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In re Zimmer Nexgen Knee Implant Products Liability Litigation

United States District Court, N.D. Illinois, Eastern Division

October 21, 2016

IN RE ZIMMER NEXGEN KNEE IMPLANT PRODUCTS LIABILITY LITIGATION
v.
ZIMMER, INC., Defendant. THEODORE JOAS and DARLENE JOAS, Plaintiffs, Nos. 11 C 5468, 13 C 9216

          MEMORANDUM OPINION AND ORDER

          REBECCA R. PALLMEYER United States District Judge.

         Defendant Zimmer Inc. manufactures knee implants, among other medical devices. Plaintiffs in this multidistrict litigation proceeding (MDL) are individuals whose native knees were replaced by Zimmer NexGen Flex knee implants during total knee replacement (TKR) surgery. They allege that they have suffered pain and loss of movement, and in some cases, have had to undergo revision surgeries, because the NexGen Flex device is prone to premature loosening.

         The second case to be scheduled for a bellwether trial in this MDL was brought by Plaintiff Theodore Joas and his wife, Darlene Joas. Mr. Joas underwent revision surgery in 2014 because of loosening in the tibial component of his NexGen Flex implant, loosening that he alleges resulted from a defect in the implant's design. The first bellwether case-brought by Plaintiff Kathy Batty and her husband, Thomas Batty-went to trial roughly one year ago and resulted in a jury verdict for Zimmer. See Batty v. Zimmer, Inc., No. 12 C 6279 [141]. In advance of the Batty trial, this court issued a number of rulings on evidentiary matters and on Zimmer's motion for summary judgment. See, e.g., In re Zimmer Nexgen Knee Implant Prod. Liab. Litig., No. 11 C 5468, 2015 WL 3669933, at *1 (N.D. Ill. June 12, 2015) [hereinafter "Batty Opinion"] (ruling on motions to exclude testimony of two of plaintiff's experts, Dr. Thomas Brown and Dr. Joseph Fetto, and granting motion for summary judgment in part and denying it in part). In Joas's case, the parties have again filed a number of motions in limine, including requests from both sides to exclude testimony from certain of the other's expert witnesses, and Zimmer has again moved for summary judgment on all counts.

         In this opinion, the court addresses Zimmer's motion to exclude the testimony of Dr. Joseph Fetto [31] under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), as well as Zimmer's motion for summary judgment [37]. Zimmer argues that Dr. Fetto's testimony should be excluded because his opinion regarding the cause of the loosening in Joas's tibial component is based on an unreliable methodology. Dr. Fetto employed a differential diagnosis, or "differential etiology, " an accepted and well-established method for determining causation, but Zimmer argues that Dr. Fetto failed to apply the method correctly. In addition to its criticism of Dr. Fetto's testimony, Zimmer contends that Plaintiffs lack reliable expert testimony to establish that the design of the NexGen Flex knee was defective or that any alleged defect caused Joas's injury. Zimmer also argues that there was nothing inadequate about the warning contained in the device's package insert and that Plaintiffs have not shown that any change in Zimmer's warning would have prevented Joas's injury.

         Plaintiffs respond that the biomechanical engineering testimony of Dr. Thomas Brown and the statistical analysis offered by Dr. David Madigan will provide a sufficient basis for the jury to conclude that the NexGen Flex contains a design defect. Further, they assert that Dr. Fetto's testimony, which is based on his examination of Joas and a review of his medical records, will establish that the implant's defective design was the cause of Joas's injury. In support of their failure-to-warn claims, Plaintiffs contend that Zimmer failed to warn about the risks of engaging in high-flexion (that is, bending the knee beyond 120 degrees) activities with the NexGen Flex knee and failed to provide adequate instructions to surgeons about the amount of cement required to affix the implant to the patient's bone. That Zimmer's warnings were inadequate and that improved warnings would have avoided Joas's injury are points so obvious, they insist, that no expert testimony is necessary to establish them.

         For the reasons discussed below, the court concludes that, because Dr. Fetto failed to apply his stated methodology in a reliable manner, his testimony must be excluded. The court also concludes that Plaintiffs have failed to present sufficient evidence to allow a jury to find for them on any of their claims. The court therefore grants Zimmer's motion for summary judgment on all counts.

