Rice v. Allergan USA, Inc.

          SUBSTITUTED MEMORANDUM OPINION ^[1]

          MADELINE HUGHES HAIKALA UNITED STATES DISTRICT JUDGE

         This matter is before the Court on defendant Allergan USA's motion to dismiss. (Doc. 23). Allergan argues that federal law preempts plaintiff Rosalie Rice's state law claims and that Ms. Rice has not stated a plausible claim for relief pursuant to Federal Rule of Civil Procedure 12(b)(6). (Doc. 24). Ms. Rice concedes that she has not adequately pleaded some of her claims, and she has indicated that she is willing to dismiss those claims without prejudice. This opinion addresses Allergan's preemption defense with respect to the balance of Ms. Rice's claims.

         STANDARD OF REVIEW

         Rule 12(b)(6) enables a defendant to move to dismiss a complaint for “failure to state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). Pursuant to Rule 8(a)(2), a complaint must contain, “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). “Generally, to survive a [Rule 12(b)(6)] motion to dismiss and meet the requirement of Fed. R. Civ. P. 8(a)(2), a complaint need not contain ‘detailed factual allegations, ' but rather ‘only enough facts to state a claim to relief that is plausible on its face.'” Maledy v. City of Enterprise, 2012 WL 1028176, at *1 (M.D. Ala. Mar. 26, 2012) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 570 (2007)). “Specific facts are not necessary; the statement need only ‘give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.'” Erickson v. Pardus, 551 U.S. 89, 93 (2007) (quoting Twombly, 550 U.S. At 555).

         A plaintiff does not have to “negate an affirmative defense in [her] complaint.” La Grasta v. First Union Securities, Inc., 358 F.3d 840, 845 (11th Cir. 2004) (internal quotation marks and citation omitted). A court may dismiss a claim on the basis of an affirmative defense when the plaintiff's “allegations, on their face, show that an affirmative defense bars recovery on the claim.” Cottone v. Jones, 326 F.3d 1352, 1357 (11th Cir. 2003). The Court must “accept[] the allegations in the complaint as true and constru[e] them in the light most favorable to the plaintiff.” Miljkovic v. Shafritz & Dinkin, P.A., 791 F.3d 1291, 1297 (11th Cir. 2015) (quoting Hill v. White, 321 F.3d 1334, 1335 (11th Cir. 2003)) (per curiam) (internal marks omitted). The Court presents Ms. Rice's allegations accordingly.

         BACKGROUND

         Allergan manufactures and distributes the LAP-BAND, a surgically implanted medical device designed to help patients lose weight. (Doc. 18, ¶¶ 19- 25, 45). The LAP-BAND is placed around the outside of the stomach to “create a small ‘pouch' in the upper part of the stomach to control the speed by which food passes to the lower part of the stomach . . .” (Doc. 18, ¶ 19). Allergan's initial efforts to obtain FDA approval for the product were not successful. (Doc. 18, ¶ 21). The FDA gave premarket approval or PMA for the LAP-BAND in 2001. (Doc. 18, ¶ 22). Premarket approval reflects a great deal of investigation by the FDA and indicates that the FDA has found that there is “reasonable assurance” that the medical device is safe and effective when used under the conditions included in the device's label. The PMA also indicates that the FDA has concluded that the manufacturer's proposed labelling for the device “is neither false nor misleading.” (Doc. 18, ¶ 9).

         When the FDA granted PMA for the LAP-BAND, Allergan's label for the product indicated a 1% risk of erosion. (Doc. 18, ¶ 31). Erosion appears to occur when the LAP-BAND slips and erodes into the stomach. (Doc. 18, ¶¶ 32, 36).^[2]Erosion can require reoperation and removal of the LAP-BAND. (Doc. 18, ¶ 32).

         After manufacturers like Allergan receive premarket approval, they must meet various reporting requirements. For example, they must report to the FDA adverse events associated with their product. (Doc. 18, ¶ 14). As a condition of PMA, Allergan agreed to conduct a post-approval clinical study to collect data on the long-term safety and effectiveness of the LAP-BAND. The clinical study had to include patient follow-up for five years post-implantation. (Doc. 18, ¶ 24). PMA also was conditioned on Allergan's compliance with general and device-specific requirements. (Doc. 18, ¶ 25). “Failure to comply with the conditions of approval invalidates [the PMA]. Commercial distribution of a device that is not in compliance with these conditions is a violation of the act.” (Doc. 18, ¶ 25).

