NONPRECEDENTIAL DISPOSITION
To be cited only in accordance with
Fed. R. App. P. 32.1
United States Court of Appeals
For the Seventh Circuit
Chicago, Illinois 60604
Argued September 9, 2009
Decided January 25, 2010
Before
JOEL M. FLAUM, Circuit Judge
TERENCE T. EVANS, Circuit Judge
ANN CLAIRE WILLIAMS, Circuit Judge
No. 09‐1362
ARTHUR W. FUESTING, Appeal from the United States
Plaintiff‐Appellant, District Court for the Central
District of Illinois.
v.
No. 2:02‐CV‐2251
ZIMMER, INC.,
Defendant‐Appellee. Michael P. McCuskey,
Chief Judge.
O R D E R
Arthur W. Fuesting alleges that Zimmer, Inc.’s knee implant was improperly sterilized
and as a result malfunctioned, causing him pain and suffering. In our earlier opinion we
excluded the testimony of Dr. James Pugh, Fuesting’s initial causation expert. On remand,
Fuesting employed the services of Dr. Robert Rose, who testified that the knee implant
oxidized while it was implanted because Zimmer used a faulty sterilization process. Dr.
Rose’s testimony suffers from the same deficiencies upon which we excluded Dr. Pugh’s
No. 09‐1362 Page 2
testimony in the earlier opinion — most importantly, it fails to link his general theories
about implant oxidation to Fuesting’s knee implant in particular. Although Dr. Rose
theorizes that Fuesting’s knee implant failed due to oxidation that occurred while it was
implanted, he fails to articulate how his conclusions about knee implants in general pertain
to Fuesting’s knee implant in particular. The record indicates that this oxidation could have
occurred in the six years after it was explanted but before Dr. Rose examined it. He also
fails to show that better sterilization methods existed at the time Fuesting’s knee was
implanted. In fact, the record reveals that the method used by Zimmer was the industry
standard. The district court did not err in excluding Dr. Rose’s testimony or that of Dr.
James McKechnie, who based his conclusions on Dr. Rose’s theories. And without his
experts, Fuesting cannot prove causation, so the district court properly granted summary
judgment in Zimmer’s favor.
I. BACKGROUND
A full factual background for this case can be found in our earlier opinion, Fuesting v.
Zimmer, Inc., 421 F.3d 528 (7th Cir. 2005) (“Fuesting I”), so we need recount only those facts
directly relevant to this appeal. Zimmer, Inc. manufactures orthopedic implants. In 1992,
Arthur W. Fuesting had his right knee replaced with Zimmer’s I/B Knee implant. By May
2001, Fuesting was experiencing swelling in his right knee. Before its implantation, Zimmer
sterilized the knee implant using a technique called gamma irradiation in air (“GIA”).
In October 2002, Fuesting filed suit against Zimmer on a theory of design defect,
claiming negligence and strict liability based on Zimmer’s decision to sterilize his right knee
implant using GIA instead of another method. Fuesting proffered Dr. James Pugh as an
expert witness in support of his claims. Dr. Pugh opined that the design of the implant was
defective because it delaminated and therefore failed due to oxidation caused by the GIA
sterilization process, and manufacturers such as Zimmer should have known in 1991 that
better sterilization processes were available (such as gamma irradiation in an inert
environment or sterilization with ethylene oxide). The district court denied Zimmer’s
pre‐trial motion to exclude Dr. Pugh’s testimony as unreliable under Federal Rule of
Evidence 702. The case went to trial, and a jury found in favor of Fuesting, awarding him
$650,000 in damages.
Zimmer appealed, and we reversed in Fuesting I, finding that the district court erred by
failing to exclude Dr. Pugh’s testimony as unreliable. Specifically, we found that Dr. Pugh
failed to: (1) “bridge the analytical gap” between his opinion that GIA sterilization leads to
oxidation and the failure of Fuesting’s knee implant in particular; (2) show that his methods
were subject to peer review and approval; (3) rule out alternative possibilities for causation;
and (4) show that better sterilization methods were available in 1991. We instructed the trial
court to enter judgment for Zimmer, but before it could do so, the Supreme Court issued its
No. 09‐1362 Page 3
decision in Unitherm Food Systems, Inc. v. Swift‐Eckrich, Inc., 546 U.S. 394 (2006), which
suggested that it was inappropriate for a court of appeals to award judgment in the absence
of a properly‐filed postjudgment motion for judgment as matter of law in the district court.
