United States District Court, W.D. New York
August 25, 2005.
JOHN J. BILLONE and SANDRA BILLONE, Plaintiffs,
SULZER ORTHOPEDICS, INC., Defendant.
The opinion of the court was delivered by: MICHAEL TELESCA, Senior District Judge
DECISION and ORDER
Plaintiffs John J. Billone and Sandra Billone (collectively
"plaintiffs") bring this diversity action against defendant
Sulzer Orthopedics, Inc. ("defendant"), alleging various state
law causes of action with respect to the implantation of a
prosthetic knee replacement system inserted into Mr. Billone's
right knee in 1996. Defendant now moves to preclude the testimony
of plaintiffs' expert witness, and for summary judgment in its
favor. For the reasons set forth below, defendant's motion to
preclude the testimony of plaintiffs' expert witness is denied
and its motion for summary judgment is: granted with respect to
plaintiffs' strict liability for negligent manufacture claim,
duty to warn claim and breach of express warranty claim; and
denied with respect to plaintiffs' strict liability for negligent
design claim, negligent design, manufacture and inspection claim
and breach of implied warranty claim.
Mr. Billone has experienced pain in his right knee since he was
a teenager, and in 1996 decided to undergo partial knee replacement surgery on the advice of Dr. Stephen L. Kates. On
April 22, 1996, Dr. Kates successfully implanted a "Natural Knee
Unicompartmental Replacement System" (the "implant" or "knee
replacement system") in Mr. Billone's right knee. The implant,
which is designed and manufactured by defendant, is intended to
be an alternative to total knee replacement for patients
suffering unicompartmental knee disease. It is a symmetric system
consisting of a cast cobalt-chromium femoral component, a wrought
titanium alloy tibial base plate and an ultra high molecular
weight polyethylene tibial insert.
After surgery, Dr. Kates warned plaintiff not to overuse the
knee during recovery, since the implant is indicated for patients
with a more sedentary lifestyle. However, shortly after the
surgery, Mr. Billone returned to his busy plumbing and mechanical
business, and undertook several home improvements. Mr. Billone
met with Dr. Kates on several occasions subsequent to the surgery
to review the implant's status. Each time, Dr. Kates warned
plaintiff not to overuse his knees.
In September 1997, plaintiff complained to Dr. Kates about pain
in his right knee. X-rays revealed that a fragment of the implant
had broken from the posterior portion of the tibial base plate
and had shifted within the knee. Remedial surgery was needed, and
was completed in November 1997. Plaintiffs now bring suit,
alleging, inter alia, that the implant was defective. In support of their claims, plaintiffs have engaged the
services of Dr. David J. Quesnel, a mechanical engineer and
professor at the University of Rochester, who holds a Ph.D. in
Materials Science and Engineering and an M.S. in Materials
Science. Plaintiffs expect that Dr. Quesnel will testify that the
implant failed as a result of a design and manufacturing defect
found in the tibial base plate component and also as a result of
a design defect and manufacturing defect in the tibial insert
I. Defendant's Motion to Preclude Plaintiff's Use of
Quesnel's Expert Testimony
The admissibility of expert testimony is governed by Federal
Rule of Evidence 702, which provides that:
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 the case.
In Daubert v. Merrell Dox Pharmaceuticals, Inc., the Supreme
Court established the role of district courts as "gatekeepers,"
charged with the responsibility of ensuring that scientific
expert testimony is both relevant and reliable. See
509 U.S. 579 (1993). See also Kuhmo Tire Co., Ltd. v. Carmichael, 526 U.S. 137
(1999) (applying Daubert gatekeeping role to evaluation of
testimony by engineers concerning product manufacture or design).
