Vassallo v. Baxter Healthcare Corp

Brief Fact Summary. Vassallo (Plaintiff) underwent breast implantation surgery in 1977. In 1992, it was discovered that the silicone had leaked or ruptured.

Synopsis of Rule of Law. A manufacturer will not be held liable under an 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.

Facts. Plaintiff underwent breast implantation surgery in 1977. The silicone breasts that Plaintiff received were silicone gel manufactured by Heyer Schulte Corporation. Through a series of corporate transactions, Baxter (Defendant) assumed responsibility for breast implant product manufactured by Heyer. In 1992, Plaintiff complained of chest pains and underwent a mammogram. The mammogram had revealed that the breast implants had possibly ruptured. They were removed in 1993 and were replaced with saline implants. During the course of this surgery, the surgeon noted permanent scaring on Plaintiff’s pectoral muscles, which Plaintiff attributed to the silicone gel. The implants themselves were encapsulated in scar tissue with multiple nodules of silicone granulomas. Dissection of the scar tissue revealed that the left implant has ruptured and the right implant has several pinholes in it through which silicone gel could escape. During trial evidence indicated that by 1977, Heyer Schulte
knew its implants were not consistent as far as durability or destructibility. Heyer did not warn of the consequences of gel migration in the body. Heyer also did not disclose to Plaintiff the potential complications associated with breast implants. Plaintiff stated that if she had known that the implants could cause permanent scarring, chronic inflammation and problems to her immune system, she would not have gone ahead with the procedure. The trial court returned a verdict for Plaintiff. Defendant appealed.

Issue. Should Defendant’s products liability be conditioned on Defendant’s actual or constructive knowledge of the risks of the product?

Held. Yes. Judgment affirmed because Defendant did have actual or constructive knowledge.
* Under the Restatement Third, an overwhelming majority of jurisdictions supports the proposition that a manufacturer has a duty to warn only of risks that were known or should have been known to a reasonable person.
* A manufacturer also has a duty to perform reasonable testing prior to marketing a product and to discover risks and risk avoidance measures that testing would reveal.
* Defendant will not be held 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 by way of reasonable testing prior to marketing the product.
* A manufacturer will be held to the standard of knowledge of an expert in the appropriate field and will remain subject to a continuing duty to warn of risks discovered following the sale of the product at issue.

Discussion. Defendant won on appeal but lost the case because the jury found that Defendant knew or should have known of the dangers of breast implants. The tests done by Defendant were incomplete and Defendant knew there was a possibility the implants could cause injury.