Drug Recalls

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market.

Drug recalls may be conducted on a company’s own initiative or by Food and Drug Administration (FDA) request. FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.

Recall Classification

• Class I: A dangerous or defective product that could cause serious health problems or death.

• Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.

• Class III: A products that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Alerting the Public

Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. But if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist.

If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it.

Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.

Weekly Enforcement Report

All recalls are posted weekly in the FDA enforcement report located on the FDA’s website. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard. Ongoing recalls that have not been classified are also published in the enforcement report as “not yet classified” in the classification field. After the recall classification has been determined, the recall is updated in the enforcement report with its appropriate classification.

Determining the Effectiveness of the Recall

FDA evaluates the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions.

Products Liability Litigation for Defective Drugs

Defective drugs may also be the subject of products liability litigation. Products liability refers to a claim or lawsuit against a manufacturer or seller of a product for the recovery of damages related to personal injury, death, or property damage claimed to be caused by a defective product.

A products liability claim or lawsuit may be based on the legal theories of strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.

Product liability claims may be made against the manufacturer of component parts, an assembling manufacturer, the wholesaler, and the retailer. And product liability claims may be made by the consumer who purchased the product or by someone else who borrowed or used the product.

Product liability laws vary from state to state, and product liability claims may be based on the state’s court opinions (also known as case law or common law) or on the state’s statutes—which are usually the version of the Uniform Commercial Code (UCC) adopted by the state.

For example, under a state’s version of Article 2 of the UCC (dealing with sales of goods) there are implied warranties of merchantability and of fitness of the goods for a particular purpose included in every sale of goods. In some states these warranties may be waived by agreement, but in other states they may not be waived. See U.C.C. §2-314 and U.C.C. §2-315.

And under a strict liability theory of products liability, the amount of care or precaution taken by the manufacturer is not relevant—the manufacturer will be liable for the harm result from the defective product.

To prevail on a products liability claim, the claimant or plaintiff must prove the product:

• was defective in its design (a design defect) because there was a safer alternative design for the product;

• was defective in its manufacture (a manufacturing defect) because its production departed from the intended design, was significantly or materially different from the other products of the same design, did not work as intended, and was more dangerous to the consumer than expected; or

• was defective in its marketing (a marketing defect) because the product’s advertising and instructions for use were inadequate or failed to warn consumers of hidden (latent) dangers in the product.

In Texas, drug recalls are managed in accordance with federal regulations, primarily overseen by the Food and Drug Administration (FDA). The FDA classifies recalls into three categories based on the potential health risk: Class I for products that could cause serious harm or death, Class II for products that may cause temporary health problems, and Class III for products that violate FDA regulations but are unlikely to cause adverse health reactions. Public notification of a recall is issued depending on the extent of distribution and the level of health hazard posed by the drug. Patients in Texas should consult with their health care professional for guidance if they possess a recalled drug. The FDA posts all recalls in its Weekly Enforcement Report on its website, including the classification of the recall once determined. In cases where a drug recall is ineffective, the FDA may require additional actions from the company. Additionally, Texas follows products liability laws that allow individuals to seek damages for injuries caused by defective drugs. These claims can be based on various legal theories, including strict liability, negligence, or breach of warranty, and can be directed against manufacturers, wholesalers, or retailers. To succeed in a products liability claim, the plaintiff must prove that the product had a design, manufacturing, or marketing defect. Texas law, influenced by the Uniform Commercial Code (UCC), includes implied warranties of merchantability and fitness for a particular purpose in the sale of goods, which may or may not be waivable depending on the state's adoption of the UCC provisions.