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August 17, 1993

NITA REITER, Plaintiff,


The opinion of the court was delivered by: LAWRENCE M. MCKENNA



 "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. *fn1"

 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). *fn2" 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 ...

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