In Re: Zimmer Nexgen Knee Implant Products Liability Litigation
MEMORANDUM Opinion and Order Signed by the Honorable Rebecca R. Pallmeyer on 6/17/2015. Mailed notice. (etv, )
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
IN RE: ZIMMER NEXGEN KNEE
IMPLANT PRODUCTS LIABILITY
KATHY L. BATTY,
ZIMMER, INC., ZIMMER HOLDINGS,
INC., and ZIMMER ORTHOPAEDIC
SURGICAL PRODUCTS, INC.,
MDL No. 2272
Master Docket No. 11 C 5468
No. 12 C 6279
Judge Rebecca R. Pallmeyer
MEMORANDUM OPINION AND ORDER
Kathy Batty is one of hundreds of Plaintiffs who have sued Defendants, Zimmer, Inc. and
its affiliates (collectively, "Defendant" or "Zimmer"), manufacturers of the Zimmer NexGen Flex
Knee system. Batty and others, who have had the NexGen Flex system implanted, allege that
the femoral and tibial components of the system are prone to premature loosening, resulting in
pain and loss of movement. Ms. Batty's case has been chosen for a "bellwether" trial. Both
parties have identified several expert witnesses. In an earlier ruling , the court considered
challenges to two of Ms. Batty's proposed experts, Dr. Thomas Brown and Dr. Joseph Fetto. In
this opinion, the court addresses Zimmer's objections to expert testimony from Ms. Batty's
treating surgeon, Dr. Alan Klein . For the reasons set forth here, those objections are
sustained in part and overruled in part.
Dr. Alan Klein was Ms. Batty's treating surgeon from June 2, 2008 through December 6,
2010. (Dep. of Alan Klein, Ex. A to Zimmer Mem. in Supp. of Fifth Daubert Mot. [1299-1],
hereinafter "Klein Dep.," 34:18–23.) He diagnosed Ms. Batty as suffering from "bone-on-bone
arthritis in both knees." (Id. at 40:4–6.) When conservative treatments failed to alleviate her
pain, he recommended total knee replacements for both knees. (Id. at 40:7–23.) He performed
knee replacement surgeries in April 2009, implanting the Zimmer NexGen LPS-Flex Gender
Solutions Female knee implants in each knee. (Id. at 40:17–41:1, 47:11–13.)
Ms. Batty began complaining of pain in her knees in July 2010.
X-rays taken in
November 2010 showed "some radiolucencies around her right tibial tray that" may have been
"a little bit enlarged from" the x-rays taken immediately after surgery. (Klein Dep. at 149:15–19.)
The bone scan that Dr. Klein ordered in response to those November 2010 findings suggested
that loosening and infection were likely, but blood tests he ordered to test for infection came
back negative. (Id. at 148:18–19; 149:8–23.) Having determined that Ms. Batty's knees were
loose but not infected, Dr. Klein referred her to Dr. Sewecke, another doctor in his practice, for a
(Id. at 149:8–16.)
Dr. Sewecke's evaluation revealed "evidence of
radiolucency at the bilateral tibial components," and he observed that the tibial components
appeared to be in varus alignment—that is, the tibial component was not aligned parallel to the
tibial bone, but was tilted outward. (Id. at 75:9–12, 75:20–76:1.) On March 1, 2011, Dr. Klein
referred Ms. Batty to Dr. Lawrence Crossett, another orthopedic surgeon. Dr. Crossett also
concluded that her x-rays showed tibial loosening in both knees, and that Ms. Batty required
revision surgeries. (Dep. of Lawrence Crossett, Ex. C to Zimmer Reply Mem. in Supp. of Mot.
for Summ. J. [1488-3], hereinafter "Crossett Dep.," 130:2–3.)
Dr. Crossett performed the
revision surgeries on April 18, 2011 (right knee) and May 11, 2011 (left knee), implanting the
DePuy LCS revision system in each of Ms. Batty's knees. (Revision Reports, Ex. 25 to Decl. of
Ronca in Supp. of Resp. to Zimmer Mot. for Partial Summ. J. [1462-25].)