Therefore, we amended the original opinion and remanded the case to the district court for
further proceedings. Fuesting v. Zimmer, Inc., 448 F.3d 936 (7th Cir. 2006).
On remand, Fuesting hired a new expert, Dr. Robert Rose, who submitted a paltry five‐
page expert report primarily filled with background facts. Dr. Rose’s report stated that
upon examination, he found a tell‐tale “white band” indicating that Fuesting’s knee implant
failed because of oxidation that occurred while the implant was “in vivo” (implanted in
Fuesting). The district court excluded Dr. Rose’s testimony, and also excluded the
testimony of Fuesting’s treating physician, Dr. McKechnie, because he relied on the opinion
of Dr. Rose in forming his conclusions. Since the district court excluded all of Fuesting’s
causation testimony, it granted Zimmer’s summary judgment motion. Fuesting now
appeals.
II. ANALYSIS
A. Exclusion of Expert Testimony from Dr. Rose and Dr. McKechnie
In both strict liability and negligence actions regarding design, Illinois law (under
which Fuesting’s claims proceed) requires plaintiffs to establish “the existence of a defective
condition in the product at the time it left the manufacturer’s control,” Carrizales v. Rheem
Mfg. Co., 589 N.E.2d 569, 580 (Ill. 1991), and “a causal link between the alleged design defect
. . . and [the plaintiff’s] injury,” Baltus v. Weaver Div. of Kidde & Co., 557 N.E.2d 580, 586 (Ill.
1990). Toward both these ends, Fuesting proffered the expert testimony of Drs. Rose and
McKechnie. Without expert causation testimony, Fuesting’s claims fail. Fuesting I, 421 F.3d
at 537‐38.
The admissibility of scientific expert testimony is governed by Federal Rule of Evidence
702, and in particular Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Rule 702 provides:
If scientific, technical, or other specialized knowledge will assist
the trier of fact to understand the evidence or to determine a
fact in issue, a witness qualified as an expert by knowledge,
skill, experience, training, or education, may testify thereto in
the form of an opinion or otherwise, if (1) the testimony is
based upon sufficient facts or data, (2) the testimony is the
product of reliable principles and methods, and (3) the witness
has applied the principles and methods reliably to the facts of
No. 09‐1362 Page 4
the case.
Rule 702 requires the district court to perform a “gate‐keeping” function before
admitting expert scientific testimony in order to “ensure that any and all scientific
testimony or evidence admitted is not only relevant, but reliable.” Daubert, 509 U.S. at 589.
Before considering whether the testimony “will assist the trier of fact to understand or
determine a fact in issue,” a district court must make “a preliminary assessment of whether
the reasoning or methodology underlying the testimony is scientifically valid.” Id. at
592‐93. To aid courts in assessing the reliability of scientific expert testimony, the Supreme
Court set forth the following, non‐exhaustive list of “guideposts” for consideration: (1)
whether the scientific theory can be and has been tested; (2) whether the theory has been
subjected to peer review and publication; (3) the theory’s known or potential rate of error
when applied; and (4) whether the theory has been “generally accepted” in the scientific
community. Id. at 593‐94; see also Chapman v. Maytag Corp., 297 F.3d 682, 687 (7th Cir. 2002).
We review de novo whether the court correctly applied Daubert’s framework, and we
review the court’s decision to admit or exclude expert testimony for abuse of discretion.
Kunz v. DeFelice, 538 F.3d 667, 675 (7th Cir. 2008).
In this case, Dr. Rose’s testimony fails for essentially the same reasons that Dr. Pugh’s
did. First, Dr. Rose’s testimony did not show that his theory that these knee implants
oxidize “in vivo” has sufficient acceptance in the scientific community. He cited several
articles that he wrote, the most recent one in 1986, but the bulk of these articles concern the
oxidizing of an implant prior to implantation. He failed to point to any peer reviewed
studies that discuss the oxidation rates of this type of implant in vivo. In this case, the
implant sat on a shelf for seven months before implantation, was in vivo for nine years, and
then sat on a shelf again for six additional years before Dr. Rose examined it. Dr. Rose
failed to cite any articles or studies that he or any one else conducted regarding how one can
discern whether the oxidation occurred before or after implantation. And in this case, it is
perfectly plausible that the oxidation occurred after it was removed. Dr. Rose also did not
rule out possible alternative methods of causation. Zimmer, as well as the implant industry
as a whole, admits that GIA causes at least some oxidization. However, Dr. Rose failed to
proffer any evidence that GIA caused this oxidation to occur at a rapid rate while the
implant was in Fuesting. Nor did he articulate why this oxidation could not have occurred
during the six years after it was explanted and before he examined it, rather than while it
was in vivo. He also did not discuss other possible reasons for the device’s failure, such as
Fuesting’s weight or gait. Nor does he explain how the device’s oxidation caused the device
to fail — the mere presence of oxidation does not prove that the oxidation caused the device
to malfunction.
