Summary judgment is appropriate where an examination of the record reveals "no genuine issue of material fact and, based on the undisputed facts, the moving party is entitled to judgment as a matter of law." D'Amico v. City of N.Y., 132 F.3d 145, 149 (2d Cir. 1998); see Fed. R. Civ. P. 56(c). All inferences must be drawn and all ambiguities resolved in favor of the nonmoving party. SCR Joint Venture L.P. v. Warshawsky, 559 F.3d 133, 137 (2d Cir. 2009). If it appears that a reasonable jury could return a verdict for the nonmoving party, the Court may not grant summary judgment. Id. If, however, the moving party demonstrates that there are no genuine issues of material fact, "the nonmoving party must come forth with evidence sufficient to allow a reasonable jury to find in [its] favor." Roe v. City of Waterbury, 542 F.3d 31, 36-37 (2d Cir. 2008) (punctuation omitted).
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 various forms of products liability, statutory violations, and other state law tort claims. Satiety has moved for summary judgment under Fed. R. Civ. P. 56. The motion is granted, but Burgos is granted leave to file an amended complaint on or before December 17, 2010.
On November 19, 2008, Lucia Burgos was a patient at Columbia Presbyterian Hospital undergoing an experimental form of bariatric surgery using a device called the Transoral Gastroplasty Stapling System, to which the parties refer as "TOGA." (Compl. ¶ 60, Def. Mot. at 4.) The TOGA was developed and manufactured by Satiety pursuant to a detailed plan filed with the Food and Drug Administration ("FDA"). Burgos's surgery was part of a series of clinical trials of the TOGA device being conducted around the country pursuant to FDA regulation. (Def. Mot. at 3; see Exh. E.) The TOGA was not for general sale, and was used only in the context of the FDA-approved and -regulated trials. (See Exh. D.)
Prior to the surgery, Burgos signed a 12-page informed consent form, acknowledging the risks of the procedure and waiving various causes of action against Satiety that might arise from the use of the TOGA device. (Exh. H; see Def. Mot. at 4.) During the surgery, Burgos's esophagus was perforated by the TOGA device, allegedly as a result of a malfunction in the device itself rather than any form of negligence by the doctor performing the surgery. (Compl. ¶ 61; Def. Mot. at 4.) Such an injury was explicitly contemplated by the consent form signed by Burgos. (Exh. H at 8 (classifying perforation of the esophagus as one of several "[m]ore serious risks" of the TOGA procedure); see Def. Mot. at 4.) After the TOGA device allegedly malfunctioned, the surgeon aborted the TOGA stapling procedure and repaired the perforation of Burgos's esophagus. (See Exh. I.) The repair was successful. (See id.)
Because of the alleged malfunction, Burgos claims that she has suffered "severe and permanent personal injuries." (Compl. ¶ 60; see id. at ¶ 62.) Burgos brought suit against Satiety for her injuries, and Satiety has moved for summary judgment.
B. The Federal Regulatory Scheme
The federal government has been heavily involved in regulating the safety, effectiveness, and development of medical devices since 1938. Medtronic v. Lohr, 518 U.S. 470, 475 (1996). Several decades later, in order to deal with a spate of state-law tort claims across the country that followed the failure of several complex medical devices, Congress passed the Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. ("MDA"), which modified the Food, Drug, and Cosmetics Act, 21 U.S.C. § 301 et seq. ("FDCA"). See Riegel v. Medtronic, Inc., 552 U.S. 312, 315-16 (2008). The MDA introduced a rigorous pre-market approval process (the "PMA"), which minutely regulates everything from the development, chemical or mechanical composition, and testing of a new device to its labeling, manufacture, and distribution. The PMA is
effectiveness" of new devices. Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 585 (E.D.N.Y. 2009). No new medical device may be manufactured or marketed until it has gone through the PMA process or its equivalent, and "[a]fter premarket approval, there can be no change in the design, manufacturing or labeling of a medical device that would affect safety or effectiveness of the device" without an extensive review by the FDA. Id.
Medical devices in the early testing phase, such as the TOGA, though still governed by the MDA, can be excused from compliance with the PMA via an Investigational Device Exemption ("IDE"). 21 U.S.C. § 360j; see 21 C.F.R. § 812 et seq.; Becker v. Optical Radiation Corp., 66 F.3d 18 (2d Cir. 1995). The IDE was established "to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose." 21 U.S.C. § 360j(g)(1). An IDE permits clinical trials of a new device sought to be brought to market, providing researchers with a way to test devices whose safety and effectiveness have not yet been proven to the standards otherwise imposed by the PMA. Id.; see United States v. Prigmore, 243 F.3d 1, 6 (1st Cir. 2001). The ...