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In re Zimmer Nexgen Knee Implant Products Liability Litigation

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

January 3, 2017

ZIMMER, INC., Defendant. BEVERLY GOLDIN, Plaintiff, Nos. 12 C 2048, 11 C 5468



         Plaintiff Beverly Goldin had a total knee replacement (TKR) in 2009. By late 2011, the knee implant-the NexGen Flex knee manufactured by Defendant Zimmer, Inc.-had failed, becoming so loose that Ms. Goldin required a second knee replacement. In this lawsuit, Plaintiff alleges that Defendant Zimmer failed to warn that Plaintiff's excessive weight could cause her knee to fail.

         Ms. Goldin's case is one of hundreds that have been assigned to this court as part of a multidistrict litigation proceeding (MDL), in which plaintiffs allege they suffered injury caused by premature loosening of the Zimmer NexGen Flex knee implant. This case is the third to be scheduled for a bellwether trial. The first such case, brought by plaintiff Kathy Batty, resulted in a jury verdict for Defendant. See Batty v. Zimmer, Inc., No. 12 C 6279 [141]. The court granted summary judgment for Zimmer in the second bellwether case, brought by Theodore Joas, and that ruling is now on appeal. See In re Zimmer Nexgen Knee Implant Prod. Liab. Litig., No. 11 C 5468, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) [hereinafter "Joas"]. Unlike Batty or Joas, Plaintiff in this case does not assert a claim that her NexGen Flex knee implant was defectively designed. Rather, she contends that Defendant failed to provide adequate warnings about the implant's risk of loosening in patients like her. Specifically, she contends that Defendant did not adequately warn about the device's risk of loosening when implanted in obese patients. She relies in part on the testimony of Dr. Sonny Bal, an orthopedic surgeon, who opines that Defendant's warning labels and instructions were indeed inadequate and that Zimmer's failure to provide proper warnings about the risk of implantation in obese individuals caused Plaintiff's injuries.

         Defendant Zimmer has moved to exclude Dr. Bal's testimony [53] under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and has moved for summary judgment [43]. Defendant argues that Dr. Bal is not qualified to offer an opinion about the adequacy of a medical device's warning labels and that his opinions about the adequacy of Defendant's warnings and their role in causing Plaintiff's injury are unreliable. As Dr. Bal is the only expert Plaintiff will call to testify about the adequacy of warnings and causation, Zimmer believes that excluding his testimony would entitle it to summary judgment on Plaintiff's failure-to-warn claim. And even if the court allows Dr. Bal to testify, Defendant contends the court should grant summary judgment because, according to Defendant, there is no evidence that inadequate warnings were the cause of Plaintiff's injuries, and the court should find that the NexGen Flex's warning labels are adequate as a matter of law.

         For the reasons stated below, the court grants Defendant's motions in part and denies them in part. Contrary to Defendant's contentions, the court concludes that Dr. Bal is sufficiently qualified to offer his opinions in this case and that those opinions are not so unreliable that the jury should not consider them. In addition, the court concludes that there are disputed issues of material fact concerning the adequacy of Defendant's warnings and their role in causing Plaintiff's injury. Those issues should be resolved by a jury.[1] The court does conclude, however, that certain opinions of Dr. Bal's are not based on sufficient facts or data. In addition, Plaintiff has failed to respond to Defendant's motion for summary judgment regarding certain claims. Thus the court grants Defendant's motions with regard to those counts in Plaintiff's complaint.


