Yes, the Food and Drug Administration (FDA) can force a recall of a prescription or over-the-counter medication to take the dangerous product off the market. In most cases, the drug manufacturer will issue a recall notice on its own after the discovery of a manufacturing defect or voluntarily recall the drug after receiving notice from the FDA.
However, in extreme cases, the FDA has the right to force a recall by going to court to require the manufacturer to recall the drug. The FDA could, in extreme cases, obtain legal authority to seize the drug itself.
FDA Monitoring of Drugs in the United States
Congress empowered the FDA to ensure that drugs, vaccines, and medical devices remain safe for public consumption. A specific FDA agency known as the Center for Drug Evaluation and Research will evaluate medications placed on the market to determine if they remain effective and safe for consumption.
The FDA then approves drugs after careful analysis and allows manufacturers to place them into the marketplace. If a consumer has issues with a drug, they can report any adverse side effects or complications through the MedWatch program.
Understanding Drug Recalls
Recalls of drugs occur when the FDA determines that a medication is unsafe and dangerous for consumers, and the drug company must immediately remove it from the marketplace. Some of the reasons that the FDA will issue a recall notice include:
- It has dangerous side effects
- A safer alternative to the drug exists
- Consumers could misuse the drug, causing severe injury or death
In some cases, a manufacturing defect or contamination caused a specific batch of a drug otherwise safe for human consumption under ordinary conditions to become unsafe. The FDA will only force a recall of that batch.
Types of Drug Recalls
The FDA has different categories of drug recalls depending on the amount of danger posed by the pharmaceutical drug:
- Class I: Use of the drug could cause severe injury or death.
- Class II: Use of the drug could cause either temporary or permanent health issues.
- Class III: Use of the drug is not likely to cause any serious health consequences.
- Market withdrawal: Typically arises from an issue with tampering after manufacturing and not a problem with the drug itself.
How the FDA Recalls a Drug
A drug recall can occur in three different ways:
- The manufacturer initiates a recall on its own, which is the most common form of recall after discovering a danger with the drug.
- The FDA discovers a challenge or danger with the drug and requests that the drug manufacturer voluntarily recalls it.
- The FDA forces a recall when the manufacturer refuses to issue a recall of the drug. In this case, the FDA may go to court to force the manufacturer to recall the drug, or in extreme cases, obtain legal authority to seize the drug.
In most cases, the FDA does not force a recall as a manufacturer will willingly recall a dangerous or defective drug from the marketplace to avoid any other consumers suffering injuries or fatalities.
How Consumers Discover if a Drug Is Under Recall
If you believe that you suffered ill effects from a drug and want to determine if the FDA or the manufacturer has issued a recall notice, consider the following sources:
- You might receive direct notification from the drug manufacturer.
- You might visit the Recalls, Market Withdrawals and Safety Alerts section of the FDA website.
- The FDA issues weekly Enforcement Reports.
- Media websites that report when a drug receives either a voluntary or mandatory recall notice.
What to Do if You Suffer Injuries from a Drug
If you suffered injuries because of injuries from a drug, make sure to follow these steps.
Seek Medical Attention
The most crucial step to take if you suffered any drug injuries is to seek immediate medical attention. Some injuries may remain minor, while other injuries may not present severe or life-threatening symptoms until later. At any point that you feel you have any injuries resulting from a drug, you should seek medical attention and evaluation from a qualified healthcare provider.
Consider a Product Liability Claim
If you suffer injuries because of a defective drug, you might have the legal right to pursue a product liability case against a drug manufacturer, the pharmacy that stocked the medicine, and other parties.
Product liability claims arise when a consumer suffers an injury because of a manufacturer placing an unsafe or dangerous product into the stream of commerce. Bringing a product liability claim can prove legally challenging and complicated. You might want to consider how a product injury attorney could help you file a claim and receive compensation for your injuries and losses.
Learn More About How a Product Liability Lawyer Can Help
If the FDA issues a recall regarding a drug, and you discover that you suffered either past or current injuries resulting from the drug, you might have the right to move forward with a legal claim depending on the facts and circumstances.
Whether the FDA actually forced a recall of the drug or the manufacturer did so voluntarily, you might have the legal right to pursue compensation if you suffered any injury or harm resulting from a defectively manufactured or designed pharmaceutical drug.
You could consider visiting with the legal team at Ben Crump Law, PLLC, by calling (800) 959-1444 today. We can explain your rights to pursue justice and receive compensation for your injuries and losses. An award could include lost income resulting from an inability to return to work, loss of enjoyment of life, pain and suffering, medical bills, or even additional compensation if it appears you could die due to your injuries related to a defective drug.