Recalls are issued for defective consumer products, prescription drugs and medical devices every day. Typically, recalls are initiated after a company receives reports of injuries or deaths associated with the use of its product. A company's duty to protect the health and safety of the public requires it to take immediate action upon being informed of a potential defect with its product. Issuing a recall is an important first step in fulfilling this duty. However, if the FDA regulates the product, the recall triggers a host of corporate duties under Title 21 of the Code of Federal Regulations.
During the initial phases of a recall, a committee of FDA scientists evaluate the health hazard presented by the product being recalled. Based on this evaluation, the FDA assigns a numerical designation, i.e. I, II, or III, to the product to indicate the degree of health risk the product poses to consumers. A Class I recall is the most serious type of recall. The FDA uses this high-risk distinction only when there is a reasonable probability that the product will cause serious adverse health consequences or death. Class II recalls are reserved for those products that may cause temporary or medically reversible adverse health consequences or if the risk of serious adverse health consequences are remote. A recall product is given a Class III designation if exposure to, or use of, the product is not likely to cause adverse health consequences.
For any class of recall, the FDA's main goal is to ensure that the actions taken by the company are adequate to protect the public health. To achieve this goal, every recall is carried out according to an FDA approved recall strategy. A recall strategy is a planned course of action tailored specifically to the recalled product.
The duty to develop a recall strategy depends upon who initiates the recall. The FDA would develop the strategy if it requests the recall; however, such a request is reserved for very urgent situations and is rarely employed. The FDA views most recalls as a voluntary action taken by manufacturers and distributors to carry out their responsibility to protect the public health and well being from products that present a risk of injury to consumers. During a voluntary recall, the initiating firm must develop the recall strategy, which is subject to FDA approval. Regardless of who develops the strategy, certain elements must be taken into account. These elements include: depth of the recall, i.e. degree of hazard and extent of distribution; need for public warnings; and the extent and effectiveness of oversight.
A recall's classification determines not only the steps the company has to take but also the level of FDA oversight. For example, in a Class I recall, the FDA conducts a number of audits to make sure the company's recall efforts are appropriate and effective. However, the level of involvement and timing of the FDA's intervention does not change the company's obligation to take appropriate action. Ultimately, the responsibility for an adequate recall belongs to the manufacturer or distributor.
Manufacturers and distributers of defective products, medical devices and prescription drugs are wholly responsible for the damages these products inflict on innocent consumers. Liability may also arise if the company initiates a recall and then fails to follow through and comply with appropriate FDA recall procedures. The voluntary nature of a recall stems from a company's duty to protect the public from defective products. Violating FDA regulations is contrary to good industry practice and places all consumers at serious risk.
The attorneys of JONES WARD PLC represent hundreds of persons all across the country who have been injured by defective products, prescription drugs and medical devices. If you or someone you know has been injured by a defective or recalled product, drug or device, contact attorney Terrance Massey. You can reach him by phone at (502) 882-6000 or by email at tj@jonesward.com.
