Vassallo v. Baxter Healthcare Corp.

• Decision Date: 16 July 1998
• Citation: 696 N.E.2d 909,428 Mass. 1
• Parties: Florence VASSALLO & another 1 v. BAXTER HEALTHCARE CORPORATION & another. 2
• Court: United States State Supreme Judicial Court of Massachusetts Supreme Court

Page 909

696 N.E.2d 909

428 Mass. 1

Florence VASSALLO & another ¹ v. BAXTER HEALTHCARE CORPORATION & another. ²

Supreme Judicial Court of Massachusetts Middlesex.

Argued May 5, 1998.

Decided July 16, 1998.

David R. Venderbush, Los Angeles, CA (Harry T. Daniels, Boston, with him) for defendants.

Fredric L. Ellis, Belmont (Edward D. Rapacki, with him), for plaintiffs.

Hugh F. Young, Jr., Reston, VA, and David R. Geiger, Boston, for Associated Industries of Massachusetts & others, amici curiae, submitted a brief.

Before WILKINS, C.J., and ABRAMS, LYNCH, GREANEY and MARSHALL, JJ.

GREANEY, Justice.

In this products liability case, the plaintiff Florence Vassallo claimed that the defendants, Baxter Healthcare Corporation and Baxter International, Inc., were liable to her for damages because silicone breast implants, manufactured by a predecessor company to the defendants (Heyer-Schulte Corporation), that had been implanted in her were negligently designed, accompanied by negligent product warnings, and breached the implied warranty of merchantability, with the consequence that she was injured. The plaintiff Vincent Vassallo claimed a loss of consortium. The plaintiffs also asserted a claim for violation of G.L. c. 93A, §§ 2(a) and 9.

A jury in the Superior Court heard the negligence and breach of warranty claims, returned verdicts (in response to special questions) on those claims in favor of the plaintiffs, and assessed damages. The judge entered a separate memorandum of decision on the G.L. c. 93A claim in which she found the defendants liable for a violation of that statute. The judge concluded that the defendants' conduct was not knowing or wilful, determined that an assessment of additional compensatory damages would duplicate the damages determined by the jury, and awarded the plaintiffs their reasonable attorney's fees and costs. The defendants appealed from the judgment, and we allowed their application for direct appellate review.

We conclude that the determinations of liability as to the negligence and G.L. c. 93A claims are correct, and the judgment can be affirmed on this basis. As a result, we need not consider the defendants' arguments concerning the warranty findings.

We conclude, however, that we should change our products liability law to conform to the clear majority rule regarding what has to be shown to recover in a breach of warranty claim for failure to warn of risks associated with a product, and we do so in Part 3 of this opinion.

The jury could have based their verdicts on the following evidence. In February, 1977, at the age of forty-eight, Mrs. Vassallo underwent breast implantation surgery. The silicone gel breast implants that Mrs. Vassallo received were manufactured by Heyer-Schulte Corporation in October, 1976. Through a series of corporate transactions, the defendants assumed responsibility for breast implant products manufactured by Heyer-Schulte.

In 1992, Mrs. Vassallo underwent a mammogram after complaining of chest pains that extended up under her left armpit. The mammogram revealed that her breast implants possibly had ruptured. The silicone gel implants were subsequently removed in April, 1993, and were replaced with saline implants. During the course of the explant surgery, the surgeon noted severe, permanent scarring of Mrs. Vassallo's pectoral muscles which she attributed to the silicone gel. The implants themselves were encapsulated in scar tissue with multiple nodules of silicone granulomas. Dissection of the scar tissue capsules revealed that the left implant had ruptured, releasing free silicone gel, while the right implant was intact, but had several pinholes through which silicone gel could escape.

The plaintiff's pathology expert, Dr. Douglas Shanklin, indicated that, based on the cellular responses shown in the pathology slides of Mrs. Vassallo's breast tissue taken at the time of explant, the rupture had been longstanding, perhaps for several years. According to Dr. Shanklin, Mrs. Vassallo's pathology slides showed silicone granulomas, giant cells, lymphocytes, and macrophages, all of which indicated a chronic immunological and inflammatory reaction to the silicone implants. Dr. Shanklin also identified deposits of silica and lymphocytic vasculitis, which, he testified, were evidence that Mrs. Vassallo suffered from an autoimmune disease caused by the silicone gel.

