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In Re: Zimmer Nexgen Knee Implant Products Liability Litigation

August 16, 2012


The opinion of the court was delivered by: Hon. Rebecca R. Pallmeyer

This Document Relates to All Cases


Plaintiffs, more than 500 individuals who underwent total knee replacement ("TKR") surgeries, bring suit againstDefendants, Zimmer Inc. and its affiliates (collectively, "Defendants" or "Zimmer"), manufacturers of the Zimmer NexGen Knee system.Plaintiffs allege that certain components of that system are prone to premature loosening, which has led to pain and loss of movement, necessitating revision surgery in some cases.OnAugust 8, 2011, the United States Judicial Panel on Multidistrict Litigation issued a transfer order consolidating Plaintiffs' cases in this court for pretrial proceedings.

Pursuant to this court's Order of December 19, 2011, Plaintiffs filed a Master Long Form Complaint and Jury Demand (the "Master Complaint") on January 12, 2012. Defendants filed a motion to dismiss, in part, the Master Complainton March 14, 2012. For the reasons explained below, Defendants' motion is denied.


Plaintiffs' claims involve a tibial componentdesigned for use with minimally invasive surgery techniques (the "MIS Tibial component"), and four "high-flex" femoral components (the Cruciate Retaining (CR)Flex and Legacy Posterior Stabilized (LPS)Flex components, and the "Gender Solutions" versions thereof (collectively, the "Flex femoral components")). (Master Long Form Compl. & Jury Demand [211] (hereinafter, "Master Compl."), ¶ 7.)*fn2 According to Plaintiffs, the MIS Tibial component, approved by the FDA in 2005, was a "low profile design" intended to be implanted using a smaller incision, with the benefits of reduced blood loss, less pain, shorter hospital stays, and shorter rehabilitation. (Id. ¶¶ 64, 88.) In 2010, after a study found a significantly higher failure rate among MIS Tibial components when implanted without a drop-down stem that extended further into the tibia (id. ¶ 149), and after Zimmer had received complaints of loosening of the implanted devices requiring revision surgery (id. ¶ 155), Zimmer issued an "Urgent Field Safety Notice"/ "Urgent Device Correction" letter to all customers using the MIS Tibial component (id. ¶ 115). The letter cautioned that the "MIS procedures are inherently challenging and can involve reduced visibility, which may lead to difficulty with achieving proper implant alignment and cement fixation" (id. ¶ 115), and further warned against implanting the device without the drop-down stem (Pls.' Technical Mem. at 13). In September of 2010, the FDA classified Zimmer's response as a Class II recall ofmore than 68,000 MIS Tibial components, noting that the FDA had received 114 Medical Device Reports of loosening that required revision surgery. (Id. ¶¶ 17, 155-56.)

Though the Flex femoral componentshave not been similarly subject to a recall, Plaintiffs allege that these components are similarly prone to loosening. The Flex femoral components are "high-flex" devices, designed to accommodate flexion (bending of the knee), up to 155 degrees.

(Id. ¶¶ 9, 62-63; Pls.' Technical Mem. at 7-8.) While a typical, healthy knee has the capacity to bend between 155 to 160 degrees, the Zimmer NexGen non-Flex knees that preceded the Flex versions were able to achieve only between 120 to 130 degrees of flexion. (Master Compl. ¶¶ 9, 39, 57.) Plaintiffs allege that Zimmer marketed the Flex knee design for patients with more active lifestyles, particularly for those who garden or kneel for prayer, or for those whose cultural activities and lifestyles require considerable squatting or kneeling activities. (Id. ¶¶ 102-10.)

Plaintiffs cite to a number of studies in peer-reviewed journals, however, that observe high rates of looseningfor Flex femoral components. (Master Compl. ¶ 128-29; Pls.' Technical Mem. at 11;Pls.' Resp. at 31.)*fn3 The studies hypothesize that the loosening is caused by asymmetric distribution of the heightened forces during deep knee flexion. See P. Bollars et al., Femoral Component Loosening in High-Flexion Total Knee Replacement, 93-B J. Bone & Joint Surgery 1355, 1361 (2011) ("[H]igh-flexion designs have a greater risk for loosening of the femoral component than conventional TKR designs. The absence of femoral load sharing between the prosthetic component and the condylar bone during flexion is in our opinion an important contributing factor."); Sung-Do Cho et al., Three- to Six-Year Follow-Up Results After High-Flexion Total Knee Arthroplasty: Can We Allow Passive Deep Knee Bending?, 19 Knee Surgery, Sports Traumatology, Arthroscopy 899, 903 (2011) ("[W]ith passive deep knee bending, excessive compressive force could be applied at the posterior femoral condyle, leading to distal shear and anterior tensile forces . . . . Inadequate bony support of the posterior femoral condyle may result in micromotion and early loosening of the femoral component."); H. S. Han et al., High Incidence of Loosening of the Femoral Component in Legacy Posterior Stabilised-Flex Total Knee Replacement, 89-B J. Bone & Joint Surgery 1457, 1460 (2007) ("If deep knee flexion is achieved, asymmetrical loading between the medial and lateral compartments of a TKR may contribute to loosening and failure of the implant.").*fn4 Plaintiffs also question whether NexGen Flex femoral components offer any real benefit in flexion, citing studies that show no statistically significant difference in the range of motion achieved by those with Flex devices when compared with that of those implanted with their non-Flex counterparts.(Master Compl. ¶¶ 127, 131.)