         In May 2009, because of persistent, severe pain in her right knee, Plaintiff visited an orthopedic surgeon named Dr. Russell Windsor. (Expert Rep. of Dr. Thomas E. Baier [45-4] (hereinafter "Baier Rep."), Ex. D to Def.'s Stmt. of Undisputed Material Facts [45] (hereinafter "Def.'s Stmt."), ¶ 1.) As Defendant's expert, orthopedic surgeon Dr. Thomas Baier, observed, by the time of her first visit with Dr. Windsor, Plaintiff had "exhausted all non-surgical options for the treatment of her right knee degenerative arthritis, including attempts at weight loss and use of nonsteroidal anti-inflammatory drugs and hyaluronate injections." (Id.) Ms. Goldin was 58 years old at the time of the visit. (Expert Rep. of Dr. Sonny Bal [50-1] (hereinafter "Bal Rep."), Ex. B. to Def.'s Mem. in Supp. of Mot. to Excl. [50] (hereinafter "Def.'s Bal Mem."), 3.) Dr. Windsor testified that patients who, like Plaintiff Goldin, have exhausted non-surgical options and continue to experience persistent pain caused by arthritis are "at a crossroad." (Dep. of Dr. Russell Windsor [45-2] (hereinafter "Windsor Dep."), Ex. B to Def.'s Stmt., 153:19.) "[E]ither they continue to live their life substantially limited, knowing that the arthritis will worsen, or they have the replacement. It's either or. And it's their choice." (Id. 153:20-24.)

         Plaintiff elected to undergo TKR surgery, which Dr. Windsor performed in August 2009, replacing Plaintiff's native right knee with a Zimmer NexGen Flex implant. (Def.'s Stmt. ¶ 4.) As explained in earlier rulings, the NexGen Flex implant is designed to allow TKR patients to bend their knees at greater angles of flexion than they could with "standard" knee implants (including Zimmer's "Standard" version of the NexGen implant). See In re Zimmer Nexgen Knee Implant Prod. Liab. Litig., No. 11 C 5468, 2015 WL 3669933, at *2 (N.D. Ill. June 12, 2015) [hereinafter "Batty Opinion"] (describing the NexGen Flex device in greater detail). Dr. Windsor selects his TKR patients' implants based on his own experience with the products and his general experience as a surgeon. (Def.'s Stmt. ¶¶ 55-56.) Plaintiff Goldin herself played no role in the selection of her implant, read no brochures or literature about the NexGen Flex implant before her surgery, and was unaware of the brand of implant she would receive. (Id. ¶¶ 57-58.)

         At the time of surgery, Plaintiff was 61 inches tall and weighed 241 pounds, giving her a body mass index ("BMI") of 45.5. (Def.'s Stmt. ¶ 6.) In general, a BMI between 25 and 30 is considered "overweight, " a BMI between 30 to 35 is considered "obese, " a BMI of 35 to 40 is considered "morbidly obese, " and a BMI over 40 is considered "super obese." (Pl.'s Stmt. of Add'l Material Facts [58-1] (hereinafter "Pl.'s Stmt. Add'l Facts"), Ex. A to Pl.'s Summ. J. Resp. ¶ 1.) The parties agree that at the time of Plaintiff's surgery in 2009, it was well-known within the orthopedic community that heavy and obese patients are at increased risk for implant failure. (Def.'s Stmt. ¶ 41.) It is also undisputed that written materials accompanying Plaintiff's implant included language concerning the risk of implant failure in obese patients. The "package inserts" accompanying the femoral and tibial components of the NexGen Flex that Dr. Windsor implanted in Plaintiff contain a section labeled "PATIENT COUNSELING INFORMATION." (Id. ¶¶ 15-16.) Among other information, that section includes the statement that "Complications and/or failure of total knee prostheses are more likely to occur in patients with unrealistic functional expectations, heavy patients, physically active patients, and/or with patients that fail to follow through with the require rehabilitation program." (Id. ¶¶ 15-16.) The section also states that patients should be instructed about the possibility that the implant or its components may wear out, fail, or need to be replaced, and that the implant may not last for the rest of the patient's life. (Id.) In addition, the surgical technique guide for the implant includes a section labeled "Patient Selection, " which instructs surgeons that "[i]n determining the appropriateness of this implant for any patient, careful consideration should be given to the following criteria . . . . 6. The patient should not be obese." (Id. ¶ 18.)

