FDA Issues Warning about Malfunctioning EpiPens

On March 24, 2020, the FDA issued a warning alerting patients, caregivers, and health professionals that the auto-injectors in the EpiPen 0.3mg and the EpiPen Jr. 0.15mg, and the authorized generic versions, may have injection problems that can cause serious injury or death due to delayed treatment.

EpiPens combine medicine, generally epinephrine, into a medical device. Epinephrine acts on the whole body to shut down allergic responses by constricting the blood vessels, leading to increased blood pressure, and decreased swelling. This allows the muscles around the airways to relax, causing the lungs to open. Epinephrine also prevents the release of more allergic chemicals, which stops the progression of the allergic response. People with severe allergic reactions often carry around an EpiPen, as a life saving device if they are exposed to certain substances to which they are vulnerable.

In its warning, the FDA explained that the EpiPen 0.3mg and the EpiPen Jr. 0.15mg, which are made by Pfizer and distributed by Mylan, may contain various defects that result in delayed injection or improper injection. The FDA reported issues with the blue safety release on some of the pens, causing the device to activate prematurely, and issues with sliding the pen out of its carrier tube, due to deformation of the tube. Both of these issues could result in a patient not receiving medication at a moment when it could be lifesaving.

The attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner have been fighting for the rights of people injured by defective products for decades. If you or someone you know has been severely injured because an EpiPen did not function properly or by any other defective product, contact the experienced attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner at (713) 222-7211 or toll free at 713-222-7211.