Product Liability, Prescription Drugs, and Medical Devices
Product liability law, also called “products liability”, governs the liability of manufacturers, wholesalers, distributors, and vendors for damages caused by dangerous or defective products. The goal of product liability laws is to help protect consumers from dangerous products, while holding manufacturers, distributors, and retailers responsible for putting into the marketplace products that they knew or should have known were dangerous or defective. Depending upon the jurisdiction, the liability of the various parties involved as the product passes from the manufacturer to the consumer will vary.
Product liability frequently involves retail items, but can extend to pretty much anything that can be sold. It is possible, for example, for a product liability action to arise from a defect in real estate such as a leaky wall or poorly installed vapor barrierthat causes mold to grow inside a wall, or from a product used in real estate, such as defective siding.
Product liability claims can be brought under a number of theories, depending upon local law.
Design Defects: Liability arises from a mistake or oversight in the design of a product, which makes it dangerous when used as intended, or when used for another reasonably foreseeable purpose.
Manufacturing Defects: Liability arises from a defect that results from the manufacturing process.
Marketing Defects: A marketing defect involves such issues as inadequate warning labels or instructions, which, for example, prevent a user from recognizing a defect in the product, or from being aware of how to safely use or apply the product.
The elements of what a plaintiff must prove to prevail in a product liability action will also vary with the jurisdiction. It may be possible for a plaintiff to pursue more than one theory of liability.
Negligence: In a negligence action, the plaintiff must typically demonstrate that the parties responsible for placing the product into commerce had a duty to provide goods fit for their foreseeable uses, would have detected the defect with the exercise of reasonable care in the design, manufacture, or inspection process, failed to meet its obligations, and that the plaintiff was injured by the product as a result of the defect while engaged in a foreseeable use of the product.
Strict Liability: Under a strict liability standard, once the plaintiff establishes that a product is defective, liability results from that fact alone no matter how much care was applied during design, manufacture, marketing, distribution and sale.
Breach of Warranty: A warranty is essentially a contract of fitness between a manufacturer or vendor and its customer. Under a breach of express warranty theory, the plaintiff alleges the violation of the actual written warranty associated with a product. Under a breach of implied warranty theory, the plaintiff alleges that although there is no express warranty or the defect alleged is not covered by the express warranty, a defect in the goods renders them unfit for the purpose intended.
Many jurisdictions have created comprehensive product liability statutes, to govern litigation over injuries caused by defective products. Some states adhere more closely to a strict liability model, while some have very narrow product liability standards and place a significant burden of proof on a plaintiff. Some may defer to the safety determination made by a federal agency, such as the FDA’s review of pharmaceutical products, and shield manufacturers from defects unless the plaintiff can demonstrate that they misled the reviewing agency. They may also immunize parties beyond the point of manufacture, unless the plaintiff can demonstrate that they had actual knowledge of a product defect.
Products liability law aims to protect consumers when products containing defects cause damage. Under this law, the manufacturers of the defective product are considered liable for any harm caused to consumers during their usage of the product.
If you believe you might have a products liability case against a manufacturer, you should be aware of some of the key points and frequently asked questions regarding products liability law.
A Brief Overview of Products Liability Law
Products liability claims are typically based on either negligence or strict liability. In order to receive damages, the plaintiff must prove that the manufacturer’s product is defective. There are three types of product defects –design defects, manufacturing defects, and defects in marketing.
Design defects are defects that are inherent to the product, existing before it is even manufactured. Manufacturing defects, on the other hand, occur during the construction and/or production phase. Defects in marketing involve improper product safety information.
Products liability law is governed by tort law. There is no federal products liability law. However, most states have adopted Article 2 of the Uniform Commercial Code (UCC), which deals with the sale of goods.