         The parties disagree about whether Dr. Windsor cautioned Plaintiff that her obesity level increased the risk that her implant would fail. Dr. Windsor testified in his deposition that he does explain the risks of TKR surgery to his patients, and discusses, among other things, "mechanical loosening, infection, wear, rough estimates as to the longevity of the implant and how that can be affected by body weight and activity levels." (Id. ¶ 48; Windsor Dep. 29: 4-12.) He said he would have had such a conversation with Plaintiff. (Def.'s Stmt. ¶ 48; Windsor Dep. 30:7-9.) Later in the deposition, Dr. Windsor confirmed that for a patient whose BMI is greater than 35, he advises that longevity of the implant is "possibly and probably compromised based on the fact that she is well beyond a normal average weight, " and warns that the implant might be "subject to a shorter longevity just because [her] body weight is higher than the norm." (Def.'s Stmt. ¶ 51; Windsor Dep. 78:11-23.) Plaintiff, for her part, denies that Dr. Windsor ever counseled her about the impact her weight could have on the longevity of her implant and never advised her to lose additional weight. (Pl.'s Stmt. Add'l Facts ¶ 6.)

         Whether or not Dr. Windsor told Plaintiff prior to her surgery that her elevated BMI placed her at greater risk for premature implant failure, Dr. Windsor's testimony suggests that over the last three to four years (that is, since Plaintiff's 2009 surgery), he has changed the counseling he provides to obese patients, based on newly available general data regarding TKRs in obese patients. (Windsor Dep. 137:1-12, 139:10-14.) Today, Dr. Windsor tells patients who are morbidly obese (BMI greater than 35) or super obese (BMI greater than 40) that "they're at an increased risk of mechanical failure, whether it be loosening, implant breakage, instability, infection." (Id. 137:16-22.) He also tells those patients "it's a good idea to lose weight, " but he acknowledges that "practically speaking, they don't" lose weight or they eventually gain back the weight they lose.[2] (Id. 138:1-4.) He did not provide this counseling to Plaintiff because, back in 2009, "we didn't see a specific difference."[3] (Id. 140:11-16.) In addition, for morbidly obese or super obese patients, Dr. Windsor now adds a stem extension to the implant's tibial component and fully cements it to the bone in order to better anchor the component. (Id. 138:9-14.) Defendant asserts that Dr. Windsor has always warned about the increased risk of mechanical failure in morbidly obese and super obese patients and that the only change in Dr. Windsor's counseling is that he now counsels patients about the possibility of adding the stem extension to the tibial component. (Def.'s Resp. to Pl.'s Stmt. Add'l Facts [76] ¶ 12.) In the court's view, Dr. Windsor's testimony may be ambiguous on this point (see generally Windsor Dep. 136:17-141:1), but Plaintiff's characterization is a fair one. Asked directly whether the counseling Ms. Goldin would receive from him, were she to have a knee replacement now, "would be different than the counseling she received in 2009, " Dr. Windsor responded that his counseling would indeed differ, regardless of what type of implant he used. (Id. 144:11-24.)

         After Plaintiff's TKR surgery, she suffered from an "insidious onset of pain" over a period of roughly two years. (Pl.'s Stmt. Add'l Facts ¶ 2.) By December 2011, the tibial component of her implant had loosened and collapsed into approximately 25 degrees varus (that is, angled in a way to give her a bowlegged appearance). (Id. ¶ 3.) Another orthopedic surgeon, Dr. Joel Buchalter, diagnosed Plaintiff with a "catastrophic failure of right total knee arthroplasty, " and he performed a revision surgery on December 15, 2011, removing her implanted components and "massive osteolytic lesions" and replacing the implant with a new device. (Id. ¶ 4; Operative Report [58-4] at 1.) Although Defendant's expert, Dr. Baier, opines that Plaintiff's injury was caused by multiple factors, including her obesity, continued weight gain, bone loss, component alignment, and uneven cement mantle distribution, it is undisputed that Plaintiff's weight was a primary factor in the failure of her initial TKR. (Def.'s Resp. to Pl.'s Stmt. Add'l Facts ¶ 5.)

