"Reiter") opposes Zimmer's motion and seeks an order for a continuance, pursuant to Rule 56(f) of the Federal Rules of Civil Procedure, staying this Court's determination of Zimmer's summary judgment motion. For the reasons that appear below, Zimmer's motion is granted in part and denied in part and Plaintiff's motion is denied.
"On September 18, 1989, while a patient at The Hospital for Joint Diseases Orthopedic Institute, plaintiff . . . underwent surgery to replace her left hip with a prosthesis." (Zimmer's 3(g) Statement P 1.) Plaintiff's surgeon, Dr. Victor Frankel, "prepared Ms. Reiter's femur for the reception of the prosthesis by first enlarging the bone canal with reamers." (Id. P 2.) Dr. Frankel planned "to fill the femoral canal with a grouting material, commonly called 'bone cement', in which the prosthesis would be seated." (Id.) Bone cement is an acrylic material comprised of two basic components, a polymer and a monomer. (Id. P 4.)
According to Reiter, "the specific batch of Zimmer bone cement used during the course of her surgery, hardened prematurely, resulting in the plaintiff's femur being needlessly fractured, causing a failed procedure with a permanent disability." (Pl.'s Mem. at 1.) It is undisputed that the "medical records in this case show that Dr. Frankel used Zimmer bone cement with batch number 66688200, expiration date of December, 1991." (Zimmer's 3(g) Statement P 10.) Dr. Frankel testified that "the premature hardening of the cement" caused the cracking of Reiter's femur. (Ex. A to Levy Aff. at 10.) Bone cement is prepared by mixing its component parts "in a bowl, wait until it got sort of smooth on the surface, then roll it around in your hands for a while and make sort of a snake out of it, poke that down the thermal canal." (Id. at 46.) After pouring the bone cement into a dispenser gun, Dr. Frankel "felt it was too viscous to go through the small hole in the canal, and I pulled it out, as I have done in other cases, to roll it up and push it down the canal." (Id. at 47.) According to Dr. Frankel, the average set time for Zimmer's bone cement is approximately ten to twelve minutes.
As a result of the premature hardening of the bone cement, Dr. Frankel was unable to insert the prosthesis beyond the midpoint of Plaintiff's femur. He "tried to seat the prosthesis further by tapping it with a hammer." (Zimmer's 3(g) Statement P 9.) "The forces created by striking the prosthesis caused plaintiff's femur to crack. . . . At that point, Dr. Frankel decided to remove the prosthesis and the bone cement and make a second attempt with a new batch of bone cement. . . . His second attempt was successful and he concluded the operation." (Id.)
Plaintiff seeks damages for personal injuries and asserts state law tort causes of action sounding in strict products liability (Compl. P 16) and negligence. (Id. P 20.) The parties agree that this Court has subject matter jurisdiction over the instant action pursuant to 28 U.S.C. § 1332.
Summary judgment may be granted only where "there is no genuine issue as to any material fact" and a party is "entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c). The court is not to weigh evidence and decide the truth, but rather to determine whether or not there exists a genuine issue for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986); Owens v. New York City Housing Authority, 934 F.2d 405, 408 (2d Cir.), cert. denied, U.S. , 112 S. Ct. 431 (1991). The Court must draw all reasonable inferences, and resolve all ambiguities, in favor of the nonmoving party. Cargill, Inc. v. Charles Kowsky Resources, Inc., 949 F.2d 51, 55 (2d Cir. 1991); Schwabenbauer v. Board of Education, 667 F.2d 305, 313 (2d Cir. 1981). A motion for summary judgment must be denied if the evidence is such that a reasonable jury could return a verdict for the nonmoving party. Anderson, 477 U.S. at 248.
In the present case, the material facts are not in dispute except with respect to Plaintiff's negligent manufacture claim, and the parties' motions can, with that limitation, be determined as a matter of law.