"[T]he District Court must determine whether the proffered
testimony has a sufficiently reliable foundation to permit it to
be considered." Amorgianos v. National Railroad Passenger
Corporation, 303 F.3d 256, 265 (2d Cir. 2002) (quoting
Daubert, 509 U.S. at 597). In Daubert, the Supreme Court
listed several factors which district courts may look to in
assessing the reliability of proposed expert testimony,
including: (1) whether the expert's testimony is capable of being
tested; (2) whether the theory proffered by the expert has been
subjected to peer review; (3) the known or potential rate of
error associated with the expert's underlying techniques; (4)
whether standards or controls were used in testing; and (5)
whether the technique and theory employed by the expert are
generally accepted in the relevant scientific community.
509 U.S. at 592-594.
However, "the test of reliability is `flexible,' and
Daubert's list of specific factors neither necessarily nor
exhaustively applies to all experts or in every case." Kumho
Tire Company LTD. v. Carmichael, 526 U.S. 137, 141 (1999). The
Court's objective is "to make certain that an expert, whether
basing testimony upon professional studies or personal
experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert
in the relevant field." Id., at 151. Defendant anticipates that Dr. Quesnel will testify that in his
opinion, the implant removed from Mr. Billone failed as a result
of defective design and inferior manufacturing. Defendant
contends that Dr. Quesnel's opinion should be excluded from
consideration at trial because he: (1) is not an expert in the
use, manufacture or design of prosthetic devices; (2) failed to
consider whether plaintiff was the type of patient the
manufacturer intended or expected would receive the knee
replacement system; (3) failed to consider condition of
plaintiff's ACL prior to surgery in relation to the wear on the
knee replacement system; (4) failed to consult industry standards
regarding possible alternative grades of polyethylene suitable
for use in prosthetic devices; and (5) failed to conduct tests on
the knee replacement system itself to prove his theory of
causation. As such, defendant argues, Dr. Quesnel is not
qualified to render an expert opinion and his opinions are
unreliable and should be excluded from consideration at trial.
Defendant is correct in stating that while "trained experts
commonly extrapolate from existing data . . . nothing in either
Daubert or the Federal Rules of Evidence require[s] a district
court to admit opinion evidence that is connected to existing
data only by the ipse dixit of the expert. A court may
conclude that there is simply too great an analytical gap between
the data and the opinion proffered." General Electric Co. v.
Joiner, 522 U.S. 136, 146 (1997). In fact, courts should exclude
expert testimony that is "speculative or conjectural, or if it is
based on assumptions that are so unreasonable and contradictory as to
suggest bad faith. . . ." Boucher v. Suzuki Motor Corp.,
73 F.3d 18, 21 (2d Cir. 1996). However, where an expert's underlying
methodology is reliable, defects in the conclusion drawn should
be explored on cross-examination and go the weight of the
evidence, not its admissibility. McCullock v. H.B. Fuller
Company, 61 F.3d 1038, 1043 (2d Cir. 1995). Moreover, the
Supreme Court has emphasized the "liberal thrust" of Rule 702,
favoring the admissibility of expert testimony. Blanchard v. Eli
Lilly & Co., 207 F. Supp.2d 308, 316 (D.Vt. 2002) (quoting,
Daubert, 509 U.S. at 588).
I find that Dr. Quesnel's professional engineering experience
and the methodology he used in rendering his opinion satisfies
the requirements of Federal Rule of Evidence 702, and that
defendant's criticisms of Dr. Quesnel's opinions may be explored
on cross-examination rather than by defendant's motion to
completely exclude such testimony. Dr. Quesnel's curriculum
vitae and deposition testimony demonstrate that he is an expert
in the field of product design. He has more than thirty years of
mechanical engineering experience and currently serves as a
consultant in "Failure Analysis & Investigative Engineering,"
where he investigates the causes of "automobile chassis failures,
engine component failures and fracture of glassware." See
Curriculum Vitae of Dr. David J. Quesnel, p. 36, Defendant's
Appendix to Local Rule 56.1 Statement of Material Facts, Ex. O
(Doc. No. 45). He also currently teaches biomechanics at the University of Rochester, where he evaluates
the joints, structures and components of the human body in
relation to the loads forces and stresses they must endure. See
Deposition of Dr. David J. Quesnel, pp. 34-36, Defendant's
Appendix to Local Rule 56.1 Statement of Material Facts, Ex. P
(Doc. No. 45). In addition, Dr. Quesnel apparently will rely upon
his personal examination of the knee replacement system that was
removed from Mr. Billone. As such, there exists a sufficiently
reliable basis for Dr. Quesnel to offer his expert opinion as to
why the knee replacement system removed from Mr. Billone was
defective. Defendant may, upon cross-examination, contest Dr.
