As noted by the FDA, “If a person is experiencing an allergic reaction and anaphylaxis and cannot access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death.”
Those who survive despite the device failure face serious, life-altering implications.
Often, when the FDA receives several similar complaints about a product, they will begin an investigation into the product. If the complaints are valid, the manufacturer will often voluntarily recall the product, with the FDA assisting in administering the recall.
A product recall will notify consumers, who will obtain instructions on whether to stop using the product or how to get a replacement or repair to make the product safe. The company may also face legal claims from those who suffered injury or loss due to the defect.
Three types of defects can result in a product liability claim. Defects involving the product's design often affect every lot of the product produced using that design. When recalls only list certain lots of a product, a manufacturing error may have caused the defect.
If a recall involves a problem with the product's labeling—such as the failure to include instructions or disclose known risks of using the product—the product may undergo required changes to the packaging label to include that information.
Here is a look at some of the issues that can occur due to an EpiPen failure.