         Plaintiff offers the testimony of Dr. Bal to demonstrate (1) that Plaintiff's obesity caused her implant to loosen and fail, and (2) that the written materials accompanying Plaintiff's implant failed to provide adequate warning about the risks of implant failure in morbidly obese patients. Dr. Bal is a board-certified orthopedic surgeon and a professor in the Department of Orthopaedic Surgery at the University of Missouri Health Care in Columbia, Missouri. (Bal Rep. at 1, 3.) Dr. Bal received his medical degree from Cornell University, a master's degree in business administration from Northwestern University, and a law degree from the University of Missouri School of Law. (Id. at 1-2.) He has also completed the requirements for a Ph.D. in materials engineering from the Kyoto Institute of Technology in Kyoto, Japan.[4] (Dep. of Dr. Sonny Bal [50-2] (hereinafter "Bal. Dep."), Ex. B to Def.'s Bal Mem., 17:11-14.) Dr. Bal has been performing hip and knee replacements for the past twenty years and usually performs between 150 and 400 knee replacements each year. (Bal Rep. at 2; Bal Dep. 27:8-13.) In addition, he has acted as a paid consultant for hip and knee device manufacturers, including for Defendant, and has assisted in the design of implant components. (Bal Rep. at 2, 30.) As a practicing orthopedic surgeon, Dr. Bal keeps abreast of medical and scientific developments in his field in order to provide optimal care to his patients. (Id. at 2.)

         To determine the cause of Plaintiff's injury, Dr. Bal reviewed Plaintiff's medical records, certain of Defendant's internal memoranda, scientific studies regarding the performance of NexGen Flex implants, and expert reports and deposition testimony from Drs. Thomas Brown and Joseph Fetto, both of whom testified in the Batty trial and whose expert reports the court has discussed previously. (Id. at 9-10); see also Joas, 2016 WL 6135684, at *3-*6, *8-*14, *17-*18; Batty Opinion, 2015 WL 3669933, at *7-*33 (N.D. Ill. June 12, 2015). According to Dr. Bal, Plaintiff's NexGen Flex implant "failed in reasonable medical probability due to an inability of the tibia to support the stress routinely applied at the component/tibia juncture, especially in a patient of [Plaintiff's] weight." (Bal Rep. at 10.) Dr. Bal opines that, in particular, the tibial component of Plaintiff's implant was unable to support the repetitive stresses placed on it during deep knee bending. (Id.) He asserts that Plaintiff was encouraged to engage in activities that required bending her knees at high-flexion angles. (Id. at 16.)

         TKR implants, he explains, usually last for a period of ten to fifteen years or longer. (Id. at 11.) According to Dr. Bal, apart from obesity, there are a number of factors that could potentially contribute to premature failure of a knee implant, including trauma, diabetes, vascular conditions, osteoporotic bone, excessive activity, poor surgical technique, malalignment of the implant's components, or poor cementing of the components to the bone. (Id.) As Dr. Bal explains in his report, however, nothing in Plaintiff's medical record indicates that any of those non-weight-related factors was a likely cause of Plaintiff's injury. (Id.)

         Dr. Bal”s report states that scientific and medical literature recognizes a significant difference in the stress placed on a TKR implant when a patient engages in high degrees of flexion. (Id. at 14.) Dr. Bal does not specify the literature to which he refers for that proposition, but he does list the studies, articles, and documents he reviewed in forming his opinion. (Id. at 17-22.) In his deposition, Dr. Bal clarified that he relied on Dr. Brown's research and opinions for evidence that deep knee bending creates high, localized stress loads on the tibial component of the implant and can result in loosening. (Bal Dep. 118:15-119:12.) This court has previously ruled that Dr. Brown's opinions regarding the causes of tibial loosening are admissible. See Batty Opinion, 2015 WL 3669933, at *16-*18. During his deposition, Dr. Bal also discussed peer-reviewed literature that he believes supports the theory that high flexion leads to failure of the NexGen Flex. (See Bal Dep. 48:19-51:7.) Dr. Bal takes Dr. Brown's analysis one step further, reasoning that the extra weight present in an obese patient would place additional stress on the tibial component during deep knee bending. (Bal Rep. at 10.) He notes that the scientific literature supports the proposition that patients with high BMI scores are more likely to suffer from implant failure and that obesity has been considered a factor in implant failure for decades. (Id. at 13, 15-16.) Based on this literature, and on his review of the expert reports of Drs. Fetto and Brown, Dr. Bal opines that Defendant had the knowledge, resources, and ability to conduct tests, and to warn, about the NexGen Flex's risks when implanted in morbidly obese patients. (Id. at 15-16.)

