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Lucia Burgos v. Satiety

April 5, 2011


The opinion of the court was delivered by: John Gleeson, United States District Judge:



Plaintiff Lucia Burgos brings suit against defendant Satiety, Inc. ("Satiety"), alleging violations of the Food, Drug, and Cosmetic Act (the "FDCA"), as well as several state-law parallel claims. Satiety has moved to dismiss the amended complaint. The motion is granted in part and denied in part.


In a complaint filed on June 11, 2010, Burgos brought suit against Satiety, alleging that an experimental medical device it had developed for the treatment of obesity had caused Burgos injury in violation of both federal and state law. The device was designed to allow for stomach stapling without surgery; the stapling mechanism was instead slipped down the patient's throat and esophagus, thereby avoiding the need for an incision. In a memorandum and order dated November 30, 2010, I determined that Burgos's allegations were preempted by the comprehensive federal regulatory scheme administered by the Food and Drug Administration ("FDA") and dismissed the complaint. Burgos v. Satiety, Inc., 2010 WL 4907764, at *3 (E.D.N.Y. Nov. 30, 2010) ("Burgos I").*fn1 However, noting that the federal regulatory scheme "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulation," id. (quoting Riegel v. Medtronic, 552 U.S. 312, 330 (2008)), I granted Burgos leave to replead her claims as state-law parallel claims. Id. at *4.

In an amended complaint filed on December 17, 2010, Burgos sets forth two causes of action: one for negligence and one for negligent manufacture. The new complaint is almost entirely devoid of factual allegations, relying instead upon the facts alleged in the first complaint. Opp. at 2. Satiety has moved to dismiss the amended complaint.*fn2

I now grant Satiety's motion in part, and deny it in part. As explained below, the first cause of action remains preempted, and parts of the second do not adequately allege a parallel claim; therefore, Satiety's motion with respect to those sections of the amended complaint is granted. However, Satiety's motion with respect to Burgos's allegations regarding its Investigational Device Exemption ("IDE") and 21 U.S.C. § 351 is denied.


A. Motion to Dismiss

In order to survive a motion for judgment on the pleadings under Fed. R. Civ. P. 12(c), a plaintiff must "state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). In evaluating the plaintiff's claim I construe the complaint liberally, accepting its well-pled factual allegations as true and drawing all reasonable inferences in favor of the non-moving party. Chambers v. Time Warner, Inc., 282 F.3d 147, 152 (2d Cir. 2002). Although the complaint must be supported by more than "mere conclusory statements," Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009), it need not provide "detailed factual allegations." Twombly, 550 U.S. at 555.*fn3

B. Negligent Manufacture

In her first cause of action, Burgos alleges that Satiety's TOGA stomach-stapling device failed and perforated her esophagus due to "improper workmanship and error of Satiety at the point of manufacture which took place during the manufacturing process." (Am. Compl. ¶ 22.) She further alleges that the TOGA device had "an impurity, imperfection and/or other product defects . . . [which] was a deviation from Satiety's quality manufacturing standards for the TOGA System," leaving the device in a "defective condition and unreasonably dangerous to plaintiff when it left Satiety's hands." (Id. ¶¶ 23-25.) Finally, she alleges that the device "was used in the manner intended." (Id. ¶ 27.) Burgos fails to cite any federal statute or regulation to support her claim of negligent manufacture.

This claim again runs afoul of federal preemption doctrine. Because Burgos cites no federal statute or regulation underlying Satiety's alleged negligent manufacture, she does not "allege a state-law cause of action that parallels a violation of the FDCA." Burgos I at *3. As was more fully discussed in Burgos I, negligent manufacture is one of the many state law tort claims that is preempted by the federal regulatory scheme that governs the testing and approval process for experimental medical devices. See id. (claim of negligent manufacture is preempted); Berish v. Richards Med. Co., 928 F. Supp. 185, 192 (N.D.N.Y. 1996) ("A complex structure was set forth to monitor, investigate, record, and, if necessary sanction with withdrawal medical devices granted an IDE. Accordingly, the plaintiff's claim of negligent manufacture is preempted, as it is clear that there was federal law in conflict with state law and Congress had filled the field." (quotation marks omitted)); Richman v. W.L. Gore & Assocs., Inc., 881 F. Supp. 895, 901 (S.D.N.Y. 1995) ("[S]tate ...

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