         BACKGROUND

         In February 2008, at the relatively young age of 54, Joas underwent total knee replacement surgery because rheumatoid arthritis was causing persistent pain in his left knee. (Report of Dr. Joseph Fetto, re: Theodore Joas (July 22, 2016), Ex. B to Zimmer's Mem. in Supp. of Mot. to Exclude Test. of Dr. Joseph Fetto (hereinafter "Def.'s Fetto Mem.") [32-2], (hereinafter "Fetto Rep."), at 2.) Dr. Bryan Larson performed the surgery at Sacred Heart Hospital in Eau Claire, Wisconsin, and selected the Zimmer NexGen Flex knee implant that would replace Joas's native knee. (Id.) As the court has discussed previously, the NexGen Flex implant was designed to allow patients to achieve higher flexion than they could when using the "Standard" version of Zimmer's NexGen implant. See Batty Opinion, 2015 WL 3669933, at *2-*3.[1] At the time of his surgery, Joas weighed 202 pounds and stood five feet, seven inches tall, giving him a body mass index (BMI) of 31. (Dep. of Dr. Joseph Fetto, Ex. C to Def.'s Mem. in Supp. of Mot. to Excl. Testimony of Dr. Joseph Fetto [32-3] (hereinafter "Fetto Dep.), at 358:6-11.)

         Joas's recovery from surgery went well, and he was eventually able to return to work for Pepsi Bottling Group, where his job required him to lift and carry heavy loads and to squat repetitively during the course of a day. (Id.) After returning to work, Joas continued to engage in physical therapy at home and also participated in other physical activities, including exercising on a stationary bicycle and recreational hunting, canoeing, and fishing. (Id.) At some point in 2011 or 2012, however, Joas again began to experience pain in his left knee. (See Dep. of Theodore Joas, Ex. L to Def.'s Mem. in Supp. of Mot. to Excl. Testimony of Dr. Joseph Fetto [32-12] (hereinafter "Joas Dep.), at 200:1-11.) In August 2012, Dr. William Decesare ordered an x-ray and bone scan of Joas's knee, the results of which were consistent with aseptic loosening of the tibial component of Joas's implant. (Fetto Rep. at 2.) Joas then saw an orthopedic surgeon, Dr. Scott Cameron, who concurred with the diagnosis of aseptic loosening of the tibial component and performed a revision of that component in October 2014, again at Sacred Heart Hospital in Eau Claire. (Id.)

         Plaintiffs contend that Joas's tibial component loosened because the design of the NexGen Flex causes premature loosening in TKR patients who engage in high-flexion activities following their surgeries, a risk about which Zimmer allegedly failed to warn. Plaintiffs' complaint alleged a host of claims: strict liability design defect, strict liability failure to warn, strict liability manufacturing defect, negligence, negligent misrepresentation, breach of express warranty, breach of implied warranty, violation of Wisconsin consumer protection law, unjust enrichment, and fraudulent concealment. (See Pls.' Approved Short Form Compl. [1] at 5-8.) Plaintiffs also alleged that Zimmer's wrongdoing supports an award of punitive damages. (Id. at 8.) Zimmer has moved for, and advanced arguments in support of, summary judgment on all counts, but Plaintiffs responded only to the arguments regarding design defect, failure to warn, negligence, and punitive damages. In support of their design defect and negligence claims, Plaintiffs offer the expert testimony of Dr. Brown, Dr. Madigan, and Dr. Fetto. In particular, Plaintiffs rely on the testimony of Dr. Brown and Dr. Madigan to support the contention that the NexGen Flex design predisposes the implant to tibial loosening, while Dr. Fetto's testimony is offered to establish that it was a defect in the NexGen Flex that caused Joas's loosening. Plaintiffs offer no expert testimony in support of their failure-to-warn claims. The court discusses the proposed testimony of Plaintiffs' experts below, before discussing the facts underlying Plaintiffs' failure-to-warn claims.

