FDA Raises Concerns About the Failure of EpiPens

Defective Epi Pen

In September 2017, the Food and Drug Administration wrote a letter to Pfizer, the maker of the EpiPen, stating that the company had failed to investigate claims of defective units. In several of the complaints, patients had died or become extremely ill because the EpiPen had failed to fire properly.

In the letter, the FDA said, “[Y]our own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.”

Uncertainty Over True Scope of EpiPen Failures

The letter from the FDA points to a potentially much bigger problem with the EpiPen. Because the manufacturer hasn’t conducted thorough investigations, it is unclear exactly how many people have been harmed because of faulty EpiPens. Pfizer’s response to the letter does not indicate that they are taking the matter as seriously as they should.

As quoted in the New York Times and several other news outlets, a Pfizer spokeswoman issued a statement saying the company was confident in the safety of the EpiPen, adding that “it’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.”

For watchdog groups and concerned users of the device, this response is not only inadequate, it is a strikingly cavalier statement about the potentially fatal failure of the EpiPen. The EpiPen is used to treat life-threatening allergic reactions, and the reliability of the device is essential to the safety and survival of its users.

In March, Meridian Medical Technologies expanded a voluntary recall of EpiPens, which likely prevented many faulty devices from reaching users. A spokesperson from the FDA also said that they are not aware of any defective EpiPens on the market. However, this is of little comfort to people who use an EpiPen, nor does it mean that there are no malfunctioning devices still in possession of consumers.

Concerns for Users of the EpiPen

Drug safety advocates recommend that EpiPen owners check to see if their device was covered by previous recalls and talk to doctors if they are concerned about the safety. It’s unfortunate that so many people who rely on EpiPens are being asked to do legwork that should have been done by the device’s manufacturer. For those who have already suffered harm because of a faulty EpiPen, this advice is too little, too late.

This is not the first wave of bad news for EpiPen users, who have experienced highly-publicized skyrocketing prices for the device. It was only after a public outcry over the price raise that the makers offered a more affordable, generic variety of the auto-injector.

The reputation of the EpiPen and that of its manufacturers has taken a serious hit over the past couple of years, but the harm suffered by its users significantly overshadows the problems facing Pfizer and its product.

If you or a loved one relies on the EpiPen and you’ve suffered serious harm because of a faulty device, you should explore all legal options. The defective medical device attorneys at the Louthian Law Firm offer free consultations to meet with EpiPen users and talk about their options.

Contact Bert Louthian to schedule a free consultation. Call us today at (888) 311-2873 or fill out our online contact form to get started.