VASSALLO V. BAXTER HEALTHCARE CORP.
696 N.E.2d 909 (1998)
NATURE OF THE CASE: Vassallo (P), injured person and her husband, filed a product
liability action against Baxter (D), corporations, alleging negligent design, negligent
product warnings, breach of implied warranty of merchantability, and violation of Mass. Gen.
Laws ch. 93A, 2 (a) and 9, regarding breast implants. The husband claimed a loss of
consortium. The Superior Court found in favor of Ps. D appealed.
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 scaring 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.
ISSUE:
RULE OF LAW:
HOLDING AND DECISION:
LEGAL ANALYSIS:
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