In February 1977, at the age of forty-eight, Florence Vassallo underwent breast implantation surgery and received silicone gel breast implants manufactured in October 1976 by Heyer-Schulte Corporation. Through a series of corporate transactions, Baxter Healthcare Corporation and Baxter International, Inc. assumed responsibility for breast implant products manufactured by Heyer-Schulte. Vincent Vassallo joined as plaintiff claiming loss of consortium, and the plaintiffs also asserted a claim for violation of G. L. c. 93A, §§ 2(a) and 9.
In 1992, after complaining of chest pains extending under her left armpit, a mammogram revealed that Mrs. Vassallo's breast implants possibly had ruptured. The implants were removed in April 1993 and replaced with saline implants. During explant surgery the surgeon noted severe permanent scarring of the pectoral muscles, encapsulation in scar tissue with multiple nodules of silicone granulomas, a ruptured left implant releasing free silicone gel, and several pinholes in the right implant.
At trial the plaintiffs presented expert testimony from Dr. Douglas Shanklin on pathology slides showing silicone granulomas, giant cells, lymphocytes, macrophages, silica deposits, and lymphocytic vasculitis indicating a chronic immunological reaction and autoimmune disease. Doctor Batich also 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. Dr. Bruce Freundlich described atypical connective tissue disease symptoms and concluded Mrs. Vassallo suffered from the condition based on her medical records and physical examination findings including tobacco pouch mouth, puffy fingers, skin thickening, telangiectasia, hyperreflexia, dry eyes, elevated antinuclear antibodies, hair loss, and memory problems. Dr. Eric Gershwin testified that silicone gel acts as an adjuvant stimulating the immune system and that Mrs. Vassallo's symptoms were consistent with atypical autoimmune disease caused by her ruptured implant.
Heyer-Schulte internal correspondence showed awareness in 1976 of an FDA Talk Paper documenting migration and death after liquid silicone injections. An animal study showed gel migration and inflammatory responses. Heyer-Schulte received 129 complaints of ruptured gel implants that year. The company also knew of gel bleed through intact shells. The company conducted few animal studies and no clinical studies on its implants, relied on Dow Corning data that failed a ninety-day toxicity test, and furnished a 1976 product insert data sheet warning only of easy rupture by excessive stress without addressing gel bleed, undetected ruptures from normal stress, or immune-system effects. Mrs. Vassallo stated that, if she had known that the implants could cause permanent scarring, chronic inflammation, and problems with her immune system, she would not have gone ahead with the implantation procedure.
A Superior Court jury returned verdicts for the plaintiffs on negligence and breach of warranty claims 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. Before trial the defendants filed three motions in limine to exclude the testimony of the plaintiffs’ experts, Drs. Gershwin, Freundlich, and Batich. The judge held a nonevidentiary pretrial hearing on the defense motions in limine. At this critical point, in response to a direct question asked by the judge, the defendants’ counsel specified that their objection was based solely on the ground previously advanced at the pretrial hearing on the motions in limine that the opinions to be put before the jury by Drs. Gershwin and Freundlich were inadmissible "without epidemiologic studies."
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