FDA Drug Recalls

Feb 18, 2016 | Defective Drugs, Medical Malpractice, Person Injury, Product Liability

Drug recalls that are initiated by the U.S. Food and Drug Administration (FDA) happen all of the time. Unfortunately, that usually means that someone – or several people – suffered from side effects or dangerous results due to the drug that was recalled. If you live in Oklahoma City and have suffered injuries from a drug that was recalled, or if you realize you have taken a recalled drug, you should contact an Oklahoma personal injury lawyer to find out if you can file a lawsuit.

The FDA’s Role in Monitoring Drug Safety

While not all drug recalls are initiated by the FDA, the administration plays a key role in drug recalls and monitoring drug safety. Medicines are tested rigorously for efficacy and safety before they can be put on the market for consumers. After drugs are put on the market, manufacturers have to work with the FDA to monitor any unforeseen concerns or issues with the medicines.

When Are Drugs Recalled?

When a pharmaceutical drug is deemed unsafe, the FDA or the drug manufacturer has a duty to remove that drug from the market. A recall is initiated when a drug has been found to be too dangerous for consumers who are taking it. The drug may have caused serious side effects, there might be a safer alternative for the drug, or a consumer’s unauthorized or improper use of the drug may have resulted in serious injury or death. Contamination or error in manufacturing can cause a specific batch to be recalled, as well.
There are three ways a drug can be recalled:

  •      Recall is initiated by the manufacturer.
  •      FDA requests the manufacturer recall the drug voluntarily.
  •      FDA orders the recall by the manufacturer.

When a drug has been recalled, the manufacturer and the FDA will notify consumers via direct notification, public notification, or media coverage.

Types of Product Recalls

Recalls are classified by the severity of danger the drug poses to consumers. Here are the classifications, listed most severe first:

  •      Class I recall – the probability is reasonable that a consumer will suffer serious health problems or death if they use or are exposed to the drug.
  •      Class II recall – use or exposure to drug may cause temporary health problems or health problems that are medically reversible. Remote risk the drug will cause serious health problems.
  •      Class III recall – exposure or use is not likely to cause negative health consequences.
  •      Market withdrawal – drug has minor problem not normally monitored by FDA. (i.e. post manufacturing tampering)
  •      Medical device safety alert – medical device poses unreasonable risk of substantial harm to user.

What to Do If You Are Injured

If the use of a pharmaceutical or an over-the-counter medication has harmed you, you should immediately report it to your doctor and the FDA. You should also contact an Oklahoma personal injury lawyer, as you may be able to file a product liability lawsuit against the manufacturer of the drug. To contact the Robles Law Firm, you can call 405-232-7980.