Primiano v. Cook

• Court: U.S. Court of Appeals — Ninth Circuit
• Writing for the Court: KLEINFELD
• Citation: Primiano v. Cook, 598 F.3d 558 (9th Cir. 2010)
• Decision Date: 10 March 2010
• Docket Number: No. 06-15563.,06-15563.
• Parties: Marylou PRIMIANO; Charles Primiano, Plaintiffs-Appellants, v. Yan COOK; Stryker Corporation; Robert J. Tait M.D.,Defendant, Howmedica Osteonics Corporation, Defendant-Appellee.

598 F.3d 558

Marylou PRIMIANO; Charles Primiano, Plaintiffs-Appellants, v. Yan COOK; Stryker Corporation; Robert J. Tait M.D., Defendant, Howmedica Osteonics Corporation, Defendant-Appellee.

No. 06-15563.

United States Court of Appeals Ninth Circuit.

Argued and Submitted Feb. 13, 2008.

Submission Withdrawn and Supplemental

Briefing Requested March 3, 2008.

Resubmitted July 15, 2009.

Filed March 10, 2010.

As Amended April 27, 2010.

COPYRIGHT MATERIAL OMITTED

Peter C. Wetherall, Las Vegas, NV, for plaintiffs-appellants Marylou and Charles Primiano.

Frederick D. Baker (argued), Wayne A Wolff, San Francisco, CA; Ralph A. Campillo, Los Angeles, CA, for defendant-appellee Howmedica Osteonics Corporation.

Appeal from the United States District Court for the District of Nevada, James C Mahan, District Judge, Presiding. D.C. No. CV-03-00373-CM/PAL.

Before: D.W. NELSON, ANDREW J KLEINFELD, and HAWKINS, Circuit Judges.

ORDER AMENDING OPINION AND AMENDED ORDER

ORDER

The opinion filed on March 10, 2010, and appearing at 598 F.3d 558 (9th Cir.2010), is amended as follows:

1. At page 563, after the sentence "We review summary judgment de novo." and footnote 5, add the sentence "We review rulings on the admissibility of expert testimony under Federal Rule of Evidence 702 for abuse of discretion."

2. At page 563, at the end of the newly added sentence, append a new footnote 6 with the following text in the footnote "Cabrera v. Cordis Corp., 134 F.3d 1418, 1420 (9th Cir.1998)." Renumber the remaining footnotes accordingly.

With this amendment, the panel has unanimously voted to deny the petition for rehearing. Judge Kleinfeld has voted to deny the petition for rehearing en banc, and judges D.W. Nelson and Hawkins so recommend. No further petitions for rehearing will be entertained.

The full court has been advised of the petition for rehearing en banc and no judge of the court has requested a vote on the petition for rehearing en banc. Fed. R. App. P. 35.

The petition for panel rehearing and the petition for rehearing en banc are denied. OPINION

KLEINFELD, Circuit Judge:

We address admissibility under Daubert¹ of medical testimony.

I. Facts

Marylou Primiano has suffered a miserable ordeal since she had elbow surgery. The question raised by her litigation² is whether her ordeal resulted from a defective product, the artificial elbow Howmedica Osteonics Corporation manufactured. The district court granted summary judgment against her and dismissed her case but that result could not have occurred had her medical expert's testimony been considered. His testimony would have established a genuine issue of material fact, because he thought the plastic bearing between the metal parts of the artificial elbow wore out so quickly that it must have been defective. The district court ruled that his testimony was inadmissible, leaving Primiano with inadequate evidence to establish a genuine issue of fact. The question before us is whether excluding Primiano's expert's testimony was an abuse of discretion.

Ms. Primiano, an active 36-year-old woman, fell in her kitchen and broke her elbow. The injury, serious for anyone, was especially serious for her, because she has had rheumatoid arthritis for years. Unlike osteoarthritis, a degenerative process of wear and tear on the joints, rheumatoid arthritis is a chronic inflammatory disease of the connective tissue in the joints.³ Her physician, Robert J. Tait, M.D., performed surgery April 18, 2000, two days after her fall. He replaced her elbow joint with a device made by the defendant, Howmedica, consisting of titanium pieces to replace the bone and polyeth-ylene components to prevent the metal from rubbing against metal.

Two thirds of the way through surgery, Dr. Tait discovered that Howmedica had made a mistake in the packing and shipping, so even though he was replacing Ms. Primiano's right elbow, the humeral component (the humerus is the arm bone running from the elbow to the shoulder) sent to him was labeled for the left arm. He consulted Howmedica's representative ("Did I kill him? No, I didn't.") with Ms. Primiano's arm open on the table and was told that the components are symmetrical, identical in every respect except that the locking pin goes in the opposite side of the left humeral component, so the component he had could be used. The hole had to be drilled in Ms. Primiano's bone from the inside instead of the outside, but the artificial joint would be equally functional. Dr. Tait completed the operation, and it appeared to be a success.

