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BILLONE v. SULZER ORTHOPEDICS

August 25, 2005.

JOHN J. BILLONE and SANDRA BILLONE, Plaintiffs,
v.
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.

BACKGROUND

  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 component.

  DISCUSSION

  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.
Fed.R.Evid. 702.

  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, ...


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