Zimmer deposed Dr. Klein on January 14, 2014 as a fact witness only. During his
deposition, however, both parties solicited testimony from Dr. Klein about a wide range of topics
beyond his treatment of Ms. Batty. For example, Dr. Klein testified regarding the forces that
operate in the knee during flexion. He explained that if an implant cannot mimic the natural
knee's axial rotation—that is, internal and external rotation—during flexion, the result is a "stress
on the implant-bone interface," specifically a shearing, or pulling, stress. (Klein Dep. at 193:22–
194:5.) He also commented on the strength of the cement bond, asserting that "if you flex your
knee too far — see, normally a tibia is in compression, and the stresses, the cement are [sic]
really good in compression. But if you load it abnormally, it would no longer be in compression,
but in shear, and cement is not strong in shear." (Id. at 163:21–164:1.) Because the cement is
not as strong in shear, repeated cycles of shearing stress could cause the implant to loosen.
(Id. at 194:6–20.) When designing an implant, he continued, a manufacturer should attempt to
avoid shearing forces at the bone-implant interface. (Id. at 164:2–8.)
After Dr. Klein's deposition, Zimmer retained Dr. Stuart Goodman, a board-certified
orthopedic surgeon who earned the Ph.D. in Medical Science from Lund University in Sweden.
As part of his expert report, Dr. Goodman criticized Dr. Klein's surgical technique, opining that
he had implanted the tibial components at an improper angle and used too little cement to
secure the components to the bone. (Stuart Goodman Exp. Rep., Ex. C to Pl.'s Resp. to
Zimmer's Mot. to Exclude Dr. Klein [1456-3], hereinafter "Goodman Rep.," 2, 20.) Dr. Goodman
contends that Dr. Klein's surgical technique, rather than the design of the components, was the
cause of Ms. Batty's loosening. (Id.at 20.)
On September 19, 2014, in response to Dr. Goodman's report, Plaintiff disclosed a
rebuttal report prepared by Dr. Klein. (See Sept. 9, 2014 Letter, Ex. B to Zimmer Mem. in Supp.
of Fifth Mot. to Exclude [1299-2]; Klein Rebuttal Rep., Ex. C to Zimmer Mem. in Supp. of Fifth
Mot. to Exclude [1299-3], hereinafter "Klein Rebuttal.") The rebuttal consists of a two-page
letter in which Dr. Klein explains that while "it does appear that both knees look like they are in
varus alignment in the immediate postoperative films and subsequently got worse," the x-ray
prints were unreliable because the films did not show the whole leg (from hip to ankle).
Moreover, he notes that it is difficult to measure the angles of the implants because most of the
x-rays "were rotated due to the fact that most of them were bilateral knees on the same film."
(Id. at 1.) That is, Ms. Batty's legs were either internally or externally rotated, in relation to the xray beam, when the x-rays were taken.
According to Dr. Klein, "one cannot accurately
determine the true alignment of the tibial component without having a long leg film, which was
never obtained." (Id.) In any event, even if the tibial components were in varus alignment, Dr.
Klein observed that "in [his own practice] . . . many tibias are placed in a few degrees of varus
and function quite well. In fact, the literature supports many tibias are placed in a few degrees
of varus or valgus and do well." (Id. at 1–2.) As Zimmer notes, Dr. Klein does not specify what
"literature" he is referencing in the rebuttal report, though he later clarified in a declaration 1 that
"[t]he literature I referenced in my rebuttal report includes the literature reported by Dr.
Goodman which says that overall anatomic valgus predicts longer survival for knee implants
when the tibial alignment is less than or equal to 3 degrees of varus." (Decl. of Alan Klein,
Ex. B. to Pl.'s Resp. to Zimmer's Fifth Mot. to Exclude [1456-2], hereinafter "Klein Decl." ¶ 7.)
Finally, Dr. Klein asserts that he believes the tibial components were well-aligned because "on
the weight bearing views [of the x-rays], the tibial components are parallel to the ground, which
would mean the stress would be evenly distributed, and thus less likely to loosen." (Klein
Rebuttal at 2.)
With respect to his cementing technique, Dr. Klein wrote in his rebuttal report that he has
performed 100s of total knee replacements using 1 pack of cement. . . . I contend
that the entire undersurface of the tibias had full cement and it is my practice to
manually interdigitate2 additional cement into the tibia prior to inserting the
The declaration was attached to Plaintiff's response to Zimmer's motion to
exclude Dr. Klein's testimony. The declaration elaborates on the topics covered in Dr. Klein's
rebuttal report: alignment, cementing techniques, and his attempts to identify a cause of the
loosening. (See generally Klein Decl.)
