Allbright v. Teva Pharm. USA, Inc.
Allbright v. Teva Pharm. USA, Inc.
Opinion of the Court
*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 BACKGROUND
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.
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 ,
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.,
However, a court's determination of whether state law is preempted by federal law should be examined through the lens of two broad presumptions. First, "[i]n all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, [the court] starts with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Wyeth ,
Here, Plaintiff benefits from the presumption against preemption because states have traditionally regulated matters of health and safety affecting their citizens. See In re Fosamax Prod. Liab. Litig. ,
*1327(finding no implied preemption of FDA and Florida state law for brand name manufacturer of alendronate). However, over the last century, Congress has enacted significant and wide-sweeping public health laws which regulate drugs such as alendronate. In 1906, Congress passed the Federal Food and Drugs Act, ch. 3915,
Despite this far-reaching regulation to "protect the public health and assure the safety, effectiveness, and reliability of drugs," Congress also took steps to preserve state law. Wyeth ,
The FDCA places ongoing duties to on brand name manufactures to investigate the safety and design of its drugs post-market, conduct post-market surveillance of its drugs, and to "change its drug label based on safety information that becomes available after a drug's initial approval." Id. at 570,
No so for generic manufactures. Unlike the obligations on brand name manufacturers, Congress has sharply distinguished the duties placed on generic manufactures like Defendant Teva. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Amendments to the FDCA, to allow generic drugs to forego the FDA's onerous approval process so that generic drugs could enter the market faster and for lower cost. See Tsavaris v. Pfizer, Inc. ,
Several recent Supreme Court cases control the preemptive effect of the FDCA on generic manufacturers. In Mensing , the Supreme Court addressed the preemptive effect of the FDCA on state tort law for a generic manufacturer. There, plaintiff alleged claims against the generic manufacturer of metoclopramide based on a state law theory of failure to adequately warn of the risk of developing a severe neurological disorder. Mensing ,
Subsequently in Mutual Pharmaceutical Co. v. Bartlett ,
While the Supreme Court has conclusively found that failure to warn and design defect claims against a generic manufacturer are preempted, claims based on a generic manufacturer's failure to update labels consistent with its "sameness" duty are not preempted. Fulgenzi v. PLIVA, Inc. ,
III. ANALYSIS
Teva moves to dismiss all of Plaintiff's claims based on federal impossibility preemption. Defendant argues that "[w]hile framed in various causes of action, including design defect and negligence, the gravamen of all of Plaintiff's claims is that Teva is liable to Plaintiffs [sic] for having allegedly failed to adequately warn healthcare professionals of the risk of osteonecrosis of the jaw...associated with the use of alendronate sodium, and that Teva should have redesigned alendronate sodium." ECF No. [11] at 1-2; see also ECF No. [18] at 4. Accordingly, Defendant argues that each of Plaintiff's claims is preempted by federal law under Mensing and Bartlett and must be dismissed with prejudice.
In its Opposition, Plaintiff does not separately rebut each of Defendant's arguments but rather sets forth a single argument that Defendant had a duty to change its warning labels because, under Mensing , a generic manufacturer is required to propose stronger labels if it believes such warnings are needed. See ECF No. [16] at 2-3. Plaintiff further bolsters its argument by citing to In re Fosamax (Alendronate Sodium) Products Liability Litigation ,
*1330ECF No. [16] at 2-3. However, while the Supreme Court reviewed the conflicting arguments presented by the parties and the FDA as to this duty, it declined to decide whether any duty existed at all, stating: "Because we ultimately find pre-emption even assuming such a duty existed, we do not resolve the matter." Id. at 617,
A. Count I: Strict Liability-Defective Design
Plaintiff's first cause of action alleges that alendronate is "defective in its design or formation" because it is "unreasonably dangerous" and "its foreseeable risks exceed[ its] benefits ...." ECF No. [5-1] ¶ 84. Plaintiff further alleges that Teva knew or should have known that alendronate was defective, was aware of the foreseeable harm that alendronate could cause Plaintiff, and that Plaintiff was harmed as a proximate cause of the defective design. Id. ¶¶ 86, 88. Defendant moves to dismiss this claim under Bartlett and its progeny, arguing that the claims are preempted under federal law. ECF No. [11] at 10-11. In its Opposition to the Motion, Plaintiff does not appear to respond to Defendant's arguments based on design defect, and to the extent that her arguments regarding failure to warn can be construed as related to a design defect, as noted above, that authority is inapplicable here. See generally ECF No. [16].
