Berger v. Medtronic, Inc.

• Decision Date: 19 January 1995
• Citation: 623 N.Y.S.2d 985,164 Misc.2d 378
• Court: New York Supreme Court
• Parties: Sidney BERGER, Plaintiff, v. MEDTRONIC, INC., Defendant.

Page 985

623 N.Y.S.2d 985

164 Misc.2d 378

Sidney BERGER, Plaintiff, v. MEDTRONIC, INC., Defendant.

Supreme Court, Queens County,

IA Part 3.

Jan. 19, 1995.

Joseph J. Filardi, Manhassett, for plaintiff.

Quirk and Bakalor, New York City, for defendant.

JOHN A. MILANO, Justice.

In this action to recover damages for the alleged failure of a ventricular lead of a pacemaker defendant Medtronic, Inc. seeks an order granting partial summary judgment dismissing the complaint on the grounds of federal preemption.

Plaintiff commenced the within action on June 18, 1993 by the service of a summons and complaint against Medtronic, Inc., the manufacturer of a pacemaker and leads. A pacemaker generator model number 76026, along with a ventricular lead model number 4004, and an atrial lead model number 4016 were implanted into plaintiff in May 1989. The pacemaker and leads were removed and replaced on April 27, 1993 due to its alleged failure to properly function. Plaintiff in his complaint alleges four causes of action against Medtronic, Inc. It is alleged that Medtronic, Inc. was negligent in its design, manufacture, testing, inspection, distribution, marketing and sale of the pacemaker and leads, that it was negligent in advising and consulting with the operating physician, and failed to provide proper warnings, and that it was negligent in its failure to provide proper follow-up and maintenance of the plaintiff following the initial surgery. Plaintiff also alleges causes of action for breach of express and implied warranty, strict products liability, and providing improper aid, assistance and advice regarding the implantation of the pacemaker and leads.

Defendant Medtronic, Inc. served its answer on July 13, 1993 and served an amended answer on July 20, 1993, in which it asserted federal preemption as an affirmative defense. Defendant also served a demand for a bill of particulars, which plaintiff belatedly responded to on March 21, 1994. Plaintiff thereafter, pursuant to a stipulation, so ordered by the court, dated May 25, 1994, agreed to serve a supplemental bill of particulars setting forth the specific manufacturing or design defects, if any, as regards the pulse generator, the ventricular lead and the atrial lead. Plaintiff, in a supplemental bill of particulars, limited his claims to the ventricular lead model 4004, which allegedly fractured or disconnected, causing the pacemaker to fail to function. In view of the plaintiff's failure to particularize any claims regarding the pacemaker or atrial lead, his claims are limited to the ventricular lead model number 4004.

Defendant Medtronic, Inc. now seeks an order granting partial summary judgment dismissing plaintiff's negligence, strict products liability, breach of warranty and failure to warn claims, on the grounds that these claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. (21 U.S.C. § 301, et seq.)

Plaintiff, in opposition, asserts that summary judgment should be denied, as there has been little or no discovery, and that the documents submitted by defendant are photocopies and not originals. Plaintiff also asserts that his claims are not barred by the federal statutes.

Plaintiff's claim regarding the need for discovery is without merit. The documents relating to the premarket approval of the subject medical device have long been made available for public disclosure by the Food and Drug Administration. ("FDA") (See, 21 C.F.R. Part 814.) These documents, therefore, are not solely within defendant's possession, and plaintiff has been aware of the federal preemption defense for well over a year. Moreover, as plaintiff does not allege that defendant failed to follow FDA procedures or that the FDA withdrew its approval of the subject device, further discovery is not warranted. The affidavit and documentary evidence submitted herein is sufficient for the court to determine whether plaintiff's claims are barred by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The defense of preemption constitutes a challenge to this court's subject matter jurisdiction, and can be raised at any time. (See, Thomas v. Best, 104 A.D.2d 37, 482 N.Y.S.2d 368; Marine Midland Bank v. Bowker, 89 A.D.2d 194, 456 N.Y.S.2d 243, affd. 59 N.Y.2d 739, 463 N.Y.S.2d 441, 450 N.E.2d 247; Lacks v. Lacks, 41 N.Y.2d 71, 390 N.Y.S.2d 875, 359 N.E.2d 384; Gomez v. Gomez, 86 A.D.2d 594, 446 N.Y.S.2d 127; affd. 56 N.Y.2d 746, 452 N.Y.S.2d 13, 437 N.E.2d 272.)

