Nature of the Case
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Facts
Vassallo (P), at the age of 48, underwent breast implantation surgery in 1977. The silicone breasts that P got were silicone gel manufactured by Heyer Schulte Corporation. Through a series of corporate transactions, Baxter (D) assumed responsibility for breast implant product manufactured by Heyer Schulte. In 1992, P complained of chest pains and underwent a mammogram. The mammogram had revealed that the breast implants had possibly ruptured and they were removed in 1993 and were replaced with saline implants. During the course of this surgery, the surgeon noted permanent scarring on P's pectoral muscles, which P attributed to the silicone gel. The implants themselves were encapsulated in scar tissue with multiple nodules of silicone granulomas. Dissection of the scar tissue revealed that the left implant has ruptured and the right implant has several pinholes in it through which silicone gel could escape. During trial, evidence indicated that by 1977, Heyer Schulte knew its implants were not consistent as far as durability or destructibility and that the silicone gel could leak through to the exterior surface of the implant and possibly have detrimental effects on the body. Tests done by Heyer on gel received and used from Dow showed serious product defects and toxicity past 90 days. Heyer did furnish warnings concerning gel implants that excessive stress could easily cut or rupture the implants and that Heyer could not guarantee gel containment in the case of a rupture. The warnings did not address the issue of gel bleed and the fact that a rupture could result from normal stresses and could persist undetected for a significant period of time before discovered. Heyer did not warn of the consequences of gel migration in the body. The literature also did not address the potential complications associated with breast implants as pertains to chronic inflammation, permanent tissue scarring, or possible effects on the immune system. P stated that if she had known that the implants could cause permanent scarring, chronic inflammation, and problems to her immune system, she would not have gone ahead with the procedure. P got the verdict for negligence and breach of warranty. The trial judge ruled on violation of G.L. C 93A, sections 2(a) and 9. The judge concluded that the violations were not knowing and willful and determined that additional compensatory damages would duplicate those already awarded and then gave P reasonable attorney fees and costs. D appealed.
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