Vassallo v. Baxter Healthcare Corp.
Massachusetts Supreme Judicial Court
696 N.E.2d 909 (Mass. 1998)
Florence Vassallo (plaintiff) received silicone-gel breast implants manufactured by Heyer-Schulte Corporation in 1977; Baxter Healthcare Corp. and Baxter International, Inc. (defendants) later assumed responsibility for Heyer-Schulte's breast-implant products. In 1992, a mammogram revealed Vassallo's left implant had ruptured and her right implant was leaking silicone gel through small holes, causing permanent tissue scarring, chronic inflammation, and immune-system problems; she testified she wouldn't have had the surgery had she known the leakage risks. Trial evidence showed Heyer-Schulte knew of possible leakage risks at the time Vassallo received her implants and didn't inform her of all potential risks. The jury found the defendants had actual or constructive knowledge of these risks and found them liable for negligence; the defendants appealed.
Whether a defendant may be held liable for breach of 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 by way of reasonable testing prior to marketing the product.