NEILS v. STEINBERG (2018)

Defendant Alcon Laboratories, Inc. (hereinafter “Alcon”) moves for an order, pursuant to CPLR 3211(a)(1),(2),(7), dismissing the amended verified complaint as to it. Alcon also seeks dismissal on the grounds that the plaintiff's claims as to Alcon are preempted by federal law pursual to § 360k(a) of the Medical Device Amendments to the United States Food, Drug & Cosmetic Act as well as the Supreme Court decision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).

The following papers were read:

Notice of Motion–Affirmation–Exhibits A–F—1–9

Memorandum of Law

Affirmation in Opposition–Exhibits A–B 10–12

Affirmation in Reply–Exhibit A–Memorandum of Law 13–15

By way of background, this case arises from the plaintiff's use of a prescription medical device that was designed and manufactured by Alcon. Plaintiff's physician implanted the device, the Alcon AcrySof® IQ Posterior Chamber intraocular lenses, on October 14, 2014 to treat the plaintiff's cataracts. Plaintiff claims she was injured by the subject device and by a subsequent procedure performed on October 28, 2014. In this action, plaintiff asserts four causes of action against Alcon; two causes of action sounding in breach of express warranty, the next in implied warranty and the last in negligence. Alcon has denied the subject device was defective and has denied it is liable to the plaintiff in any manner whatsoever.

Dismissal is warranted under CPLR 3211(a)(1) only if the documentary evidence submitted conclusively establishes a defense to the asserted claims as a matter of law (see Leon v. Martinez, 84 N.Y.2d 83, 614 N.Y.S.2d 972, 638 N.E.2d 511 [1994] ). Dismissal is appropriate under CPLR 3211(a)(2) where the court does not have jurisdiction of the subject matter of the cause of action (see CPLR 3211 [a][2] ). Further, on a motion to dismiss a complaint pursuant to CPLR 3211(a)(7), the standard is whether the pleading states a cause of action, not whether the proponent of the pleading has a cause of action (see Guggenheimer v. Ginzburg, 43 N.Y.2d 268, 401 N.Y.S.2d 182, 372 N.E.2d 17 [1977] ). In considering such a motion, the court must accept the facts as alleged in the complaint as true, accord plaintiff the benefit of every possible favorable inference, and determine only whether the facts as alleged fit within any cognizable legal theory (see Nonnon v. City of New York, 9 N.Y.3d 825, 842 N.Y.S.2d 756, 874 N.E.2d 720 [2007] ). Whether a plaintiff can ultimately establish its allegations is not part of the calculus (see EBC I, Inc. v. Goldman, Sachs & Co., 5 N.Y.3d 11, 799 N.Y.S.2d 170, 832 N.E.2d 26 [2005] ).

The subject device is a Class III medical device that was approved by the United States Food & Drug Administration pursuant to the premarket approval process. The United States Supreme Court has held that the express preemption provision in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, 21 USC § 360k(a) precludes any state law claim that would impose requirements that are different from or in addition to those requirements established pursuant to the FDA's approval of that device (see Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 [2008] ).

The Court in Riegel developed a two step analysis to determining if state law claims were preempted. Specifically, the Court must determine whether the Federal Government has established requirements applicable to the specific device. If so, the Court must then determine whether the common-law claims are based upon New York requirements with respect to the device that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness of the device or to any other matter included in a requirement applicable to the device (id.).

The AcrySof® lens is a Class II premarket approved device, subject to the rigorous review process conducted by the FDA. This process constitutes a specific federal determination of safety (see Raleigh v. Alcon Laboratories, Inc., 403 Ill. App. 3d 863, 343 Ill.Dec. 206, 934 N.E.2d 530 [Appellate Court of Illinois, First District, Fifth Division 2010] ). The Court finds, as a matter of law, that the first prong of the Riegel preemption analysis applies to the AcrySof® intraocular lens at issue in the case.

Turning next to the second prong of the Riegel test, the Court finds that the plaintiff's claims of breach of express warranty, implied warranty and negligence constitute a requirement relating to the safety or effectiveness of a medical device regulated by the Medical Device Amendment that is different from, or in addition to, a requirement applicable to the device (see 21 USC § 360k[a] ). As a result, these claims are preempted by the Medical Device Amendment (see Raleigh v. Alcon Laboratories, Inc., 403 Ill. App. 3d 863, 343 Ill.Dec. 206, 934 N.E.2d 530 [Appellate Court of Illinois, First District, Fifth Division 2010] appeal denied by 238 Ill. 2d 673, 347 Ill.Dec. 258, 942 N.E.2d 461).

Based upon the foregoing, the defendant Alcon's motion to dismiss is granted, pursuant to CPLR 3211(a)(2) and 21 USC § 360k(a, and plaintiff's complaint is dismissed as to it.

The related action Index No. 52301/2016 is scheduled for a further discovery conference on July 17, 2018 at 10:00 a.m. Adjournments are only granted with leave of the Court.

The foregoing constitutes the decision and order of the Court. This decision and order has been filed electronically.

James D. Pagones, J.