The Court agrees that under Mensing and Bartlett, Plaintiff's claims based on design defect are preempted. To comply with its design obligations under the FDCA, Teva must manufacture alendronate such that it is identical in all material respects to the brand name drug, Fosamax. See
B. Counts II & III: Strict Liability-Failure to Warn and Negligence Based on Allegations that Defendant Failed to Deviate Alendronate's Label from the FDA Approved Brand Name Label
Count II alleges that Teva knew or should have known about the risks of alendronate, failed to warn Plaintiff of these risks associated with alendronate, and downplayed the "serious and dangerous side effects of alendronate." ECF No. [5-1] ¶¶ 92-94. In particular, Allbright alleges that Teva should have changed its warning label or notified the FDA that it should change the approved warning label based on the risks of alendronate. See, e.g. ,
The Court agrees that Plaintiff's failure to warn claim based on an obligation of *1331Defendant to deviate its alendronate label from the approved brand name label is preempted. Guarino v. Wyeth, LLC ,
In Count III, Plaintiff alleges that Teva did not exercise due care when it failed to test alendronate before release; failed to analyze pre-market and post- market data; designed, manufactured, labeled, marketed, advertised, promoted, distributed, and sold alendronate without adequate warnings; and continued manufacturing alendronate without appropriate warning and instruction labels. ECF No. [5-1] ¶¶ 105-06. As with Count II, in support of her negligence cause of action Allbright alleges that Teva should have changed its warning label or notified the FDA that it should change the approved warning label based on the risks of alendronate. See, e.g. , id. ¶¶ 12-13, 26, 35, 51-52. Plaintiff further alleges that as a proximate result of Defendant's negligence, Allbright developed severe and permanent injuries, including osteonecrosis of the jaw. Id. ¶ 107. In its Motion, Defendant argues that this claim is also preempted by federal law. ECF No. [11] at 11-13. Additionally, Defendant argues that to the extent Plaintiff's negligence claim asserts that Defendant had a state law duty to test, investigate, and conduct market surveillance which may have produced evidence that could have been presented to the FDA resulting in a label change, these claims are further precluded by Mensing. Id. at 12-13.
The Court agrees that Plaintiff's negligence claims based on failure to change the labels or design of alendronate in violation of Defendant's obligations under federal law are precluded. See Tsavaris v. Pfizer, Inc. ,
C. Counts II & III: Strict Liability-Failure to Warn and Negligence Based on Allegations that Defendant Failed to Update Alendronate's Labels Consistent with the FDA Approved Brand Name Label
In contrast to claims based on a generic manufacturer's failure to change labels or design in violation of the its federal duties, claims regarding failure to update warning labels consistent with brand name labels-that is, violations of a generic manufacturer's "duty of sameness"-are not preempted by federal law. See, e.g. , Fulgenzi v. PLIVA, Inc. ,
*1332Del Valle v. PLIVA, Inc. , No. CIV.A. B:11-113,
Plaintiff has alleged that Teva failed to timely update warning labels as required by the FDA's 2004 guidance. ECF No. [5-1] ¶ 41. In both Count II and Count III, Plaintiff alleges that Teva failed to include proper warning labels. See id. ¶¶ 92, 94, 105. However, Plaintiff's specific allegations regarding Teva's failure to update alendronate labels consistent with the brand name labels are sparse, at best. See id. ¶¶ 40-43. To the extent Plaintiff's negligence and strict liability failure to warn claims can be read as an allegation that Defendant breached its "duty of sameness" by failing to update its labels consistent with directives from the FDA, these claims are not preempted. However, Plaintiff has not provided sufficient factual matter to withstand Defendant's Motion. Plaintiff thus will be permitted to amend to include that viable claim. Accordingly, Counts II and III are dismissed with leave to replead those counts only under a theory of liability not preempted by federal law.
IV. CONCLUSION
Accordingly, for the foregoing reasons, it is ORDERED AND ADJUDGED as follows:
1. Defendant's Motion, ECF No. [11] , is GRANTED.
2. COUNT I is preempted by federal law and DISMISSED WITH PREJUDICE .
3. To the extent that the claims in COUNT II AND COUNT III are premised on theories of liability preempted by federal law, those claims are DISMISSED WITH PREJUDICE.
4. To the extent that the claims in Count II and Count III are premised on theories of liability not preempted by federal law, those claims are DISMISSED WITHOUT PREJUDICE. Plaintiff is granted leave to replead her non-preempted claims and shall FILE her amended complaint by no later than December 15, 2017 .
DONE AND ORDERED in Chambers at Miami, Florida, this 30th day of November, 2017.
The Court accepts the well-pleaded factual allegations found in the complaint, ECF No. [5-1] ("Complaint") as true. Am. Dental Ass'n v. Cigna Corp. ,
Teva argues in its Motion that it timely updated its labels to match the FDA approved amendments to the brand name label in early 2010. However, for the purposes of the Motion, the Court treats Plaintiff's allegations as true.
Reference
- Full Case Name
- Anita ALLBRIGHT v. TEVA PHARMACEUTICALS USA, INC.
- Status
- Published