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September 8, 1995

NITA REITER, Plaintiff, against ZIMMER INCORPORATED, Defendant.

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


 Plaintiff Nita Reiter ("Reiter") commenced this action against Defendant Zimmer Incorporated ("Zimmer") alleging that the premature hardening of Zimmer bone cement during hip replacement surgery caused her debilitating personal injuries. Zimmer moved for summary judgment, arguing that Reiter's tort claims were preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., and the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. §§ 360c et seq.

 I. Failure of Zimmer Bone Cement

 Dr. Victor Frankel explained the difficulties he encountered replacing Nita Reiter's left hip with a prosthesis:

My technique is to use a cement gun [to fill the femoral canal so as to receive the prosthesis], mix the cement in a cup and then pour it into the gun in two minutes and then inject it. During the process of injecting the cement, it started to become very firm. The cement was then removed from the gun and finger packed into the canal. The prosthesis was immediately inserted. Prior to being fully seated the cement hardened with excessive speed. Within five minutes of the time the cement was first mixed it was completely hard and the prosthesis was fixed in the femur half in and half out. In the attempt to insert the femur in the presence of rapidly hardening cement, part of the femoral shaft fractured due to the increased hoop stresses. It was then necessary to remove the prosthesis and the cement.
The average setting time for the Zimmer bone cement is usually 13 to 17 minutes in our operating room. Setting time of five minutes is quite unexpected and does not allow the surgeon to properly implant the prosthesis.

 (Letter from Dr. Frankel to Pl.'s Att'y, dated April 15, 1991.)

 Zimmer bone cement consists of two components: a powder and a liquid. When the two are mixed in the operating room, a chemical reaction begins, and the mixture starts to set or "cure." After a few minutes the mixture becomes a soft putty and can be used to fix the prosthesis. In about 10 minutes, the mixture hardens and the prosthesis cannot be moved. (Stanton *fn1" Report at 2.) The cement hardens due to the presence of benzoyl peroxide ("BPO") in the powder. (Id. at 4.) "The BPO concentration is critical to the reaction rate of the mixed Zimmer Bone Cement and, so, to the length of time available to the surgeon to use the mixed cement." (Id. at 17.)

 Reiter contends that the batch of cement used in her operation may have hardened prematurely because it was improperly formulated and blended. It is uncontested that batch #66688200 twice failed a cure test during the blending stages of the formulation:

The BPO apparently was not added in accordance with the batch instructions because a note on the Set-up Sheet for this stage reads, "Because of failure on the 1st 45,000g (grams) cure test... only 3,435g (grams) was added...," page 3 of 4. From the dates involved, this failure appears to be reported on CPL 88-989, "Failed," December 7, 1988, and on CPL 88-992, "Reblend, Failed," December 7, 1988. Two days later, "Reblend #2, Passes," was recorded on CPL 88-998, December 9, 1988.

 (Stanton Report at 5.) Stanton suggests that this "attempt to coax' the defective batch into conformity" by adding more BPO may have been a substantial factor in the cement's premature hardening. (Stanton Aff. P 24.)

 II. Regulation of Class III Medical Devices

The premarket approval process is designed to provide a "reasonable assurance of . . . safety and effectiveness" for medical devices which are too dangerous or unknown to permit less regulation. 21 U.S.C. § 360c(a)(1)(C). Post-approval regulation is designed to keep the FDA apprised of ongoing safety findings or any other information about the device as it becomes available. Id. §§ 360e(e) & 360i(a).
Pursuant to the premarketing approval process, the FDA requires applicants to submit proposed labeling, extensive safety testing data and descriptions of manufacturing methods and materials. Id. § 360e(c)(1). Upon reviewing the materials in a comprehensive manner, the FDA may approve the device for sale or return the application to the applicant for further information or testing. Id. § 360e(d)(1). . . Once the device is approved, the FDA retains the power to withdraw approval of the product permanently or suspend its approval temporarily if it determines that the device has become unsafe or its labeling inadequate. Id. § 360e(e)(1)-(3). To assist the FDA in making these determinations, manufacturers must maintain records and make reports to the FDA on information pertinent to the device. Id. § 360i(a).

 King v. Collagen Corp., 983 F.2d 1130, 1131-32 (1st Cir.), cert. denied, 126 L. Ed. 2d 52, 114 S. Ct. 84 (1993).

From 1976 through the date of Nita Reiter's surgery, Zimmer could make no change in the design, manufacture or label affecting the safety or effectiveness of Zimmer bone cement without the prior review and approval of the FDA. (See the FDA's listing of examples of changes requiring FDA pre-approval at 21 CFR § 814.39.) In addition to the requirement that the FDA pre-approve such changes, Zimmer continued with the same record-keeping and reporting duties as had existed when bone cement was marketed under the NDA. See 21 CFR §§ 814.82 and 814.84.

 (Def.'s Reply Mem. at 4.)

 III. Alleged Failure to Comply ...

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