Certain products are regulated by the U.S. Food and Drug Administration (FDA), and when a problem materializes regarding those products, the FDA takes action to ensure consumer safety. One action taken is known as an FDA recall, where the FDA prompts the manufacturer to recall a defective product. A person injured by the same product might think that a recall is proof of liability and, thus, file a product liability lawsuit in Texas to recover compensation. Unfortunately, it is not as easy or simple as the process may suggest.
What is an FDA Recall?
The FDA protects the public health of Americans through FDA recalls. This protection is done by monitoring food, drugs, biological products, and medical devices to ensure they are safe and effective to use. The FDA's scope includes a range of products including:
- medications (for both humans and animals)
- blood-related products
- radiation-emitting products
- animal feed
If a product violates a law or rule administered by the FDA and poses a threat to public health, the agency will recommend the manufacturer recall it. The FDA rarely issues recalls itself. The manufacturer typically does the recall on a voluntary basis, with the FDA's assistance.
What Injuries Are Caused by Products Recalled by the FDA?
FDA recalls apply to defective products that may result in injury or death. The FDA has scope over a wide variety of products, so there is a range of injuries or health problems FDA recall products can cause.
Some examples of injuries caused by FDA recalled products include:
- Allergic reactions
- Nausea and vomiting
- Injuries from a car accident
- Brain injuries
- Death, in extreme cases
The FDA classifies recalls into three categories, depending on their risk level.
FDA Recall Classification
Class I recalls are the most urgent and usually relate to defective products that may cause severe injury or death.
Class II recalls apply to products that may cause a short-term health issue or have a small chance of causing a serious problem. Most FDA recalls are Class II.
Class III recalls are the least serious and apply to products with minor defects unlikely to cause injury or death.
Can I Sue in Texas for an Injury Caused by a Recalled Product?
You don't have an automatic right to sue simply because the FDA has issued or prompted a recall.
However, if you've been injured or a loved one has died as a result of an FDA recall product, then you may be able to file a product liability claim. You generally need to show that
- The product was defective, and
- The defect caused the injury and subsequent losses.
You can show that the product was defective in part by using the recall, but you will need additional evidence to prove the defect and to link the defect to the injury. For this, you can use evidence like photos, videos, layperson testimony, and expert testimony, among other forms of evidence.
Likewise, a manufacturer cannot use a recall as an automatic defense to a product liability claim. To defeat a product liability lawsuit, a manufacturer must prove that the recall was communicated directly to you and sufficiently warned you of the dangers associated with using the product.
What to Do if Injured by a Product in San Antonio?
If you've been injured by an FDA recall product, you should immediately seek medical assistance.
Take care to preserve any necessary evidence in the event you want to later file a product liability claim. This includes your medical records and the product itself, where it's safe to do so (although be sure to keep it securely, so that others won't use it).
You should then speak to a personal injury lawyer experienced in product liability cases. They can advise you as to whether you have a basis for a product liability case and the next steps to preserve the product and other evidence.