         I. Dr. Brown's Proposed Expert Testimony

         The court discussed Dr. Brown's biomechanical engineering opinions extensively in its ruling on Zimmer's Daubert motion to exclude his testimony in Batty. See Batty Opinion, 2015 WL 3669933, at *7-*18. Over Zimmer's objections, the court permitted Dr. Brown to testify that the design of NexGen Flex predisposes the implant to femoral and tibial loosening. Id. Unlike in Batty, there is no evidence in this case that the femoral component of Joas's implant loosened, so the court will confine its discussion to Dr. Brown's theory of tibial loosening. Essentially, the theory of tibial loosening Dr. Brown presented in Batty is as follows: When individuals engage in high-flexion, weight-bearing activities (deep squatting, for example), there is the potential for significantly elevated loading to concentrate on the posterior (that is, the rear) surface of the tibial component. This high concentration of loading can then cause the tibial component to "rock" or "toggle, " which could lead to loosening of the component, or "fixation interface failure, " over time. See Id. at *16; (Supp. Expert Report of Thomas Brown, Ex. A to Def.'s Mot. for Summ. J. [34-1] (hereinafter "Brown Supp. Rep."), at 1.) Patients who receive the NexGen Standard implant are unlikely to flex their knees to an angle greater than 130 degrees, Dr. Brown explains, because at that angle of flexion, the femoral bone would impinge on, or collide with, the tibial component. (See Expert Report of Thomas Brown, Ex. 3 to Pls.' Resp. to Zimmer's Second Daubert Mot. [121-1] (hereinafter "Brown Rep."), at 48.) The NexGen Flex, however, has a posteriorly extended femoral component, which allows patients who receive the implant to achieve an additional 25 degrees of flexion before "impingement" would occur. (Id. at 49.) Dr. Brown's initial expert report, prepared in advance of the Batty trial, criticized Zimmer for failing to conduct testing to compare the propensity for micro-motion under "worst-case scenarios" for the respective Standard and Flex designs; that is, Zimmer did not compare the micro-motion of the Standard knee's tibial component at its maximum flexion angle of 130 degrees with that of the Flex knee's tibial component at its maximum flexion angle of 155 degrees. (Id.) According to Dr. Brown's theory, the increased flexion in patients with Flex implants would cause increased loading forces on the posterior surface of the tibial component as well as additional shifting of the force toward the component's posterior edge.[2] (See Brown Supp. Rep. at 1.)

         In Batty, the court declined to exclude Dr. Brown's opinion regarding tibial loosening because Dr. Brown had reliably explained why the Flex design would be more prone to tibial loosening than would the Standard design under high flexion. Batty Opinion, 2015 WL 3669933, at *16. Although Dr. Brown did not conduct any tests to show that the Flex knee actually would be subject to increased micro-motion (and thus loosening) at high-flexion angles, the court noted that testing of an opinion is not a prerequisite for its admissibility. The court concluded that Dr. Brown was free to criticize Zimmer's internal testing and to infer what an alternative testing protocol would have revealed. Id. at *17. In the supplemental report that Dr. Brown recently submitted, he attempts to quantify the moment (that is, the product of the contact force and the distance of the femoral component's posterior translation, or shift) that would tend to cause toggling or micro-motion at various flexion angles. (See Brown Supp. Rep. at 6.) But in this supplemental report, and during his most recent deposition, Dr. Brown's clarification of his opinions casts doubt upon the court's previous conclusion that Dr. Brown could reliably infer that patients implanted with a Flex device, as opposed to a Standard device, actually would experience increased toggling and micro-motion of their tibial components. Though Dr. Brown's modeling did find toggle moment increases in the range of 30% to 60%-80% at various high-flexion angles, he conceded that without reliable interfacial stress data for the tibial components of Flex devices, "there is no way to formally quantify whether or not these levels of additional toggle moment demand would represent an unacceptable risk for fixation interface failure." (Id. at 7.) He opines that the increased toggle moments warrant serious concern and should have prompted Zimmer to investigate whether the toggle moment levels he has quantified would cause interface failure, but he admits that he has "no way of knowing" what the results would have been, had Zimmer conducted the appropriate testing. (Dep. of Thomas Brown, Ex. B to Def.'s Mem. in Supp. of Second Daubert Mot. [34-2] (hereinafter "Brown Dep."), at 97:15-98:15.)

         In both his initial expert report and his supplemental report, Dr. Brown discusses alternative implant designs. As mentioned above, Dr. Brown compared the NexGen Flex with the NexGen Standard and concluded that a patient's ability to achieve high flexion with the NexGen Flex knee could increase the risk of toggling, and thus loosening, of the implant's tibial component. But Dr. Brown concedes that "there seems little if any reason for concern about NexGen-Flex performance below the [range of 120 to 130 degrees]." (Brown Supp. Rep. at 6- 7.) And if a patient were to engage in flexion above the range of 130 degrees, Dr. Brown admitted it would be safer for him or her to do so with a Flex implant than with a Standard implant. See Batty Opinion, 2015 WL 33669933, at *17 (citing Brown's deposition testimony from Batty). In his initial report, Dr. Brown also mentions that some of Zimmer's academic collaborators, including Dr. Peter Walker and Drs. Guoan Li and Harry Rubash, were concerned about the possibility of excessive posterior edge loading of the polyethylene insert but that Zimmer "opted not to implement specific design suggestions by Walker and Li and Rubash" in the NexGen Flex. (Brown Rep. at 31.) According to Brown, Zimmer eventually did implement "several of these changes, " but in a different product. (Id.) The one design feature of that subsequent product that Dr. Brown mentions is the elimination of a required two-millimeter bone cut prior to implantation of the device (a design change that has no relevance to tibial loosening, according to Dr. Brown). (Id. at 38.) In his supplemental report, Dr. Brown also alludes to a specific design alternative conceived by Drs. Li and Rubash. The one paragraph in his report devoted to that design reads as follows:

