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Maxwell v. Howmedica Osteonics Corp.

May 10, 2010

BEVERLY R. MAXWELL, PLAINTIFF,
v.
HOWMEDICA OSTEONICS CORP., DEFENDANT.



The opinion of the court was delivered by: Hon Glenn T. Suddaby, United States District Judge

DECISION and ORDER

Currently before the Court in this products liability action, filed by Beverly Maxwell ("Plaintiff") against Howmedica Osteonics Corp. ("Defendant"), is Defendant's motion for summary judgment. (Dkt. No. 28.) For the reasons set forth below, Defendant's motion is granted in its entirety, and Plaintiff's Complaint is dismissed.

I. RELEVANT BACKGROUND

A. Plaintiff's Complaint

On March 27, 2008, Plaintiff filed her Complaint in this action. (Dkt. No. 7.) Liberally construed, Plaintiff's Complaint, brought under theories of negligence and strict products liability, asserts against Defendant claims of design defect and failure to warn, arising from the injuries she sustained during a total knee replacement surgery on June 15, 2004. (Dkt. No. 2.) More specifically, Plaintiff alleges that she sustained personal injuries as a result of (1) Defendant's defective design of a total knee-replacement system known as the Duracon Total Knee System ("Duracon System"), which it manufactured, and (2) Defendant's failure to provide adequate warning labels regarding the Duracon System's metallic components in its prosthetic knee, in particular, the prosthetic knee's "high percentage of nickel," which created a foreseeable danger, and caused her to suffer an allergic reaction. (Id.) Familiarity with the remaining factual allegations supporting Plaintiff's claims in her Complaint is assumed in this Decision and Order, which is intended primarily for review by the parties.

B. Deadline for Service of Expert Disclosures

On April 18, 2008, United States Magistrate Judge David E. Peebles issued a Uniform Pretrial Scheduling Order in this action. (Dkt. No. 14.) That Order required, among other things, Plaintiff to serve expert disclosures by June 1, 2009. (Id. at 2.) On May 28, 2009, upon the request of the parties, Magistrate Judge Peebles reluctantly issued an Amended Scheduling Order, noting that there would be "NO FURTHER EXTENSIONS OF THE DEADLINES UNDER ANY CIRCUMSTANCES." (Text Amended Scheduling Order filed May 28, 2009.) That Amended Order required, among other things, Plaintiff's expert disclosures to be served by July 15, 2009, and Defendant's expert disclosures to be served by September 14, 2009. (Id.)*fn1

C. Undisputed Material Facts

The following material facts are asserted and established (through the citation to admissible record evidence) by Defendant in its Local Rule 7.1 Statement, and either expressly admitted by Plaintiff or unsuccessfully controverted by her in her Local Rule 7.1 Response. (Compare Dkt. No. 28, Attach. 3 [Def.'s Rule 7.1 Statement] with Dkt. No. 33 [Plf.'s Rule 7.1 Response].)*fn2

On June 15, 2004, Plaintiff underwent a total knee replacement procedure at Oswego Hospital in Oswego, New York. The procedure was performed by Dr. William Mahon, an orthopedic surgeon. The product implanted into Plaintiff was the Duracon System manufactured by Defendant. The product labels reveal that the following metal components were implanted into Plaintiff: (1) Howmedica Cemented Stem Extender (Cat# 6476-8-250; Lot# LCM123); (2) Duracon Non-Beaded Femoral Component (Cat# 6630-0-515; Lot# LTTLK); and (3) Howmedica Universal Tibial Baseplate (Cat# 6632-3-620; Lot# NOKF).

The Duracon System is an FDA-regulated medical device that can only be sold to licensed health care providers and must be prescribed for use by a licensed surgeon based upon his or her education, training and experience, and based upon his or her own medical judgment and assessment of the patient's specific needs. All potential risks associated with use of the Duracon System were provided by Defendant to Dr. Mahon as the learned intermediary. The package inserts for the Duracon System components distributed with the components themselves contained specific information regarding the metallic composition of the components. The package inserts for the Duracon System warned specifically of the potential for material sensitivity and reactions to the metallic components.

In accordance with expert disclosure deadlines, Plaintiff disclosed one expert, Dr. Michael Clarke, an orthopedic surgeon who performed Plaintiff's "revision" surgery on August 8, 2005. Dr. Clarke opines that "Plaintiff suffered from an exacerbation of a probable true nickel allergy arising out of insertion of the [Duracon System] . . ." and that, during the revision surgery, the Duracon System had to be removed and replaced with a Smith & Nephew Genesis II Oxinium femur ("the Genesis II") which "is almost nickel free." (Dkt No. 32, Attach. 1 [Affid. of Dr. Clarke].)

Familiarity with the remaining undisputed material facts of this action, as set forth in the parties' Local Rule 7.1 Statement and Local Rule 7.1 Response, is assumed in this Decision and Order, which is intended primarily for review by the parties. (Id.)

D. Defendant's Motion for Summary Judgment

On August 6, 2009, Defendant filed a motion for summary judgment in this action. (Dkt. No. 28.) Generally, in support of its motion, Defendant asserts the following two arguments: (1) Plaintiff's entire Complaint should be dismissed because she has failed to introduce expert witness testimony demonstrating either a design defect or the existence of inadequate warnings, and such testimony is required to establish such claims; and (2) Plaintiff's failure-to-warn claim should be dismissed because Defendant warned physicians and the medical community of the specific risk at issue in this action. (Dkt. No. 28, Attach. 1, at 5-11 [Def.'s Mem. of Law].)

On September 11, 2009, after receiving an extension by the Court, Plaintiff filed an opposition to Defendant's motion. (See Text Order filed 9/2/09; Dkt. No. 32.) In her opposition, Plaintiff addresses only Defendant's first argument (i.e., its argument regarding Plaintiff's failure to adduce expert testimony), neglecting to address Defendant's second argument (i.e., its argument regarding its having provided warnings to physicians and the medical community). (Id. at 6-7.) More specifically, Plaintiff argues that expert testimony is not necessary under the circumstances for three reasons: (1) "[n]ickel is widely known and accepted in the medical profession as highly toxic," a fact of which the Court can, and should, take judicial notice; (2) the medical records in the action establish that Plaintiff's body was harmed by the implantation of the Duracon System; and (3) Plaintiff has adduced an affidavit establishing the existence of a feasible alternative to the Duracon System (i.e., a device manufactured by Smith & Nephew, which contains a negligible amount of nickel). (Id.)

On September 18, 2009, Defendant filed a reply in further support of its motion for summary judgment. (Dkt. No. 36.) Generally, in its reply, Defendant (1) rejects Plaintiff's three arguments regarding her failure to adduce expert testimony, and (2) argues that Plaintiff has failed to address Defendant's argument regarding its having provided warnings to physicians and the medical community. (Id. at 2-7.)

II. LEGAL STANDARD GOVERNING MOTIONS FOR SUMMARY JUDGMENT

In their motion papers, the parties demonstrated an accurate understanding of the general standard governing motions for summary judgment. As a result, and for the sake of brevity, the Court will not recite the well-known general legal standard governing motions for summary judgment in this Decision and Order, but will direct the reader to the Court's decision in Pitts v. Onondaga County Sheriff's Dep't, 04-CV-0828, 2009 WL 3165551, at *2-3 (N.D.N.Y. Sept. 29, 2009) (Suddaby, J.), which accurately recites that general legal standard.

The Court will add only one point. Implied in the burden-shifting legal standard described in Pitts v. Onondaga County Sheriff's Dep't is the fact that, where a nonmoving party willfully fails to adequately respond to a properly filed motion for summary judgment, a district court has no duty to ...


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