King v. Searle Pharmaceuticals, Inc.

• Decision Date: 14 April 1992
• Docket Number: No. 880214,880214
• Citation: 832 P.2d 858
• Parties: Prod.Liab.Rep. (CCH) P 13,169 Debra KING, et al., Plaintiffs and Appellant, v. SEARLE PHARMACEUTICALS, INC., a foreign corporation, and Doran V. Porter, M.D., Defendants and Appellee.
• Court: Utah Supreme Court

Page 858

832 P.2d 858

Prod.Liab.Rep. (CCH) P 13,169

Debra KING, et al., Plaintiffs and Appellant, v. SEARLE PHARMACEUTICALS, INC., a foreign corporation, and Doran V. Porter, M.D., Defendants and Appellee.

No. 880214.

Supreme Court of Utah.

April 14, 1992.

Wayne B. Watson, Provo and Terri C. Bingham, Orem, for Debra King.

J. Anthony Eyre, Heinz J. Mahler, Salt Lake City, for Searle Pharmaceuticals.

David W. Slagle, Salt Lake City, for Doran V. Porter.

STEWART, Justice:

This is an appeal from a summary judgment in favor of defendant Searle Pharmaceuticals, Inc., and against plaintiff Debra King on her claims against Searle based on strict liability and negligence for personal injury. The trial court ruled that plaintiff failed to demonstrate a material issue of fact as to whether Searle caused the alleged injury. The trial court certified its judgment pursuant to Rule 54(b) of the Utah Rules of Civil Procedure. Plaintiff's action against Dr. Doran V. Porter remains in the trial court. The summary judgment was properly certified because all claims against Searle were finally adjudicated by the trial court.

King contends that the trial court erred in granting summary judgment because the doctrine of res ipsa loquitur established a prima facie case of liability against Searle and therefore raised a material issue of fact as to causation with respect to both claims against Searle.

I. FACTS

In January 1983, Dr. Doran V. Porter implanted in King's uterus an intrauterine contraceptive device (IUD) known as the Cu-7. The Cu-7 was designed, manufactured, and marketed by Searle. Dr. Porter testified on deposition that he had examined King two weeks after the implantation and that he thought the device was then in a proper position. Approximately a month and a half later, King became pregnant. When Dr. Porter attempted to locate and remove the device, he could not find it. In May 1983, King had a spontaneous abortion and was admitted to a hospital to remove the Cu-7. In an exploratory laparoscopy, the Cu-7 was found outside the uterus in her abdominal cavity and removed.

King filed suit against Dr. Porter for medical malpractice and against Searle for negligence and strict liability. Searle filed a motion for summary judgment supported by an affidavit from Dr. Howard G. McQuarrie, a physician specializing in obstetrics and gynecology, who had reviewed plaintiff's medical records and various depositions taken in the case. Dr. McQuarrie had also conducted clinical research on the Cu-7 prior to its approval by the Food and Drug Administration, had used the device in his clinical practice, and had reviewed numerous articles, publications, and reports concerning the Cu-7 and other IUD contraceptive devices. He concluded generally that the Cu-7 was neither defective nor unreasonably dangerous and, specifically, that King's injury was not caused by "any negligence or other fault on the part of Searle." His affidavit also asserted that "perforation of the uterus by the Cu-7 at the time of insertion can occur in the absence of negligence or fault on the part of the treating physician or any other party."

In opposition to Searle's motion for summary judgment, plaintiff filed the affidavit of Robert E. Baier, Ph.D., the director of the Health-Care Instruments and Devices Institute at the State University of New York at Buffalo. Dr. Baier's affidavit stated that he had performed laboratory studies to determine the effect of pure metallic copper on animal tissue by implanting copper under the skin of New Zealand white rabbits and that the copper had perforated the skin of the rabbits within twenty days. Dr. Baier asserted that the "copper contained in the Cu-7 intrauterine device has an almost identical effect upon the tissues of the human female, and this effect permits the device to perforate the uterus and migrate to other parts of the body." He also opined that the Cu-7 is "an inherently dangerous device inappropriate for implantation in the female uterus."

In ruling on Searle's motion for summary judgment, the trial court observed that Dr. Baier had not examined plaintiff or any of her medical records and did not know any of the particular facts concerning her complication. The trial court granted Searle's motion, holding that Dr. Baier's affidavit failed to raise a genuine issue of fact as to whether the Cu-7 was the cause in fact of plaintiff's injury. The trial court ruled that even if one assumed that Dr. Baier's affidavit raised an issue of fact as to whether the Cu-7 was inherently dangerous, that would not be sufficient to avert summary judgment because Dr. Baier's "affidavit does not, nor has plaintiff through any other means attempted to establish through credible evidence that the Cu-7 caused any injury or damage to the plaintiff."