As early as 2001 or 2002, Drs. Li and Rubash had conceived an alternative to some of the key features of the then-existing form of the Zimmer Nexgen Flex device. In my opinion their design modification was biomechanically reasonable. They wrote to Zimmer suggesting that Zimmer implement that design modification. However, Zimmer did not do so. Incorporation of this proposed design change would have constituted an alternative to the then-existing NexGen Flex design.

(Brown Supp. Rep. at 7.)

         II. Dr. Madigan's Proposed Expert Testimony

         For purposes of this particular ruling, the court need not discuss Dr. Madigan's proffered opinions in great detail. Dr. Madigan is a statistician who conducted a meta-analysis of clinical trial studies involving patients with knee implants. (See generally Report of David Madigan, Ex. A to Def.'s Mem. in Supp. of Mot. to Excl. Testimony of Dr. David Madigan [36-1].) Based on his analysis, Dr. Madigan concluded that Zimmer's Flex implants likely cause a higher risk of revision than standard devices. (Id. at 12.) In particular, by focusing on 10-year studies, he concluded that the probability that Flex implants cause a higher risk of revision than standard devices approaches 100%, and that the probability that Flex implants cause a higher risk of aseptic loosening than standard devices is 96.8%. Zimmer charges that Dr. Madigan's conclusions are based on an unreliable methodology, but for purposes of this opinion, the court assumes that his testimony would be admissible. The court does note, however, that although Dr. Madigan offers an opinion that Flex implants have a higher risk of revision and of aseptic loosening than standard devices, he does not offer any opinion about (1) the absolute rate at which Flex devices are likely to loosen or to be revised over a particular time period or (2) any aspect of the Flex design that might cause the alleged higher risk of revision relative to the standard device.

         III. Dr. Fetto's Proposed Expert Testimony

         In the Batty trial, Dr. Fetto submitted a general report detailing his opinions on the Zimmer Flex knee, as well as a report specific to Ms. Batty's knee replacement. In this case, Dr. Fetto has submitted a report on Joas's knee replacement. Dr. Fetto's case-specific Joas report incorporates the general report he prepared for the MDL as a whole.

         A. The Court's Ruling on Dr. Fetto's Opinions in Batty

         In Batty, the court allowed Dr. Fetto to testify to opinions on biomechanics, but excluded opinions regarding (1) risks of component loosening, (2) the adequacy of Zimmer's warnings, and (3) the adequacy of Zimmer's pre-market testing. Batty Opinion, 2015 WL 3669933, at *1. Some of Dr. Fetto's opinions that were excluded in Batty, regarding Zimmer's warnings and pre-market testing, are not applicable in this case, but his opinions on component loosening are relevant. In Batty, the court "[could not] discern any reliable methodology supporting Dr. Fetto's opinions regarding the design defect, [or] the risk of aseptic loosening . . . and conclude[d] that those opinions must be excluded." Id. at *19.

         Specifically, the court declined to admit Dr. Fetto's opinion that the design of the Zimmer knee replacement "forces loading onto the posterior margin of the tibial component and reduces overall contact area between the femoral and tibial components." Id. at *21 (internal citations omitted). Dr. Fetto asserted that this posterior loading "produces a lift-off stress on the front of the tibial component, " which "strains the bond between the tibial component and the tibial bone." Id. (internal citations omitted). The court acknowledged that Dr. Fetto cited evidence showing a higher revision rate for Zimmer high flex knees, but concluded that Dr. Fetto did not "sufficiently explain[] why he sees a link between the higher revision rates and the evidence of posterior loading." Id. at *22. The report he offered in Batty offered several explanations why eccentric loading causes high-flex components to loosen. At least two of these opinions are resurrected in Dr. Fetto's report on Joas. First, he again opines that high flexion causes greater forces pulling the bone and component apart: "bonds between the component and bones . . . are susceptible to 'tensile loading, ' that is, forces that pull the bone and component apart from one another." Id. at *23. Additionally, he asserts "that if testing shows lift-off of the polyethylene tray from the tibial baseplate, that lift-off implies that the forces are sufficient to lift the tibial baseplate from the bone[.]" Id. Both of these opinions were excluded because Dr. Fetto did not explain how the studies he cited supported this conclusion. Id. at *23-27.