Quesnel's conclusions, however, the ultimate value of Dr.
Quesnel's testimony will be left to the determination of the fact
II. Defendant's Motion for Summary Judgment
Rule 56 of the Federal Rules of Civil Procedure provides that a
party is entitled to summary judgment as a matter of law only
where, "the pleadings, depositions, answers to interrogatories
and admissions on file, together with the affidavits, if any,
show that there is no genuine issue as to any material
fact. . . ." FED.R.CIV.P. 56(c). The party seeking summary
judgment bears the burden of demonstrating that no genuine issue
of material fact exists, and in making the decision the court
must draw all reasonable inferences in favor of the party against
whom summary judgment is sought. Ford v. Reynolds,
316 F.3d 351, 354 (2d Cir. 2003) (citing Marvel Characters v. Simon, 310 F.3d 280,
285-86 (2d Cir. 2002)). "Summary judgment is improper if there is
any evidence in the record that could reasonably support a jury's
verdict for the non-moving party." Id.
A. Plaintiffs' Strict Liability Claim
In an action for strict products liability, a plaintiff may
assert that the product is defective due to a mistake in
manufacturing, improper design or a manufacturer's failure to
provide proper warning regarding the use of the product. Fane v.
Zimmer, 927 F.2d 124 (2d Cir. 1991). To state a valid claim
under any of these strict products liability theories, a
plaintiff must demonstrate that: (1) the product is "defective"
because it is not reasonably safe as marketed; (2) the product
was used for its normal purpose; (3) the defect was a substantial
factor in causing the plaintiff's injuries; (4) the plaintiff,
having exercised reasonable care, would not have been able to
discover the defect; and (5) the plaintiff would not have
otherwise avoided the injury through the use of ordinary care.
Urena v. Biro Manufacturing Company, 114 F.3d 359, 363 (2d Cir.
Plaintiff first claims that defendant is strictly liable for an
allegedly defective design of the knee replacement device. Under
New York State Law, a device is of defective design were it is
"not reasonably safe or presented an unreasonable risk of harm to
the user." Fane 927 F.2d at 128. Thus, a plaintiff must demonstrate that the product "presented a substantial likelihood
of harm and feasibly could have been designed more safely." Id.
Here, plaintiffs present sufficient proof to survive summary
judgment as to whether the knee replacement system removed from
Mr. Billone was defectively designed. First, Dr. Quesnel's
expected expert testimony that the implant was improperly
designed creates an issue of fact for determination by the fact
finder. As defendant explained in its motion to preclude Dr.
Quesnel's testimony, there are numerous questions concerning the
soundness of that opinion. Second, it can be inferred from Dr.
Quesnel's expert report that the knee replacement system may have
been safer if the polyethylene used within the device was of a
stronger grade. See Report of Dr. David J. Quesnel, p. 2,
Defendant's Appendix to Local Rule 56.1 Statement of Material
Facts, Ex. M (Doc. No. 45). Furthermore, defendant's arguments
that the knee implant device had been inspected numerous times
and that "only one other implant had ever been reported to Sulzer
as breaking" are unpersuasive in the context of this motion for
summary judgment. See Defendant's Reply Memorandum of Law in
Support of Its Motion to Preclude Plaintiffs' Expert Testimony
and for Summary Judgment, p. 1 (Doc. No. 49-1). While certainly
compelling evidence, it is precisely the type of evidence,
together with other relevant evidence that should be presented to
Plaintiffs also assert a cause of action for defective
manufacture of the knee replacement system removed from Mr.
