Vassallo v. Baxter Healthcare Corp.

In February 1977, Florence Vassallo (plaintiff) underwent breast implantation surgery and received silicone-gel implants manufactured by Heyer-Schulte Corporation. Baxter Healthcare Corp. (Baxter Healthcare) and Baxter International, Inc. (Baxter International) (defendants) eventually assumed responsibility for breast-implant products manufactured by Heyer-Schulte. In 1992, Vassallo had a mammogram after complaining of severe chest pain. The mammogram revealed that her left breast implant had ruptured, and her right implant contained small holes through which silicone gel was leaking. Vassallo suffered permanent tissue scarring, chronic inflammation, and problems with her immune system due to the silicone-gel leakage. She and her husband brought suit against Baxter Healthcare and Baxter International. She stated that if she had known of the risks associated with gel leakage, she would not have had the procedure. Additionally, evidence was introduced at trial showing that Heyer-Schulte knew of the possible risks associated with leakage of implants at the time they were received by Vassallo, and did not inform her of all the potential risks. The jury found that the defendants had actual or constructive knowledge of the risks of breast implants at the time they were given to Vassallo and also found the defendants liable for negligence. Baxter Healthcare and Baxter International appealed.