The opinion of the court was delivered by: MCAVOY
This action was commenced on or before September 30, 1994, in New York state Supreme Court. The defendant removed the action to this Court on or about October 24, 1994, and filed an Answer on November 21, 1994. On May 20, 1996, the defendant filed a motion for summary judgment. By a Memorandum-Decision and Order, dated June 20, 1996, this Court granted the defendant's motion in its entirety dismissing the plaintiff's Complaint. The plaintiff now moves for reconsideration of the June 20, 1996 Memorandum-Decision and Order.
Although not specific as to the claims affected, the plaintiff argues that the Supreme Court's decision in Lohr v. Medtronic, Inc., 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996) mandates that this Court reconsider its June 20, 1996 Memorandum-Decision and Order and deny the defendant's motion for summary judgment. More specifically, the plaintiff argues that Lohr "... broadened the ability of injured plaintiffs to bring tort actions based on allegedly defective medical devices." See Memorandum of Law in Support of Motion at 1. Moreover, the plaintiff argues that after Lohr pre-emption under the Medical Device Amendments of 1976 (MDA) can occur only if "... a particular state requirement threatens to interfere with a specific federal interest." Lohr, 116 S. Ct. at 2257.
The defendant, on the other hand, argues that Lohr is not even applicable to this case. The defendant reasons that Lohr concerned a device approved under a rather less stringent process called the § 510(k) process. The device at issue in this case is an investigational device exception (IDE) device, and thus, subject to more stringent approval requirements, and exempted from certain federal regulations. It is the defendant's position that if this Court adopts the Lohr plurality's position, essentially requiring a showing of regulations specific to the device at issue before finding federal pre-emption, the state claims would be pre-empted, because the IDE requirements are specific to the device at issue herein. The Court now turns to the issues presented.
A. Standard for Motion to Reconsider
"A court is justified in reconsidering its previous ruling if: (1) there is an intervening change in the controlling law; (2) new evidence not previously available comes to light; or (3) it becomes necessary to remedy a clear error of law or to prevent obvious injustice." Hester Industries, Inc. v. Tyson Foods, Inc., 160 F.R.D. 15, 16 (N.D.N.Y. 1995) (citing, Larsen v. Ortega, 816 F. Supp. 97, 114 (D.Conn. 1992), aff'd, 990 F.2d 623 (1993)); Nossek v. Brd. of Educ. of the Duanesburg Central School Dist., 1994 U.S. Dist. LEXIS 14146, 1994 WL 688298 (N.D.N.Y. 1994). It is clear from the plaintiff's arguments, discussing the Supreme Court's decision in Lohr, that the plaintiff is claiming reconsideration is proper in this instance due to a change in the controlling law. Accordingly, the Court will consider Lohr, and determine what effect, if any, that decision has on the law that should be applied to this case.
B. The June 20, 1996 Memorandum-Decision and Order
In the Memorandum-Decision and Order giving rise to the present motion, the Court dismissed the plaintiff's Complaint after finding that the plaintiff's state law claims were pre-empted by federal law. More specifically, the Court found that the MDA provide for pre-emption when "a State [established] or continue[d] in effect with respect to a device intended for human use any requirement-- (1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device" at issue. See June 20, 1996 Memorandum-Decision and Order at 6. The Court then examined the regulations applicable to a device classified as an IDE. The Court found that the IDE approval letter referenced 21 C.F.R. § 812, et seq.
"That Part of the C.F.R. set forth, inter alia, general provisions relating to IDE's, 21 C.F.R. § 812.1-812.19, the IDE application and approval process, 21 C.F.R. § 812.20-812.38, and regulations relating to FDA investigations, monitoring, record keeping, and disciplining of IDE approved device manufacturers and marketers, 21 C.F.R. § 812.40-812.150. See, e.g., 21 C.F.R. § 812.60 (composition and duties of institutional review board); 21 C.F.R. § 812.100 (responsibilities of investigators); 21 C.F.R. § 812.145 (inspections); 21 C.F.R. § 812.150(a)(4) (deviations from investigational plan); 21 C.F.R. § 812.150(b)(2) (withdrawal of IRB approval).
In this case ... the device at issue was ... investigational ... [and] substantial FDA regulations relating to the design, manufacture, and safety have been shown to apply to the device. A complex structure was set forth to monitor, investigate, record, and, if necessary, sanction with withdrawal, medical devices granted an IDE."
June 20, 1996 Memorandum-Decision and Order at 11-12. Pursuant to the above referenced analysis and the authority of the Second Circuit's decision in Becker v. Optical Radiation Corp., 66 F.3d 18 (2d Cir. 1995), the Court granted the defendant's motion for summary judgment.
Becker, decided in the context of a device classified as an IDE, stated that "it is now well established that a 'requirement' for purposes of the preemption provision of the MDA may be created by state common law as well as by statutory law." 66 F.3d at 19 (citations omitted). The device in Becker was subject to specific regulations relating to that category of device, intraocular lenses. 21 C.F.R. § 813 et seq. However, the Court's decision did not turn on that fact. Rather, the Court stated that the state law claims were pre-empted whether or not the device was subject to the specific regulations, or the general regulations relating to an IDE. Accordingly, the Becker Court then held that the state tort claims of ...