In re: Zimmer, NexGen Knee Implant Products Liability Litigation Appeal of: Theodore F. Joas and Darlene A. Joas
May 22, 2017
from the United States District Court for the Northern
District of Illinois, Eastern Division. No. 13 C 9216 -
Rebecca R. Pallmeyer, Judge.
Flaum, Easterbrook, and Sykes, Circuit Judges.
Joas underwent a total knee replacement at a Wisconsin
hospital and received a Zimmer NexGen Flex knee implant.
Within a few years, he began experiencing pain in his new
knee. X-rays confirmed that the implant had loosened and
required a surgical fix. Joas brought a panoply of claims
against Zimmer, Inc., the implant manufacturer. His case was
transferred to a multi-district litigation in the Northern
District of Illinois, where it was eventually treated as a
bellwether case. Applying Wisconsin law, the presiding judge
entered summary judgment for Zimmer.
asks us to reinstate a single claim based on a theory of
inadequate warning. His appeal raises some unresolved issues
in Wisconsin product-liability law-most notably, the
application of the "learned intermediary" doctrine,
which the Wisconsin Supreme Court has not yet had an
opportunity to address. We predict that the state high court
would follow the lead of other states and adopt this
doctrine. We affirm the judgment.
suit is the second bellwether case in a multidistrict
litigation concerning Zimmer NexGen Flex knee implants.
Plaintiffs in the litigation allege that they have suffered
pain and loss of movement because the NexGen Flex is prone to
Joas had knee-replacement surgery at a hospital in Eau
Claire, Wisconsin. His surgeon used a Zimmer NexGen Flex
implant. At the time Joas worked for Pepsi Bottling Group,
and his job required him to lift and carry heavy loads and to
squat repeatedly throughout the day. Soon after the surgery
he was able to engage in physical therapy, return to work,
and participate in recreational activities like hunting and
canoeing. By 2011, however, Joas began to feel pain in his
new knee. An x-ray and bone scan revealed aseptic loosening
of the tibial component of the implant. Translation: the bond
between the implant and the shinbone had weakened. He had
revision surgery in October 2012.
Joas sued Zimmer alleging that the NexGen Flex design causes
premature loosening for total-knee-replacement patients who
engage in activities that require a high degree of knee
flexibility. He filed his suit in federal court in New Jersey
and raised product-liability claims premised on allegations
of defective design, manufacture, and warning. (He also alleged
misrepresentation and statutory consumer-protection claims,
but he abandoned them at summary judgment.) The New Jersey
court transferred the case to a multidistrict proceeding then
underway in the Northern District of Illinois addressing
lawsuits against Zimmer based on its NexGen Flex implant.
judge designated Joas's case as a bellwether and
scheduled a trial. In the meantime Zimmer moved for summary
judgment on all claims. Among other things, the manufacturer
sought to exclude the testimony of Dr. Joseph Fetto,
Joas's expert witness. Dr. Fetto's report indicated
that his opinion testimony would be based on a differential
etiology methodology, which entailed identifying and ruling
out potential causes of the tibial loosening to arrive at the
likeliest cause of Joas's injury. Applying Rule 702 of
the Federal Rules of Civil Procedure and Daubert v.
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993),
the judge excluded Dr. Fetto's testimony as unreliable
because he did not have any discernible basis for determining
which potential causes of the loosening were reasonable and
which were not.
Fetto was Joas's only expert who would testify that a
defect in the knee implant caused his injury. With his
expert's testimony excluded, Joas could not prevail on
his claims based on defective design or manufacture. The
exclusion of Dr. Fetto's testimony also left a causation
gap in Joas's claim based on inadequate warning. To the
extent that this claim could survive without Dr. Fetto's
testimony, the judge rejected it as deficient in other
respects and entered summary judgment for Zimmer on all
limits his appeal to his claim based on defective warning.
The claim rests on two theories. Joas argues that Zimmer (1)
failed to issue proper warnings directly to him as the
recipient of the knee replacement; and (2) failed to issue
proper warnings to his surgeon, who implanted the device.
Joas does not quarrel with the exclusion of Dr. Fetto's
testimony. Rather, he urges us to allow this claim to go
forward based on the testimony of Dr. John Dearborn,
Zimmer's expert witness. Dr. Dearborn testified in
deposition that he would have used two bags of cement to
properly bond a knee implant to the patient's shinbone.
Joas's surgeon, Dr. Bryan Larson, used only one bag of
cement, consistent with his normal practice. Joas maintains
that Zimmer had a duty to warn that two bags of cement are
needed to achieve a proper bond.
judge disallowed the claim for two reasons. First, she
applied the learned-intermediary doctrine, which (as relevant
here) holds that the manufacturer of a medical device has no
duty to warn the patient as long as the manufacturer provides
adequate warnings to the physician. Second, the judge held
that even if Zimmer had a duty to warn the surgeon, Joas has
no evidence of causation because Dr. Larson testified in
deposition that he did not read the packaging material Zimmer
sent with the NexGen Flex implant. Rather, he testified that
he based his surgical technique entirely on his general
medical training and his surgical fellowship. So an improved
warning, the judge held, would not have made any difference.
overcome this factual deficit, Joas asked the judge to
recognize and apply a legal presumption that the surgeon
would have heeded an improved warning had Zimmer provided
one. The judge declined to do so, holding that the proposed
"heeding presumption" has no support in Wisconsin
aspects of the failure-to-warn claim raise novel questions
under Wisconsin law. We turn first to Joas's claim that
Zimmer breached a duty to directly warn him. That
inquiry requires us to predict whether the Wisconsin Supreme
Court would recognize the learned-intermediary doctrine for
use in defective-warning cases involving medical devices. We