Products liability: design tests, warranty theories, and federal preemption

Black-letter propositions

1. 01

   MacPherson v. Buick held that a manufacturer who negligently makes a product that is dangerous if defective, knowing it will be used without inspection, is liable to the remote user without privity; Greenman then held that a manufacturer is strictly liable in tort when an article placed on the market, to be used without inspection, proves to have a defect that injures a human being.

2. 02

   Barker v. Lull gives design defect two tests: the product fails if it does not perform as safely as an ordinary consumer would expect, or if, on balance, its benefits do not outweigh its risks, and on the risk-benefit test the burden shifts to the defendant once the plaintiff shows the design proximately caused injury.

3. 03

   UCC section 2-313 creates an express warranty from any affirmation of fact or promise that becomes part of the basis of the bargain; section 2-314 implies a warranty of merchantability, including fitness for ordinary purposes, when the seller is a merchant, and serving food or drink for value is a sale; section 2-315 implies a warranty of fitness for a particular purpose when the seller knows the purpose and that the buyer relies on its judgment.

4. 04

   Section 2-316 controls disclaimers: to exclude merchantability the language must mention merchantability and, in a writing, be conspicuous; a fitness disclaimer must be written and conspicuous; expressions like as is exclude all implied warranties; and a buyer who examined the goods as fully as desired has no implied warranty for defects the examination should have revealed.

5. 05

   Section 2-318 has three alternatives on who may sue for breach of warranty: Alternative A covers the buyer's family, household and guests, Alternative B any natural person who may reasonably be expected to use, consume or be affected by the goods and is injured in person, and Alternative C any person, and the seller may not exclude the extension.

6. 06

   Federal preemption can bar state claims: Riegel held the Medical Device Amendments bar common-law claims about the safety or effectiveness of a device with premarket approval; Wyeth v. Levine held FDA approval of a brand-name drug's label is not a complete defense to a failure-to-warn claim; Mensing and Bartlett preempted claims against generic manufacturers that turn on labeling; and Bruesewitz held the vaccine act preempts design-defect claims against vaccine makers.

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Common wrong turns

• Merchantability and fitness for a particular purpose are different warranties, and only the second depends on the buyer's reliance on the seller's skill.
• A disclaimer that never mentions merchantability, or that is inconspicuous, does not exclude the implied warranty of merchantability.
• Wyeth v. Levine, which allows a claim against a brand-name drug maker, does not control a claim against a generic manufacturer.

Worked example

A buyer tells a hardware clerk that she needs a ladder for roofing work and relies on the clerk's advice. The clerk sells her a light indoor ladder, which collapses under her weight on a steep roof.

Practice this topic

From negligence to strict liability

MacPherson v. Buick Motor Co. rejected the privity limit on negligence claims against manufacturers. Judge Cardozo wrote that a manufacturer who puts a finished product on the market to be used without inspection by its customers is liable if he is negligent where danger is to be foreseen. In Greenman v. Yuba Power Products, the California Supreme Court held that a manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being.

In Barker v. Lull Engineering Co., the court gave design defects two routes. A product is defective if it fails to meet ordinary consumer expectations as to safety, or if, on balance, it is not as safely designed as it should be. On the second route, once the plaintiff shows that the design proximately caused the injury, the burden shifts to the defendant to prove that the product is not defective. The court stressed that the trier of fact must focus on the product, not on the manufacturer's conduct.

Warranties under Article 2

UCC section 2-313 says any affirmation of fact or promise by the seller that relates to the goods and becomes part of the basis of the bargain creates an express warranty. Section 2-314 implies a warranty of merchantability if the seller is a merchant, and it says the serving for value of food or drink to be consumed on the premises or elsewhere is a sale. Merchantable goods must pass without objection in the trade, be fit for the ordinary purposes for which they are used, and be adequately contained, packaged and labeled. Section 2-315 implies a warranty of fitness where the seller has reason to know the particular purpose and that the buyer is relying on its skill or judgment.

Section 2-316 limits disclaimers. To exclude merchantability, the language must mention merchantability and, if written, be conspicuous. A fitness disclaimer must be in a conspicuous writing. Expressions like as is or with all faults exclude implied warranties, and a buyer who examined the goods as fully as desired has no implied warranty for defects the examination ought to have revealed. Section 2-318 offers states three alternatives on who may sue: family, household and guests under Alternative A, any natural person who may reasonably be expected to use, consume or be affected by the goods under Alternative B, and any person under Alternative C.

Federal preemption of state product claims

In Riegel v. Medtronic, the Supreme Court held that the Medical Device Amendments' pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. In Wyeth v. Levine, it held that federal law does not pre-empt a claim that a brand-name drug's label lacked an adequate warning, because the manufacturer could have strengthened the label under the FDA's changes-being-effected regulation and bears responsibility for its label at all times.

In PLIVA v. Mensing, the Court held that federal drug regulations applicable to generic manufacturers directly conflict with, and pre-empt, state failure-to-warn claims, and in Mutual Pharmaceutical v. Bartlett it held that state design-defect claims that turn on the adequacy of a drug's warnings are pre-empted for generics. In Bruesewitz v. Wyeth, it held that the National Childhood Vaccine Injury Act pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury from a vaccine's side effects.

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