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.
The matter comes before the court on Defendant Wyeth Pharmaceuticals, Inc.'s motion to dismiss, (Doc. 21), and Defendant Upsher-Smith Laboratories, Inc.'s motion to dismiss, (Doc. 7). Plaintiff Michael Allain, as executor of the estate of Robert Earl Dreher Sr., asserts a wrongful death claim against Defendants Wyeth Pharmaceuticals, Inc., Sandoz Pharmaceuticals Corp., Bovartis Pharmaceuticals Corp., and Upsher-Smith Laboratories, Inc. (Doc. 1). In its motion to dismiss, Wyeth argues that Plaintiff's complaint should be dismissed pursuant to Rule 8(a)(2) and 12(b)(6) for failure to state a claim. (Doc. 21). Similarly, Upsher-Smith contends that the plaintiff's complaint should be dismissed pursuant to Rule 12(b)(6) for failure to state a claim. For the reasons discussed below, the court will grant Wyeth's and Upsher-Smith's motions.
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). Pleadings that contain nothing more than "a formulaic recitation of the elements of a cause of action" do not meet Rule 8 standards, nor do pleadings suffice that are merely based upon "labels or conclusions" or "naked assertions" without supporting factual allegations. Twombly, 550 U.S. at 555, 557.
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).
The Supreme Court has identified "two working principles" for the district court to use in applying the facial plausibility standard. The first principle is that, in evaluating motions to dismiss, the court must assume the veracity of well-pleaded factual allegations; however, the court does not have to accept as true legal conclusions even when "couched as  factual allegation[s]" or "threadbare recitals of the elements of a cause of action, supported by mere conclusory statements." Iqbal, 556 U.S. at 677-78. The second principle is that "only a complaint that states a plausible claim for relief survives a motion to dismiss." Id. at 679. Thus, under prong one, the court determines the factual allegations that are well-pleaded and assumes their veracity, and then proceeds, under prong two, to determine the claim's plausibility given the well pleaded facts. That task is "context specific" and, to survive the motion, the allegations must permit the court based on its "judicial experience and common sense... to infer more than a mere possibility of misconduct." Id. If the court determines that well-pleaded facts, accepted as true, do not state a claim that is plausible, the claim must be dismissed. Id.
II. STATEMENT OF FACTS
Cordarone is an anti-arrhythmic heart medication, which is manufactured and distributed by Defendant Wyeth Pharmaceuticals, Inc. The FDA first approved Cordarone for use within the United States starting in 1985. Unlike most prescription drugs, the FDA approved Cordarone under a special needs approval process that did not require a randomized clinical trials process. The FDA approved Cordarone for use "as a drug of last resort for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia when these conditions would not respond to other available anti-arrhythmic drugs and therapies." (Doc. 1).
In 1998, Defendant Upsher-Smith Pharmaceuticals Inc. applied for and received FDA approval to market, manufacture, and sell a generic version of Cordarone, called Pacerone. That same year, in 1998, Defendants Sandoz Pharmaceuticals, Inc. and Novartis Pharmaceuticals Corp. also received FDA approval to manufacture and sell a generic version of Cardarone called amiodarone hydrochloride, the drug's chemical name. (Doc. 1).
Although Cordarone, Pacerone and the other generic formulation known as amiodarone hydrochloride were only approved as drugs of last resort, Defendants were aware that many amiodarone prescriptions were written for "off-label" purposes. To combat this off-label use, the FDA between 1985 and 2004 required Wyeth to repeatedly modify Cordarone's labeling and warnings. During this time period, the FDA also sent a letter to Wyeth instructing the company to stop endorsing the drug in a manner that "downplayed the risks and promoted the drug as a first line anti-arrhythmic therapy." (Doc. 1 at ¶ 33). In 1989, 1992, and 1998, the FDA determined that Wyeth violated its regulations by disseminating false and misleading materials to physicians and the public without adequate risk information concerning the use of Cordarone. (Doc. 1).
At some undisclosed time, Mr. Dreher was diagnosed with atrial fibrillation and chronic renal failure. Both conditions were manageable and not deemed to be life threatening. In February of 2011, Dr. Macy Smith prescribed Mr. Dreher a 90-day course of 200mg amiodarone tablets to treat his atrial fibrillation. These specific tablets of amiodarone were the generic version of Cardarone that were manufactured, marketed, and distributed by Defendants Sandoz and Novartis. Mr. Dreher ingested the drug according to the instructions. Because Mr. Dreher was not in a situation of last resort as to his atrial fibrillation, his use of amiodarone was considered an off-label use of the drug. Mr. Dreher was unaware that his use was off-label, and he did not receive a Medication Guide accompanying the drug. (Doc. 1). Plaintiff alleges that had Mr. Dreher been provided with a Medication Guide, he "would not have taken amiodarone." (Doc. 1 at ¶ 40).
In the spring of 2011, after taking amiodarone, Mr. Dreher experienced many of the serious side effects outlined in the Medication Guide, including lung damage, shortness of breath, wheezing, trouble breathing, coughing, tiredness, weakness, nervousness, irritability, restlessness, decreased concentration, and depression. (Doc. 1). In August of 2011, Dr. Vance Plumb prescribed Mr. Dreher a 90-day course of 200mg tablets of Pacerone® manufactured by Defendant Upsher. (Doc. 21). Again, Mr. Dreher was not provided with a Medication Guide or the appropriate and up-to-date warning labels. In August 2011, Mr. Dreher fell in his garden, fractured a rib, and suffered a puncture wound that never fully healed. In September of 2011, Dr. Plumb lowered Mr. Dreher's dosage of amiodarone. (Doc. 1).
According to the complaint, "[f]rom February 2011 to January 2012, [Mr. Dreher] continuously told his family, I don't feel right. I'm out of breath all of the time, even when just walking to get the mail.'" (Doc 1 at ¶ 47). Prior to ingesting the drug, Mr. Dreher participated in normal day-to-day activities. However, during the time that he was taking the drug, Mr. Dreher "experienced symptoms of shortness of breath, productive cough, which eventually produced signs of blood, longer than normal healing of wounds, paler than normal pigment of skin, and signs of gout, sunken in cheeks and face." (Doc. 1 at ¶ 48). Mr. Dreher's last ...