Just one year after a Congressional investigation regarding the skyrocketing price of EpiPen, a medical device used to treat life-threatening allergic reactions (anaphylaxis), the manufacturers of EpiPen are embroiled in yet another controversy.
On September 5, 2017, the U.S. Food and Drug Administration (FDA) sent a warning letter to the Pfizer company that manufacturers EpiPen and EpiPen, Jr. auto-injectors (Meridian Medical Technologies, Inc.), regarding “significant violations of current good manufacturing practice requirements.” [1]
The letter accuses Meridian of failing to properly investigate more than 100 complaints that the EpiPen malfunctioned during life-threatening emergencies, including situations where patients later died.
The FDA noted that Meridian received more than 171 complaints about EpiPens that failed to activate between 2014 and 2017. During this time period, distraught consumers reported that EpiPen did not function properly when needed. Meridian also received reports that injectors had spontaneously dispensed epinephrine before they were used so that the drug was no longer available when the user attempted to activate the product. Yet, despite these alarming reports and the fact that faulty EpiPens were linked to patient deaths, Meridian continued to put potentially-dangerous EpiPens on the market.
The FDA admonished Meridian in its warning letter, noting that Meridian failed to expand the scope of its investigations into these serious and life-threatening failures or take appropriate corrective actions until the FDA initiated an inspection of the facility where the devices are manufactured. The FDA concluded, “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of these products is inadequate.”
The FDA ordered Meridian to correct the violations cited in its letter and threatened legal action if Meridian fails to do so.
The potential impact of faulty EpiPens and EpiPen, Jr.’s cannot be overstated.
According to the Wall Street Journal, doctors wrote prescriptions for 3.6 million EpiPens in 2015. According to FARE (Food, Allergy, Research and Education), an estimated 15 million Americans have food allergies. [2] Studies also show that food allergies among children have jumped 50 percent in the past decade. This potentially life-threatening condition now affects 1 in 13 children under age 18. [3] Every three minutes, a food allergy reaction sends someone to the emergency room – equaling about 200,000 visits per year.
The National Institute of Allergy and Infectious Diseases recommends that the 1-2 percent of Americans who have experienced an anaphylactic reaction to anything—from food to bee stings to medications—carry two epinephrine injections at all times, replacing them yearly as they expire. [4] Epinephrine degrades quickly, so keeping EpiPens current is essential. And although competitors are coming onto the scene, EpiPen has controlled as much as 95% of the market in recent years. [5]
A severe allergic reaction (anaphylaxis) can cause shock, a sudden drop in blood pressure and trouble breathing. Anaphylaxis can occur minutes after exposure to a specific allergy-causing substance (allergen). In some cases, there may be a delayed reaction or anaphylaxis may occur without an apparent trigger. When anaphylaxis occurs, the prompt administration of epinephrine can mean the difference between life and death. Meridian’s manufacturing practices, as outlined in the FDA’s letter, are a grave concern.
Allen & Allen is accepting cases involving serious illness, injury and death resulting from faulty EpiPens and EpiPen, Jr.’s. If you or a loved one has been caused to suffered as a result of a faulty EpiPen or EpiPen, Jr., call us for a free consultation.
[1] https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
[2] https://www.foodallergy.org/
[3] https://www.washingtonpost.com/posteverything/wp/2016/08/25/epipens-save-lives-if-they-cost-too-much-kids-will-die/?utm_term=.1c7e761c5ef9
[4] https://www.niaid.nih.gov/
[5] http://fortune.com/2017/06/19/fda-mylan-epipen-adamis-symjepi/
