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Link v. Zimmer Holdings

November 26, 2008

JOYCE LINK, PLAINTIFF,
v.
ZIMMER HOLDINGS, INC., ZIMMER U.S., INC., AND ZIMMER, INC., DEFENDANTS.



The opinion of the court was delivered by: Judge Virginia M. Kendall

MEMORANDUM OPINION AND ORDER

Plaintiff Joyce Link ("Link") filed suit against Defendants Zimmer Holdings, Inc., Zimmer U.S., Inc. and Zimmer, Inc. (collectively "Zimmer") in the Circuit Court of Cook County alleging claims of strict liability, negligence and breach of warranty based on injuries she incurred as a result of a faulty knee replacement. Zimmer removed the case to this Court under 28 U.S.C. § 1332. Zimmer now moves for summary judgment, arguing that Link's claims are preempted by the Medical Device Amendments, 21 U.S.C. §§ 360c, et seq. ("MDA") to the Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq. For the reasons stated below, this Court grants Zimmer's Motion for Summary Judgment.

STATEMENT OF FACTS*fn1

On June 14, 2000, Link underwent a knee replacement surgery on her left knee during which Zimmer's "Natural Knee II" ("N-K II") was implanted in her knee. Def. 56.1 at § 3. In October of 2004, the N-K II was removed from Link's knee. Id. at § 4. Link alleges in her Complaint that the N-K II was removed to prevent further osteolysis caused by the N-K II. Id. at § 5. Link also alleges that the N-K II was defectively designed using materials that were "prone to wear." Id.

The N-K II is a Class III medical device and therefore subject to a rigorous premarket approval application ("PMA") process conducted by the Food and Drug Administration. ("FDA"). Id. at §§ 7-8. Zimmer submitted its original PMA application for the "Natural Knee System with Cancellous Structured Titanium" on January 12, 1994. Id. at § 9. As required by the FDA, Zimmer's PMA application contained detailed information regarding the design, manufacturing, quality control, marketing, and distribution methods proposed for the N-K II. Id. at § 11.

Specifically, Zimmer submitted the following items, all of which were required by statute and regulation: 1) a statement of components, ingredients and properties and of the operation of the device, including pictorial representations, an explanation of how the device functions, the scientific concepts that form the basis for the device, and its physical and performance characteristics; 2) the methods, facilities and controls used in manufacturing, processing, packaging and storing the device, aimed at allowing the FDA to make a judgment regarding quality control; 3) a description of the properties of the device relevant to diagnosis and treatment of medical conditions; 4) the results of nonclinical laboratory studies; 5) the results of all clinical studies; 6) the results of all published reports regarding the safety and effectiveness of the device; and 7) all proposed labeling, instructions, literature and advertising regarding the device. Id. at § 9. On May 21, 1996, Zimmer submitted an Amendment to their PMA application seeking to include the second generation Natural Knee system as well as the N-K II System, the system about which Link complains, to its PMA application. Id. at § 10.

The FDA took considerable time reviewing the PMA application, raised questions, and required additional submissions from Zimmer. Id. at § 12. On March 21, 1997, the FDA approved the application for the Natural-Knee and N-K II systems. Id. at § 13. Such approval represents a specific federal determination that the N-K II is safe and effective. Id. at § 18.

The approval limited the systems to prescription use in accordance with 21 C.F.R. § 801.109 and FDA labeling requirements. Id. at § 14. It also included three mandatory conditions of approval: 1) submission of a supplemental PMA for FDA approval prior to making any changes that would change the safety or effectiveness of the devices; 2) submission of annual post-approval reports to the FDA pursuant to the requirements of 21 C.F.R. § 814.84; and 3) submissions of Adverse Reaction Reports and Device Defect Reports under relevant circumstances. Id. at § 15. In addition, the PMA required Zimmer to complete a post-approval study to evaluate the nine year survivorship of the device. This requirement included the submission of annual progress reports including survivorship data and patient accounting until the completion of the nine-year study. Id. at § 16. FDA approval for the design and manufacturing process used for the N-K II continues to this day. Id.

When Link was implanted with the N-K-II device, Zimmer maintained the approval of the N-K II as a Class III medical device in compliance with MDA regulations and with continuing FDA supervision. Id. at § 17. The manufacturing records for the N-K II implanted in Link show that all its components were manufactured in compliance with FDA approved specifications. Id. at § 19.

STANDARD OF REVIEW

Summary judgment is proper when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). In determining whether a genuine issue of fact exists, the Court must view the evidence and draw all reasonable inferences in favor of the party opposing the motion. Bennington v. Caterpillar Inc., 275 F.3d 654, 658 (7th Cir. 2001); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). However, the Court will "limit its analysis of the facts on summary judgment to evidence that is properly identified and supported in the parties' [Local Rule 56.1] statement." Bordelon v. Chicago Sch. Reform Bd. of Trustees, 233 F.3d 524, 529 (7th Cir. 2000).

DISCUSSION

The Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act imposed detailed federal oversight onto the introduction of new medical devices onto the market. Riegel v. Medtronic, 128 S.Ct. 999, 1003 (2008). The level of federal oversight varies depending on the risks the devices present. Id. Class III devices, such as the N-K II, are given the greatest oversight and are subjected to a rigorous premarket approval process. Id. at 1004.

The MDA includes a provision that expressly preempts state law. Id. at 1006. It states: "No State or political subdivision of a State may establish or continue in effect with respect to a ...


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