A drug company engages in a product recall when it withdraws a drug from the market because of a defect or danger it poses to consumers or a violation of federal law. In contrast, a company carries out a market withdrawal of a drug to correct a minor issue or problem that is not dangerous to consumers and not technically subject to legal action by the U.S. Food and Drug Administration (FDA). Essentially, the difference between a product recall and a market withdrawal is the risk of harm that the drug could cause consumers who take it.
The FDA defines a product recall as the process to remove a drug or medical product from the market because it violates the laws that the FDA administers and enforces. Drug manufacturers have a legal duty to produce drugs that are safe for consumers to use. When those drugs prove to be defective or dangerous, they also have a responsibility to protect the public from them. A product recall is a voluntary action that a company takes to protect the public’s health and safety.
The Drug Recall Process
A company can voluntarily recall a drug, or the FDA can request that a company recall a drug or order a company to withdraw a drug. Most of the time, recalls are voluntary, and an FDA order mandating a recall is rare.
When a recall occurs, the FDA monitors the process and issues guidance to ensure the company has a valid plan to notify consumers who may have taken the drug. Common notifications involve press releases, direct mail and email to consumers, and notices to doctors who prescribed the drug to their patients. The FDA also posts all drug recalls in a weekly enforcement report on its website and issues press releases to news outlets, too.
Companies also routinely offer refunds for the return of the drugs to retail outlets or medical offices. Depending on the problem with the drug, the companies may replace the drugs, or your doctor may prescribe you a different drug altogether.
Drug Recall Classes
When the FDA becomes aware that a drug manufacturer has recalled a drug, it makes the recall public. However, it also assesses the risk that the drug poses to consumers and categorizes it into one of three recall classes based on the level of risk: Class I, Class II, or Class III.
Class I recalls include drugs that could cause severe medical problems or death for consumers. Class II drugs could pose minor or temporary medical conditions in consumers that are treatable or have a slight risk of more serious harm. Class III drugs are unlikely to cause any adverse health reactions but still violate FDA laws in some way.
A market withdrawal does not involve a dangerous or defective drug or any violation of FDA-related laws or regulations. Instead, these drugs have a minor defect or issue that is not sufficient for the FDA to find any legal violation. Some common examples might include companies rotating their stock or routinely repairing or replacing the equipment used to produce the drug.
If allegations of tampering with a drug arose, but they did not originate with the manufacturing process, the company also might withdraw the drug from the market. Once the company corrects the issue, it typically returns the drug to the market.
However, a market withdrawal might occur in another scenario. If a drug manufacturer observes that a drug has declining sales over time, it may choose to discontinue the drug and withdraw the remaining drugs from the market. This situation might occur if another manufacturer or the company itself has replaced the drug with a newer and more effective drug.
It also might occur if a company has developed a different treatment protocol for the medical condition that does not involve the drug. Whatever the case may be, the drop in drug sales causes the company to voluntarily discontinue or withdraw the drug from the market.
Get Legal Assistance with Your Defective Drug Claim
The difference between a product recall and a market withdrawal can be crucial in the context of a legal claim resulting from a defective or dangerous drug. The actions of the drug company, either to engage in a market withdrawal or a product recall, can affect any legal claims for compensation that you may have. When you have suffered injuries after taking a defective drug, you might have legal recourse.
If you are interested in taking legal action, getting in touch with Ben Crump Law, PLLC, could be a first step toward pursuing compensation for your losses from drug manufacturers. We can evaluate your situation, review the evidence, and determine whether you have a valid legal claim. Call (800) 959-1444 to learn how to get started on the claims process today.