Billone. In a manufacturing defect case, the plaintiff must prove that "the product failed to perform in the intended manner due to
a flaw in the manufacturing process." Macaluso v. Miller, 2005
WL 563169 at *5 (S.D.N.Y. 2005) (citing Denny v. Ford Motor
Company, 662 N.E.2d 730, 735, n. 3 (N.Y. 1995)).
Plaintiffs have apparently abandoned this claim, since they did
not present any questions of fact with regard to whether the knee
replacement system was defectively manufactured, nor did they
assert any argument in their Opposition to Defendant's Motion for
Summary Judgment. See Plaintiffs' Memorandum of Law (Doc. No.
48). Accordingly, judgment is granted in favor of defendant on
plaintiffs' strict liability defective manufacturing claim, and
that claim is dismissed with prejudice.
B. Plaintiffs' Negligent Design, Manufacture and Inspection
Plaintiffs also argue that defendant is liable for the injuries
plaintiff suffered as a result of the failure of the knee implant
because it was negligent in the design, manufacture and
inspection of the implant. To prove negligence under New York
State Law, a plaintiff must demonstrate that: (1) defendant had a
duty to plaintiff; (2) defendant breached that duty; and (3) the
breach of duty was the proximate cause of the plaintiff's
injuries. Fernandez v. Chios Shipping Co., Ltd., 542 F.2d 145,
155 (2d Cir. 1976).
Defendant asserts that it is entitled to summary judgment in
its favor on plaintiffs' negligence claim because plaintiffs are
unable to establish the second and third elements necessary to state a valid claim of negligence. I find otherwise. As explained
above, Dr. Quesnel's anticipated expert testimony that a design
defect caused the failure of the implant, and thereby injured Mr.
Billone, creates sufficient questions of fact so as to allow
plaintiffs' negligence claim to proceed to determination by a
fact finder. If defendant in fact improperly designed,
manufactured or inspected the implant, as opined by Dr. Quesnel,
and that defect caused the failure of the implant, also as opined
by Dr. Quisnel, then defendant may have been negligent.
Defendant's evidence to the contrary, including the implant
contraindications and limitations for its use, is an insufficient
basis for the Court to declare as a matter of law that defendant
was not negligent in the design, manufacture and inspection of
the implant. Accordingly, defendant's motion for summary judgment
on plaintiffs' negligence claim is denied.
C. Plaintiffs' Duty to Warn Claim
Plaintiffs next allege that defendant was negligent in failing
to properly warn users that the implant might fail. To state a
valid cause of action for failure to properly warn, a plaintiff
must demonstrate that "the warning was inadequate and that the
failure to adequately warn of the dangers of the [implant] was a
proximate cause of his or her injuries." Krasnopolsky v.
Warner-Lambert Company, 799 F. Supp. 1342, 1346 (E.D.N.Y. 1992).
However, under the informed intermediary doctrine, a manufacturer
of a medical device has no duty to warn the patient directly, but
instead must properly warn the physician who has a duty to act as an "informed intermediary" between the manufacturer and the
patient. Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 322, 344
(W.D.N.Y. 2001). "If the doctor is sufficiently warned, the
product is not defective. . . . Nor is a manufacturer responsible
for how a learned intermediary conducts his business." Id.
In support of its motion for summary judgment on this claim,
defendant proffers the deposition testimony of Mr. Billone's
physician, Dr. Kane, which states that he was adequately informed
of the implant's limitations, specifically that: (1) the package
insert included with the product adequately explained the risks
associated with the implant, including those of which plaintiff
presently complains; (2) he was aware of the limitations of the
implant; and (3) he communicated this information to Mr. Billone
prior to inserting the implant in 1996. See Deposition
Transcript of Dr. Stephen L. Kates, pp. 16-17, Defendant's
Appendix to Local Rule 56.1 Statement of Material Facts, Ex. J
(Doc. No. 45).
