EpiPen Malfunction Problems Involving Deaths, Severe Injuries Not Properly Investigated by Manufacturer: FDA

Hundreds of reports of problems with EpiPens went unaddressed by manufacturers, who should have issued an EpiPen recall, according to federal drug regulators. 

On September 5, the FDA issued a warning letter to Meridian Medical Technologies, Inc., a subsidiary of Pfizer, which manufactures EpiPens that are later distributed by Mylan. According to the letter, the manufacturer failed to adequately investigate 171 sample pens sent back due to malfunctions between 2014 and 2017.

The emergency allergy auto-injectors provide a critical treatment for individuals with severe allergies or asthma attacks. Many individuals carry an EpiPen at all times to inject epinephrine, a chemical that narrows blood vessels and opens the airways to the lungs, in the event they are having a serious or life-threatening allergy or asthma attack.

The pens contain epinephrine, commonly referred to as adrenaline, a hormone that can reverse severe low blood pressure and increase the heart rate, muscle strength, blood pressure, and sugar metabolism. Treatment of epinephrine can also reverse wheezing, severe skin itching, hives and various other symptoms of an allergic reaction.

“If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness,” the FDA letter states. “You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.”

The agency notes that the manufacturer received “hundreds” of complaints that the pens failed to operate during emergency situations, and in some cases consumers died as a result. The FDA inspectors noted that many of the complaints involved a failure of the auto-injectors to function, as well as complaints that they had released the medication spontaneously before they were activated.

The letter also admonishes the manufacturers for not issuing an EpiPen recall in one case, even when they identified a defect in a critical component and confirmed that it had been the cause of similar problems in numerous complaints.

The FDA has ordered the manufacturing facility to correct the problems in how it has addressed previous complaints.

The letter comes as Mylan faces a number of EpiPen lawsuits over its pricing of the auto-injector pens.

Most, if not all, of the complaints seek class action status to present claims for various groups of potential consumers who have used or need to use the injections, potentially impacting millions of Americans.

On August 3, the U.S. JPML determined that all pending and future cases should be transferred to U.S. District Judge Daniel Crabtree in the District of Kansas for coordinated pretrial proceedings as part of an EpiPen multidistrict litigation (MDL).

Mylan has been the subject of Congressional hearings, lawsuits and public ridicule and derision since it sextupled the price of the epinephrine shots after purchasing the EpiPen brand in 2007. Critics claim that Mylan is price-gouging consumers by charging $600 for a pack of two EpiPens, which cost about $100 just 10 years ago.