Vassallo v. Baxter Healthcare Corporation and Baxter International, Inc.
428 Mass. 1, 696 NE 2d 909 (1998)
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Rule of Law:
A manufacturer will not be held liable under an implied warranty of merchantability for failure to provide warnings or instructions about product risks that were not reasonably foreseeable at the time of sale or could not have been discovered through reasonable testing prior to marketing.
Facts:
- Heyer-Schulte Corporation manufactured silicone gel breast implants.
- By 1975, Heyer-Schulte's president acknowledged that the company's implants were 'fragile' and 'not consistent as far as durability or destructibility is concerned.'
- In 1976, Heyer-Schulte had received 129 complaints of ruptured implants and was aware of studies documenting silicone gel migration and inflammatory responses in the body.
- The company's 1976 product warnings did not address the potential for undetected rupture, 'gel bleed' from intact implants, or the long-term consequences of gel migration, such as chronic inflammation or immune system effects.
- In February 1977, Florence Vassallo underwent a breast implantation surgery and received Heyer-Schulte's silicone gel implants.
- Vassallo stated that if she had been informed of the risks of permanent scarring, chronic inflammation, and immune system problems, she would not have undergone the procedure.
- In 1993, Vassallo's implants were removed, revealing that the left implant had ruptured, releasing free silicone gel, and the right implant had pinholes allowing gel to escape.
- Vassallo suffered from severe, permanent scarring of her pectoral muscles and was diagnosed by experts as having an atypical autoimmune disease caused by her exposure to the silicone gel.
Procedural Posture:
- Florence Vassallo and Vincent Vassallo sued Baxter Healthcare Corporation and Baxter International, Inc. in the Superior Court (a state trial court).
- The plaintiffs' claims included negligence, breach of the implied warranty of merchantability, and violation of a state consumer protection statute, G. L. c. 93A.
- A jury returned verdicts in favor of the plaintiffs on the negligence and breach of warranty claims and assessed damages.
- The trial judge, in a separate decision, found the defendants liable for violating G. L. c. 93A and awarded the plaintiffs attorneys' fees and costs.
- The defendants (appellants) appealed from the judgment entered against them.
- The Supreme Judicial Court of Massachusetts (the state's highest court) granted the defendants' application for direct appellate review, bypassing the intermediate appellate court.
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Issue:
Does the implied warranty of merchantability impose liability on a manufacturer for failing to warn of product risks that were not known or reasonably knowable according to the state of scientific and technical knowledge at the time of manufacture and sale?
Opinions:
Majority - Greaney, J.
No. A manufacturer is not liable under the implied warranty of merchantability for failing to warn of risks that were not reasonably foreseeable or discoverable at the time of sale. The court adopts the majority 'state of the art' approach, which conditions a manufacturer's duty to warn on its actual or constructive knowledge of a product's risks. Previously, Massachusetts applied a minority 'hindsight' standard, which imputed full knowledge of all risks to the manufacturer, regardless of whether they were knowable at the time of sale. The court changes this rule because the goal of the law is to induce conduct capable of being performed, which is not advanced by imposing liability for failure to warn of unknowable risks. This change aligns Massachusetts law with the Restatement (Third) of Torts: Products Liability, which requires that foreseeable risks could have been reduced or avoided by reasonable warnings. The manufacturer is held to the standard of an expert in the field and has a continuing duty to warn of risks discovered after the sale.
Analysis:
This decision marks a pivotal shift in Massachusetts products liability law, moving the Commonwealth from a distinct minority of states with a strict 'hindsight' liability standard for failure to warn to the clear majority 'state of the art' position. By requiring plaintiffs to prove that a risk was known or reasonably knowable to the manufacturer at the time of sale, the court makes failure-to-warn claims under the implied warranty of merchantability more difficult to win. This change aligns Massachusetts doctrine with the Restatement (Third) of Torts and harmonizes the state's warranty law with negligence principles regarding foreseeability. While the rule is changed prospectively, it will significantly impact future products liability litigation in the state by focusing the inquiry on the scientific knowledge available when the product was marketed.
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