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Hernandez v. Wyeth-Ayerst Laboratories, Inc.

United States District Court, N.D. Illinois, Eastern Division

April 18, 2017

FERNANDO HERNANDEZ, individually and as next friend and executor of the estate of KATHERINE HERNANDEZ, deceased, Plaintiff,


          Robert W. Gettleman United States District Judge

         Plaintiff Fernando Hernandez has brought a wrongful death claim on behalf of the estate of his wife, Katherine Hernandez, against defendants for injuries she sustained after taking a prescription drug, amiodarone hydrochloride (“amiodarone”). Defendants Sandoz Inc. and Eon Labs, Inc. (“Sandoz”)[1] moved to dismiss the complaint under Federal Rules of Civil Procedure 12(b)(6) and 8(a)(2). For the reasons described below, defendant's motion is granted in part and denied in part.


         Wyeth-Ayerst received approval from the Food and Drug Administration (“FDA”) to market and sell amiodarone (which it sold under the brand name Cordarone) in late December of 1985. Wyeth-Ayerst was authorized to market and sell amiodarone only as a drug of last resort for patients suffering from life-threatening ventricular fibrillation and ventricular tachycardia, and only when those patients did not respond to other drugs and therapies. Sandoz received FDA approval to market, sell, and distribute the generic formulation of the drug in 1998.[3] As a generic manufacturer of amiodarone, Sandoz is required to comply with the same FDA requirements as Wyeth-Ayerst. Specifically, under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., Sandoz has a “duty of sameness, ” which requires it to ensure that its labeling is identical to Wyeth-Ayerst's FDA-approved labeling. The FDCA also requires manufacturers of certain drugs (brand-name or generic) to provide medication guides to their distributors, who are then required to provide them to people whose prescriptions those distributors fill. Amiodarone is one of those drugs. As with labeling, the medication guides provided for generic drugs must be identical to those provided for the brand-name counterparts. Medication guides are provided to patients to explain the permissible uses of a drug and the consequences of misusing it “in plain English.”

         Plaintiff alleges that Sandoz violated the FDCA in two ways. First, plaintiff alleges that Wyeth-Ayerst and Sandoz “embarked on a course of conduct, the purpose of which was to increase amiodarone sales as an initial, first-line anti-arrhythmic medication, a use for which amiodarone has never received FDA approval; i.e., an ‘off-label' use.” Plaintiff alleges that Sandoz, along with Wyeth-Ayerst, aggressively marketed amiodarone for off-label use despite their knowledge that such use posed serious health risks and without informing physicians or patients of those risks, as required by the FDCA. Next, plaintiff alleges that Sandoz violated the FDCA by failing to provide distributors of amiodarone with medication guides.

         Plaintiff's wife had been diagnosed with non-life-threatening atrial fibrillation when she was prescribed a 90-day course of 200mg amiodarone tablets in May 2013.[4] According to plaintiff, the prescribing doctors were victims of Sandoz's scheme to aggressively market amiodarone for off-label use, and they would not have prescribed the drug had they been informed of the risks associated with such use. Plaintiff further alleges that his wife was also unaware of the risks associated with amiodarone because she never received a medication guide. Plaintiff claims that his wife would not have taken amiodarone if she had known the risks.

         According to plaintiff, his wife began to suffer many of amiodarone's unfortunate side effects after she started taking it. Those side effects are outlined in the medication guide, which she never received, and include: shortness of breath; wheezing; trouble breathing; coughing; tiredness; weakness; nervousness; irritability; restlessness; decreased concentration; and depression. Plaintiff alleges that his wife's condition continued to deteriorate as she continued to take amiodarone until she was diagnosed with amiodarone toxicity on September 26, 2013, after which she stopped taking it. Plaintiff further alleges that the amiodarone remained in his wife's body after she stopped taking it, and that she suffered with recurring pneumonia and severe lung damage until she died from amiodarone-induced lung disease on November 3, 2013.[5]


         I. Legal Standard

         A motion brought under Rule 12(b)(6) challenges the sufficiency of the complaint. Hallinan v. Fraternal Order of Police of Chi. Lodge No. 7, 570 F.3d 811, 820 (7th Cir. 2009). Under Rule 8(a)(2), a complaint must include a short and plain statement of the claim showing that the pleader is entitled to relief. Fed.R.Civ.P. 8(a)(2). The pleading must describe the claim in sufficient detail to give the defendant fair notice of what the claim is and the grounds on which the claim rests. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). The allegations must plausibly suggest that the plaintiff has a right to relief, raising the possibility above the “speculative level.” Id.

         This standard demands that a complaint contain sufficient factual matter to state a claim that is plausible on its face and allege more than legal conclusions or “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. When ruling on a Rule 12(b)(6) motion to dismiss, the court accepts the complaint's well-pleaded factual allegations as true and draws all reasonable inferences in the plaintiff's favor. Sprint Spectrum L.P. v. City of Carmel, Indiana, 361 F.3d 998, 1001 (7th Cir. 2004).

         II. Analysis

         Sandoz argues for dismissal on a number of grounds. Sandoz first argues that plaintiff's complaint should be dismissed because it was not filed within the time allowed by the statute of limitations. Next, Sandoz argues that plaintiff's claims are preempted by federal law. Finally, Sandoz argues that plaintiff's claims are insufficiently pled. The court will address these arguments in turn.

         A. Statute ...

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