Products Liability Claim against Manufacturer of Medical Devices
Products Liability Claim against Manufacturer of Medical Devices

Products Liability Claim against Manufacturer of Medical Devices in Nursing Homes


I. Introduction To Product Liability Law:
The law of product liability is the area of law which deals with the liability of the manufacturer, wholesaler or retailer of a product for injuries resulting from dangerous and defective products. Products subject to the law run the spectrum from food, drugs, appliances, automobiles, medical devices, medical implants, blood, tobacco, or even commercial jets. At common law (law derived from judicial holdings carried over to the United States from England) the sale of a product was viewed as a commercial transaction upon which only the parties to the commercial contract could sue. The law has evolved to the point where today virtually anyone injured by a “defective” product (defined as a product which is unreasonably dangerous for its intended use; see below) can bring an action for damages against any party in the distributive chain of the product, whether it be the manufacturer, the wholesaler, the retailer or even the maker of a component part.

II. Theories Upon Which Suit Can Be Brought:
There are a number of theories or counts upon which an injured party can bring an action in product liability law. The plaintiff may include a count for each theory, or may choose to sue on only one. The theories are:

Breach of Implied and Express Warranties
Strict Liability

These theories overlap to a great extent and are the result of historic evolution of the law, with strict liability being the newest, having originated with a California court decision called Greenman v. Yuba Power Products, Inc. , 59 Cal.2d 57, 27 Cal. Rptr. 697, 377 P.2d 897(1963). Until the Greenman decision, a plaintiff was required to either proceed under a negligence theory, in which he was required to prove negligence, or proceed under a warranty theory, in which case he was required to be in “privity” of contract with the defendant, meaning that a contractual relationship had to be established between the injured party and the defendant sought to be sued. The contractual origin of breach of warranty claims is best illustrated by the fact that to this day the implied and express warranties, under which some product liability claims are brought, are contained in a compilation of commercial statutes called the Uniform Commercial Code, to which most jurisdictions adhere. Under strict liability theory a plaintiff is not required to prove either negligence or that he was in privity of contract with the manufacturer or other seller. Some commentators argue that there is little difference between proving that a product was unreasonably dangerous for its intended use and proving that a manufacturer or other seller was negligent for releasing into the stream of commerce a product that was unreasonably dangerous for its intended use. Others argue that in cases where the state of technology was such that the danger was not known to the manufacturer at the time of sale and could not be discovered, the ability to proceed without showing negligence is important in assisting a jury to arrive at a verdict.

III. The Meaning of the Terms “defect” and “defective”
One of the most common terms to arise in product liability litigation is “ defect”. In the eyes of the law this term has a broader meaning than one might expect. The law considers any product which is unreasonably dangerous for its intended use to be defective. In considering this definition, it is important to remember that the term “unreasonably” dangerous is crucial to the meaning of the term “defective”. Thus, a product may be inherently dangerous but have such utility that the danger is one which would not be considered “unreasonable”. For instance, gasoline is an inherently dangerous product, but its utility far outweighs any danger posed by it. Therefore, the law does not consider gasoline unreasonably dangerous for its intended use. Should the day arrive where an alternative, less dangerous, and no more costly fuel is developed, the law would permit a product liability action to prove that gasoline is an unreasonably dangerous product, and is, therefore, defective. Similarly, a knife is unquestionably a dangerous product, but the law wouldn’t consider it “unreasonably” dangerous. On the other hand, a knife with a handle so fragile it will snap under ordinary use would be an unreasonably dangerous product, and, therefore, defective. Another factor which may be evaluated in determining whether a product is defective is the adequacy of warnings. Obviously, an inadequate warning will increase the danger posed by a product, and may, itself, be negligence on the part of the manufacturer. In addition, an adequate warning may be all that is required to result in a factual determination that a danger posed by the product did not constitute an unreasonable risk of harm. The converse may also be true. An otherwise useful product carrying inherent risks may be determined to be unreasonably dangerous for its intended use solely due to the absence of an adequate warning alerting the user to the danger.