Dr. Klein explained that interdigitation means that "the cement is sort of seeping
into the pores of the bone." (Klein Dep. at 60:5–7.) Dr. Robert Booth, an orthopedic surgeon
and Zimmer consultant, explained interdigitation as "a fancy word" for "mash[ing the cement]
down with our thumb and push[ing] it into the pores of the bone." (Dep. of Robert E. Booth,
Ex E. to Pl.'s Resp. to MSJ on Mult. Grounds [1466-5], 262:12–16.)
prosthesis and then to remove any excess cement. . . . It is my practice to use as
much cement as necessary on the tibial component and save additional cement
for the femoral and the patella component.
(Id.) As further evidence that he used sufficient cement, he asserts that "[n]either of the femoral
components in this patient loosened and [they] were noted to be well fixed on revision surgery.
Clearly, there was enough cement left for the femur and the patella as well." (Id.) Had the
cement been inadequate, he continues, the loosening would have manifested in the femoral
component first, rather than the tibial component. He also acknowledged that Dr. Goodman
might not see the cement interface on the x-ray, but explained that "[t]he amount of cement that
is visible on a postoperative x-ray is dependent on the exact positioning of the x-ray beam
versus the tibial component as well as the technique used during the x-ray as well as the degree
of osteopenia 3 of the bone." (Id.)
Zimmer urges the court to limit Dr. Klein's testimony to his treatment of Ms. Batty. The
opinions he offered regarding the forces operating on the implants, the possibility of edge
loading and lift-off, and the adequacy of Zimmer's testing—all of those were formed outside the
course of treatment and are not based on reliable methodologies, Zimmer contends. (Zimmer
Mem. in Supp. of Fifth Mot. to Exclude , hereinafter "Zimmer Mem.," 3.) Dr. Klein's
rebuttal report should also be excluded, Zimmer continues, because it is unreliable and fails to
comply with Federal Rule of Civil Procedure 26(a)(2)(B), which requires specially-retained
experts to submit complete reports documenting their opinions. (Zimmer Mem. at 11–14.)
Plaintiff responds that Dr. Klein will not be called to testify regarding "forces or the
specific testing Zimmer performed." (Pl.'s Resp. to Zimmer's Fifth Mem. , hereinafter
"Pl.'s Resp.," 2.) What Plaintiff does intend to offer are the opinions presented in Dr. Klein's
rebuttal report. Those opinions, Plaintiff asserts, do not extend "outside his treatment of Mrs.
"Osteopenia refers to bone density that is lower than normal peak density but not
low enough to be classified as osteoporosis."
Opsteopenia – Overview, W EBMD
http://www.webmd.com/osteoporosis/tc/osteopenia-overview (last accessed May 27, 2015).
Batty, his surgical technique, his professional practice, and his experience as a trained and
experienced joint replacement surgeon."
(Id. at 1.)
And because Dr. Klein has not been
retained or specially employed to provide expert testimony, Plaintiff contends, his testimony is
not subject to the requirements of Rule 26(a)(2)(B).
As noted, Zimmer advances two arguments in support of its motion to exclude any
testimony by Dr. Klein that covers topics other than his treatment of Ms. Batty. First, Zimmer
notes the absence of the expert report called for by Rule 26(a)(2)(B) for any expert "retained or
specially employed" by Plaintiff. Second, Zimmer urges that such testimony must be excluded
under Federal Rule of Evidence 702 and Daubert because Dr. Klein is unqualified and has
employed no reliable methodologies to reach his conclusions. Plaintiff responds that as her
treating physician, Dr. Klein is not subject to the requirements of 26(a)(2)(B) and need only
provide a summary disclosure under Rule 26(a)(2)(C). Moreover, Plaintiff contends that all of
Dr. Klein's opinions are based on his "extensive training and practical experience as an
orthopedic surgeon over the past 20 years along with his treatment of Mrs. Batty," and he is
therefore well-qualified to provide opinions regarding alignment, cementing technique, and the
causes of Ms. Batty's loosening. (Pl.'s Resp. at 1.)