In their opposition to defendant's motion for summary judgment,
plaintiffs claim that defendant carries the burden of proof with
respect to proving the sufficiency of the warning. Nonetheless,
plaintiffs neither disagree with the informed intermediary
doctrine, nor offer proof to rebut the substance of Dr. Kates'
deposition testimony. After a thorough review of the evidence, I
conclude as a matter of law that defendant adequately warned Dr.
Kates of the risks associated with the implant. Since defendant
provided sufficient warning to Dr. Kates, plaintiffs' failure to
properly warn claim is dismissed with prejudice. D. Plaintiffs' Breach of Warranty Claims
Lastly, plaintiffs assert that defendant is liable for breach
of express warranty as well as breach of implied warranty because
the implant was defective, unmerchantable, unsafe and otherwise
unfit for its intended purpose.
For a plaintiff to prevail on a breach of express warranty
claim, defendant must make an express warranty. Daley v. McNeil
Consumer Products Co., 164 F.Supp. 2d 367, 376 (S.D.N.Y. 2001).
Plaintiffs have failed to present evidence of any such express
warranty made by defendant. Accordingly, defendant's motion for
summary judgment in its favor on plaintiffs' breach of express
warranty claim is granted, and that claim is dismissed with
For a plaintiff to prevail on a cause of action alleging breach
of implied warranty, he must prove that: (1) the product was
defectively designed or manufactured; (2) the defect existed when
the manufacturer delivered it to the purchaser or user; and (3)
the defect is the proximate cause of plaintiff's injuries.
Silivanch v. Celebrity Cruises, Inc., 171 F.Supp.2d 241, 259
(S.D.N.Y. 2001). "One who sells a product in a defective
condition unreasonably dangerous at the time it is sold[,] to the
consumer or his property[,] is subject to liability for physical
harm. A product may be defective if the seller fails to give
reasonable warnings of danger or a defect in the product known at
the time of manufacture or discovered afterwards when the seller
by exercising reasonable diligence, could have made such warnings or instructions
available to the user or consumer."
Here, defendant contends that it is entitled to summary
judgment on plaintiffs' breach of implied warranty claim because
Dr. Quesnel's opinion is "speculative at best", that Dr. Quesnel
fails to propose a safer alternative and that the implant was not
defective when inserted into Mr. Billone by Dr. Kates in 1996. In
support of this assertion defendant cites statistics which
indicate that no other implant from the same lot as Mr. Billone's
malfunctioned and that since 1989 only one complaint similar to
plaintiffs' has been reported. However, as discussed above, when
viewed along with Dr. Quesnel's expert opinion, these arguments
create material facts best left for the determination of a jury.
Furthermore, plaintiff need not prove that there exists a safer
alternative to the implant in order to state a valid claim of
breach of implied warranty, since that is not an element
necessary to establish a prima facie case under that cause of
action. Groome v. Matsushita Electric Corp., 2000 WL 341134
(E.D.N.Y. 2000). Accordingly, plaintiffs have presented
sufficient questions of material fact with respect to their
breach of implied warranty claim, and defendant's motion for
summary judgment on that claim is denied.
For the reasons set forth above, I find that Dr. Quesnel's
expert opinion meets the requirements of Rule 702 of the Federal
Rules of Evidence, and thus is admissible. I also find that plaintiffs have presented sufficient questions of material fact
to survive defendant's motion for summary judgment with respect
to their strict liability for negligent design claim, negligent
design, manufacture and inspection claim and breach of implied
warranty claim. However, no questions of material fact exist with
respect to plaintiffs' strict liability for negligent manufacture
claim, duty to warn claim and breach of express warranty claim.
Accordingly, defendant's motion to exclude the expert testimony
of Quesnel is denied. Defendant's motion for summary judgment is
granted with respect to plaintiffs' strict liability for
negligent manufacture claim, duty to warn claim and breach of
express warranty claim and those claims are dismissed with
prejudice; and denied with respect to plaintiffs' strict
liability for negligent design claim, negligent design,
manufacture and inspection claim and breach of implied warranty
ALL OF THE ABOVE IS SO ORDERED.
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