At issue is the preemptive effect of the Federal Food, Drug, and Cosmetic Act (the "FFDCA"), 21 U.S.C. §§ 301, et seq., and its amendments known as the Medical Device Amendments of 1976 ("MDA") 21 U.S.C. § 360c et seq., on plaintiff's common-law tort claims. Under the MDA, the FDA is required to classify all medical devices into one of three categories based on the degree of regulation necessary to assure safety and effectiveness. All three classes are subject to "general controls", including labeling requirements and good manufacturing practices. (See, 21 U.S.C. §§ 360c, 360i, 360j.) Class III devices require that the FDA grant premarket approval ("PMA") prior to sale, because they present a potential unreasonable risk of illness or injury. (21 U.S.C. § 360c[a][1][C][ii][II].)

It is undisputed that the pacemaker and the atrial and ventricular leads which were implanted into plaintiff in May 1989 are Class III medical devices. (21 C.F.R. §§ 870.3610, 870.3680[b].) The only device at issue herein is the ventricular lead model number 4004. The FDA granted premarket approval to defendant for the 4004 lead, pursuant to a supplemental PMA application, on February 10, 1989. Defendant had previously obtained a PMA for another lead model 4003, on July 29, 1986. The model 4003 pacing lead is an endocardial, tined, ventricular packing lead, and model 4004 is a bipolar version of this lead.

The Supremacy Clause of the Constitution invalidates state laws that interfere with, or are contrary to federal law. (U.S. Const., Art. VI, cl. 2; Cipollone v. Liggett Group, 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407.) A federal statute will supersede state tort remedies only if that is the clear and manifest purpose of Congress. (Cipollone v. Liggett Group, Inc., supra at 516, 112 S.Ct. at 2617.) Congress may express its intent explicitly in the language of the statute, or impliedly by passing a regulatory scheme that extensively covers the field of regulation. (See, Jones v. Rath Packing Co., 430 U.S. 519, 97 S.Ct. 1305, 51 L.Ed.2d 604; Fidelity Federal Savings & Loan Assn. v. de las Cuesta, 458 U.S. 141, 102 S.Ct. 3014, 73 L.Ed.2d 664.)

Turning now to the statute at issue, Section 360k of the MDA provides, in pertinent part, that:

"[N]o State or political subdivision of a State may establish or continue 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 this Act to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act."

(21 U.S.C. § 360k[a].) The existence in the MDA of an express preemption provision, thus precludes reliance on the doctrine of implied preemption. (See, Reiter v. Zimmer Inc., 830 F.Supp. 199; Fogal v. Steinfeld, 620 N.Y.S.2d 875; Michael v. Shiley, Inc., 1994 WL 59349 (E.D.Pa.), see also, Stamps v. Collagen Corp., 984 F.2d 1416 [5th Cir.]; cert. denied, --- U.S. ----, 114 S.Ct. 86, 126 L.Ed.2d 54; King v. Collagen Corp., 983 F.2d 1130 [1st Cir.] cert. denied, --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52; Slater v. Optical Radiation Corp., 961 F.2d 1330 [7th Cir.] cert. denied --- U.S. ----, 113 S.Ct. 327, 121 L.Ed.2d 246.)

The FDA has promulgated regulations implementing § 360k. Under 21 C.F.R. § 808.1(d): "state or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act". In addition, 21 C.F.R. § 808.1(b) provides that § 360k applies to any state or local requirement "having the force and effect of law (whether established by statute, ordinance, regulation or court decision)." The only regulation specifically pertaining to pacemaker leads appears at 21 C.F.R. § 870.3680(b). Inasmuch as this section only identifies pacemaker leads as a "permanent pacemaker electrode", and classifies such devices as a Class III device requiring premarket approval, the court is required to determine whether there are other requirements pertaining to the pacemaker leads within the meaning of section 360k that would preempt state law claims.

State tort claims involving Class III medical devices have been litigated almost exclusively in the federal courts. Several courts have ruled that state law claims based upon malfunctioning Class III medical devices are preempted by the MDA. (Stamps v. Collagen Corp., 984 F.2d 1416 [5th Cir.1993]; cert. denied --- U.S. ----, 114 S.Ct. 86; 126 L.Ed.2d 54; King v. Collagen Corp., 983 F.2d 1130 [1st Cir.1993]; cert denied --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52; Michael v. Shiley, Inc. [E.D.Pa.1994], 1994 WL 59349; Kemp v. Pfizer, Inc., 835 F.Supp. 1015 [E.D.Mich.1993]; Bravman v. Baxter Healthcare Corp., 842 F.Supp. 747 [SDNY 1994].) These courts determined that under the premarket approval process the FDA approved a Class III device only if it found that the applicant had made a showing of reasonable assurance that the device was safe and effective, that the methods used in manufacturing, processing and packing conformed to requirements, that the proposed labeling was not false or misleading in any particular, and that the device conformed to a performance standard in effect. (21 U.S.C. § 360e[d][2].) These courts have thus concluded that the rigorous premarket...