Valentine v. Baxter Healthcare Corp.

81 Cal. Rptr. 2d 252, 68 Cal. App. 4th 1467, 99 Daily Journal DAR 245, 99 Cal. Daily Op. Serv. 223, 1999 Cal. App. LEXIS 14
CourtCalifornia Court of Appeal
DecidedJanuary 7, 1999
DocketA075385
StatusPublished
Cited by44 cases

This text of 81 Cal. Rptr. 2d 252 (Valentine v. Baxter Healthcare Corp.) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 68 Cal. App. 4th 1467, 99 Daily Journal DAR 245, 99 Cal. Daily Op. Serv. 223, 1999 Cal. App. LEXIS 14 (Cal. Ct. App. 1999).

Opinion

Opinion

REARDON, J.

This product liability case against the manufacturer of silicone gel breast implants has been twice tried. The first jury returned *1471 special verdicts for the defense on strict liability and fraud, but hung on the causation element of the negligence count. (Valentine I.) The second jury returned a special verdict for the defense on negligent design and manufacturing, but deadlocked on negligent failure to warn and hung on the causation element of the negligent testing and inspection count. (Valentine II.)

Several questions never before decided emerge: Did the court presiding over the first trial have the power to accept special verdicts on some causes of actions, reserve judgment until termination of the entire action, declare a mistrial as to the remaining causes of action and then order a limited retrial? Did the defense verdict in the first trial on strict liability failure to warn subsume the cause of action for negligent failure to warn so that the court presiding over the second trial was within its authority to direct a defense judgment on that negligence count? Did that court also correctly direct a defense judgment on negligent testing and inspection upon concluding that a failure to test or inspect, standing alone, cannot cause injury? In the published portion of this opinion, we resolve that the trial court was within the law and its authority on these matters. Concluding that no prejudicial errors were committed with respect to other matters, we affirm the judgment.

I. Facts

A. Facts Concerning Mrs. Valentine

In early 1975, after the birth of her son, Mildred Valentine (Mrs. Valentine) 1 consulted Dr. Foster about having a “breast lift” or maximum mastopexy. Dr. Foster explained that the procedure would involve hospitalization, general anesthesia and two to three incisions in each breast. Dr. Foster also informed Mrs. Valentine of the alternative of the silicone breast implant, performed in the office with local anesthesia.

Dr. Foster advised Mrs. Valentine about the risks attendant to the implant procedure, including infection, contracture, hematoma and numbness. He never told her that implants were perfectly safe. Nor did Dr. Foster refer to any risk that the gel could migrate or bleed out into the body. However, at that time he had no knowledge of the concept of gel bleeding or migration, other than upon rupture of the implant. Dr. Foster has always kept abreast of the literature and developments in the area of plastic surgery, primarily by reading journals and attending continuing education seminars and conventions. During the time he treated Mrs. Valentine, he never came across any information that silicone implants caused systemic illness.

*1472 On January 22, 1975, Mrs. Valentine underwent the augmentation surgery with silicone breast implants manufactured by Heyer-Schulte Corporation (Heyer-Schulte). Shortly thereafter, she developed one of the complications Dr. Foster warned about—capsular contracture in the left breast. Dr. Foster performed an open capsulotomy procedure in March 1975. This entailed removing the implant, dividing the scar tissue and inserting a new implant. To reduce further contracture, Dr. Foster injected cortisone into the left breast pocket; a week later he injected an antibiotic into the pocket to eliminate a staph infection.

Nevertheless, contracture returned to the left side. This time Dr. Foster performed a closed capsulotomy, squeezing the breast to rupture the excess scar tissue. Four years later he again performed a closed capsulotomy, once on both sides, and a month later on one side.

Mrs. Valentine was diagnosed with lupus 2 around 1976.

Dr. Rizk, a pulmonary care specialist, began treating her in 1991. Due to the severity of her lung disease, Dr. Rizk decided the breast implants should be removed and on August 18, 1992, Dr. Ramos, a plastic surgeon, performed the exploration. He reported that the implant shells were intact—not ruptured. There was no evidence of silicone outside the scar capsule, and no tissue or defects associated with the implants. When he opened the scar capsule to remove the implant, Dr. Ramos did observe some sticky gel material on the outside of the implant. Although he assumed the material would come in contact with the inside of the scar capsule, he did not see any silicone anywhere else and did not think a tissue biopsy was necessary.

Nonetheless, in December 1995 3 appellant underwent a magnetic resonance imaging (MRI) scan to determine if there was any silicone left behind after the implants were removed. Dr. Middleton performed the MRI. He found a granuloma, a “silicone soaked scar, a massive tissue which has silicone all through it . . . .” However, Dr. Middleton was not sure if the granuloma was located just outside, or outside and separated from, the capsule. In January 1996 Dr. Emery removed the granuloma. He described the location as in the capsule and resting up against the pectoral muscle but not penetrating the muscle. Dr. Emery sent the specimen to Dr. Ortega, a pathologist, for analysis. Analyzing the granuloma specimen, Dr. Ortega *1473 diagnosed a foreign body reaction consistent with the presence of silicone and typical of what is seen in women with silicone breast implants. The granuloma was attached to the capsule or scar tissue; it was not attached to the muscle tissue, and there was no evidence of silica. 4

Experts at both trials testified that: (1) Mrs. Valentine had lupus; (2) lupus is appreciably more common in women (particularly young women) than men and more common in African-American women (Mrs. Valentine was African-American); (3) Mrs. Valentine suffered symptoms of lupus before undergoing the implant process; (4) the epidemiological studies indicate there is no causal relationship between breast implants and autoimmune diseases such as lupus; 5 and (5) Mrs. Valentine’s symptoms did not improve significantly upon removal of the implants.

B. Facts Concerning Heyer-Schulte

Heyer-Schulte was formed in 1962. 6 It manufactured a variety of silicone products for implantation in humans, including hydrocephalic shunts, penile prostheses, kidney shunts, and urethral stents, as well as custom devices. The quality assurance department answered directly to the president, not to the production unit. The company had a quality assurance program for raw materials as well as finished goods, with various checks at different phases of the manufacturing process. For example, Heyer-Schulte quarantined the raw silicone components upon receipt from the supplier, and then, as to each batch, tested the physical properties of the raw material to determine if it conformed with vendor specifications. In particular, the incoming silicone gel materials were tested to determine the proper ratio between the components in order to attain the proper gel consistency.

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Cite This Page — Counsel Stack

Bluebook (online)
81 Cal. Rptr. 2d 252, 68 Cal. App. 4th 1467, 99 Daily Journal DAR 245, 99 Cal. Daily Op. Serv. 223, 1999 Cal. App. LEXIS 14, Counsel Stack Legal Research, https://law.counselstack.com/opinion/valentine-v-baxter-healthcare-corp-calctapp-1999.