The court agrees with Zimmer that, insofar as Dr. Klein's testimony exceeds the scope of
his treatment of Ms. Batty, he must comply with the requirements of Rule 26(a)(2)(B). Any
testimony regarding Zimmer's pre-market testing, the forces at work in the knee joint, or the
likelihood of implant lift-off, therefore, will be excluded. The court disagrees, however, with
Zimmer's assertion that the opinions contained in the rebuttal report require him to prepare an
expert report. Dr. Klein's opinions regarding the alignment of the components, the adequacy of
Dr. Klein's cementing technique, and causation are sufficiently related to his treatment of Ms.
Batty and may be offered without compliance with Rule 26(a)(2)(B).
Requirements of Rule 26
Rule 26 requires experts who are "retained or specially employed to provide expert
testimony" to submit a detailed expert report containing a "complete statement" of their opinions,
the "facts and data considered," the witness's qualifications, and a statement of compensation.
FED. R. CIV. PRO. 26(a)(2)(B). If, however, "the witness is not required to provide a written
report," under Rule 26(a)(2)(B), an expert need only provide a disclosure containing the "subject
matter" of his or her testimony and a "summary of the facts and opinions to which the witness is
expected to testify." FED. R. CIV. PRO. 26(a)(2)(C). Zimmer urges that several of Dr. Klein's
opinions, elicited in his deposition and contained in his rebuttal report, constitute testimony of a
"retained" expert under 26(a)(2)(B) requiring a complete expert report.
Plaintiff acknowledges that Dr. Klein has not submitted an expert report that complies
with the requirements of Rule 26(a)(2)(B), but rather urges that "[b]etween Dr. Klein's deposition
testimony and his rebuttal report Zimmer cannot claim that they were not properly put on notice
of his testimony.”
He has, thus, complied with the summary disclosure requirements of
26(a)(2)(C), the only requirements applicable to him as a treating physician, Plaintiff contends.
(Pl.'s Resp. at 3.) Plaintiff notes that when Rule 26(a)(2)(C) was added in 2010, the Committee
Notes explained that frequent examples of experts who are required to submit summary
disclosures in place of expert reports "include physicians and other health care professionals."
FED. R. CIV. PRO. 26 (Committee Notes, 2010 Amendments).
Significantly, however, in Meyers v. National Railroad Passenger Corp. (Amtrak), 619
F.3d 729, 734 (7th Cir. 2010), the Seventh Circuit held that "a treating physician who is offered
to provide expert testimony as to the cause of the plaintiff's injury, but who did not make that
determination in the course of providing treatment, should be deemed one 'retained or specially
employed to provide expert testimony in the case,' and thus is required to submit an expert
report," pursuant to Rule 26(a)(2)(B). Id. at 734–35. The purpose of this requirement is "to
provide adequate notice of the substance of the expert's forthcoming testimony and to give the
opposing party time to prepare for a response." (Id. at 734.) Meyers dictates that any of Dr.
Klein’s opinions not formed in the course of his treatment of Ms. Batty are inadmissible if not
disclosed in a complete expert report pursuant to Rule 26(a)(2)(B).
Plaintiff notes that Meyers was decided prior to the 2010 amendments adding Rule
26(a)(2)(C)'s summary disclosure procedure and argues that the amendments "clarified that
treating physicians are not required to submit a complete expert report." (Pl.'s Resp. at 3.) The
court does not read the 2010 amendments this way. The Committee Notes accompanying
those amendments suggest that the first question courts must address is whether an expert is
required to issue a report under 26(a)(2)(B) or not: the summary disclosure process was added
for "expert witnesses who are not required to provide reports under Rule 26(a)(2)(B) . . . [a]n
(a)(2)(B) report is required only from an expert described in (a)(2)(B)." The 2010 amendments
did not alter the scope of 26(a)(2)(B), which governs experts who are "retained or specially
employed." Though decided prior to the 2010 amendments, Meyers established a test for
determining when a treating physician is "retained or specially employed" within the meaning of
26(a)(2)(B). The 2010 amendments, thus, did not alter how courts should address the threshold
question of which experts are covered by 26(a)(2)(B), but rather, added a summary disclosure
requirement for experts not retained or specially employed.
