Fane v. Zimmer, Inc.

Decision Date08 March 1991
Docket NumberD,No. 528,528
Citation927 F.2d 124
PartiesProd.Liab.Rep.(CCH)P 12,766 Paula FANE and Kjell Fane, Plaintiffs-Appellants, v. ZIMMER, INC., Defendant-Appellee. ocket 90-7417.
CourtU.S. Court of Appeals — Second Circuit

Denise L. Hummel, Tarrytown, N.Y. (Pirrotti & Hummel, Tarrytown, N.Y., of counsel), for plaintiffs-appellants.

Thomas M. Hirschen, Schenectady, N.Y. (Friedman, Hirschen, Miller & Coughlin, Schenectady, N.Y., of counsel), for defendant-appellee.

Before MESKILL and ALTIMARI, Circuit Judges, and DORSEY, * District Judge.

MESKILL, Circuit Judge:

This is an appeal from a judgment of the United States District Court for the Northern District of New York, Foley, J., granting a directed verdict in favor of the defendant-appellee, Zimmer, Inc. (Zimmer), thereby dismissing plaintiffs-appellants Paula and Kjell Fane's products liability and negligence action. The judge directed a verdict for Zimmer after both sides had presented their cases but before the action was submitted to the jury.

Paula and Kjell Fane appeal from the directed verdict asserting that the district court improperly usurped the jury's traditional functions of making credibility determinations and weighing the evidence. The Fanes also claim that the district court substituted its judgment for the jury's in deciding the adequacy of the product's warnings and Zimmer's tests on the product, in finding no negligent misrepresentation and in failing to assess punitive damages against Zimmer. Finally, the Fanes aver that proof of proximate cause did not require medical expert testimony.

We affirm the judgment of the district court.

BACKGROUND

On August 18, 1987, Mr. and Mrs. Fane filed suit against Zimmer in the Supreme Court of the State of New York, County of Delaware asserting claims of negligent failure to warn, strict products liability for design defect and loss of consortium arising out of the physical injury to Paula Fane. Mrs. Fane was injured when a device, manufactured by Zimmer and implanted in her hip, failed. Zimmer removed the case to the United States District Court for the Northern District of New York on the basis of diversity of citizenship.

Trial was held from March 21 to March 29, 1990 before Judge Foley. The following summarizes the relevant testimony given.

Fanes' Case

The ensuing chronology is derived from evidence introduced by the Fanes.

This action arises out of the third of a series of hospitalizations of Paula Fane. In 1973 Paula Fane suffered a fractured left hip as a result of an automobile accident. After recovery her left hip began bothering her again and, in 1982, she began seeing Dr. Elting for the pain. Dr. Elting, at that time, noticed arthritic trauma to Mrs. Fane's left hip and recommended surgery. Dr. Elting intended to change the angle of the ball in the socket of Mrs. Fane's hip and to stop the wear on the hip that could be seen in x-rays. Surgery was performed in January of 1983 at which time the femur was broken below the hip and a wedge of bone was removed to change the angle of the top of the femur. At that time Dr. Elting implanted in Mrs. Fane's hip and leg a device, generically known as an internal fixation device, to hold the pieces of the bone together to facilitate healing. Healing was expected to take several months. Because the surgery had created a length disparity in Mrs. Fane's legs, making the left leg shorter than the right, Dr. Elting again performed surgery on Paula Fane's left hip on June 16, 1983. In an attempt to lengthen the left femur, he intentionally fractured the femur in two places and inserted pieces of bone from Mrs. Fane's pelvis between the ends of the femur. Dr. Elting implanted another internal fixation device to affix the bone pieces.

On July 30, 1984, Dr. Elting again performed surgery on Paula Fane. He testified that the purpose of this surgery was to insert a bone graft in her hip to further lengthen her leg and to correct the disparity that had existed since the January 1983 surgery. This surgery also involved an intentional refracture of the bone to permit insertion of the graft. Dr. Elting removed the device from Paula Fane's hip and implanted a new internal fixation device, the key-free compression tube and ETC side plate (key-free device). This device, manufactured by Zimmer, is the focus of this litigation. The key-free device had eight screw holes, through which screws were implanted in the femur. The key-free device was 156 mm in length, and the top portion was slanted at an angle of 140 degrees. Dr. Elting testified that the only purpose for which he implanted the key-free device was to hold the bone fragments, including the graft, together during healing.

