Drug recalls have been on the rise over recent years, affecting an estimated 81% of consumers in the United States. But when the federal Food and Drug Administration (FDA) finds a problem with a drug, what happens when a drug is recalled? And what does it mean for victims who want to file a Maryland product liability claim? A recent industry news source outlined the drug-recall process, which provides a good overview for those unfamiliar with the process.
A drug recall is an action by the manufacturer of the drug to remove a defective or harmful product from the market after the drug is found to be in violation by FDA laws or regulations. The FDA cannot pull a product from the market. It can only request that a drug be recalled, but ultimately the pharmaceutical company must decide whether to pull the drug.
The FDA then assesses whether the recall was appropriate, classifies the recalls, and oversees the recall strategy. A recall is classified by the FDA as a class I, II, or III recall. Class I recalls are the most serious, as they are for products that could cause serious harm or death. Class II recalls are for products that pose a notable risk and threat. Class III recalls are for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences. Once a drug recall has been issued, officials from state health departments and pharmacy boards, drug manufacturers, and others may contact pharmacies to let them know about the drug recall. The pharmacies are then responsible for making sure that the recalled product is removed and dispensed of properly. They also have to help patients by counseling them on their options in light of the recall.
If a Maryland patient is injured because of a defective or unsafe drug, the patient may file suit against the drug manufacturer. Evidence that a drug was recalled generally may be admitted in court to help establish that a medication was defective. But a plaintiff still has to prove all the elements of a product liability claim, including that the medication that the plaintiff used was defective and that the plaintiff suffered injuries as a result. The FDA does not test drugs, but it reviews test results in considering the safety of a drug before the drug is put on the market. Thus, a manufacturer also has a responsibility to monitor a drug for any problems based on consumer reports and research.
Have You Been Injured by a Recalled Drug?
If you have been injured by a recalled drug, speak with an experienced attorney about your claim. The Maryland pharmacy error attorneys at Lebowitz & Mzhen, Personal Injury Lawyers represent plaintiffs in pharmacy error cases and other medical malpractice cases throughout Maryland, Virginia, and Washington, D.C. Lebowitz & Mzhen repeatedly achieves positive results for its clients through compassionate and diligent legal advocacy. We will work hard to reduce the stress on you as much as possible so that you can get your life back on track. To set up a free consultation, call 1-800-654-1949 or contact us online.