Stilwell v. Smith & Nephew, Inc.

• Decision Date: 11 April 2007
• Docket Number: No. 05-15000.,05-15000.
• Citation: 482 F.3d 1187
• Parties: Lisa STILWELL, Plaintiff-Appellant, v. SMITH & NEPHEW, INC., a corporation, Defendant-Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

482 F.3d 1187

Lisa STILWELL, Plaintiff-Appellant, v. SMITH & NEPHEW, INC., a corporation, Defendant-Appellee.

No. 05-15000.

United States Court of Appeals, Ninth Circuit.

Argued and Submitted December 5, 2006.

Filed April 11, 2007.

Joseph W. Charles, Glendale, AZ, briefed and argued for the appellant.

Raymond R. Cusack and Stephen T. Portell, Tucson, AZ, briefed for the appellee. Mr. Portell argued for the appellee.

Appeal from the United States District Court for the District of Arizona; Susan R. Bolton, District Judge, Presiding. D.C. No. CV-03-01322-SRB.

Before: BRIGHT,^* D.W. NELSON, and BERZON, Circuit Judges.

BRIGHT, Circuit Judge:

Plaintiff and appellant Lisa Stilwell ("Stilwell") sustained two broken legs in a 1995 automobile accident. During her surgical treatment and recovery, doctors twice implanted a Russell-Taylor metal reconstruction nail ("RT nail") to stabilize a compound subtrochanteric fracture of her right femur.¹ These two nails failed during the healing process, causing Stilwell pain, suffering, and disability. She brought this action against the defendant and appellee Smith & Nephew, Inc., manufacturer of the devices. Stilwell asserted claims based on strict liability, negligence, and breach of warranty. The district court rejected her claims for lack of proof of causation and ordered summary judgment in favor of Smith & Nephew. Stilwell asserts a single issue on appeal. She argues that the district court erred by barring the expert testimony of a metallurgist, Arun Kumar, Ph.D., under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and its progeny. Stilwell relied on the expert opinion to prove causation and, after the court's Rule 702 order, conceded that she could not prevail. We conclude that the court wrongly excluded the testimony but, after reviewing the record, affirm the grant of summary judgment for Smith & Nephew because evidence of record, including Kumar's deposition testimony and reports, does not demonstrate that any alleged defects were a cause of the delayed healing of Stilwell's fractured leg.

I.

In 1995, when Stilwell suffered a compound subtrochanteric fracture resulting in distal displacement and shortening of her right leg, doctors first attempted to repair her fractured femur with an Omega screw and side plate.² But—after twice replacing loose screws in the side plate in March 1995 and May 1996—they determined that the bone had not fused and the hardware had failed. Stilwell's doctors replaced the screw and plate in March 1998 with an RT nail, which failed and was replaced with a similar device three years later, in April 2001.³ In November 2002 doctors determined the second nail had failed and replaced it with a different device. Stilwell, asserting that the RT nails failed in April 2001 and November 2002 because they were defectively designed or manufactured, sought compensation from Smith & Nephew. She hired Kumar to examine the two devices removed from her leg and determine why they had failed. Kumar's curriculum vitae indicates that he specializes in the "[f]ailure analysis of metallic and non-metallic . . . materials and electronic components" and has "[e]xtensive experience in metallurgical failure analysis of . . . medical implants." He received a bachelors of science in physics, chemistry, and math; a bachelors of engineering in metallurgical engineering; a masters of science in engineering, with an emphasis in metallurgy and metal processing; and finally a doctorate in engineering. Kumar's c.v. also lists numerous memberships in professional societies, relevant work and teaching experience, and publications.

Kumar issued his first report in August 2003. He conducted three non-destructive tests on the RT nails and concluded that they "fractured due to fatigue." He noted that fatigue was "of a low stress, high cycle type," and that "sharp corners of the rod at the intersection of the slant screw hole and the outer diameter surface of the implant create[d] a high stress concentration area, enabling fatigue cracks to initiate at low stress levels." He concluded that "[t]his constitutes a design/ manufacturing defect, since the sharp corners could be ground and polished for a smoother transition between the two intersecting surfaces."

Smith & Nephew first deposed Kumar in February 2004. Kumar responded repeatedly that his expertise was in metallurgy, as opposed to medicine or biomechanical engineering. He did, however, express his opinion regarding the potential life of intermedullary nails:

Q. Are you saying that the intermedullary nails, which are the subject matter of this lawsuit, would never fail if there was never any union [of the bones]?

