Vassallo v. Baxter Healthcare Corporation

Brief Fact Summary.

Vassallo was injured by the defective design of her silicone gel breast implants.

Synopsis of Rule of Law.

A defendant is not 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. Instead, 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.

Facts.

Vassallo was injured by the defective design of her silicone gel breast implants. She sued for negligent design, negligent product warnings, and breach of the implied warranty of merchantability. Her husband claimed loss of consortium.

Issue.

Should Baxter Healthcare Corporation be liable for defective design if it did not have actual or constructive knowledge of the risks of the product?

Held.

Affirmed.

Though the court’s ruling would normally absolve Baxter Healthcare Corporation of any liability for defective design if it did not have actual or constructive knowledge of the risks of the product, the court precluded Baxter Healthcare Corporation from taking advantage of this change in law because of the jury’s sustainable verdict on negligence in failing to warn of known risks.

Discussion.

Baxter Healthcare Corporation requested a jury instruction that would limit a manufacturer’s duty to warn only of risks “known or reasonably knowable in light of the generally accepted scientific knowledge available at the time of the manufacture and distribution of the device.” The trial judge refused and instead applied a strict liability standard under current law on the duty to warn under the implied warranty of merchantability, which presumes that a manufacturer is fully informed of all risks associated with the product at issue regardless of the state of the art at the time of sale.

The majority of states follow Restatement (Second) of Torts § 402A comment j (1965), which limits the sellers’ duty to warn to risks known or should have been known to a reasonable person. The Products Liability Restatement § 2(c) reaffirms this notion, stating that a product is defective because of inadequate warnings when the foreseeable risks of harm could have been mitigated by reasonable warnings and no warnings rendered the product not reasonably safe.