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Blackburn v. Shire US, Inc.

United States District Court, N.D. Alabama, Southern Division

May 8, 2017

SHIRE US, INC., et al., Defendants.



         I. Introduction

         This matter is before the court on Defendants' Motion to Dismiss Plaintiff's First Amended Complaint. (Doc. # 44). In their motion and accompanying memorandum of law (Doc. # 45), Defendants argue that Plaintiff's Amended Complaint is due to be dismissed in its entirety. Defendants' motion is fully briefed. (Docs. # 45, 51, 52). For the reasons stated below, Defendants' Motion is due to be granted in part and denied in part.

         II. Factual Background[1]

         Defendants engage in the distribution, marketing, and sale of the drug known as LIALDA. (Doc. # 41 at ¶ 8). In November 2013, Plaintiff was prescribed LIALDA for treatment of his Crohn's disease. (Id. at ¶ 39). Plaintiff took LIALDA, as prescribed, from November 2013 until February 2015. (Id.). In September 2015, Plaintiff was diagnosed with Stage IV renal failure and severe chronic interstitial nephritis. (Id. at ¶ 45). Plaintiff contends that LIALDA causes toxicity to build up in the kidneys over time, and he alleges that his kidney injuries were a direct result of his continued use of LIALDA. (Id. at ¶¶ 43-47).

         Plaintiff asserts that LIALDA's label contained a defect, which was present both in January 2007 (when LIALDA was initially approved by the FDA), and in November 2013 (when Plaintiff was first prescribed LIALDA). (Id. at ¶¶ 17, 18). He contends that LIALDA's defective label caused his injuries. (Id. at ¶¶ 36, 47). LIALDA's label warned of the possibility that a consumer may develop kidney damage from use of the product. Indeed, the LIALDA label in use at the time Plaintiff was prescribed the drug[2] warned that “[r]enal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine.” (Id. at ¶ 18) (emphasis added). Accordingly, Plaintiff does not contend that Defendants failed to warn that use of LIALDA may result in kidney injury.

         Instead, he takes issue with the following language, also from LIALDA's label: “[i]t is recommended that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy.” (Id.). Plaintiff alleges that this recommended “periodic” evaluation constitutes a defective and unsafe instruction for use of LIALDA. (Id. at ¶ 22). He contends that the term “periodic, ” as generally used in drug labels, refers to either semi-annual or annual testing. (Id.). However, he asserts that an appropriate LIALDA label should include instructions recommending “evaluation of renal function by a simple serum (blood) test of creatinine levels on a monthly basis for the first three months after initiation of therapy and then on a quarterly basis for at least one year.” (Id. at ¶ 25). Plaintiff asserts that Defendants' recommendation of only “periodic” testing, as opposed to the more specific testing regimen detailed in his Amended Complaint, proximately caused his kidney injury. (Id. at ¶ 26). Plaintiff asserts claims for failure to warn under the Alabama Extended Manufacturers Liability Doctrine (“AEMLD”), fraud, suppression and concealment, and breach of express warranty.

         III. Standard of Review

         The Federal Rules of Civil Procedure require only that the complaint provide “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). Still, the complaint must include enough facts “to raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). 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 based merely upon “labels and conclusions” or “naked assertion[s]” without supporting factual allegations. Twombly, 550 U.S. at 555, 557. In deciding a Rule 12(b)(6) motion to dismiss, courts view the allegations in the complaint in the light most favorable to the nonmoving party. Watts v. Fla. Int'l Univ., 495 F.3d 1289, 1295 (11th Cir. 2007).

         To survive a motion to dismiss, a complaint must “state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). 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. A plausible claim for relief requires “enough fact[s] to raise a reasonable expectation that discovery will reveal evidence” to support the claim. Twombly, 550 U.S. at 556. The Supreme Court has recently identified “two working principles” for a district court to use in applying the facial plausibility standard. First, 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 when they are “couched as . . . factual allegation[s].” Iqbal, 556 U.S. at 678. Second, “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Id. at 679.

         Application of the facial plausibility standard involves two steps. Under prong one, the court must determine the scope and nature of the factual allegations that are well-pleaded and assume their veracity; and under prong two, the court must proceed 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 the 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 claims are due to be dismissed. Id.

         IV. Analysis

         Defendants' brief in support of their Motion to Dismiss makes a number of arguments which purport to establish bases to dismiss Plaintiff's Amended Complaint. The court will address Defendants' arguments in turn.

         A. Impossibility Preemption

         It is axiomatic that “[u]under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are ‘without effect.'” Mutual Pharm. Co. v. Bartlett, 133 S.Ct. 2466, 2470 (2013) (quoting Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). However, “[i]n all pre-emption cases, and particularly in those in which Congress has ‘legislated… in a field which the States have traditionally occupied, ' … we ‘start 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.'” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). Here, Defendants argue that Plaintiff's state law claims, which allege that LIALDA's label is inadequate under state law, are preempted by federal law related to the labelling of prescription drugs. (Doc. # 45 at pp. 13-18).

         While Plaintiff alleges that Defendants had a duty under Alabama state law to issue adequate testing requirements and warnings (see Doc. # 41 at ¶ 150), federal law imposes more complex drug labeling requirements. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 612 (2011). Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), drug manufacturers must gain approval from the United States Food and Drug Administration (“FDA”) before marketing any drug in interstate commerce. Mut. Pharm. Co. v. Bartlett, 133 S.Ct. 2466, 2470 (2013); see 21 U.S.C. § 355(a). This premarket approval of a new drug application (“NDA”) requires FDA approval of the exact text contained in the drug's proposed label. See 21 U.S.C. § 355; 21 C.F.R. §314.105(b). The FDA may approve of an NDA only if the drug in question is “safe for use” under “the conditions of use prescribed, recommended, or suggested in the proposed labelling thereof.” 21 U.S.C. § 355(d).

         Generally, “a manufacturer may only change a drug label after the FDA approves a supplemental application.” Wyeth v. Levine, 555 U.S. 555, 568 (2009); 21 C.F.R. § 314.70. However, there are certain instances in which a drug manufacturer may unilaterally make changes to a drug's label without the FDA's prior approval. Under the “changes being effected” (“CBE”) regulation, a manufacturer may unilaterally change the label of its drug to “add or strengthen a contraindication, warning, precaution, or adverse reaction” without waiting for FDA approval. § 314.70(c)(6)(iii)(A).

         In those instances when state and federal law conflict, and it is “impossible for a private party to comply with both state and federal requirements, ” state law is preempted. Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (internal quotation marks omitted). Given their obligations under the FDCA, Defendants argue that it would be impossible for them to comply with federal ...

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