Consistent with this analysis, the Seventh Circuit itself has continued to apply the
Meyers test after the 2010 amendments. See E.E.O.C. v. AutoZone, Inc., 707 F.3d 824, 833
(7th Cir. 2013) ("[A] treating physician can provide an expert opinion without submitting a written
report if the physician's opinion was formed during the course of the physician's treatment, and
not in preparation for litigation.") (quoting Meyers v. Nat'l R.R. Passenger Corp., 619 F.3d 729,
734–35 (7th Cir. 2010)). See also Piskorowski v. Target Corp., No. 12-cv-8865, 2014 WL
321436, at *2 (N.D. Ill. Jan. 29, 2014) ("the amendments did not alter who was required to file
an expert disclosure" but rather altered the type of disclosures required for experts not retained
or specifically employed.)
Plaintiff argues that Dr. Klein has not been retained or specially employed to provide
expert opinions in this case and that "[a]ll of Dr. Klein's expert opinions were formed either
during or after his treatment of Mrs. Batty." (Pl.'s Resp. at 1.) True enough, but the question
the court must answer is which of his opinions were formed during his treatment, and which
after. The court turns to that question now.
Scope of testimony
Zimmer urges that Dr. Klein's opinions regarding the forces in the knee, edge loading,
implant lift-off, and the adequacy of Zimmer's testing are untethered to his treatment of Ms.
Batty and must be excluded for failure to comply with Rule 26. Effectively conceding the point,
Plaintiff has represented that she does not intend to call Dr. Klein to offer opinions on these
topics. In any event, those opinions would be excluded because they exceed the scope of Dr.
Klein's treatment and have not been presented in an expert report identifying the facts and data
supporting his conclusions. See FED. R. CIV. PRO. 37(c)(1) ("A party that without substantial
justification fails to disclose information required by Rule 26(a) . . . is not, unless such failure is
harmless, permitted to use as evidence at trial, at a hearing, or on a motion any witness or
information not so disclosed.") 4
Zimmer maintains that the rebuttal report also failed to comply with the requirements of
Rule 26(a)(2)(B) and should likewise be excluded. (Zimmer Mem. at 13; Zimmer Reply Mem. in
Supp. of Fifth Daubert Mot. , hereinafter "Zimmer Reply," 1–2.) Dr. Klein's rebuttal report
covers three categories: (1) the alignment of the implants, (2) his cementing technique, and (3)
the cause of Ms. Batty's loosening. The court concludes that those opinions relate to Dr. Klein's
Without any description of the basis of his opinions, the court is also required to
conclude that they are inadmissible under Federal Rule of Evidence 702 and Daubert. An
expert's "failure to explain his methodology," permits the court to "conclude that the report
offer[s] 'nothing of value to the judicial process.'" Minix v. Canarecci, 597 F.3d 824, 835 (7th Cir.
2010) (quoting Wendler, 521 F.3d at 791). See also Wendler & Ezra, P.C. v. Am. Int'l Grp., Inc.,
521 F.3d 790, 791 (7th Cir. 2008) ("An expert who supplies nothing but a bottom line supplies
nothing of value to the judicial process.").
treatment choices. Moreover, those opinions were presented in his deposition upon questioning
about his treatment of Ms. Batty, and Zimmer is therefore not prejudiced by their admission in
Alignment of implants
Dr. Klein opines in his rebuttal report that Ms. Batty's tibial components are well-aligned.
Zimmer urges he did not form this opinion during the course of treatment, but rather, reached
this conclusion only for this litigation. (Zimmer Reply at 3.) The court disagrees.
explained that it is normal practice to take an x-ray in the recovery room immediately after
surgery, and while those x-rays are not as accurate as those taken in the x-ray room with the
patient standing, "[it] gives us an idea about alignment." (Klein Dep. at 65:1–7.) Moreover, at
Ms. Batty's first follow-up visit after both knees had been replaced, Dr. Klein again took x-rays,
which, according to his notes, showed "well fixed total knees." (Id. at 121:23–122:14.) Dr. Klein
explained that when he wrote "well fixed total knees" he meant that the knees "were aligned
well, there was cement appropriate around the prosthesis, no gaps, no fractures, good
alignment." (Id. at 122:13–18.) His rebuttal report confirms that his assessment of Ms. Batty's
alignment is based on his experience as a surgeon and thus is intertwined with opinions he
formed during the course of her treatment. Specifically, he states that "in my own practice . . .
many tibias are placed in a few degrees of varus and function quite well," to explain why he
believed her alignment was good. (Klein Rebuttal at 1–2.)
Zimmer urges that, even if Dr. Klein evaluated Ms. Batty's alignment during the course of
treatment, he went further at his deposition and in his rebuttal report. During the deposition, Dr.
