Although pharmaceutical drugs and medical devices must pass stringent approval procedures, they are still at the center of personal-injury lawsuits every year. The U.S. Food and Drug Administration (FDA) is tasked with protecting the public from defective and dangerous medical devices and drugs. The FDA does this by reviewing and recalling products that fail to pass the approval process.
Medical device definition and classifications
Medical devices are tools used by doctors to treat patients, they range from tongue depressors to lasers used for surgery. The FDA has established three classes of medical devices, based on the risks they pose and the regulatory controls necessary to ensure safety. Class I devices are those used in everyday treatment that are very unlikely to cause serious injury. Examples of Class I devices are elastic bandages and gloves. Most medical devices are categorized as Class II devices, those that are vital to treatment and unlikely to cause serious injury to patients when used as directed. Examples of Class II devices include electric wheelchairs, surgical pumps, and some pregnancy tests. Finally, Class III devices are those that present the greatest risk and therefore require the most stringent regulatory controls. Class III devices include bone or breast implants and pacemakers.
Medical Device Recalls
The Federal Food, Drug, and Cosmetic Act authorizes the FDA to monitor and regulate products determined to be unsafe or non-compliant. A medical device recall is a method of correcting or removing an unsafe product from the market. Normally, the manufacturer or distributor voluntarily agrees to a recall in the interest of public health and safety. However, in rare instances, the FDA must issue a mandatory recall via court action.
The FDA categorizes recalls into three classes, depending on the severity of the potential hazard. Class I recalls are reserved for the most dangerous devices, ones that can cause serious health problems or even death, such as a defective artificial heart valve. A Class II recall is designated for products that may cause temporary or medically-reversible consequences, for example, surgical utensils packaged in way that makes them unsterile. Finally, a Class III recall is one where there is very little likelihood of adverse health effects. An example would be a device with a mislabeled package indicating an incorrect size.
A voluntary recall is initiated when a company realizes that a medical device violates FDA regulations and requires inspection, repair, or adjustment. The company submits a proposal to the FDA that identifies the problem, assesses potential health risks, determines whether the problem violates the law, and indicates the recall classification. Upon receipt of a proposal, the FDA will notify the public through its Medical Device Recalls database.
Pharmaceutical drugs are sold to millions of people each year, making drug safety a continuous effort. To protect users from unnecessary health risks, the FDA regulates drugs just as it does medical devices. When the FDA determines that a drug poses a health risk to users, it is recalled, and manufacturers work to fix the issue. A drug recall effectively removes the prescription or over-the-counter drug from the market.
Reasons for FDA drug recalls include the discovery of previously-unknown negative interactions with other drugs, or errors in manufacturing or packaging. Also, studies sometimes reveal health risks after the drug has been distributed to users. For example, drugs linked to increased risk of stroke, kidney failure, or heart attack will be recalled. A drug also may be recalled when it is found to negatively interact with vitamins or foods in a way that can harm the user. As with medical devices, pharmaceutical companies may voluntarily recall an unsafe drug, commonly after receiving numerous reports of user injuries or learning of health risks from new research studies or clinical trials.
The FDA uses a recall classification system for pharmaceutical drugs like the one used for medical devices, with three classes based on severity of potential injury. A Class I recall is the most serious and involves drugs that are likely to cause serious health consequences or even death. Class II recalls involve drugs that may cause temporary or reversible health problems. A Class III recall involves a drug that is unlikely to cause health problems but that violates either manufacturing or labeling laws set forth by the FDA.
The FDA works closely with manufacturers to facilitate each recall. Recalled drugs are included in the FDA’s Drug Recall database, which can be searched online. The FDA also helps manufacturers remove recalled drugs from the marketplace by notifying pharmacies, which, in turn, notify patients of the recall.
Bianca Ybarra is a Staff Writer for GetLegal.com. She is a graduate of the University of Houston Law Center and a member of the State Bar of Texas.