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Allbright v. Teva Pharmaceuticals USA, Inc.

United States District Court, S.D. Florida

November 30, 2017




         THIS CAUSE is before the Court upon the Motion to Dismiss and Memorandum of Law in Support by Defendant Teva Pharmaceuticals USA, Inc. (“Teva” or “Defendant”) on September 25, 2017. ECF No. [11] (“Motion”). The Court has carefully reviewed the Motion, all opposing and supporting materials, the record in this case and the applicable law, and is otherwise fully advised. For the reasons set forth below, the Motion is granted.


         Defendant Teva is a manufacturer of alendronate, the generic version of osteoporosis drug Fosamax. See ECF No. [5-1] ¶¶ 7, 18. The FDA approved Teva to manufacture this generic drug, a nitrogenous bisphosphonate, in September 1995. Id. ¶ 18. According to the Complaint, throughout the 1990's and 2000's, patients taking alendronate reported severe negative side effects, including osteonecrosis in the jaw, as well as other dental and bone complications. Id. ¶¶ 25, 30.

         Plaintiff Anita Allbright (“Plaintiff or “Allbright”) was prescribed alendronate either sometime in 2008 or in September 2009. Cf. Id. ¶¶ 27, 58 with Id. ¶ 65. She took alendronate “on-and-off until January of 2015.” Id. ¶ 66. In the months prior to when she ceased taking the drug, Allbright began experiencing symptoms affecting her jaw, mouth, and teeth with increasing severity. In November 2014, Allbright sought dental treatment for pain in the back of her jaw. Id. ¶ 67. On December 17, 2014, Allbright developed “a lump on the right side of her jaw” and “extreme swelling under her tongue, ” for which she was prescribed an antibiotic. Id. ¶ 68. On January 21, 2015, “a piece of [] Allbright's jaw bone was protruding during a routine dental cleaning, ” and on February 4, 2015, “another piece of jaw bone became dislodged.” Id. ¶¶ 69-70. These bone pieces were subsequently pathologically evaluated and Allbright was diagnosed with “necrotic bone osteonecrosis of the jaw from bisphosphonates.” Id. ¶¶ 70-71. In the months following of 2015, Allbright experienced tooth and jaw pain, shingles, painful lumps of the jaw, loss of teeth fixation, and a full tear and retraction of the supraspinatus tendon which required a reverse shoulder replacement. Id. ¶72-77. In May of 2017, Allbright re-fractured her right shoulder. Id. ¶ 78.

         Plaintiff alleges that she has “developed osteonecrosis of the jaw and/or other jaw and bone injuries after ingesting alendronate.” Id. ¶¶ 9, 65. “Before taking bisphosphonates, [Allbright] was asymptomatic and in reasonably good health.” Id. ¶ 64. Allbright alleges that the injuries she has since sustained are “severe and permanent” (id. ¶ 10) and that her injuries will “continue into the indefinite future” (id. ¶ 16). Plaintiff “would not have taken these drugs if she had been informed of the unreasonable risk of osteonecrosis.” Id. ¶ 14.

         Plaintiff alleges that generic manufacturer Teva knew or should have known that alendronate was defectively designed because it was unreasonably dangerous and its foreseeable risks exceeded any benefits. Despite this knowledge, Defendant continued to manufacture, market, and distribute alendronate. ECF No. [5-1] ¶¶ 80-86. Plaintiff further alleges that Defendant failed to properly warn her and her physician of the risks of taking alendronate because Defendant (1) failed to investigate reports of negative side effect like those experienced by Allbright and conduct post-market surveys regarding those side effects; (2) concealed alendronate's negative side effects and its “unreasonably dangerous risks”; (3) provided misleading and incomplete information in the packaging inserts of the drug and in the Physician's Desk Reference, a publication widely used and relied upon by physicians when prescribing medications; and (4) failed to update the labels of alendronate pursuant to direction by the FDA in 2004. See Id. ¶¶ 11-14, 16, 26-27, 31, 33, 42, 45-47.

         With regard to allegations regarding failure to update alendronate's labels, Plaintiff alleges that on August 25, 2004, in its post-marketing safety review of bisphosphonates including alendronate, the FDA advised Defendant that it “should amend the labeling for the respective bisphosphonates medication to specifically warn of the risk of osteonecrosis of the jaw.” Id. ¶ 40. According to the Complaint, Defendant “has refused to accede to the FDA request timely and to this day still does not adequately and/or specifically warn of the exceptional medical complication risk of osteonecrosis of the jaw in the label for alendronate.” Id.¶ 41.[2] FDA cited Teva for violating federal regulations by overstating the benefits of alendronate and minimizing its risks. Id. ¶ 43. The Complaint also alleges that Teva failed to engage in the FDA's process of implementing stronger warnings, known as the “changes being effected” or CBE process. ECF No. [5-1] ¶ 35.

         Based on these allegations, Plaintiff originally filed her Complaint in the Seventeenth Judicial Circuit in and for Broward County, Florida on August 11, 2017. ECF No. [5-1]. Plaintiff asserts three causes of action against Defendant: Count I: Strict Liability - Defective Design; Count II: Strict Liability - Failure to Warn; and Count III: Negligence. Id. On September 18, 2017, Defendant timely removed the action to this Court based on diversity. ECF No. [1]. Defendant now moves to dismiss the Complaint under Federal Rule of Civil Procedure 12(b)(6) because the claims asserted by Allbright are preempted by federal law.


         A. Motion to Dismiss

         A motion to dismiss under Rule 12(b)(6) challenges the legal sufficiency of a complaint. See Fed.R.Civ.P. 12(b)(6). To survive such a motion, a claim “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.' ” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). Although this pleading standard “does not require ‘detailed factual allegations, ' . . . it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation, ” meaning that a plaintiff is required to plead sufficient “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 556-56). Thus, while a court must accept well-pleaded factual allegations as true, “conclusory allegations . . . are not entitled to an assumption of truth-legal conclusions must be supported by factual allegations.” Randall v. Scott, 610 F.3d 701, 709-10 (11th Cir. 2010). When considering a motion to dismiss, the Court construes the pleadings broadly and views the allegations in the complaint in the light most favorable to the plaintiff. Bishop v. Ross Earle & Bonan, P.A., 817 F.3d 1268, 1270 (11th Cir. 2016) (quoting Hill v. White, 321 F.3d 1334, 1335 (11th Cir. 2003).

         B. Federal Preemption of State Tort Law

         Under the Supremacy Clause, federal law “shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const., Art. VI, cl. 2. A “federal statute may preempt state law either expressly, by the statute's language, or implicitly, by the statute's structure and purpose.” Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1371 (11th Cir. 1999) (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (finding state law claims expressly preempted by the Medical Device Amendments, 21 U.S.C. § 360c et seq., to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. for the pre-market approval process for new devices). “In the absence of an express command, federal law will preempt state law if that law actually conflicts with federal law or if the federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it.” Id. (internal quotations and citations omitted). Thus, where state and federal law “directly conflict, ” state law must give way. PL ...

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