United States District Court, N.D. Alabama, Southern Division
MICHAEL W. ALLAIN, as Executor of the Estate of ROBERT EARL DREHER, SR., Deceased, Plaintiff,
WYETH PHARMACEUTICALS, INC., et al., Defendants.
KARON OWEN BOWDRE, Chief District Judge.
On February 14, 2014, Plaintiff Michael Allain, as executor of the estate of Robert Earl Dreher Sr., brought suit against Defendants Wyeth Pharmaceuticals, Inc., Sandoz Pharmaceuticals Corp., Novartis Pharmaceuticals Corp., and Upsher-Smith Laboratories, Inc.,  asserting a claim for wrongful death. (Doc. 1). On January 14, 2015, this court dismissed without prejudice Mr. Allain's Complaint as insufficiently pled and for failing to state a claim against the Defendants. (Doc. 32). Mr. Allain subsequently filed his First Amended Complaint, again asserting a wrongful death claim against Upsher-Smith, Sandoz, and Wyeth. (Doc. 34). This matter is now before the court on Upsher-Smith and Sandoz's ("Generic Defendants") motions to dismiss. (Docs. 38 & 45). Also before the court is brand-name manufacturer Wyeth's motion to dismiss. (Doc. 36).
In their current motions, the Defendants contend that Mr. Allain's First Amended Complaint fails to cure the deficiencies in his initial Complaint and that it still fails to state a claim. For the reasons discussed below, the court will GRANT the Generic Defendants' motions and GRANT IN PART and DENY IN PART Wyeth's motion.
I. Standard of Review
A Rule 12(b)(6) motion to dismiss attacks the legal sufficiency of the complaint. Generally, the Federal Rules of Civil Procedure require only that the complaint provide "a short and plain statement of the claim' that will give the defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests." Conley v. Gibson, 355 U.S. 41, 47 (1957) (quoting Fed.R.Civ.P. 8(a)). A plaintiff must provide the grounds for his entitlement, but Rule 8 generally does not require "detailed factual allegations." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley, 355 U.S. at 47). It does, however, "demand more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Ashcroft v. Iqbal, 566 U.S. 662, 678 (2009).
The Supreme Court explained that "[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim that is plausible on its face.'" Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). To be plausible on its face, the claim must contain enough facts that "allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678. Although "[t]he plausibility standard is not akin to a probability requirement, " the complaint must demonstrate more than a "sheer possibility that a defendant has acted unlawfully." Id. (internal quotation omitted). "Where a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief." Id. (internal quotation omitted).
FDA Regulatory Framework
Pursuant to the Federal Food, Drug, and Cosmetic Act ("FDCA"), the Food and Drug Administration regulates the approval of both brand-name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(1) (brand-name drugs); 21 C.F.R. § 314.94(a)(8) (generic drugs). Under the FDCA, the requirements for obtaining FDA approval vary greatly depending on whether the manufacturer is seeking approval for a new drug or is applying to manufacture a generic version of an already approved drug. A manufacturer seeking approval of a new drug must demonstrate that the drug is safe and effective, and that the proposed labeling of the drug is accurate and adequate. See 21 U.S.C. § 355(b); 21 U.S.C. § 352(f)(2). In contrast, a generic manufacturer seeking FDA approval must only demonstrate that the generic drug is chemically and practically the bioequivalent of the brand-name drug and that the labeling is the same as that approved for the brand-name drug. See 21 U.S.C. 355(j)(4)(G).
Statement of Facts
The following facts are taken from Mr. Allain's First Amended Complaint and are accepted as true for the purposes of the motions to dismiss.
FDA Approval of Cordarone
In 1985, Wyeth Pharmaceuticals received FDA approval to begin manufacturing and selling Cordarone in the United States. Cordarone is a prescription drug approved as a "drug of last resort" for patients suffering from life-threatening ventricular fibrillation or ventricular tachycardia and is only to be used in situations where the patient's condition would not respond to other available drugs and therapies. Wyeth was the sole manufacturer of Cordarone from 1985 until Upsher-Smith and Sandoz received FDA approval to begin manufacturing and selling generic versions of Cordarone in 1998. Upsher-Smith produced a generic version of Cordarone known as Pacerone, and Sandoz produced a generic version known by the drug's chemical name, amiodarone hydrochloride. Both of the generic versions were the bioequivalent of Cordarone and mirrored the warning labels of Cordarone.
Although the FDA approved the sale of Cordarone and its generic equivalents, Cordarone was known to cause numerous side effects, the most serious of which is pulmonary lung disease. Cordarone can cause two different types of lung disease. First, it can produce a pneumonia like condition, which can cause shortness of breath and coughing. This condition usually improves once the patient stops ingesting the drug. Second, it can cause stiffening of the lungs that restricts a patient's breathing. This condition can occur years after a patient finishes taking Cordarone and can be fatal. Because of the serious side effects of Cordarone, the FDA required that manufacturers of Cordarone and its generic counterparts either (1) provide Medication guides "in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription, " or (2) provide "the means to produce Medication Guides in sufficient numbers" for the distributor of the drug to provide the guides to the consumers. See 21 C.F.R. § 208.24(b).
Mr. Dreher's use of Generic Amiodarone
In February of 2011, Robert Dreher's physician, Dr. Macy Smith, prescribed him a ninety-day course of generic amiodarone tablets manufactured by Sandoz to treat Mr. Dreher's atrial fibrillation. Because Mr. Dreher suffered from atrial fibrillation, not ventricular fibrillation, and because his condition was not life threatening, his use of the drug was considered "off-label." At the time Mr. Dreher filled his prescription, the pharmacy should have provided Mr. Dreher with a medication guide. However, the pharmacy allegedly failed to do so because Sandoz had not provided the medication guide to the pharmacy, as required by the FDA. Because he did not receive a medication guide, Mr. Dreher was not informed of the risks of amiodarone or that his use of the drug was considered "off-label."
In August of 2011, Mr Dreher received a second prescription for a ninety-day course of amiodarone from a physician at the Veterans Affairs office. That doctor prescribed Mr. Dreher a ninety-day course of Pacerone manufactured by Upsher-Smith. Mr. Dreher's use of Pacerone was also "off-label." When Mr. Dreher filled his prescription for Pacerone at his pharmacy, the pharmacy again failed to provide a medication guide to Mr. Dreher warning of the risks of Pacerone. This time, the pharmacy allegedly failed to do so because Upsher-Smith had failed to fulfill its FDA mandated duty to provide the medication guides to the pharmacy.
From February 2011 to January 2012, Mr. Dreher experienced many of the symptoms associated with amiodarone use, including shortness of breath, wheezing, trouble breathing, coughing, and tiredness. Mr. Dreher's condition continued to deteriorate, and, on February 15, 2012, Mr. Dreher passed away at the age of ...