I. Applicability of Rule 12(b)(6)

As a preliminary matter, the parties disagree about whether Defendants are entitled to bring a motion to dismiss particular causes of action in Plaintiffs' Master Complaint. Plaintiffs raise two objections to 12(b)(6) motion practice: (1) that Defendants waived their right to bring a motion to dismiss when, prior to the consolidation of these cases in this Multidistrict Litigation ("MDL"), the Defendants filed answers to the complaints in individual actions involving each of the devices at issue;*fn5 and (2) that the Plaintiffs' individual actions should not be subject to a "master motion to dismiss" directed at the Master Complaint, which is merely an administrative device that Plaintiffs objected to filing in the first place. The court addresses each of these arguments in turn.

A motion under Rule 12(b)(6) for failure to state a claim upon which relief may be granted "must be made before pleading if a responsive pleading is allowed." FED. R. CIV. P. 12(b). A motion for judgment on the pleadings under Rule 12(c) may be filed after pleadings are closed, however, and such a motion is governed by the same standard as a 12(b)(6) motion. See Buchanan-Moore v. Cnty. of Milwaukee, 570 F.3d 824, 827 (7th Cir. 2009).Thus, Defendants are free to file a Rule 12(c) motion arguing that complaints failed to state a claim upon which relief can be granted. See FED. R. CIV. P. 12(h)(2)(B). The fact that Defendants have styled their motion to dismiss as a Rule 12(b)(6) motion does not alter this analysis. See Alioto v. Town of Lisbon, 651 F.3d 715, 718 (7th Cir. 2011) (citing McMillian v. Collection Prof'ls Inc., 455 F.3d 754, 757 n.1 (7th Cir. 2006)). The court concludes that it makes no difference whether Defendants' motion is a 12(b)(6) motion in response to the Master Complaint-which, as an amended complaint, supercedes the original complaint, rendering all prior pleadings without legal effect, see Massey v. Helman, 196 F.3d 727, 735 (7th Cir. 1999)-or a motion filed after the close of pleadings under Rule 12(c).

Plaintiffs' second challenge to the propriety of this motion requires more analysis. They contend that a "master motion to dismiss" targeted at the Master Complaint is inappropriate in light of the purposes of a consolidated complaint in an MDL. Plaintiffs cite a number of MDL opinions which recognize that a "master" or "consolidated" complaint is a "procedural device used to promote judicial efficiency and economy," not to be "given the same effect as an ordinary complaint" or considered to "'merge the suits into a single cause, or change the rights of the parties, or make those who are parties in one suit parties in another.'" In re Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 141-42, 144 (E.D. La. 2002) (quoting 9 Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 2382 (1971)) (citing Diana E. Murphy, Unified and Consolidated Complaints in Multidistrict Litigation, 132 F.R.D. 597 (1991)); see also In re Vioxx Prods. Liab. Litig., 239 F.R.D. 450, 454 (E.D. La. 2006) ("[A] master complaint is only an administrative device used to aid efficiency and economy and, thus, should not be given the status of an ordinary complaint."); In re Digitek Prods. Liab. Litig., MDL No. 2:08-md-01968, 2009 WL 2433468, at *8 (S.D. W. Va.Aug. 3, 2009) (considering a motion to dismiss in light of "[t]he administrative nature of a master complaint and its focus on facilitating management of the litigation, as opposed to being a primary operative pleading"). This court agrees that "master" or "consolidated" complaints must be interpreted in light of the "primary purpose" of multidistrict litigation: "to promote efficiency through the coordination of discovery." In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1997 WL 109595, at *2 (E.D. Pa. Mar. 7, 1997); see also 28 U.S.C. § 1407(a) ("[T]ransfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.").

In light of a master complaint's administrative purpose, several MDL courts have refused to entertain motions to dismiss master complaints where doing so would require case-specific rulings to determine the sufficiency of each individual plaintiff's factual allegations. See In re Nuvaring Prods. Liab. Litig., No. 4:08MD1946 RWS, 2009 WL 4825170, at *2 (E.D. Mo. Dec. 11, 2009); In re Trasylol Prods. Liab. Litig., No. 08-MD-1928, 2009 WL 577726, at *8 (S.D. Fla. Mar. 5, 2009). In Trasylol, for example, the court, faced with over 400 separate cases, assessed the sufficiency of the master complaint's fraud claims with "substantial leniency"; the court concluded that any master complaint that contained all of the plaintiff-specific allegations defendant demanded would "completely remov[e] the compromise and attempt at efficiency the Parties and [the court] had in mind in allowing the filing of the Consolidated Master Complaint." Trasylol, 2009 WL 577726 at *8. Similarly, the Nuvaring court concluded that case-specific rulings on the sufficiency of the plaintiffs' allegations "are neither the purpose, nor the forte of a court presiding over a multi-district litigation. A MDL seeks to promote judicial economy and litigant efficiency by allowing the transferee court to preside over matters common among all cases. . . . Given this function, the transferee court typically does not rule on cumbersome, case specific legal issues."

Nuvaring, 2009 WL 4825170, at *2 (quoting In re Phenypropanolamine Prods. Liab. Litig., No. MDL 1407, 2004 WL 2034587, at *2 (W.D. Wash. Sept. 3, 2004)). The court agrees with this rationale. With more than 549 individual actions already consolidated in this litigation, the Master Complaint cannot be expected to include specific factual matter for claims that require plaintiff-specific proof. The proper court to hear dispositive motions concerning the sufficiency of plaintiff-specific allegations is the transferor court, see Manual for Complex Litigation (Fourth) ยง 22.37 ("When the MDL pretrial proceedings are concluded and individual cases are remanded to the transferor courts, the transferor ...

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