         Furthermore, the court in Batty pointed out that Dr. Fetto did not describe "why the Zimmer high-flex design, as opposed to high flexion generally, creates an increased risk of posterior edge loading." Id. at *22 (emphasis in original). The court concluded: "In sum, Dr. Fetto has not sufficiently explained how he reached the conclusion that Zimmer's designs cause aseptic loosening of the tibial component[, ]" because "he has failed to connect the dots in a way that enables the court to adequately examine the bases for his conclusions and conduct a reliability analysis." Id. at *32. Consequently, Dr. Fetto's opinions that Zimmer's high-flex design increased the risk of component loosening were excluded. Id. at *32.

         B. Dr. Fetto's Report on Joas

         The parties agree that the court's rulings regarding the admissibility of Dr. Fetto's opinions in Batty also apply in this case. (Tr. of Aug. 26, 2016 Hr'g, Ex. E to Def.'s Fetto Mem. [32-5], at 15:13-22.) Dr. Fetto has submitted a new report specific to Joas's tibial component loosening. In this new report, Dr. Fetto conducts a differential etiology, which purports to consider all reasonable potential causes of an ailment and systematically rule out causes one by one.[3] (Fetto Rep. at 3.) "[I]n a differential etiology, the doctor rules in all the potential causes of a patient's ailment and then by systematically ruling out causes that would not apply to the patient, the physician arrives at what is the likely cause of the ailment."[4] Myers v. Illinois Cent. R.R. Co., 629 F.3d 639, 644 (7th Cir. 2010). To support his etiology, Dr. Fetto reviewed Joas's medical records, radiologic images, depositions of Joas and his treating doctors, and Joas's explanted device. (Fetto Rep. at 1, 7-8.) Dr. Fetto also interviewed Joas twice and conducted a physical exam and medical history. (Id. at 1.)

         Dr. Fetto begins by determining which causes to rule in. Dr. Fetto's list of potential causes included: "trauma, medical comorbidities, [5] infection, particulate debris, surgical error, problems with the cement, and mechanical causes." (Id. at 3.) Dr. Fetto also rules in "patient factors" such as excessive weight, poor quality bone, or excessive activities. (Id.) Although he notes that "polyethylene[6] wear that in turn causes microscopic particulate debris which causes an immunologic reaction in the bone, " is a potential cause of loosening, he apparently does not rule that in because "Dr. Cameron[, who performed Joas's revision surgery, ] testified that there was not a dramatic amount of wear debris." (Id. at 2.)

         Second, Dr. Fetto rules out causes that he opines were not the cause of Joas's component loosening. He reviewed "the records provided and the depositions provided" and found no evidence of comorbidities, infection, or poor or improper surgical technique. (Id. at 3- 4.) He also finds no "evidence of improper rehabilitation or level of activity following his surgical procedures[.]" (Id. at 4.) Second, he opines that Joas engaged in high-flexion activities, but that they were not "abusive." (Id. at 5.) Third, Dr. Fetto states that he found no evidence of bone problems, metabolic disorders, or other medical conditions. (Id. at 6.) Finally, he states that he "considered [Joas's] medication history, including his rheumatoid arthritis medications, and did not see anything in the medical records, surgical reports or diagnostic imaging, that would suggest they contributed to the aseptic loosing." (Id. at 6.) As a result, Dr. Fetto concludes "[t]his leaves only mechanical sources of failure related to the specific design of the implant Joas received to be considered." (Id. at 4.)

         Having concluded that this final cause could not be ruled out, Dr. Fetto devotes the remainder of the report to explaining why the design defect caused Joas's knee replacement failure. (Id. at 4-6.) Dr. Fetto opines that Joas's knee implant failed for the same reasons stated in his general report. According to Dr. Fetto, as a replaced knee bends and achieves greater degrees of flexion, the following occurs: First, external rotation of the femur causes posterior translation (that is, shifting back) of the lateral femoral condyle.[7] (Id. at 4.) Second, posterior migration of the femoral component causes asymmetric loading of the tibial plateau and the femoral component. (Id.at 4.) Third, asymmetric contact of the femoral condyles, or liftoff, causes excessive and asymmetric loading. (Id.) Dr. Fetto concludes that this asymmetric loading places undue stress on the tibia, which he opines is what happened to Joas. (Id.) He concludes that the asymmetric loading "is evident in Joas's case, which demonstrated aseptic loosening beneath the tibial component." (Id.) Dr. Fetto notes that "[t]hese findings are consistent with the eccentric loading described . . . in my general report associated with Zimmer High Flex implants." (Id.)