King states that the issue on appeal is whether the trial court erred "in determining the degree of causal proof required to establish a prima facie case as to Searle Pharmaceuticals." A more correct statement of the issue, however, is whether King has established a factual dispute as to the cause in fact of her injury. King apparently phrases the issue as she does because her expert's affidavit did not state that Searle's product, the Cu-7, in fact caused King's injury. To bridge the factual gap as to causation, King asserts that she raised a factual issue as to Searle's responsibility for the injury under the doctrine of res ipsa loquitur by showing that "(1) King was injured by the Cu-7; (2) the Cu-7 was under the exclusive control of the defendants, [and] (3) absent negligence, either in design or implantation, the Cu-7 should not have perforated King's uterus."

To place the issue in proper focus, we emphasize that whether Dr. Porter was negligent in implanting the IUD was not an issue presented to the trial court on Searle's motion for summary judgment and is not now an issue on appeal. Furthermore, although plaintiff alleges that she was injured by the Cu-7, that fact has yet to be established. Plaintiff's spontaneous abortion could theoretically have been caused by an inherent defect in the IUD, by the manner in which Dr. Porter implanted it, or by some other means.

Plaintiff now concedes that Dr. Baier's affidavit did not create a factual issue as to whether Searle's design or production of the Cu-7 was the cause of her injury. She contends, however, that it is unfair to require her to adduce direct evidence of causation because it is impossible to do so and that the doctrine of res ipsa loquitur is sufficient to create a factual inference of product defect or negligence by Searle sufficient to preclude summary judgment.

II. RES IPSA LOQUITUR

Res ipsa loquitur is essentially an evidentiary rule that allows an inference of negligence to be drawn when human experience provides a reasonable basis for concluding that an injury probably would not have happened if due care had been exercised. Ballow v. Monroe, 699 P.2d 719, 721 (Utah 1985); see also Anderton v. Montgomery, 607 P.2d 828, 833-34 (Utah 1980). Since res ipsa loquitur generally raises only an inference and not a presumption of negligence, the fact finder may choose either to accept or reject that inference. Ballow, 699 P.2d at 723; Kusy v. K-Mart Apparel Fashion Corp., 681 P.2d 1232, 1235 (Utah 1984). ¹

The doctrine of res ipsa loquitur requires a plaintiff to establish a foundation from which an inference of negligence can be drawn. That foundation is usually established by proving the following three elements:

(1) the accident was of a kind which, in the ordinary course of events, would not have happened had the defendant used due care;

(2) the agency or instrumentality causing the accident was at the time of the accident under the exclusive management or control of the defendant; and

(3) the plaintiff's own use or operation of the agency or instrumentality was not primarily responsible for the accident.

Ballow, 699 P.2d at 721; Kusy, 681 P.2d at 1235; Anderton, 607 P.2d at 833.

The second element, exclusivity of management or control, should not be rigidly applied. Rather, that element should focus on the degree of a defendant's management or control necessary to provide a persuasive inference of liability on the defendant's part. In other words, something less than exclusive management or control may suffice to make out a prima facie case of res ipsa loquitur. To establish the second requirement, the plaintiff need only show "that it is more likely than not that the defendant was the party responsible for the injury." Ballow, 699 P.2d at 721. Thus, the fact that Searle did not have exclusive management or control of the Cu-7 at the time critical to the events causing plaintiff's injury does not necessarily prevent plaintiff from establishing a prima facie case of liability based on res ipsa loquitur if the circumstances of the case otherwise raise a reasonable inference that Searle was liable under either products liability or negligence law.

Ultimately, however, to establish a res ipsa loquitur case, the plaintiff must lay a foundation from which it can be established that negligence was probably the cause of the injury. The law is clear that an undesired complication or result from medical treatment does not by itself imply that the result was caused by someone's breach of a duty of due care. Talbot v. Dr. W.H. Groves' Latter-Day Saint Hosp. Inc., 21 Utah 2d 73, 75, 440 P.2d 872, 873 (1968).

In ordinary res ipsa loquitur cases, the foundation from which a logical conclusion can be drawn that an injury was probably caused by negligence is the common knowledge and experience of the community with respect to how such events generally occur. Ballow, 699 P.2d at 722. In some kinds of cases, however, the circumstances giving rise to the injury and the probabilities that the causative factors were created by a breach of legal duty are outside the realm of the common knowledge and experience of lay...