At issue is the preemptive effect of the Federal Food, Drug, and Cosmetic Act (the "FFDCA"), 21 U.S.C. §§ 301 et seq., and amendments to the FFDCA, known as the Medical Device Amendments of 1976 (the "MDA"), 21 U.S.C. §§ 360c et seq., on Plaintiff's common law tort claims. Pursuant to the MDA, the Food and Drug Administration (the "FDA") classifies all medical devices in one of three categories. "Class I devices generally pose little or no threat to public health and safety . . . Class II items are more complex than Class I and include such devices as oxygen masks used in anesthesiology and tampons." Stamps v. Collagen Corp., 984 F.2d 1416, 1418 (5th Cir.), petition for cert. filed, 61 U.S.L.W. 3870 (U.S. June 16, 1993) (No. 92-1989). Class III devices require premarket approval from the FDA because such items "present a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii)(II). Polymethylmethacrylate bone cement, the type of bone cement utilized in Plaintiff's hip surgery, is a Class III device. 21 C.F.R. § 888.3027(b).
Certain FDA approvals are required before a Class III device may be commercially distributed. 21 C.F.R. § 888.3027(c).
In her opposition to Zimmer's motion, Reiter relies to a large extent on the contention that "all of the regulations applicable [to] Class III medical devices are merely general procedural requirements." (Pl.'s Mem. at 21.) "Quite simply, there exist no specific regulations or requirements for the manufacturing or testing of bone cement, and more practically, none of the statutory or regulatory provisions which are applicable for approval of Class III devices are device-specific in character." (Id.) Under the particular circumstances of the instant case, the Court cannot agree.
On May 17, 1976, the FDA approved Zimmer's new drug application for its polymethylmethacrylate bone cement. The FDA "concluded that the drug is safe and effective for use as recommended in the submitted labeling." (Ex. B to Sherman Aff.) "The FDA originally classified [Zimmer's bone cement] as a drug, not a medical device." (Zimmer's Reply Mem. at 2.) According to Zimmer, prior to its approval, "the FDA required that Zimmer conduct clinical studies with the bone cement before Zimmer could submit a New Drug Application (NDA) to the FDA for its consideration." (Id. at 3.) These studies "lasted three years and were conducted under the strict protocols established by the FDA for clinical studies of new drugs." (Id.) With enactment of the MDA, bone cement was reclassified as a medical device. 21 C.F.R. § 888.3027(a) & (b). "Eventually Zimmer's NDA designation for bone cement changed to Premarket Approval of Application (PMA) designation, and Zimmer's manufacture and sale of bone cement became subject to the FDA's regulations." (Sherman Aff. P 15.)
The Supremacy Clause of the Constitution
invalidates state laws that interfere with, or are contrary to federal law. The Supreme Court long ago held that "basic to this constitutional command" is the fact that all state law that conflicts with federal law is without effect. Maryland v. Louisiana, 451 U.S. 725, 746, 68 L. Ed. 2d 576, 101 S. Ct. 2114 (1981) (citing McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316, 427, 4 L. Ed. 579 (1819)). When "the field which Congress is said to have pre-empted has been traditionally occupied by the States . . . 'we start with the assumption that the historic police powers of the States [are] not to be superseded by the Federal Act unless that [is] the clear and manifest purpose of Congress.'" Jones v. Rath Packing Co., 430 U.S. 519, 525, 51 L. Ed. 2d 604, 97 S. Ct. 1305 (1977) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)).
"In determining whether a federal law pre-empts a state regulation, 'our task is to ascertain Congress' intent in enacting the federal statute at issue.'" Cable Television Association of New York, Inc. v. Finneran, 954 F.2d 91, 95 (2d Cir. 1992) (quoting Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 95, 77 L. Ed. 2d 490, 103 S. Ct. 2890 (1983)). In order to discern Congress' intent in enacting the FFDCA and the MDA, the starting place is the statute itself. "Where . . . the statute's language is plain, 'the sole function of the courts is to enforce it according to its terms.'" United States v. Ron Pair Enterprises, Inc., 489 U.S. 235, 241, 103 L. Ed. 2d 290, 109 S. Ct. 1026 (1989) (citations omitted); see also United States v. Goldberger & Dubin, P.C., 935 F.2d 501, 506 (2d Cir. 1991) ("words of a statute should be given their normal meaning and effect in the absence of a showing that some other meaning was intended"). "The purpose of a statute includes not only what it sets out to change, but also what it resolves to leave alone. . . . The best evidence of that purpose is the statutory text adopted by both Houses of Congress and submitted to the President." West Virginia University Hospitals, Inc. v. Casey, 499 U.S. 83, , 113 L. Ed. 2d 68, 111 S. Ct. 1138, 1147 (1991).
Section 360k(a) of the MDA provides, in pertinent part, that:
No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement --