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Krammes v. Zimmer, Inc.

United States District Court, M.D. Pennsylvania

July 24, 2015



EDWIN M. KOSIK, District Judge.

Before the Court are Defendants' Motion to Dismiss Plaintiffs' Second Amended Complaint (Doc. 26). For the reasons which follow, the Court will grant in part and deny in part Defendants' motion to dismiss.


On May 16, 2011, Plaintiffs filed a Complaint (Doc. 1). Defendants filed their first Motion to Dismiss (Doc. 5), on July 14, 2011. On August 16, 2011, by Order of the United States Judicial Panel on Multidistrict Ligitation, the case was transferred to the Northern District of Illinois (Doc. 13). The case was then transferred back to the Middle District of Pennsylvania on July 11, 2014 (Doc. 14). Plaintiffs filed the Amended Complaint (Doc. 23), on November 21, 2014. The Counts in the Amended Complaint include: Count I - Strict Liability (Design Defect); Count II - Strict Liability (Manufacturing Defect); Count III - Negligent Failure to Warn; Count IV - Negligent Design Defect; Count V - Negligence; Count VI - Negligent Misrepresentation; and Count VII - Loss of Consortium.

Defendants filed the instant motion to dismiss (Doc. 26), on December 22, 2014. After extensions of time were granted, the motion was briefed by both parties. On March 17, 2015, the Court heard oral argument on the motion. The motion is ripe for disposition.


The following facts are taken from Plaintiffs' Amended Complaint and are accepted as true for purposes of the instant motion. Plaintiffs allege that Defendants developed, designed, tested, manufactured, distributed, marketed and sold the Zimmer NexGen Legacy Posterior Stabalized porous femoral component with a LPS Flex articular surface ("LPS High Flex") and the NexGen Trabecular Metal MIS Stemmed Tibial component ("MIS Tibial"), of the Zimmer NexGen total knee replacement system. (Doc. 23, Second Am. Compl., at ¶ 1.) On August 1, 2008, Plaintiff James Krammes's physician, implanted a Zimmer NexGen Knee system, including a LPS High Flex, with a porous femoral component, and a MIS Tibial. (Id. at ¶ 54.)

Following the knee replacement, Mr. Krammes experienced pain and returned to his physician several times. (Id. at ¶ 57.) On or about August 24, 2009, x-rays revealed prosthetic loosening for the first time. (Id. at ¶ 58.) Mr. Krammes had a second surgery on September 30, 2009, to revise/replace the MIS Tibial and LPS High Flex, due to loosening. (Id. at ¶ 59.) During surgery, "Plaintiff's doctor discovered a lack of boney ingrowth with the femoral component, delamination of the tibia component and loosening of the posterior page." (Id.) The implant was then revised with the Zimmer NexGen Legacy Posterior Stabilized ("LPS") femur, extra stemmed length tibial component, and a LCCK spacer. (Id.) On June 23, 2010, Mr. Krammes had a third surgery to revise/replace the implant due to a possible nickel allergy. (Id. at ¶ 60.)

In December 2009, Zimmer recalled certain lots of the MIS Tibial implant because of a manufacturing defect. (Id. at ¶ 45.) It was determined that the titanium portion of the implant was separating from the trabecular metal material of the implant, which would cause the implant to delaminate and the implant become loose while in the patient. (Id.) 846 implants were affected by the recall. (Id.) On March 10, 2010, the Food and Drug Administration classified Defendants' efforts as a Class II Recall. (Id. at ¶ 47.)


A motion under Rule 12(b)(6) allows the defendant to raise the defense that the plaintiff fails to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). Rule 8 of the Federal Rules of Civil Procedure provides that a pleading must set forth a claim for relief which contains a short and plain statement of the claim showing that the pleader is entitled to relief; the complaint must provide the defendant with fair notice of the claim. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). The issue in a motion to dismiss is whether the plaintiff should be entitled to offer evidence to support the claim, not whether the plaintiff will ultimately prevail. See Phillips v. Cnty. of Allegheny, 515 F.3d 224, 232 (3d Cir. 2008) (the Rule 8 pleading standard "simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element."); Nami v. Fauver, 82 F.3d 63, 65 (3d Cir. 1996).

The onus is on the plaintiff to provide a well-drafted complaint that alleges factual support for its claims. "While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds' of his entitle[ment] to relief' requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555 (alteration in original and internal citations omitted). The Court need not accept unsupported inferences, Cal. Pub. Employees Ret. Sys. v. The Chubb Corp., 394 F.3d 126, 143 (3d Cir. 2004), nor legal conclusions cast as factual allegations, Twombly, 550 U.S. at 556. Legal conclusions without factual support are not entitled to the assumption of truth. See Ashcroft v. Iqbal, 556 U.S. 662, 677-679 (2009) ("Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not" satisfy the requirements of Rule 8).

Once the Court winnows conclusory allegations from those allegations supported by fact, which it accepts as true, the Court must engage in a common sense review of the claim to determine whether it is plausible. This is a context-specific task, for which the Court should be guided by its judicial experience. The Court must dismiss the complaint if it fails to allege enough facts "to state a claim to relief that is plausible on its face." Iqbal, 556 U.S. at 677 (quoting Twombly, 550 U.S. at 570). A "claim has facial plausibility when the plaintiff pleads factual ...

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