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McCutcheon v. Zimmer Holdings

August 6, 2008

ARDIS MCCUTCHEON, PLAINTIFF,
v.
ZIMMER HOLDINGS, INC., ET AL., DEFENDANTS.



The opinion of the court was delivered by: Milton I. Shadur Senior United States District Judge

MEMORANDUM OPINION AND ORDER

Ardis McCutcheon ("McCutcheon") brought this product liability action against Zimmer Holdings, Inc., Zimmer US, Inc., Zimmer, Inc., Zimmer Daniel Associates and Zimmer Smith Associates (collectively "Zimmer," treated here as a singular noun to avoid awkwardness in this opinion's verb usage), asserting that Zimmer had defectively designed and manufactured an artificial knee replacement device known as the Natural Knee II ("N--K II") that was implanted in McCutcheon's knee in 1998. As a result of the N-K II's assertedly defective nature, McCutcheon says she experienced pain and suffering and incurred significant medical expenses associated with a second knee replacement surgery she was forced to undergo in 2004.

Zimmer has now moved for summary judgment under Fed. R. Civ. P. ("Rule") 56. For the reasons stated in this opinion, its motion is granted.

Summary Judgment Standards

Every Rule 56 movant bears the burden of establishing the absence of any genuine issue of material fact (Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986)). For that purpose courts consider the evidentiary record in the light most favorable to nonmovants and draw all reasonable inferences in their favor (Lesch v. Crown Cork & Seal Co., 282 F.3d 467, 471 (7th Cir. 2002)). But to avoid summary judgment a non-movant "must produce more than a scintilla of evidence to support his position" that a genuine issue of material fact exists (Pugh v. City of Attica, 259 F.3d 619, 625 (7th Cir. 2001)) and "must set forth specific facts that demonstrate a genuine issue of triable fact" (id.). Ultimately summary judgment is warranted only if a reasonable jury could not return a verdict for the non-movant (Anderson v. Liberty Lobby, Inc., 466 U.S. 242, 248 (1986)).

This District Court has implemented Rule 56 through its LR 56.1, which requires both sides to submit factual statements supported by record evidence. As to any non-movant (such as McCutcheon) who seeks to avoid summary judgment, LR 56.1(b)(3)(B) calls for "a response to each numbered paragraph in the moving party's statement, including, in the case of any disagreement, specific references to the affidavits, parts of the record, and other supporting materials relied upon." In addition LR 56.1(b)(3)(C) requires the non-movant to submit "a statement, consisting of short numbered paragraphs, of any additional facts [not set out in the movant's papers] that require the denial of summary judgment...."

McCutcheon and her counsel have not complied with LR 56.1. They did not file the required response to Zimmer's LR 56.1(a)(3) statement, nor did they file a statement of additional facts. Instead they have merely sprinkled various asserted facts into a memorandum that is otherwise wholly dedicated to advancing legal arguments as to why Zimmer's motion should be denied. Even more critically, they have not supported any of those asserted facts with admissible evidence such as exhibits or affidavits.

Put simply, McCutcheon's response--or nonresponse, really--to Zimmer's 56.1(a) statement is wholly inadequate. Under LR 56.1's enforcement provision, "[a]ll material facts set forth in the statement required of the moving party will be deemed to be admitted unless controverted by the statement of the opposing party." And our Court of Appeals has "consistently held that a failure to respond by the non-movant as mandated by the local rules results in an admission" of facts (Smith v. Lamz, 321 F.3d 680, 683 (7th Cir. 2003)). What follows then is a summary of the facts as advanced by Zimmer in its LR 56.1 statement.*fn1

Factual Background

N-K II is an artificial knee replacement device designed and manufactured by Zimmer (Z. Mem. 1, Z. St. ¶11). It has been classified by the Food and Drug Administration ("FDA") as a Class III medical device and was approved by the same agency through an extensive process known as premarket approval (Z. St. ¶¶7-8).

Zimmer began the premarket approval process on January 12, 1994 when it submitted an application to the FDA regarding the Natural-Knee(r) System with Cancellous Structured TitaniumTM ("Natural-Knee")(Z. St. ¶9). On May 21, 1996 Zimmer tendered an amendment to its pending application, seeking to expand it so that it would include the N-K II as well (Z. St. ¶10).

As required by the FDA, Zimmer's premarket approval application contained detailed information as to the design, operation, manufacturing methods and processes, quality control procedures, marketing and distribution of the N-K II (Z. St. ¶¶9, 11). It also contained descriptions of all clinical and non-clinical laboratory studies concerning the N-K II, copies of all proposed labeling, operating instructions, literature and advertising for the device and a bibliography of published reports concerning its safety and effectiveness (id.). And in response to questions later posed by the FDA, Zimmer provided the agency with even more data, information and supporting documents (Z. St. ¶12).

On March 21, 1997 the FDA approved Zimmer's premarket approval application for both the Natural-Knee and the N-K II (Z. St. ¶13). Since that time the FDA has subjected both devices to several post-marketing requirements (Z. St. ¶14). For instance, Zimmer must submit (1) a premarket approval supplement that the FDA reviews before Zimmer can make any changes to the design, manufacturing or warnings of the devices, (2) annual FDA post-approval reports that satisfy the regulations in 21 C.F.R. §814.84 and (3) in some specified circumstances, adverse reaction and device defect reports (id.). Zimmer must also complete a post-approval survivorship study designed to evaluate the nine-year survivorship of its two devices (Z. St. ¶15). As part of that last requirement, Zimmer must provide the FDA with a post-approval study protocol and, continuing through the end of the post-approval study, annual progress reports summarizing survivorship data and patient accounting (id.).

On August 10, 1998 McCutcheon underwent knee replacement surgery during which the N-K II device was implanted in her right knee (Z. St. ¶3). Six years later (on September 10, 2004) that device was surgically removed from McCutcheon's knee (Z. St. ¶4). According to McCutcheon, that removal was necessary to "repair ...


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