Product liability law focuses on the liability of a supplier of a product that causes physical harm to a person or property by a defect in the product. If a product does not perform as well as expected, causing purely economic loss to the buyer, this is a sales issue and not product liability. However, when a defective product causes injury, the manufacturer of the product, as well as the distributor, wholesaler, and retailer who sold it, may be liable to the person injured based on any of the following legal theories, depending on the circumstances in which the person was injured:

1. Intentional torts;
2. Negligence;
3. Strict liability (defective products that cause an injury); or
4. Breach of an express or implied warranty.

Determining the type of liability involved is important because it affects key issues of the case. For the purpose of this article, we will concentrate on strict liability and express/implied warranty.

Strict Liability

Recently, courts have held manufacturers and suppliers of defective products strictly liable in tort to consumers and users for injuries caused by defective products. Keep in mind that the plaintiff in any suit must prove both a defect in the product that is attributable to the manufacturer or supplier, and that the defect caused the injury.

A product may be defective in manufacture, in design, or in the sufficiency of the warning accompanying it.

Kinds of defects:

1. Manufacturer defects. This is the unintended condition of the product at the time it left the control of the manufacturer, and the product not conforming to the manufacturer's own production standards.
2. Design defects. The product was in a condition as to meet the manufacturer's standard, but was designed in such a way that it presented an undue risk of harm in normal use. This type of defect case can lead to negligence, as well as leave the manufacturer liable for failure to design its product so as to minimize foreseeable harm caused by other parties or conditions.
3. Inadequate warning. In addition to the product itself, defects may arise from packaging and inadequate instructions, warnings, or labels. Inadequate warnings may make a product defective when the dangers are not apparent to the consumer or users. Unexpected dangers are something that a reasonable user would have no reason to expect or anticipate in the product.

Before a doctor can treat a patient, he or she must warn the patient as to the dangers of an adjustment (informed consent). The same holds true of any medical equipment. If there is a risk or danger to your patient in using the equipment, the patient must be advised.

When you purchase used equipment, the seller of the used product may be liable for safety defects attributed to the design or manufacturer if they conflict with the purchaser's reasonable expectations of the product. In these cases, an "as is" disclaimer does not shield the seller from liability. Some courts bar this type of claim because the buyer cannot reasonably expect the product to be free of defects. The liability question arises when the product/equipment has been altered from the original design of the manufacturer, by a seller not connected to the original manufacturer. All states have held that any person injured by a defective product can seek a tort liability claim.

Strict liability applies only where the injuries or damages have resulted from a defective product. Strict liability does not extend to services provided by a doctor. However, if the doctor is negligent in performing those services, he may still be held liable from a negligence standpoint and not a product defect issue that causes injury to a patient.

Imposing strict liability depends on two separate issues:

1. Type of defect (manufacturer, design, and lack of warning); or
2. Standard used to determine the defect (unforeseeable or unreasonable danger, misuse, or carelessness of the product by the user).

Note: The manufacturer has the duty to warn the user of any risks, no matter how small. The doctor has a duty to use the product properly and warn the patient of any potential dangers of using the product.

The burden is on the plaintiff to prove that the product was defective when it left the manufacturer's or seller's control and a causal relationship exists to the plaintiff's injury and the use of the equipment.

Kinds of recovery include:

1) Personal injury (or death); or 2) Economic losses.

Defenses in Strict Liability

If you are sued by a patient, it will usually be a negligence case (malpractice). If a patient is injured on a piece of equipment that was not defective, the suit will be a negligence issue. If the patient was injured and the equipment was defective, you will probably still get sued. However, you have a strict liability case against the manufacturer or supplier for the defective equipment that caused the patient's injury.

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1. Contributory Negligence. Failure to discover or guard against danger, or failing to exercise reasonable care to discover the danger or guard against it, traditionally is not a valid defense to a strict liability claim in most states. However, you may have a contributory negligence claim against the manufacturer or seller of the product if you are sued for injuring a patient if that injury was caused by a defective piece of equipment.
2. Unreasonable Use. You can be sued in a contributory negligence case along with the manufacturer and/or supplier in the sense of unreasonable misuse of a defective product in a manner for which no reasonable person would use it and the patient is injured.
3. Comparative Fault. If the injury was caused by the plaintiff's careless use of the product. Most states limit recovery by the plaintiff. Example: If you place electrodes in one location on the patient and the patient moves the electrodes to another location other than what you instructed the therapist to do. If injury occurs, the plaintiff contributed to their own injury.

Note: One who knows of the danger or risk involved, and unreasonably continues to use the product, may be held to have assumed the risk. This is a valid defense to strict liability.

Liability Based Upon Breach of Warranty

Rather than relay negligence or strict liability as a basis for liability, courts may also impose liability for breach of warranty in a contract action.

1. Express Warranty
2. Implied Warranty
3. Goods Versus Services

Damages for breach of warranty are substantially the same as in a strict liability action. All damages proximately caused by the breach, including pain and suffering and personal injury, are recoverable.

Defenses to Warranty Actions

1. Contributory Negligence. This is usually not a defense in itself for the doctor in a negligence case. However, if the product was defective in some way, then the doctor has an action against the manufacturer, supplier, or both.
2. Assumption of Risk. This is a defense in warranty action. Keep in mind you can still be sued from a negligence standpoint under strict liability or in breach of warranty cases if the patient is injured. However, you may have an action against the manufacturer, supplier, or both under strict liability or warranty law.

Kenneth Ross, DC, JD, is a former criminal law enforcement officer with 18 years of experience. He teaches and specializes in tort law, negligence, risk management, medical records, expert witness, and criminal issues involving practice boundaries. He practices chiropractic in Orlando, Fla. He can be reached at (866) 225-5055 or via e-mail at .