Damitio, J.D.

An estate that saw most of its wrongful death claims dismissed was able to state sufficient facts to maintain a plausible claim against a brand name drug manufacturer based on its aggressive promotion of the off-label use of its drug, a district court ruled. The estate was also permitted another chance to amend its complaint to provide specific facts detailing how the generic drug manufacturer’s promotional activities caused physicians to prescribe its drug for off-label uses (Allain v. Wyeth Pharmaceuticals, Inc., June 29, 2015, Owen Bowdre, K.).

Background. Wyeth Pharmaceuticals, Inc. received approval from the FDA in 1985 to manufacture and sell the drug Cordarone®, which is a “drug of last resort” for patients with life-threatening ventricular fibrillation or ventricular tachycardia. The drug is intended for use only when a patient is not responding to other drugs. In 1998, the FDA granted approval to Upsher-Smith Laboratories, Inc. and Sandoz Pharmaceuticals Corp. to manufacture and sell generic versions of Cordarone. Upsher-Smith produced a generic version known as pacerone, and Sandoz produced the drug under the name of amiodarone hydrochloride.

Side effects. Cordarone had a known side effect of causing a type of lung disease that can be fatal and can occur years after an individual finishes taking the drug. The FDA required the drug’s manufacturers to provide medication guides to dispensers for distribution to patients.

Decedent. Robert Dreher, Sr. was prescribed a 90-day course of generic amiodarone in February 2011 to treat his atrial fibrillation. The prescription of the drug was considered an “off-label” use because Dreher’s condition was non-life-threatening atrial fibrillation and not ventricular fibrillation. The pharmacy did not provide Dreher with a medication guide when he filled his prescription because the manufacturer, Sandoz, did not provide the guide to the pharmacy as required by the FDA. As a result, Dreher did not receive any information about the risks of the drug or that his use was considered an off-label use.

In August of 2011, he received a second prescription for a 90-day course of the generic drug, which was manufactured by Upsher-Smith. When he filled his prescription a second time, he did not receive a medication guide because the Upsher-Smith did not provide the guides to the pharmacy. Dreher experienced shortness of breath, coughing, wheezing, trouble breathing, and fatigue, which were symptoms associated with amiodarone use. His condition deteriorated and he died in February of 2012.

Lawsuit. Dreher’s estate filed a wrongful death claim against the manufacturers alleging that they failed to warn him of amiodarone’s dangers and that they failed to provide the medication guides to pharmacies as required by the FDA. His estate also alleged that the brand name and generic drug manufacturers promoted amiodarone for off-label uses.

Failure to warn. The estate withdrew its failure-to-warn claims that were based on the inadequacy of warning labels. As a result, the court dismissed any failure-to-warn claims with prejudice and noted that any such claim would have been dismissed regardless of whether it was withdrawn because the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) specifically limits a generic drug manufacturer’s warnings to ensure that they are identical to the brand name drug warnings, and thus any such claims were preempted by federal law.

Off-label promotion of generics. The estate did not allege specific instances of misconduct on the part of the individual generic manufacturers, and therefore did not state a sufficient claim. Additionally, the estate’s fraudulent misrepresentation claims were deficient under the heightened pleading standards for fraud under Federal Rule of Civil Procedure 9(b). The complaint did not include “precise statements” or fulfill the “time, place, and person” pleading requirements of Rule 9(b). Specifically, the estate failed to allege that the generic manufacturers made statements to any physicians. As a result, the claims against the generic manufacturers for off-label use promotion were dismissed without prejudice. However, the estate was permitted another chance to adequately plead its claims.

Wyeth’s off-label promotion. The estate did allege sufficient factual allegations detailing how Wyeth promoted the off-label use of Cordarone to physicians and sufficiently alleged that the manufacturer’s promotional activities caused Dreher’s physicians to prescribe the drug for an off-label use. Therefore, the estate’s off-label promotion claims against Wyeth were plausible and the motion to dismiss was denied.

Medication guides. The estate’s claims based on the failure to provide medication guides were barred by either federal law or Alabama’s learned intermediary doctrine. The duty to provide medication guides arises out of federal law, and private individuals may not bring suits seeking to enforce provisions of the FDC Act (21 U.S.C. § 337(a)). Additionally, the Alabama learned intermediary doctrine imposes only a duty to provide warnings to prescribing physicians rather than directly to patients. Therefore, the manufacturers had no duty to warn Dreher of the dangers of the drug by providing a medication guide and the estate’s claims based on the failure to provide the guides were dismissed with prejudice.

The case is No. 2:14-cv-00280-KOB.

Attorneys: Christopher T. Hellums (Pittman Dutton & Hellums PC) for Michael W. Allain. Amanda Lauren James (Bradley Arant Boult Cumming LLP) for Wyeth-Ayerst Laboratories, Inc.

Companies:  Wyeth-Ayerst Laboratories, Inc.; Wyeth Pharmaceuticals, Inc.; Sandoz Pharmaceuticals Corp.; Novartis; Upsher-Smith Laboratories, Inc.

MainStory: TopStory PrescriptionDrugNews LabelingNews FDCActNews AlabamaNews

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