         Had Zimmer provided Dr. Windsor with adequate information and warnings about the risk of implant failure in obese patients, Dr. Bal asserts, Plaintiff would have received enough information (through Dr. Windsor) to decide whether TKR surgery with a NexGen Flex implant was her best option. (Id. at 17.) Instead, according to Dr. Bal, Zimmer provided inadequate information to Dr. Windsor and other implanting surgeons. Dr. Bal concedes that the "patient counseling information" section of the implant's package insert notes that complications and failure may be more likely to occur in "heavy patients, " but he points out that the label fails to explain "how much more likely the prosthesis is to fail and what constitutes heavy." (Id. at 12.) He also recognizes that the implant's surgical technique guide states that "[t]he patient should not be obese, " but he notes that that instruction fails to define obesity in terms of BMI. (Id.) Dr. Bal's most significant criticism of Defendant's labeling appears to be that there is no mention of weight or obesity in the "contraindications, " "warnings, " or "precautions" sections of the package insert. In Dr. Bal's experience, he says, most physicians look to those portions of the labeling for information to guide their counseling of patients regarding a particular device's risks and benefits. (Id. at 13.) Given the risk of implant failure in obese patients and the fact that Defendant failed to conduct studies to assess or quantify that risk, Dr. Bal believes Defendant's labeling should at least have instructed surgeons that the NexGen Flex was appropriate for use only in patients who require high-flexion capability, and should have informed surgeons that the company lacked studies about the clinical performance of the device in morbidly obese individuals. (Id. at 16.)

         Defendant challenges Dr. Bal's qualifications to offer opinions about the adequacy of warning labels or the mechanical causes of Plaintiff's implant failure. Even if the court finds Dr. Bal qualified, Defendant contends that his opinion about the NexGen Flex's label is not based on any methodology, and that the methodology underlying his causation opinion is unsound. Defendant also takes issue with some of the factual assumptions underlying Dr. Bal's analysis- for example, that Zimmer itself or Dr. Windsor encouraged Plaintiff to engage in high-flexion activities or that Plaintiff ever achieved high flexion after receiving her NexGen Flex implant. In response, Plaintiff urges that Dr. Bal's medical, legal, and engineering training, as well as his experience as a surgeon and consultant, amply qualify Dr. Bal to testify in this case. In addition, she contends that Dr. Bal's opinions are based on a reliable foundation, including his experience as a surgeon, careful review of Plaintiff's medical records, and sound application of scientific research and findings to the facts of Plaintiff's case. Regarding Defendant's argument that Dr. Bal relies on inaccurate factual assumptions, Plaintiff responds that, at least with respect to the issue of whether Plaintiff achieved high flexion (that is, greater than 120 degrees), there is sufficient evidence in the record to create a triable question of fact on that issue.

         Should the court bar Dr. Bal's testimony, Defendant notes, Plaintiff's case would lack any expert support, and Plaintiff's case could not survive a summary judgment motion. But even if the court admits Dr. Bal's expert opinion, Defendant argues, summary judgment is warranted, because the warnings accompanying Plaintiff's implant were adequate as a matter of law and because Plaintiff lacks sufficient evidence to prove that a different warning would have prevented her injury. Plaintiff responds that the record contains sufficient evidence to allow the jury to determine whether Defendant's warning was adequate and whether an inadequate warning can be considered the cause of Plaintiff's injury. The court discusses the admissibility of Dr. Bal's testimony before addressing the parties' summary judgment arguments.


         I. Dr. Bal's Expert Testimony

         Rule 702 of the Federal Rule of Evidence sets out the circumstances under which a witness may testify as an expert:

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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