The Goldberg Law Firm

legal help nationwide

icon888.637.6463toll free

Email: [email protected]

EpiPen Failures Linked To Seven Deaths

EpiPens are a staple in school nurse rooms, the purses and pockets of concerned parents, and anywhere where those who have life-threatening allergies can access them. Even though the drug, an injectable form of hormone epinephrine (adrenaline), has long been used to treat severe—and even deadly—allergic reactions, the company behind it has come under fire recently, as the device has reportedly failed to deploy appropriately.

The U.S. Food and Drug Administration received some 228 reports of failures surrounding the EpiPen and EpiPen Jr. devices in the first nine and a half months of this year, according to a recent article by Bloomberg, alleging seven deaths and 35 hospitalizations. 

A previous recall

EpiPens are produced by Pfizer Inc.’s Meridian Medical Technologies for the company Mylan, which actually sells the product. In March, Pfizer instituted a recall of some pens for a similar issue with the deployment. Though the defect was labeled as rare, reports of malfunctions have increased exponentially this year, according to data released via a Freedom of Information Act request.

Pfizer, however, dismisses the complains, saying in a statement that they often occur in situations in which a medical device is used by a non-medically trained person.

What’s the current issue?

The FDA reports don’t detail the EpiPen’s specific failures, though a recent letter from investigators of a plant that produced the devices showed that, in some cases, epinephrine had leaked out of the pens, while injectors didn’t work properly on others.

Mylan has come under fire in recent months for raising the price of the pen, as well as making changes which some competitors view as cosmetic, but which nevertheless allows the company to protect thte device from competition by generic device makers until 2025.  

No Comments

Leave a comment
Comment Information

Awards & Recognition

Badges Badges Badges Badges Badges Badges Badges

The Goldberg Law Firm Co., LPA | 31300 Solon Road, Suite 12, | Solon, OH 44139 | Phone: 888-637-6463 | Maps & Directions