         Dr. Fetto opines that higher flexion "puts excessive stress on the component-cement interface and can lead to early failure." (Id. at 5.) Dr. Fetto concludes that the design of the implant, combined with high-flexion activities, caused the device to become "debonded from the cement" used in the interface. (Id.) Dr. Fetto does not refer to any literature or give any explanation for why the implant design, and asymmetric loading generally, causes debonding, and in turn, loosening. He does assert that aseptic failure of the tibial component is recognized in the medical literature-the court presumes that he is referring to literature recognizing aseptic failure of the NexGen Flex's tibial component-but he does not cite to specific studies. (Id.) In sum, Dr. Fetto attributes Joas's component loosening to asymmetric loading: "Joas'[s] tibial implant loosened because of the asymmetric loading related to its design." (Id.)

         IV. Zimmer's Warnings

         Along with each NexGen Flex device, Zimmer includes a "package insert" containing instructions about implanting the device and warnings about the product's risks, including the risk of component loosening. Plaintiffs insist that Zimmer's warnings are inadequate. At his deposition, Joas testified that he remembered reading written materials that were "probably from Zimmer, " assuring him he "would get back to [his] active style, that [the implant] is a good knee." (Joas Dep. 168:15-169:8.) Plaintiffs note that Zimmer's marketing materials did not mention that high-flexion activities may cause early failure of the NexGen Flex device. But as Zimmer points out, Dr. Larson, Joas's implanting surgeon, testified at his deposition that he, himself, never reviewed the relevant the package inserts prior to performing Joas's TKR surgery. (Dep. of Bryan Larson, Ex. D to Def.'s Reply in Supp. of Mot. for Summ. J. [129-5] (hereinafter "Larson Dep."), at 83:24-84:24.)

         Plaintiffs also assert that Zimmer's surgical technique instructions were deficient. In particular, they rely on the testimony of one of Zimmer's experts, Dr. John Dearborn, who believes that the one bag of cement that Dr. Larson used to affix Joas's implant to his bones was inadequate. (Dep. of John Dearborn, Ex. 6 to Pls.' Mem. in Opp'n. to Def.'s Mot. for Summ. J. [114-6] (hereinafter "Dearborn Dep."), at 50:1-5.) According to Dr. Dearborn, cement should be applied across the entire tibial plateau at a consistent and continuous level of thickness. (Id. at 106:25-107:6.) Had Dr. Larson properly cemented Joas's device, using at least two bags of cement, Dr. Dearborn believes that Joas's knee implant would not have failed as early as it did. (Id. at 82:24-83:2.) Zimmer's Surgical Technique Guide for the NexGen Flex device does address cementing; it directs that "[i]f bone cement is being used, [surgeons should] apply cement to the underside of the tibial plate, around the keel, on the resected tibial surface, and in the tibial IM canal." (Zimmer Surgical Technique Guide, Ex. 17 to Pls.' Resp. to Zimmer's Stmt. of Undisputed Material Facts [115-17], at 11.) Plaintiffs point out that the guide does not specify the number of cement bags that a surgeon should use. Dr. Dearborn's expert report, however, states expressly that "[t]he basic surgical technique for implanting the [NexGen Flex] is well-documented in Zimmer's Surgical Technique Guide, but surgeons are primarily guided in their technique by the basic medical training they received during residency and/or fellowship training." (Report of Dr. John Dearborn, Ex. C to Def.'s Reply Mem. in Supp. of Mot. for Summ. J. [129-3] (hereinafter "Dearborn Rep."), 18.) Dr. Larson testified that he reviewed "parts of" the surgical technique guide back in the early 2000s, but confirmed that he learned his surgical technique-including the technique for cementing the components-"from [his] residency and [his] fellowship training." (Larson Dep. 85:13-86:6.)

         DISCUSSION

         I. Zimmer's Motion to Exclude Dr. Fetto's Testimony

         A. Daubert Standards

         Rule 702 of the Federal Rules of Evidence, which governs the admissibility of expert testimony, states:

         A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and ...

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