Ralston v. Smith & Nephew Richards Inc.

Decision Date26 December 2001
Docket NumberNo. 00-3395,00-3395
Citation275 F.3d 965
Parties(10th Cir. 2001) KAREN L. RALSTON, Plaintiff-Appellant, v. SMITH & NEPHEW RICHARDS, INC. aka Smith & Nephew North America, Defendant-Appellee
CourtU.S. Court of Appeals — Tenth Circuit

Appeal from the United States District Court for the District of Kansas (D.C. No. 98-CV-2174-GTV) [Copyrighted Material Omitted] Gary C. Haggerty and Frank A. Brancato of Brancato Haggerty & Palmentere L.C., Kansas City, Missouri, and Robert L. Wehrman of McDowell, Rice, Smith & Gaar, Kansas City, Missouri for Plaintiff-Appellant.

Peter von Gontard and Carl J. Geraci, St. Louis, Missouri, and Robert A. Henderson and Andrew M. DeMarea, Kansas City, Missouri for Defendant-Appellee.

Before TACHA, Chief Judge, EBEL and GARTH,1 Circuit Judges

GARTH, Circuit Judge

After examining the briefs and appellate record, this panel has determined unanimously to honor the parties' request for a decision on the briefs without oral argument. See Fed. R. App. P. 34(f). The case is therefore submitted without oral argument.

Plaintiff-appellant Karen Ralston appeals the district court's grant of summary judgment in favor of defendant-appellee Smith & Nephew, Inc. For the reasons discussed below, we will affirm the judgment.


Ralston was diagnosed with cancer of her left femur in 1986. That year, she underwent a series of operations and procedures to treat her cancer, including six weeks of intensive preoperative radiation therapy, removal of bone tissue, and additional postoperative radiation. These treatments significantly reduced the strength of her left leg bone.

In April 1996, Ralston tripped and fractured portions of her lower left femur extending into the knee area. Ralston was treated by Dr. William Bohn, who implanted a multihole nail (the "MultiHole Nail") manufactured by Smith & Nephew in the broken femur. The purpose of the nail was to hold fractured bone fragments in the proper position to permit healing of the bone. According to Dr. Bohn's deposition testimony (discussed infra, see Section II.B.1), one advantage of the MultiHole Nail was its ability to deal with multiple fractures, by binding several pieces of fractured bone in place for healing.

In October 1996, six and a half months after having the MultiHole Nail implanted, Ralston twisted her leg while at work, causing pain and weakness in her left leg. Upon examination, it was discovered that the MultiHole Nail had broken, and that another fracture was found in her left femur, although it was not the same fracture as had occurred before. Dr. Bohn performed a bone graft and removed the MultiHole Nail, replacing it with a longer titanium intramedullary nail that extended up Ralston's hip.

Ralston continued to have problems with her left leg, and in March 1998, Dr. Bohn performed another bone graft to relieve her continuing pain. He also referred Ralston to Dr. Howard Rosenthal, a physician specializing in oncologic orthopedics. Upon examination, he concluded that the original fractures of April 1996 had not yet healed, but that the failure of the MultiHole Nail did not prevent that original fracture from healing. In June 1999, Dr. Kimberly Templeton, an orthopaedic surgeon and associate professor at the University of Kansas Medical School, performed a total knee replacement by removing the titanium nail and the fractured femur, and implanting a piece of metal with a hinge in their place.

In April 1998, Ralston filed suit against Smith & Nephew alleging (i) design defect, (ii) manufacturing defect, (iii) various FDA violations, and (iv) negligence, including a failure to warn. Morever, she claimed that Dr. Bohn, as her treating physician, was not properly warned that another kind of nail manufactured by Smith & Nephew a five hole nail (the "Five Hole Nail") was more durable than the MultiHole Nail, and may have been more appropriately used.

In June and July 1999, Smith & Nephew filed its motion for summary judgment as well as a motion to strike Ralston's only expert at that time, Dr. Christopher Ramsay. In a hearing before the district court on September 27, 2000, Ralston's counsel agreed to Smith & Nephew's motion to strike Dr. Ramsay, substituting Dr. Templeton as their new expert. Moreover, counsel advised the court that Ralston would abandon her product defect and FDA claims, and pursue only the failure to warn cause of action. Consequently, the district court granted Ralston additional time to file a supplemental opposition to Smith & Nephew's summary judgment motion based on the "failure to warn" theory.

