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FDA: Pfizer and Mylan EpiPens & EpiPen Jrs Prove to Cause Serious Harm

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While the purpose of medical devices is to prevent injury and save lives, mistakes continue to be made, and patients become hurt. On Tuesday, March 24, the Food and Drug Administration let out a swift warning that the EpiPen 0.03mg (epinephrine auto-injector) and EpiPen Jr 0.15mg are malfunctioning and causing serious problems that could cause death and injuries to users. EpiPens are emergency devices used to stop or delay severe allergic reactions from things like foods and insect bites in both children and adults. It’s a popular brand used by families especially because the device has become widely accepted and standard throughout U.S. schools. When in use, EpiPens are forced against the thigh of the user and meant to automatically inject the hormone epinephrine to stop a dangerous allergic reaction.

The FDA issued the warning after global biopharmaceutical companies Pfizer and Mylan spoke with medical providers reporting malfunction issues with the device could cause death or serious injuries to their patients. Pfizer is the manufacturer of the EpiPens in question, and Mylan is the company selling them. It’s estimated that EpiPens impact the lives of 15 million U.S. patients (6 million kids and 9 million adults) each year.

What is Malfunctioning?

The FDA report says the EpiPen and EpiPen Jr malfunctions may prevent or delay the device from injecting the drug or cause them to eject it prematurely. Some users reported having trouble getting the EpiPen out of its carrier tube in time because of a defect. The problems were also found in their authorized generic versions.

For now, the FDA is only saying it is aware of patients being harmed, while Pfizer has said the problems involve “a very limited number” of devices.

EpiPens continue to be in the hot seat this decade. More recently, in 2017, when Meridian Medical Technologies voluntarily recalled several EpiPen brands for defective parts. Pfizer has struggled for a couple of years to resolve manufacturing quality problems, resulting in on-and-off shortages since 2018.

It is important for families and individuals of EpiPen users who have been injured to remember that if presented, they do not have to accept any large settlement for the injuries or deaths caused by a malfunctioning medication device. In some cases, you may need to file a lawsuit to recover any losses caused by the manufacturer’s negligence. An attorney can help guide you and provide specific advice and perspective to explain a likely and fair settlement.

Contact a Personal Injury Lawyer in Chicago

If you or someone in your family has experienced a personal injury due to a malfunctioning EpiPen or EpiPen Jr, take action and immediately contact Levin & Perconti by calling us at 877-374-1417 or 312-332-2872. A free consultation with an experienced Chicago personal injury lawyer will only help you during the recovery process.

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