Although Dr. Elting did not recall if he had read the package inserts sent with the key-free device, he was familiar with the risks associated with the use of the key-free device, and stated that the risks were well known. He admitted that breakage of the side plate in the key-free device is a known medical complication if the bone does not heal and become solid. Dr. Elting did not know if he conveyed information about the risks affiliated with the key-free device to Mrs. Fane. He had been using that type of device for five or six years to treat a variety of fractures, bone cuts and defects. The key-free device, he felt, had a good reputation in the medical community for safety and efficacy. In fact, Dr. Elting had implanted a device very similar to the key-free device in Mrs. Fane during her operation of June 1983.

Dr. Elting supervised Mrs. Fane's subsequent treatment. During her course of recovery from the surgery and therapy, Mrs. Fane gradually began to bear weight on her left leg and hip pursuant to the On December 29, 1985, Paula Fane began suffering from pain in her left thigh which caused her to seek emergency medical assistance. The hospital gave her pain killers and discharged Mrs. Fane that day. Mrs. Fane was readmitted to the hospital on December 31, 1985. An x-ray taken on January 1, 1986 revealed a fracture in her left femur and a fracture of the key-free device at the site of the break in her femur. The key-free device apparently broke at the top of one of the screw holes; the screw fitting in that hole also broke. Shortly thereafter, Mrs. Fane underwent surgery to remove the broken key-free device on January 7, 1986. During this surgical procedure, Dr. Elting implanted another internal fixation device. This device possessed ten screw holes and measured one and one quarter inches longer than the broken key-free device. Mrs. Fane remained in the hospital until January 21, 1986. She was subsequently readmitted on January 27, 1986 for dehydration that had occurred prior to her discharge the week before and was again discharged on January 29, 1986.

instructions of Dr. Elting. She was bearing full weight on the leg with no crutches or other external support by March or April of 1985. An x-ray taken on December 5, 1985, while the key-free device was still in place, showed what appeared to be a healing of the fracture. Dr. Elting then set a date for surgery to remove the key-free device and perform another leg lengthening operation.

In early October 1987, Paula Fane entered the hospital for removal of the ten hole device. At that time she also underwent a total hip replacement, surgery accelerated, Mrs. Fane contends, because of the damage sustained from the break of the key-free device and refracture of the femur.

Dr. Elting testified that, in 1987, he wrote a letter to plaintiffs' attorney explaining that in 1985 Mrs. Fane's femur had not healed sufficiently to prevent a refracture, contrary to the appearance presented by the December 5, 1985 x-ray.

Jerrold Steinberg, a metallurgist, testified as the Fanes' expert. Steinberg testified that the key-free device broke from stress. He also stated that the device did not have the structural integrity to survive full weight bearing, the alleged purpose for which the key-free device was used and promoted to be used. Applying the scientific tenet that "nature abhors coincidence," the metallurgist concluded that, because the metal was fatigued and metal does not have the ability to repair itself, the key-free device broke first and was a substantial factor in causing the bone fracture.

Zimmer's Case

Zimmer representative Jerry Lee Lower admitted that Zimmer did not design the key-free device or test its design. Lower testified that the alloy used in the key-free device conformed with standards set forth by the American Society of Testing Materials. Additionally, he stated that the metal forging used to produce the key-free device was tested in a number of similar devices for functionability and safety. A Zimmer internal memorandum indicated that the key-free device was not designed for full weight bearing, but rather was made to hold two segments of a fracture together during the healing process. A letter from the designer of the key-free device, Dr. Southwick, reiterated this position and stated that external support should be required for unstable fractures. The Zimmer promotional material contained numerous statements that the Zimmer device promotes or facilitates early weight bearing, but also revealed that the device was not intended for full weight bearing, nor was it suitable for such use. The package insert and promotional material contained warnings of the risks associated with use of the key-free device, including the particular risk of breakage in active patients. Zimmer's expert witness, Dr. Heineman, testified that the key-free device broke because it, and not the bone, was bearing most of the weight and stress.

After presentation of all the evidence, Judge Foley granted a directed verdict in favor of Zimmer on Zimmer's motion. Judge Foley explained that the plaintiffs, on the failure to warn issue, had failed to overcome the evidence produced by the defendant,

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