Klein was asked to review the same x-rays he had reviewed at his follow-up visits with Ms.
Batty. He observed from those x-rays that
[t]he femoral component appears to be aligned quite well. The tibial component
looks to me maybe one or two degrees in varus, if you want to be critical. But
you can't say for certain because there could be some rotational deformity of the
X-ray. But it looks like a reasonably well aligned knee replacement.
(Klein Dep. at 110:11–17.) Moreover, he explained that "looking at it today on this X-ray it looks
like that it is still probably two degrees away from perfect.
But still in very acceptable
alignment." (Id. at 112:16–19.) In the rebuttal report, he asserts that "[i]t does appear that both
knees look like they are in varus alignment in the immediate postoperative films and
subsequently got worse." (Klein Rebuttal at 1.)
Zimmer argues that these opinions were formed solely for litigation in an effort to counter
the opinions of Dr. Goodman.
(Zimmer Reply at 3–4.)
The court disagrees.
deposition occurred before Dr. Goodman completed his report; his opinions could not have
been formed to rebut Dr. Goodman's specific criticisms. Moreover, though apparently based on
his review of the x-rays during the deposition, Dr. Klein's testimony, and his opinion in the
rebuttal report, help explain and elaborate on his observations and opinions originally formed
during the course of Ms. Batty's treatment. That is, the court finds the relationship between Dr.
Klein's rebuttal reports and his treatment observations to be close enough that a separate
expert report is not necessary to put Zimmer on notice of these opinions.
Moreover, insofar as these opinions do extend beyond Dr. Klein's treatment of Ms. Batty,
and are governed by the requirements of Rule 26(a)(2)(B), the court is satisfied that the
opinions are reliable and that exclusion is not an appropriate remedy. First, Dr. Klein's opinions
on alignment and cementing are based on the same methodology he uses in his practice. See
Lapsley v. Xtek, Inc., 689 F.3d 802, 805 (7th Cir. 2012) ("The purpose of the Daubert inquiry is
to scrutinize proposed expert witness testimony to determine if it has 'the same level of
intellectual rigor that characterizes the practice of an expert in the relevant field.') (quoting
Kumho Tire 526 U.S.at 152). Evaluating the alignment and fixation of components based on
visual observations of x-rays is a critical part of Dr. Klein's practice as an orthopedic surgeon.
(See Klein Decl. ¶ 3) ("It is an important part of my follow up that at each postoperative visit I
take x-rays and check the alignment of the implants. I did that in Mrs. Batty's case.") Zimmer
asserts that because Dr. Klein acknowledged that long-leg x-rays are more reliable, his analysis
based on short-leg x-rays is necessarily unsound (see Zimmer Reply at 7), but measuring
alignment based on short-leg x-rays is a commonly used method in Dr. Klein's and other
orthopedic surgeons' practice. (See Klein Dep. at 65:1–20.) Zimmer is free to critique Dr.
Klein's assessment during cross-examination, but that criticism does not require exclusion.
Nor should these opinions be excluded for failure to provide an expert report. "The
consequence of non-compliance with Rule 26(a)(2)(B) is 'exclusion of an expert's testimony . . .
unless the failure was substantially justified or is harmless.'" Meyers, 619 F.3d at 734 (quoting
Gicla v. United States, 572 F.3d 407, 410 (7th Cir. 2009) and FED. R. CIV. PRO. 37(c)(1)).
Admitting these opinions is harmless to Zimmer:
During his deposition, Dr. Klein clearly
articulated his opinions about alignment; nothing in his rebuttal report could be construed as a
surprise. In the deposition excerpts quoted above, Dr. Klein evaluated the alignment of the
components and noted the possibility that if Ms. Batty rotated her leg while the x-ray was taken,
that rotation could undermine the accuracy of the x-rays. (See also Klein Dep. at 126:17–24)
(reviewing an x-ray and suggesting that "it just shows [how] I think rotation of the leg can affect
the alignment of the x-ray, how it appears.") He also testified that the weight-bearing x-rays
showed good alignment of the tibial component: He pointed out that the "tibial component is
completely parallel with the ground, which is shown to be very helpful to minimize excessive
stress on one side of the other. So I think I really did a very good job." (Klein Dep. at 113:1–11.)