IV. Manufacturing Defects vs. Design Defects
Another distinction which arises in product liability law is the distinction between manufacturing defects and design defects. A manufacturing defect arises when the finished product does not conform to the manufacturer’s plans or specifications. An example of this would be a jagged edge on an automobile ashtray, where the manufacturer’s plans called for a smooth edge, but a malfunction occurred during the machining process. Another example of manufacturing defects are product failures caused by substandard materials, such as exploding soft drink bottles. Design defects, on the other hand, occur when a product is manufactured exactly as the manufacturer intended, but the product itself is deemed to be unreasonably dangerous for its intended use. An automobile that cannot withstand crush injuries during a rollover accident or which will explode upon impact would be considered to have a design defect. Much of today’s product liability litigation consists of design defect cases, and this field is broad enough to cover such claims as asbestos litigation, vaccine and other drug litigation, flammable fabric litigation, dangerous power tool or appliance litigation, defective medical implant litigation (including breast implants), and any other area in which a product’s design makes it unreasonably dangerous for its intended use, thereby causing injury. The process of evaluating whether an inherent danger makes a product “unreasonably” dangerous for its intended use always involves balancing the utility of the product and its design against the risk or danger posed by the product.

V. Elements of Product Liability Claims
Although there are some differences in the elements of product liability claims founded upon negligence versus breach of implied warranty versus strict liability, there are also many common elements.

In a negligence claim a plaintiff must show that a manufacturer, seller, wholesaler or other party involved in the distributive chain or group had a duty to exercise reasonable care in the process of manufacturing or selling a product and failed to fulfill that duty, resulting in injury to the plaintiff.

B. Breach of Warranty and Strict Liability:

These theories share certain common elements which a plaintiff must prove. They also differ in several key respects from product liability actions based on negligence. The elements of warranty and strict liability claims are as follows:

Defect: As previously noted, a defect is a feature which makes a product unreasonably dangerous for its intended use.

Seller or Sale: Generally, this requirement would exclude leases or loans of products. It may also exclude products provided only incidental to a transaction in which the primary focus is service. A seller may be anyone who sells the product or a component of the product to any other party through the distributive chain, up to and including the retail sale to the consumer. A manufacturer “sells” the product to a wholesaler. A manufacturer of a component part “sells” that part to the manufacturer of the product in which the component part will be incorporated. A wholesaler “sells” the product to the retailer, who in turn “sells” the product to a consumer.

Defective at the Time it Leaves the Control of the Seller: It must be shown that the product was defective at the time it left the control of the seller. In a case against a manufacturer that time would be when the product is sold and delivered to a wholesaler. In the case of a wholesaler, that time would be when the product is sold and delivered to a retailer. With a retailer, that time would be when the product is sold and delivered to a consumer. Needless to say, if the condition of a product changes so as to render the product unreasonably dangerous after the product has left the control of a defendant, that defendant cannot be held liable, unless the change was reasonably foreseeable within the scope of the intended use of the product.

Defect Causing Plaintiff’s Injuries: In all personal injury cases causation is a crucial element of a plaintiff’s claim, and this in no less true in product liability cases. First, there must be medical causation of the injuries claimed by a plaintiff to the danger of the product. In most cases, this will not be a problem, unless the claim involves medical conditions which arguably were not caused by the injury. In addition, other defenses to product liability claims may be couched in terms of causation. For instance, a plaintiff’s failure to adhere to instructions for using the product may be described as an intervening, new cause of the plaintiff’s injury, relieving the defendant of responsibility due to lack of causation. Misuse of a product is a defense to product liability claims, and this defense may be couched in terms of causation.

No Requirement to Show Negligence and No Defense of Contributory Negligence: As previously indicated, under both strict liability and warranty theories, a plaintiff need not prove negligence. Similarly, the defense of contributory negligence of the plaintiff, available in product liability cases founded upon negligence, is not in most jurisdictions available to a defendant in cases involving strict liability and warranty. The defense of assumption of risk may or may not be available in any or all of these theories, depending upon the rulings in a particular jurisdiction.

This website is not intended to provide legal advice as each situation is different and specific factual information must be obtained before an attorney is able to assess the legal questions relevant to your situation.

If you or a loved one has suffered an injury from neglect or abuse in a nursing home or other care facility that serves the elderly throughout the state of Minnesota please contact our firm for a free consultation and information regarding the obligations of the facility and your rights as a resident or concerned family member. To contact Attorney Kenneth L. LaBore, directly please send an email to, or call Ken at 612-743-9048 or toll free at 1-888-452-6589.

Free Consultation on Issues of Elder Abuse and Neglect Serving all of Minnesota Toll Free 1-888-452-6589
Free Consultation on Issues of Elder Abuse and Neglect Serving all of Minnesota Toll Free 1-888-452-6589


Products Liability Claim against Manufacturer of Medical Devices

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