         Based on the results of its own studies, Allergan has maintained its disclosure of a 1% erosion rate for the LAP-BAND; however, outside medical studies “indicate a much higher complication rate.” (Doc. 18, ¶¶ 26-31). Outside studies reveal that the possibility of erosion increases over time. (Doc. 18, ¶¶ 33- 36) (listing a 2006 study indicating failure rates of 13.2% after 18 months, 23.8% after 3 years, 31.5% after 5 years, and 36.9% after 7 years, and finding a 9.5% erosion rate after 5 years; a 2008 study indicating failure rates of 15% after 1 to 3 years increasing to 40% after 8 to 9 years; a 2011 study indicating a 28% erosion rate after 12 years; and a 2012 study indicating a 19.2% removal rate after 6 years with band erosion as the second most common cause of removal). Although the FDA generally must approve changes to product labels, a manufacturer may add to its label, without prior FDA approval, information that strengthens a warning or precaution about an adverse reaction when the additional information “enhance[s] the safe use of the product” or “delete[s] misleading, false, or unsupported indications.” (Doc. 18, ¶ 13). Ms. Rice alleges that despite the erosion rate data from outside studies, Allergan “continues to represent in labelling and to the public erosion rates of approximately 1%.” (Doc. 18, ¶ 31).

         In early 2007, Ms. Rice's surgeon implanted the LAP-BAND to treat Ms. Rice for morbid obesity. (Doc. 18, ¶ 38). Toward the end of 2014, Ms. Rice began having difficulty swallowing, and she was vomiting frequently. (Doc. 18, ¶ 39). On November 26, 2014, Ms. Rice's surgeon discovered that the LAP-BAND “had eroded into [Ms. Rice's] stomach such that only the buckle itself was external to the stomach.” (Doc. 18, ¶ 40) (internal marks omitted). Ms. Rice's surgeon removed the LAP-BAND and “repaired the gastric perforation caused by the eroded LAP-BAND.” (Doc. 18, ¶ 40).

         Ms. Rice filed this lawsuit on August 22, 2016. (Doc. 1). She alleged seven state law causes of action against Allergan: negligence, strict liability failure to warn, design defect, manufacturing defect, breach of warranty, fraudulent misrepresentation, and violation of the Alabama Deceptive Trade Practices Act (ADTPA). (Doc. 18, ¶¶ 44-105). Pursuant to Rule 12(b)(6), Allergan has asked the Court to dismiss these claims based on express preemption, implied preemption, and failure to state a claim with sufficient factual specificity. (Doc. 24, pp. 9-10).

         ANALYSIS

         A. Sufficiency of Factual Allegations

         Before the Court may address Allergan's preemption arguments, it first must consider Allergan's argument that Ms. Rice has failed to allege sufficient facts to support her claims. Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1328 (11th Cir. 2017) (quoting Slack v. McDaniel, 529 U.S. 473, 485 (2000) for the proposition that “courts should ‘not pass upon a constitutional question although properly presented by the record, if there is also present some other ground upon which the case may be disposed of.'”). Under Rule 12(b)(6), a district court must determine whether a complaint contains “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. “Determining whether a complaint states a plausible claim for relief will [ultimately] . . . be a context-specific task that requires [a district court] to draw on its judicial experience and common sense.” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).

         Ms. Rice “concedes a lack of factual support at this time to plead parallel [state] claims” as to her third, fourth, fifth, and seventh causes of action and “concedes to dismissal of those specific claims without prejudice.” (Doc. 26, p. 1). Accordingly, the Court dismisses Ms. Rice's claims for design defect, manufacturing defect, breach of warranty, and violation of ADTPA without prejudice. This leaves Ms. Rice's claims for negligence, failure to warn, and negligent or fraudulent misrepresentation. (Doc. 18).

         1. Negligence

         Under Alabama law, to establish a claim for negligence, “the plaintiff must prove: (1) a duty to a foreseeable plaintiff; (2) a breach of that duty; (3) proximate causation; and (4) damage or injury.” Lemley v. Wilson, 178 So.3d 834, 841-42 (Ala. 2015), reh'g denied (Apr. 17, 2015) (quoting Martin v. Arnold, 643 So.2d 564, 567 (Ala. 1994)). In support of her negligence claim, Ms. Rice alleges, among other things, that Allergan “breached federal device requirements and parallel Alabama law duties to exercise reasonable and prudent care in development, testing, design, manufacture, inspection, marketing, labeling, promotion, distribution, sale, post-market surveillance and adverse events reporting of the LAP-BAND” by (1) manufacturing a device that presented “an unreasonable risk of failure, particularly over time, as it relates to band erosion and perforation, ” (2) designing and manufacturing a device “with insufficient strength or structural integrity to withstand long term placement within the human body, a manner for which the device was indicated, ” (3) “marketing and recommending to Plaintiff and her physician the use of the LAP-BAND in such a manner as to misrepresent the safety and efficacy of the device, including the heightened risk of device-associated complications over time”; (4) “failing to provide adequate labeling for the LAP-BAND device when it knew or should have known the safety and efficacy of the device was being misrepresented in its labeling”; (5) “failing to place into effect ‘labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction, ' or that ‘add or strengthen an instruction that is intended to enhance the safe use of the device, ' or ‘that delete misleading, false or unsupported indications'”; (6) “failing to report required adverse events associated with the LAP-BAND to the FDA, thereby preventing the dissemination of key safety information to Plaintiff and her physician prior to and after ...