After the deposition, Zimmer's expert, Dr. Goodman, had an opportunity to review Dr. Klein's
testimony and opinions and in fact prepared a report criticizing Dr. Klein's techniques and
opinions. (Goodman Rep. at 31) (citing "Deposition of Alan H. Klein" as one of the materials
reviewed in preparation of Dr. Goodman's report.) Zimmer is well-equipped to challenge Dr.
Klein's opinions on cross-examination and will suffer no unfair prejudice from admitting this
testimony without a complete expert report.
Dr. Klein's opinions about his cementing technique are likewise tethered to his treatment
of Ms. Batty.
The discussion of cementing technique in the rebuttal report centers on a
description of Dr. Klein's usual practice: Dr. Klein notes that he cements the tibial component
first, using as much cement as he believes is necessary, and manually interdigitates additional
cement into the tibia, before inserting the prosthesis. (Klein Rebuttal at 2.) Then he uses the
remaining cement for the femoral and patellar component, and will use a second pack at that
stage of the surgery, if he finds it necessary. (Id.) Dr. Klein's comments on his cementing
practice were an obvious and direct response to Dr. Goodman's speculation that poor
cementing practice was the cause of the loosening Ms. Batty experienced, but this does not
mean that Dr. Klein formed those opinions solely for litigation.
Zimmer argues that the court should exclude this testimony because Dr. Klein offered no
"scientific support for the required fixation strength and appropriate amount of cement required
to obtain good fixation under Ms. Batty's flexion, loads, and cycles of use." (Zimmer Mem. at
13; see also Zimmer Reply at 6 ("Even in his Declaration, Dr. Klein remains vague about the
scientific bases for his opinions about his own cementing technique, making these statements
This argument presupposes that Dr. Klein's opinions are subject to the
disclosure requirements of expert reports. Before the court evaluates whether Dr. Klein has
sufficiently disclosed the bases for his opinions, Zimmer must first explain why Dr. Klein's
description of his surgical technique constitutes an opinion formed outside "the course of
providing treatment." Meyers, 619 F.3d at 735. The closest Zimmer comes to addressing this
question is its claim that Dr. Klein is "opining that nothing about his technique contributed to her
failure, but without explaining why." (Zimmer Reply at 9.) The fact that a jury could infer from
his testimony that Dr. Klein's cementing technique was not the cause of Ms. Batty's injury, again
does not necessarily mean that Dr. Klein's opinion was formed solely for litigation. The central
question remains whether Dr. Klein formed his opinion about the amount of cement during the
course of treatment or after.
The court concludes that Dr. Klein made a determination about the adequacy of his
cementing technique during treatment. First, when cementing the components during surgery,
Dr. Klein relied on his experience implanting knees to form an opinion that the amount of
cement he used was adequate and would provide good fixation for Ms. Batty's implants. That
opinion was the basis for his decision to use one, rather than two, packs of cement. Moreover,
as articulated above, as part of his post-operative review of Ms. Batty's X-rays and at her initial
follow-up visits he concluded, and documented in Ms. Batty's medical records, that the
components were "well-fixed."
This sharply distinguishes Dr. Klein's testimony from that
considered in Meyers where the court found "no evidence . . . that either doctor previously
considered or determined the cause" of the injuries. Meyers, 619 F.3d at 735. Dr. Klein may
therefore testify regarding his opinion, formed during surgery, that "[c]learly, there was enough
cement left for the femur and the patella as well. I do use 2 packs of cement, in larger patients
with larger prostheses, but I assure you 1 pack of cement is adequate for this size component."
(Klein Rebuttal at 2.) Zimmer may, of course, challenge the basis for Dr. Klein's opinion on
cross-examination, and present evidence that one pack of cement is insufficient, but Zimmer's
criticisms do not convert Dr. Klein's opinion formed during the course of treatment into one
requiring disclosure in a Rule 26(a)(2)(B) report. 5
As with his testimony regarding the alignment of the components, the court
concludes that, even if Dr. Klein were required to submit an expert report, his failure to do so
was harmless. Dr. Klein expressed his view that his cementing technique was adequate, based
on his own personal experience, and Zimmer's expert Dr. Goodman was able to review and
criticize that opinion in his expert report. Zimmer is therefore, well-equipped to cross-examine
Dr. Klein regarding his cementing technique.
