Fogal v. Steinfeld

• Decision Date: 24 October 1994
• Parties: Linda FOGAL, as Administratrix of the Estate of Kristen Fogal, Deceased, and Linda Fogal and Richard Fogal, Individually, Plaintiffs, v. Leon STEINFELD, M.D., Rica Aaron, M.D., "John" Ritter, M.D., Manuel Estioko, M.D., George Camunas, M.D., Richard Bass, M.D., Karl Neumann, M.D., Reuben Reiman, M.D., Joseph Soloway, M.D., Myron Beer, M.D., The Mount Sinai Medical Center, Cordis Corporation and Medtronic, Inc., Defendants.
• Court: New York Supreme Court

Page 875

620 N.Y.S.2d 875

163 Misc.2d 497

Linda FOGAL, as Administratrix of the Estate of Kristen Fogal, Deceased, and Linda Fogal and Richard Fogal, Individually, Plaintiffs, v. Leon STEINFELD, M.D., Rica Aaron, M.D., "John" Ritter, M.D Manuel Estioko, M.D., George Camunas, M.D., Richard Bass M.D., Karl Neumann, M.D., Reuben Reiman, M.D., Joseph Soloway, M.D., Myron Beer, M.D., The Mount Sinai Medical Center, Cordis Corporation and Medtronic, Inc., Defendants.

Supreme Court, New York County IAS, Part 29.

Oct. 24, 1994.

Samuel & Weininger, Lake Success, for plaintiffs.

Gottlieb, Rackman & Reisman, New York City, for defendant Cordis Corp.

Quirk & Bakalor, New York City, for defendant Medtronic, Inc.

Peltz, Walker & Dubinsky, New York City, for defendants Soloway, Beer.

STANLEY L. SKLAR, Justice.

Defendant Medtronic, Inc moves for permission to amend its answer to add federal preemption as an affirmative defense to all of plaintiffs' claims. ¹

Procedural History

This action arises out of the death of the infant Kristen Fogal, who was born with a complete heart block, due to a transplacental transfer of her mother's SLE antibody, requiring the installation of a pacemaker at 9 days of life. Kristen died of cardiorespiratory arrest on October 9, 1986. The autopsy report indicated that the cathode lead wires were splayed and showed a loss of insulation housing at the splayed area with fibrous adhesions attached to that area. Mt. Sinai Medical Center and ten doctors have been sued for medical malpractice in connection with their care and treatment of the infant. In addition, plaintiffs sued Medtronic, Inc., claiming that the lead it had manufactured which was connected to a pulse generator manufactured by former defendant Cordis Corporation was defective.

This action was commenced by service of a summons and complaint on or about March 4, 1988. Plaintiffs' complaint alleges five causes of action against Medtronic. The eighth cause of action alleges that Medtronic was "negligent in the design, manufacture, inspection, assembly, distribution and placement on the market of the aforesaid pacemakers and aforesaid pacemaker components and parts and failed to warn the infant plaintiff and her parents thereof." (Complaint p 68) The ninth through eleventh causes of action sound in strict products liability, breach of express and implied warranty; the twelfth cause of action is based on the doctrine of res ipsa loquitur and is thus premised on negligence.

Medtronic served an answer to the complaint on or about April 27, 1988. Extensive discovery was undertaken including depositions of the 13 defendants. A note of issue was filed on or about November 3, 1992 and the case set down for trial by the TAP judge. Medtronic, by motion served about a year after the case was placed on the trial calendar, now moves to amend its answer to assert federal preemption as an affirmative defense to all of plaintiffs' claims against it. It is Medtronic's contention that all claims against it are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.

The Regulatory Scheme

In 1976 Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 360 et seq. (added by Pub.L. 94-295, 90 U.S. Stat. 539). The MDA was enacted in response to the rapid technological changes in the medical device field, and the perceived inadequacy of existing law to protect consumers from "increasingly complex devices which pose serious risk if inadequately tested or improperly designed or used." (S.Rep. No. 94-33, 94th Cong., 2d Sess. 3, reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1075) The MDA was also enacted with the intent of encouraging research and development of medical devices. Id. at 1071; Bravman v. Baxter Healthcare Corp., 842 F.Supp. 747, 753 (S.D.N.Y.1994).

