Vassallo v. Baxter Healthcare Corp.

Supreme Judicial Court of Massachusetts · Torts

TortsProducts liabilityFailure to warnImplied warranty of merchantabilityExpert evidenceChapter 93Afailure to warnimplied warranty of merchantability

Facts

Mrs. Vassallo received silicone gel breast implants manufactured in 1976 by Heyer-Schulte, whose responsibilities were later assumed by the defendants. In 1992 and 1993, her implants were found to have ruptured or leaked, and explant surgery revealed severe permanent scarring, scar-tissue encapsulation, and silicone granulomas. The plaintiffs introduced expert testimony that silicone gel could migrate, degrade, stimulate the immune system, and cause an atypical autoimmune disease, and that Mrs. Vassallo's condition was caused by her implant exposure. The plaintiffs also introduced evidence that before her 1977 implantation, Heyer-Schulte knew of rupture, gel bleed, migration, inflammatory reactions, and possible harmful consequences, but its warnings did not fully address those risks.

Issue

Whether the plaintiffs' expert causation testimony was properly admitted, whether the negligence and c. 93A judgments could stand, and whether Massachusetts should retain its hindsight-based implied warranty failure-to-warn rule. More specifically, the court considered whether a manufacturer may be held liable on an implied warranty failure-to-warn theory for risks not reasonably knowable at the time of sale.

Rule

In Massachusetts, a defendant is not liable under the implied warranty of merchantability for failure to warn or provide instructions about risks that were not reasonably foreseeable at the time of sale or could not have been discovered through reasonable testing before marketing the product. A manufacturer is held to the standard of knowledge of an expert in the appropriate field and remains subject to a continuing duty to warn, at least purchasers, of risks discovered after sale. In reviewing evidentiary rulings, appellate courts ordinarily consider only the specific grounds preserved in the trial court.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In 2014, Harbor Peak Medical sold an implantable pain pump in Boston. In 2022, researchers using a newly developed testing method first discovered that, in rare cases, a previously undetectable chemical reaction inside the pump could damage nearby tissue; the reaction could not have been identified by any reasonable premarket testing available in 2014.

If a Massachusetts plaintiff sues on an implied-warranty failure-to-warn theory based solely on the absence of a 2014 warning, which is the strongest argument for Harbor Peak Medical?

Explanation. Massachusetts abandoned the hindsight rule for implied-warranty failure-to-warn claims. A manufacturer is not liable under implied warranty for failing to warn of risks that were not reasonably foreseeable at the time of sale or that could not have been discovered through reasonable testing before marketing. The other choices incorrectly impose hindsight or absolute-testing liability. (Derived from Vassallo v. Baxter Healthcare Corp. (n.d.).)