Causes of Ms. Batty's Loosening
The most difficult question is whether Dr. Klein can testify about the cause of Ms. Batty's
loosening. The Seventh Circuit has cautioned that when physicians discuss causation, often
that testimony will be too far afield from treatment choices, and will necessitate a complete
expert report. See Meyers, 619 F.3d at 734–35; see also Coleman v. Am. Fam. Mut. Ins. Co.,
274 F.R.D. 641 (N.D. Ind. 2011) ("Physicians who intend to offer testimony regarding causation
of the plaintiff's injuries often go beyond the scope of treatment, requiring the physician to
submit a complete expert report.") At bottom, however, the question remains the same: which
opinions did Dr. Klein form during his treatment of Ms. Batty and which were formed solely for
Zimmer highlights portions of Dr. Klein's testimony in which Dr. Klein confirms that he
has "no opinion about the cause of the loosening of [Ms. Batty's] tibial components." (Klein
Dep. at 82:7–9.) Plaintiff responds that Dr. Klein will "not be offered to provide expert testimony
that the high flex design of Mrs. Batty's implants is what caused her implants to fail
prematurely." (Pl.'s Resp. at 13.) Rather, Plaintiff intends to call Dr. Klein to testify regarding
the "other potential causes that he ruled out and how he ruled them out." (Id.)
The court agrees with Zimmer that Dr. Klein did not determine, as part of his treatment,
that the design of Flex knee implant caused Ms. Batty's loosening, and he may not testify that
the product or its design caused the implant to loosen. But the court agrees with Plaintiff that
Dr. Klein, as part of his treatment, did rule out certain causes and may testify regarding how he
arrived at those conclusions. Dr. Klein testified that there were no complications during Ms.
Batty's surgeries (Klein Dep. at 114:25–115:6, 116:10–12), and, as explained above, his review
of her post-operative x-rays showed good alignment, good cement fixation, and proper spacing.
He also described that, during the surgery, he did not observe any abnormal anatomical
findings, such as weak bone structure or bone stock, that would cause him to anticipate
problems with Ms. Batty's knee replacements. (Id. at 115:7–15.) Dr. Klein testified that Ms.
Batty's surgery was consistent with the many other knee replacement surgeries he had
conducted and which had been successful.
(Id. at 117:18–22.)
Dr. Klein was, therefore,
surprised when the component started to loosen. (Id. at 118:4–23; 148:2.) In his effort to
determine why this had happened, he first thought was that Ms. Batty had an infection; he
ordered a bone scan and bloodwork, which ruled out that cause.
(Klein Dep. at 149:15–
150:16.) Dr. Klein also noted that nothing about Ms. Batty's activity levels could explain the
loosening, and "if it wasn't infection, I couldn't think of anything else." (Id. at 202:6–22.) Dr.
Klein does not opine in the rebuttal report that the devices caused the injury, and insofar as he
does, that testimony will be excluded for failure to comply with Rule 26(a)(2)(B). As part of his
treatment, however, Dr. Klein did rule out Ms. Batty's bone structure, the alignment of the joint,
her activity, infection, trauma to the knee, or complications from surgery as causes of the
loosening. (Id. at 202:6–22; Klein Decl. at 6.) Because those opinions were formed in the
course of treatment, Dr. Klein is not required to present a complete expert report under Rule
Testimony about warnings
In its Daubert motion, Zimmer also argues that Dr. Klein's testimony about warnings is
inadequate to show causation for Plaintiff's failure to warn claim. This argument does not
pertain to the reliability or relevance of Dr. Klein's testimony under Rule 702 or Daubert. The
court therefore declines to address the argument at this time, but will instead take it up in the
context of Zimmer's motion for summary judgment on Ms. Batty's failure-to-warn theory.
In sum, Zimmer's motion  to exclude the testimony of Dr. Klein is granted in part
and denied in part. Dr. Klein's testimony will be limited to his observations and opinions formed
during his course of treating Ms. Batty. He is precluded from opining regarding the particular
forces and stresses at work on the knee, the adequacy of Zimmer's testing, or whether the
design of the knee caused Ms. Batty's loosening. His testimony regarding the alignment and
cementing of Ms. Batty's components, as well as how he eliminated certain causes when trying
to find the source of the loosening will be admitted.
Dated: June 17, 2015
REBECCA R. PALLMEYER
United States District Judge
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