More importantly, like Dr. Pugh, Dr. Rose has failed to “bridge the analytical gap”
No. 09‐1362 Page 5
between the accepted fact that GIA sterilization causes at least some amount of oxidation
and his ultimate conclusion that Fuesting’s knee implant in particular failed because GIA,
rather than another sterilization method, was used. One indicator of unreliability is the
unjustifiable extrapolation from an accepted premise to an unfounded conclusion. See Gen.
Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997) (“A court may conclude that there is simply too
great an analytical gap between the data and the opinion proffered.”). Dr. Rose did not
answer a variety of questions posed by this court in its earlier opinion with any specificity.
Among other things, he failed to address “with respect to Fuesting’s implant in particular,
what quantum of each variable is required to set this agreed upon chain reaction in motion.
How much radiation does it take to cause oxidation, and to what degree? How much
oxidation must occur to render polyethylene more susceptible to delamination? . . . .”.
Fuesting I, 421 F.3d at 536. As we noted, “some greater methodology is required to bridge
the analytical gap between general principles and particular conclusions, and to vest
thereby the opinion with requisite reliability.” Id. Here, Dr. Rose did not employ any
“greater methodology” that linked his general observations with Fuesting’s knee implant in
particular.
Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He
concluded, in one sentence and without any support, that the industry standard was to
sterilize implants in an inert gas instead of air. However, as we held in our prior opinion,
“[the] testimony that Zimmer should have sterilized the subject implant through gamma
irradiation in an inert environment is wholly unfounded. The record reveals that, at the time
of the subject I/B Knee implant’s manufacture (1991), it was virtually universal industry
practice to sterilize such implants by gamma irradiation in air. Indeed, no manufacturer at
that time employed any of [the] proffered methods, and [Dr. Rose] has cited no
contemporary articles counseling the use of such methods.” Id. at 537; see also McMahon v.
Bunn‐O‐Matic Corp., 150 F.3d 651, 657‐58 (7th Cir. 1998) (holding that a “bare conclusion”
offered without explanation or empirical support fails the reliability requirement of Rule
702). To the contrary, “the record suggests that the I/B Knee at issue is one of the most
successful knee implants ever studied, has the longest and highest survivorship rate
published for any knee prosthesis, and has even been called the “gold standard” of its
kind.” Fuesting I, 421 F.3d at 537. For all these reasons, the district court did not abuse its
discretion in excluding Dr. Rose’s testimony.
Likewise, as we found before, because Dr. McKechnie’s testimony on causation
primarily relies on an excluded expert opinion (in this case, Dr. Rose’s), the district court
did not err in excluding it. See Fuesting I, 421 at 537. Given that all causation testimony has
been excluded, Fuesting’s strict liability and negligence claims necessarily fail, and
summary judgment in favor of Zimmer is appropriate. Id.
No. 09‐1362 Page 6
B. Alleged Discovery Violation
Fuesting argues that before this court’s ruling in Fuesting I, Zimmer failed to disclose
certain documents, though it is not clear what these documents are. He argues that had
Zimmer disclosed them, this court would not have excluded Dr. Pugh’s testimony. As a
result of this alleged discovery violation, Fuesting moved for sanctions – he asked the
district court to award summary judgment in his favor – which the district court denied. As
the district court noted in its opinion, which we review for abuse of discretion, Fuesting’s
motion to compel the production of these documents was originally denied as untimely.
See Cerutti v. BASF Corp., 349 F.3d 1055, 1067 (7th Cir. 2003). Moreover, given the variety of
reasons for excluding this expert testimony in Fuesting I, Fuesting’s argument that these
documents would have changed the court’s decision is unpersuasive. So, the district court
did not err in denying the requested sanctions.
III. CONCLUSION
For the foregoing reasons, the district court’s exclusion of the testimony of Drs. Rose and
McKechnie, denial of Fuesting’s request for sanctions, and award of summary judgment in
favor of Zimmer, are all AFFIRMED.