Allbright v. Teva Pharm. USA, Inc.

290 F. Supp. 3d 1321
CourtDistrict Court, S.D. Florida
DecidedDecember 1, 2017
DocketCase No. 17–cv–61800–BLOOM/Valle
StatusPublished

This text of 290 F. Supp. 3d 1321 (Allbright v. Teva Pharm. USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Allbright v. Teva Pharm. USA, Inc., 290 F. Supp. 3d 1321 (S.D. Fla. 2017).

Opinion

BETH BLOOM, UNITED STATES DISTRICT JUDGE

*1324THIS 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.

I. FACTUAL BACKGROUND1

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 *1325unreasonable 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 for publication 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.

II. LEGAL STANDARD

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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Goodlin v. Medtronic, Inc.
167 F.3d 1367 (Eleventh Circuit, 1999)
Cipollone v. Liggett Group, Inc.
505 U.S. 504 (Supreme Court, 1992)
Freightliner Corp. v. Myrick
514 U.S. 280 (Supreme Court, 1995)
Medtronic, Inc. v. Lohr
518 U.S. 470 (Supreme Court, 1996)
Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Riegel v. Medtronic, Inc.
552 U.S. 312 (Supreme Court, 2008)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
Wyeth v. Levine
555 U.S. 555 (Supreme Court, 2009)
American Dental Assoc. v. Cigna Corp.
605 F.3d 1283 (Eleventh Circuit, 2010)
Randall v. Scott
610 F.3d 701 (Eleventh Circuit, 2010)
Lonnie J. Hill v. Thomas E. White, Secretary of the Army
321 F.3d 1334 (Eleventh Circuit, 2003)
Eleanor Fulgenzi v. PLIVA, Inc.
711 F.3d 578 (Sixth Circuit, 2013)
Mutual Pharmaceutical Co. v. Bartlett
133 S. Ct. 2466 (Supreme Court, 2013)
Andrea Guarino v. Wyeth, LLC
719 F.3d 1245 (Eleventh Circuit, 2013)
In Re Fosamax Products Liability Litigation
742 F. Supp. 2d 460 (S.D. New York, 2010)
Arthur Drager v. PLIVA USA
741 F.3d 470 (Fourth Circuit, 2014)
Walter Lashley v. Pfizer, Incorporated
750 F.3d 470 (Fifth Circuit, 2014)
Tina Johnson v. Teva Pharmaceuticals USA, Inc., et
758 F.3d 605 (Fifth Circuit, 2014)
Connie Bishop v. Ross Earle & Bonan, P.A.
817 F.3d 1268 (Eleventh Circuit, 2016)

Cite This Page — Counsel Stack

Bluebook (online)
290 F. Supp. 3d 1321, Counsel Stack Legal Research, https://law.counselstack.com/opinion/allbright-v-teva-pharm-usa-inc-flsd-2017.