A. I really don't know the answer to that because I haven't done any testing to prove that, but in the absence of the defect that I will point out to you, that will be the case.

Kumar also repeated the conclusion of his first report, that further grinding and polishing could have extended the endurance limit of the RT nails he examined.

Kumar's second report, delivered in April 2004, included the findings of a series of destructive tests that he conducted on the RT nails, in the presence of an expert hired by Smith & Nephew. He compared his findings to the manufacturer's specifications and found that "[a] large variation in edge radius can be seen from one side to the other; the fatigue cracks had emanated at the sharper radius surface for both rods." Kumar explained:

The sharper radii measurements were 0.0003 inch and 0.00125 inch, way below the minimum requirement of the part drawing of 0.010 inch. This is a manufacturing defect and the sharper radius at the edge created a higher stress concentration factor, resulting in premature fatigue fracture of the rods. The variation in the radius around the slant hole is also a manufacturing defect and shows poor quality control during manufacturing.

As he did in his first report, Kumar concluded that the RT nails suffered from correctable defects that shortened their life.

Smith & Nephew again deposed Kumar in May 2004. He responded "out of [his] area of expertise" to a number of questions designed to explore his knowledge of internal fixation devices like the RT nail, such as, "Would you agree that as long as bone healing progresses normally an implant such as the type of nails we have in question will not undergo fatigue failure?" One exchange in particular characterizes the tension between Smith & Nephew and Kumar:

Q. With respect to these nails, though, would you agree that it's race in time; you either get union of the bone or you get fatigue failure of the nail?

A. Again, I'm not an expert in that area where one designs this for the union or nonunion [of bones]. I am looking at the failure from a metallurgical standpoint only.

Q. So in other words, we have deposed two of Lisa Stilwell's orthopedic surgeons, Dr. Kramer and Dr. Reinhert [sic]. Both of them have testified under oath that based upon their experience as orthopedic surgeons there is a race in time that takes place. You either get union or healing of the fracture or you're going to have fatigue failure of the rod.

I take it you would not disagree with that or is that outside your area of expertise?

A. That's their expertise and I cannot comment on that.

Q. So with respect to the measurements that you took, Doctor, where you have the .0003 you can't tell me if that caused the rod to fail a week before it would have failed, two weeks before it would have failed or three weeks before it failed? You can't put a quantitative distinction on that?

A. That's correct.

Kumar could not comment beyond his abstract knowledge of metals:

Q. So you can't tell me whether or not the nail as designed met the criteria for which it was designed in being used as an implant to treat a subtrochanteric fracture?

A. Correct.

According to his own testimony, he could examine the RT nail only as an object composed of metal; he did not attempt to testify regarding its design as a medical device.

Armed with Kumar's reports and deposition testimony, Smith & Nephew moved to bar his testimony. The company argued that he was unqualified to testify regarding the design, manufacture, or use of the RT nail. His expertise as a metallurgist, the company continued, should not qualify him to testify regarding whether a medical device made of metal failed due to a design or manufacturing defect. Finally, the company argued that his opinion that further grinding and polishing could have extended the life of the RT nail was without scientific basis.

The district court, applying Daubert, concluded that Kumar "acknowledged that he lacked the expertise to determine whether the nails served the biomechanical purpose for which they were designed." His "concern[ ] only with metallurgical issues," the court continued, rendered "his opinions about the defectiveness of the RT nails for use in bone healing . . . speculative, albeit speculation spawned from his testing relating to the metallurgical integrity of the nails." Because the dispute, as the court described it, was not whether the RT nail would suffer fatigue failure but rather whether the device was designed to fail only after it succeeded in supporting a union of the fractured bone, the court excluded Kumar's testimony.

The court also granted summary judgment for Smith & Nephew. In addition to Kumar, Stilwell would have relied on the deposition testimony of three treating physicians, Quentin Kramer, M.D., Charles Reinert, M.D., and Mark Spangehl, M.D. Doctor Reinert expressed concern that Stilwell's "cigarette smoking is very deleterious to fracture healing," but that he "didn't see anything at surgery that would have made us think that she would be unable to heal." Doctor Spangehl agreed with the statement that "failure rates of these types of nails is relatively rare," but...