The MDA established a three-tiered scheme of regulating medical devices. Class I devices are those deemed in need of the least regulatory oversight; tongue depressors are an example. [Stamps v. Collagen Corp., 984 F.2d 1416, 1418 (5th Cir.), cert. den. --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993) ] These devices are subject to the general controls of the Act [21 U.S.C.360c(a)(1)(A) ] Class II devices are those for which the general controls alone in the Act are not sufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls such as the promulgation of performance standards that assure their safety and effectiveness. [21 U.S.C. § 360c(a)(1)(B) ] Class II devices include such items as oxygen masks used in anesthesiology, and tampons. (Stamps supra at 1418) Class III devices are those that do not meet the criteria of the first two classes. They are defined as devices that are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health" or that present "a potential unreasonable risk of illness or injury." [21 U.S.C. § 360c(a)(1)(C)(ii) ]

A manufacturer of a Class III device must obtain premarket approval of the United States Food and Drug Administration ("FDA") pursuant to the requirements and procedures set forth in 21 U.S.C. § 360e to "provide reasonable assurance of its safety and effectiveness." [21 U.S.C. § 360c(a)(1)(C)(ii) ] However, a manufacturer may bypass the premarket approval process if it can demonstrate that its device is "substantially equivalent" to a device on the market before May 28, 1976--the effective date of the MDA--and no final regulation has been promulgated under 21 U.S.C. § 360e(b) requiring the device to have an approved premarket approval application. [21 U.S.C. § 360c(f)(3); 21 C.F.R. § 814.1(c) ] Such an exemption is obtained by submitting a premarket notification or "510(k)" ² application to the FDA 90 days before the manufacturer proposes to introduce the device into interstate commerce. [21 U.S.C. § 360(k); 21 C.F.R. § 807.81]

In the 1980s ³ a premarket notification for Class III medical devices was required to include all trade, proprietary and common names of the device; the manufacturer's registration number, proposed labels, labeling and advertisements sufficient to describe the device, its intended use and the directions for its use; data to support the contention that the device is substantially equivalent to the predicate device; if the device has undergone a significant change that could affect the safety or effectiveness of the device, or the intended use of the device has changed appropriate supporting data showing that the manufacturer has considered what consequences and effects the change or new use may have on the safety and effectiveness of the device; and any additional information requested by the FDA in order to make a substantial equivalency determination. (21 C.F.R. § 807.87) However, the regulations make clear that submission of a premarket notification or a subsequent determination by the FDA that the device is substantially equivalent to a pre-MDA device "does not in any way denote official approval of the device." (21 C.F.R. § 807.97)

In 1990 Congress passed the Safe Medical Devices Act, Pub.L. 101-629, 104 U.S.Stat. 4511, to correct various perceived difficulties in the implementation of the MDA. The purpose of the amendment was "to modify the underlying law in ways that [would] result in greater protection of the public health." H.R.Rep. No. 101-808, 101st Cong., 2d Sess. 14, repr. in 1990 U.S.Code Cong. & Admin.News 6305, 6306. One such problem involved the substantial equivalency exemption for Class III medical devices. As the legislative history of the 1990 amendments noted:

With enactment of the 1976 Medical Device Amendments, devices already on the market were permitted to remain on the market until the FDA called for a review of their safety and effectiveness. While the 1976 law requires premarket approval of potentially dangerous new medical devices, it also allows new devices that are "substantially equivalent" to the old devices to be marketed without being approved for safety and effectiveness until the FDA formally requires reviews of the old devices. None of these reviews of pre-1976 devices even began until very recently.

* * * * * *

[O]ver 80 percent of the devices that are potentially the most dangerous (Class III), enter the market on the basis of a claim by the manufacturer that they are "substantially equivalent" to a device already on the market. Although a determination of substantial equivalence involves a review by FDA of what is known of the safety and effectiveness of the devices, and may even include some additional clinical testing, it is not equivalent to an approval by the FDA of the device's safety and effectiveness.

[H.R.Rep. No. 101-808, 101st Cong., 2d Sess. 14, reprinted in 1990 U.S.Code Cong. & Admin.News 6305, 6307, emphasis added] The MDA was amended to provide that a device will not be found to be substantially equivalent if the device has different technological characteristics from the predicate device and raises questions of safety and effectiveness that are different from the predicate device or is not as safe and effective as the predicate device. [1990 U.S.Code Cong. & Admin.News, op. cit., at 6317-6318; 21 U.S.C. § 360c(i) ] The FDA amended its regulations governing 510(k) submissions, effective 1992, to require manufacturers to include a "510(k) summary" of the types of safety and effectiveness problems associated with the devices being compared as well as a "510(k) statement" certifying that a reasonable search of all information known or otherwise available about the device and similar legally marketed devices has been conducted. [57 Fed.Reg. 18062, 18066; 21 C.F.R. § 807.87(i) ]

The Medtronic Model No. 4951

According to the affidavit of Dr....