But by July, Ms. Primiano's elbow squeaked, and by December, Dr. Tait could hear the metal-on-metal contact, which he confirmed in an x-ray. In February, Dr. Tait performed a second surgery addressing the evident failure of the implant and risk of metallosis (a destructive immune response of the body to flecks of metal shaved off by metal-on-metal contact), replacing the humeral component with a longer one. He used Howmedica's left arm humeral component again, though the long instead of the standard, to avoid having to redrill the remaining bone. He observed massive metallosis and "severe polyethylene wear" on the bearing surrounding the pin. Again, the surgery appeared to go fine. But the next month, Ms. Primiano was having trouble controlling her arm and the joint had a "cracking" sound. She obtained a second opinion from an orthopedic surgeon who concluded that the components appeared "to be adequately fixed and in good position." But in June her problems with the joint had not gone away, so she consulted a third orthopedic surgeon, who recommended a third surgery. In July this surgeon replaced her Howmedica device with one from its competitor, Zimmer. That surgeon performed a fourth surgery the next April to correct loosening. A pin backed out of position, so she needed yet another surgery, her fifth, in September.

Primiano sued Howmedica, Dr. Tait, and others in state court for negligence, strict liability, breach of warranty, and loss of consortium.⁴ Howmedica removed the case to federal court based on diversity. All that is before us now is the products liability case.

In the summary judgment papers, Howmedica's experts, an orthopedic surgeon and a chemist, provided opinions that the polyethylene was as it should be, and the rapid failure of the prosthesis and excessive wear on the polyethylene components resulted from "malalignment of the prosthesis" along with increased risk of complication because of Ms. Primiano's rheumatoid arhtritis and her age. The product literature distributed to physicians said that the prosthesis would not restore function to the level expected with normal healthy bone, and was vulnerable to excessive loading from activity. Evidently, younger patients such as Ms. Primiano may do worse because they are more active. The manufacturer's literature says "Lwjhile the expected life of the total elbow replacement components is difficult to estimate, it is finite."

Primiano's expert witness, Arnold-Peter Weiss, M.D., declared that the polyethylene bushing had worn through in less than eight months, "not a usual or expected circumstance." Though finite, the typical lifespan of elbow prostheses "far exceeds" how long this one lasted. Dr. Weiss testified in his deposition that although wearstarts immediately, elbow prostheses last as long as ten or fifteen years, even twenty, and the earliest he had seen them wear out was around five to eight years, varying with the patient's activity level. Though misalignment could cause excessive wear, he had looked at the x-rays and found no significant misalignment. Nor would ordinary daily activity produce such extraordinarily rapid wear. Nor could he find technically inappropriate use of the prosthesis by Dr. Tait. His opinion was that the extraordinarily rapid wear was caused by abrasive wear and generation of debris from movement of the titanium against the polyethylene. And he concluded that the prosthesis failed to perform in a manner reasonably to be expected by a surgeon using it, because it failed too early.

The district court granted defendants' motion to exclude Dr. Weiss's testimony as not meeting the Daubert standard and granted summary judgment. The court concluded that Dr. Weiss's testimony would not be helpful to the jury. The judge reasoned: "Well, I mean it's like res ipsa loquitur, the elbow failed. Now, why did it fail? Maybe it was malpractice, maybe it was Dr. Tait." The evidence of rapid wear "doesn't make it defective." "I think [Dr. Weiss's] opinion is weakened by the fact that he didn't see the plaintiff. He didn't examine her. He didn't talk to her." "[Tjhere's no peer review... no publication... there's got to be an objective source that he relies on." The court rejected plaintiffs argument, that testimony that the premature failure was not attributable to overuse, medical malpractice, "her physiology, " or other factors external to the device, would assist the jury.

II. Analysis

1-11] We review summary judgment de novo.⁵ We review rulings on the admissibility of expert testimony under Federal Rules of Evidence 702 for abuse of discretion.⁶ The substantive question the jury would have to answer, in this diversity case arising out of state tort law, is established by Nevada law. The question whether evidence is admissible, though, is governed by federal law. The Federal Rules of Evidence "govern proceedings in the courts of the United States." ⁷ That is generally true in diversity cases because the Federal Rules of Evidence are statutes enacted by Congress.⁸ Though there are exceptions, such as state substantive law in the guise of an evidentiary rule, ⁹ no exception applies here. Ms. Primiano's burden was to establish a defect in the manufacture of the artificial elbow. In Nevada "those products are defective which are dangerous because they fail to perform in the manner reasonably to be expected in light of their nature and intended function."¹⁰ A plaintiff need not...