Doctor Christopher Batich, professor of materials science and engineering at the University of Florida, testified for the plaintiffs on the effects of silicone in the body. He discussed animal studies that demonstrated migration of silicone to various organs both from ruptured gel implants and after intramuscular injection of "radio-labeled" liquid silicone. Doctor Batich also discussed the mechanism by which silicone can degrade to low molecular weight materials in the body, ³ and explained that the use of silicone gel in breast implants was unreasonably dangerous "[b]ecause the material can get out of the implant, it can break up into small particles, it can travel through the body, and it can undergo chemical transformation into things that have biochemical effects."

Doctor Bruce Freundlich, chief of rheumatology at Graduate Hospital in Philadelphia and an associate professor of medicine at the University of Pennsylvania, indicated that silicone gel breast implants can cause atypical connective tissue disease with a variety of symptoms that can include joint pain, dry eyes and mouth, difficulty sleeping leading to chronic fatigue, breast pain, fever, reduced sensation in the hands and feet, hair loss, itching, problems swallowing, and heartburn. Doctor Freundlich also offered his opinion that Mrs. Vassallo was suffering from atypical autoimmune disease, based on a review of her medical records and a physical examination that revealed the following symptoms: "tobacco pouch mouth," or a tightening of the face around the mouth, which has been associated with scleroderma or mixed connective tissue disease; puffy fingers; an ulceration on one finger; thickening of the skin on her face and neck; telangiectasia, or small red blood vessels, of the nose; hyperreflexia; nocturnal myophonic jerking; dry eyes; elevated levels of antinuclear antibodies and IGA immunoglobin antibodies ⁴; numbness and tingling in her hands; chronic fatigue; hair loss; difficulty swallowing; and problems with memory loss. According to Dr. Freundlich, Mrs. Vassallo's problems were related to her exposure to silicone gel, and her future was "guarded."

Doctor Eric Gershwin, chief of the division of rheumatology, immunology, and allergy at the University of California at Davis School of Medicine, discussed his own clinical research, and internal Dow Corning studies, to support his conclusion that silicone gel acts as an adjuvant to stimulate the body's immune system. ⁵ Based on his research and treatment of more than 700 women with silicone gel breast implants, Dr. Gershwin stated that there is a unique constellation of symptoms seen in approximately five per cent of women with silicone breast implants, and that these symptoms, taken together, constitute an atypical autoimmune disease. Doctor Gershwin also reviewed Mrs. Vassallo's medical records and concluded that her symptoms were consistent with this atypical autoimmune disease and were caused by her ruptured silicone gel breast implant.

There was also extensive testimony as to knowledge, attributable to the defendants, of the risks of silicone gel breast implants up to the time of Mrs. Vassallo's implant surgery in 1977. According to Heyer-Schulte's own internal correspondence, the company was aware of a "Talk Paper," issued by the United States Food and Drug Administration in 1976, that documented migration to the brain, lungs, and heart, and death following injections of liquid silicone into the human body. In 1976, Heyer-Schulte received a report of an animal study, partially funded by Heyer-Schulte and conducted using miniature silicone gel implants supplied by Heyer-Schulte, that documented migration of gel from ruptured implants to the surrounding connective tissues and local inflammatory responses with fibroblastic activity and giant cell formation. The authors of the study stated: "The present tendency by manufacturers of breast implants towards ever thinner envelopes and a filler that is getting further away from gel and closer to silicone liquid must be looked at in the light of these experimental findings, and the question must be asked whether the possible advantages of these changes outweigh the disadvantages." Heyer-Schulte was also aware that some of their implants were rupturing, having received 129 complaints of ruptured gel implants in 1976. In fact, the president of Heyer-Schulte had written in 1975 that "[p]resently, mammary implants have been designed to be increasingly fragile in response to plastic surgeons' demand for softness, realistic feel and mobility." As a result, Heyer-Schulte knew that its implants were "not consistent as far as durability or destructibility is concerned." The encapsulation of the implant, and the viscous nature of the silicone gel, made it difficult to detect that a rupture had occurred, allowing the silicone to leak into the body for long periods before explantation. By 1975, Heyer-Schulte also knew that, even without a rupture of the implant shell, the silicone gel could leak (known as "gel bleed") through to the exterior surface of the implant and possibly produce "detrimental effect[s]" in the body.

Despite this knowledge of the possible adverse long-term consequences of leaking silicone in the body, Heyer-Schulte conducted few animal, and no clinical, studies to document the safety and efficacy of its silicone gel implants. When Heyer-Schulte began using silicone gel manufactured by Dow Corning in 1976, they relied primarily on the animal testing conducted by Dow Corning, despite the observations of...