428 Mass. 1, 696 N.E.2d 909 (1998)
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.1 Through a series of corporate transactions, Baxter Healthcare Corporation and Baxter International, Inc. assumed responsibility for breast implant products manufactured by Heyer-Schulte.2 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 9.3
In 1992, after complaining of chest pains extending under her left armpit, a mammogram revealed that Mrs. Vassallo's breast implants possibly had ruptured.4 The implants were removed in April 1993 and replaced with saline implants.5 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.6
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.7 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.8 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.9 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.10
Heyer-Schulte internal correspondence showed awareness in 1976 of an FDA Talk Paper documenting migration and death after liquid silicone injections.11 An animal study showed gel migration and inflammatory responses.12 Heyer-Schulte received 129 complaints of ruptured gel implants that year.13 The company also knew of gel bleed through intact shells.14 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.15 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.16
A Superior Court jury returned verdicts for the plaintiffs on negligence and breach of warranty claims and assessed damages.17 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.18 The defendants appealed from the judgment, and we allowed their application for direct appellate review.19 Before trial the defendants filed three motions in limine to exclude the testimony of the plaintiffs’ experts, Drs. Gershwin, Freundlich, and Batich.20 The judge held a nonevidentiary pretrial hearing on the defense motions in limine.21 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."22
Whether the trial judge properly admitted the causation and silicone-effects testimony of plaintiffs' experts Drs. Gershwin, Freundlich, and Batich?23
Expert opinion testimony is admissible when the witness possesses specialized knowledge.24 The methodology must rest on scientifically valid principles such as animal studies, clinical experience, and differential diagnosis even in the absence of epidemiological data.25 The trial judge determines reliability under the Lanigan standards drawn from Daubert.26
Yes. The trial judge properly admitted the causation and silicone-effects testimony of plaintiffs' experts Drs. Gershwin, Freundlich, and Batich.27 Each expert qualified through research, peer-reviewed publications, and treatment of hundreds of implant patients.28
Their opinions rested on animal migration studies, Dow Corning toxicity data, clinical symptom patterns, and differential diagnosis that eliminated other causes.29 The judge reviewed the Oregon Daubert hearing transcript and the independent chemist's report confirming the validity of the NMRS technique underlying Dr. Batich's degradation analysis.30 The defendants' limited trial objections to the lack of epidemiology and to NMRS reliability were correctly overruled on that record.31
The expert testimony was properly admitted.32
Whether the defendants preserved for appeal their objections to the admission of the plaintiffs' expert testimony?33
No. The defendants did not preserve for appeal their broader objections to the admission of the plaintiffs' expert testimony.36 At the pretrial hearing they abandoned any request for an evidentiary hearing.37 At trial they limited their objections to the absence of epidemiological studies for Drs. Gershwin and Freundlich and to the NMRS technique for Dr. Batich.38
Because those were the only grounds presented when the judge made her final rulings, appellate review is confined to the narrow issues actually preserved.39
The defendants failed to preserve broader objections.40
Whether the trial judge erred in her evidentiary rulings on post-1977 product complaints, Dow Corning studies, and published literature?41
A trial judge may admit post-sale complaints and internal studies as business records or to show continuing notice of product risks.42 The judge may exclude post-sale literature offered for its truth as hearsay.43 The same limitations apply equally to both parties. Any error is harmless when independent grounds support liability.44
No. The trial judge did not err in her evidentiary rulings on post-1977 product complaints, Dow Corning studies, and published literature.45 Post-1977 complaints were admitted solely to show notice to Heyer-Schulte of rupture and migration problems and were accompanied by a limiting instruction that they were not offered for their truth.46 Internal Dow Corning studies remained admissible as business records proving the characteristics of the gel used in Mrs. Vassallo's implants.47 Published literature after 1977 was excluded as hearsay when offered through experts, a ruling applied evenly to both sides.48
Any claimed error on testing evidence was nonprejudicial because the negligence and 93A findings rested on independent bases.49
The evidentiary rulings were correct.50
Whether the evidence supported the jury verdicts on the negligence claims?51
A manufacturer is negligent when it fails to warn of risks that were known or reasonably knowable at the time of sale or that reasonable testing would have revealed.52 The evidence of such knowledge plus inadequate warnings supports a verdict when the plaintiff would have declined the procedure had proper warnings been given.53
Yes. The evidence supported the jury verdicts on the negligence claims.54 Heyer-Schulte possessed internal knowledge of FDA-documented migration deaths, animal studies showing inflammation and gel migration, 129 rupture complaints in 1976, and gel bleed through intact shells.55 Yet the company conducted few animal studies, no clinical studies, and issued warnings that omitted immune-system effects and undetected ruptures from normal stress.56
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. The jury could reasonably find that the defendants breached their duty to warn and that the breach caused Mrs. Vassallo's injuries.57
The negligence verdicts are supported by the evidence.58
Whether Massachusetts law on breach of the implied warranty of merchantability for failure to warn should be changed to require that risks be reasonably foreseeable or discoverable by reasonable testing at the time of sale?59
A manufacturer is not liable under the implied warranty of merchantability for failure to warn of risks that were not reasonably foreseeable at the time of sale.60 A manufacturer is also not liable for risks that could not have been discovered by reasonable testing prior to marketing the product.61 The manufacturer is held to the standard of an expert in the field and remains subject to a continuing duty to warn of subsequently discovered risks.62
Yes. Massachusetts law on breach of the implied warranty of merchantability for failure to warn should be changed to require that risks be reasonably foreseeable or discoverable by reasonable testing at the time of sale.63 The prior hindsight standard imposed liability for unknowable risks and placed Massachusetts in a distinct minority.64 This approach was contrary to Restatement (Second) of Torts § 402A comment j and the newly approved Restatement (Third) of Torts: Products Liability § 2(c).65
The goal of inducing feasible conduct is not advanced by requiring warnings of risks incapable of being known.66 The revised rule aligns with the majority of jurisdictions and with the principle that a seller is charged only with knowledge that reasonable testing would reveal.67
The law is revised prospectively to the majority foreseeability standard.68
Whether the judge's findings and rulings on the G. L. c. 93A claim were proper?69
A judge's findings of fact on a G. L. c. 93A claim are reviewed for clear error.70 Legal conclusions are reviewed for correctness.71 An award of attorney's fees is proper when a violation is established even if no additional compensatory damages are assessed because they would duplicate the jury award.72
Yes. The judge's findings and rulings on the G. L. c.
93A claim were proper.73 The detailed findings that the defendants violated G. L. c.
93A §§ 2(a) and 9 by marketing implants with inadequate warnings despite known risks are not clearly erroneous.74 The legal conclusion that the conduct constituted an unfair or deceptive practice follows directly from the same evidence supporting the negligence verdict.75 The judge correctly declined additional compensatory damages to avoid duplication and properly awarded attorney's fees and costs.76 The absence of Mr. Vassallo from the demand letter caused no prejudice because all fees are attributable to Mrs. Vassallo's claim.77
The G. L. c. 93A rulings are affirmed.78