On October 6, 2000, Ralston filed her Supplemental Opposition, featuring excerpts from the September 1999 and October 1999 depositions of Dr. Templeton, as well as a new affidavit from Dr. Bohn dated October 3, 2000 (the "October 3rd Declaration"). This latter affidavit contradicted certain statements Dr. Bohn had made in an earlier deposition conducted in March 1999. In response, Smith & Nephew procured a second affidavit by Dr. Bohn dated October 11, 2000 (the "October 11th Declaration"), wherein he modified certain statements he made in the October 3rd Declaration.

A final hearing was held before the district court on November 7, 2000, after which the court ruled in favor of Smith & Nephew, finding no material issue of fact as to the inadequacy of the warnings provided by Smith & Nephew. In so ruling, the district court excluded Dr. Templeton's testimony under Fed. R. Evid. 702 on the grounds that she was unqualified to render an opinion on the subject-matter of Ralston's theory, and because her opinions were not reliable under the principles set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Moreover, the district court disregarded the October 3rd and October 11th Declarations of Dr. Bohn on the ground that they contradicted his prior deposition on March 19, 1999, and instead relied only on Dr. Bohn's deposition testimony.


In this appeal, Ralston first challenges the district court's exclusion of Dr. Templeton's expert testimony and its disregard of Dr. Bohn's October 3rd and October 11th Declarations. The district court's decision to admit or exclude evidence generally, including expert testimony, is typically reviewed under an abuse of discretion standard. See Atlantic Richfield Co. v. Farm Credit Bank of Wichita, 226 F.3d 1138, 1163-64 (10th Cir. 2000); National Assoc. Of Professional Baseball Leagues, Inc. v. Very Minor Leagues, Inc., 223 F.3d 1143, 1152 (10th Cir. 2000). A district court abuses its discretion "when it renders an arbitrary, capricious, whimsical, or manifestly unreasonable judgment." Copier v. Smith & Wesson Corp., 138 F.3d 833, 838 (10th Cir. 1998) (internal quotations omitted). "A trial court's decision will not be disturbed unless [this Court has] a definite and firm conviction that the [trial] court has made a clear error of judgment or exceeded the bounds of permissible choice in the circumstances." Beaird v. Seagate Tech., Inc., 145 F.3d 1159, 1164) (10th Cir.) (citation omitted), cert. denied, 525 U.S. 1054 (1998).


Fed. R. Evid. 702 imposes upon the trial judge an important "gate-keeping" function with regard to the admissibility of expert opinions. See generally Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). In order to determine whether Dr. Templeton's expert opinion is admissible, the district court had to undergo a two-step analysis. First, the court had to determine whether Dr. Templeton, the expert, was qualified by "knowledge, skill, experience, training, or education" to render an opinion. See Fed. R. Evid. 702. Second, if Dr. Templeton was so qualified, the court had to determine whether her opinions were "reliable" under the principles set forth under Daubert, 509 U.S. 579, and Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999). Because we find that Dr. Templeton's testimony was properly excluded on the ground that she was unqualified, we have no need to address the reliability of her conclusions under Daubert.

Dr. Templeton herself admits that she is not an expert on intramedullary nailing. Throughout her deposition testimony, she conceded several times that she knew little if anything about the subject. She admits that she has done no research with intramedullary nailing and that she was asked to testify in the Ralston litigation in order to opine on the subject of bone healing, not to discuss the adequacy of warnings.

I do absolutely no research with intramedullary nailing. My expertise is in oncology and in this instance was to bring in expertise as far as the treatment or the healing and problems with healing of a radiated bone.

Deposition Transcript of Dr. Templeton at *150. She has never been published in any matter, and the two articles that were accepted for publication had nothing to do with intramedullary nailing. Indeed, Dr. Templeton admits to never having researched the MultiHole Nail at issue in this appeal. See id. at 143 ("I've not done any research specifically looking at this nail.").

Moreover, on the issue of the adequacy of warnings generally, Dr. Templeton testified that she had never drafted, nor has ever been asked to draft, a surgical technique or warning of a product of any kind. See id. at *62 (Q: "Have you drafted a warning that you think is appropriate for this particular device in this case?" A: "No. . . ." Q: "Have you ever been asked to draft a surgical technique or warnings for a product of any kind?" A: "No."). She also testified that she had never seen a warning for any device that was similar to the form in the warning provided by Smith & Nephew in its "Warnings and Precautions Page," noting instead that the only warnings she had ever observed were "very brief warning[s]" that "they'll put down at the bottom of the page." Id. at *63.

The only reason advanced by Ralston that Dr. Templeton is qualified to testify as an expert is because she is a board...

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