EpiPen Recalls & Medical Device Failure Lawsuits

FDA Warns Pfizer in Failed EpiPen Recalls and Investigates consumer hazards

The pharmaceutical company Mylan NV has recalled EpiPen and EpiPen Jr. auto-injectors distributed between December 2015 and July 2016. The United States recall followed a separate recall of about 80,000 EpiPens from the Australian market.

The U.S. Food and Drug Administration (FDA) has instructed consumers to use the recalled auto-injectors until their replacements arrive, but noted consumers should seek emergency medical help, particularly if the device does not activate.

The FDA recall was prompted by two cases outside the U.S. in which consumers had trouble activating their EpiPens. The company has said the malfunction may be due to a “potential defect in a supplier component.” The recall release statement said the recall is being driven by the potential for life-threatening risk if a severe allergic reaction goes untreated because of a failed device.

Owned by Pfizer Pharmaceuticals, Meridian Medical Technologies manufactures the EpiPen, which is distributed by Mylan. Generic versions of EpiPens were not included in this particular recall.

Joe Lyon is a highly-rated recall lawyer and product liability lawyer representing plaintiffs nationwide in Epipen recalls and a wide variety of defective medical device claims.  

Defective Mylan EpiPen Recalls

The FDA has noted repeat violations at the Pfizer-Mylan-Meridian EpiPen facility. In one instance in April, 2016, a customer reported that an EpiPen failed. When Meridian disassembled the device, it found a deformed component that led to the problem was the exact same defect it had found months before in another failed device. In a previous inspection of the Pfizer-owned medical device facility in 2014, the FDA cited similar product safety violations.

The manufacturer of EpiPen devices has failed to address known malfunctions in its epinephrine auto-injectors even as hundreds of customer complaints were received. Mylan’s own data shows they received dozens of complaints that EpiPen products failed to operate during life-threatening emergencies. According to the Food and Drug Administration, some EpiPen failures were linked to deaths.

Neither Mylan nor its parent company have released a risk analysis related to the design flaws where appropriate. Pfizer admitted that they had not reviewed or updated the risk analysis of their EpiPens since 2009. Now the records show that between 2014 and 2017, Pfizer received 171 complaints for EpiPen products that failed to activate after the patient followed the proper sequence, prompting the Epipen recalls.

The FDA responded by saying the company’s repeated failures demonstrate “inadequate” oversight and control over the manufacture of these particular products. They went on to warn, “Failure to promptly correct these violations may result in legal action.”

Failed Epinephrine Injection Devices

EpiPens and other epinephrine auto-injectors are designed to be used during life-threatening allergic reactions to provide a quick shot of epinephrine. If they fail to fire, people experiencing a severe reaction can die or suffer serious illnesses. According to the FDA, that exact scenario is what happened to hundreds of customers.

This isn’t the first time an epinephrine auto-injector has been pulled from the shelves. In 2015, Auvi-Q injectors were recalled after they failed to administer a reliable dose of epinephrine.

Epipen Defect Lawsuits

The Lyon Firm focuses on product liability and consumer protection litigation. When patients and consumers are injured by defective medical products, they can file lawsuits against the responsible parties.

If you or a loved one has suffered an injury due to a defective Mylan EpiPen, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions regarding Epipen recalls and lawsuits.