EpiPen is one of the most commonly used and purchased allergy products on the market. It delivers a dose of epinephrine to individuals having an acute and often severe allergic reaction. Such intervention often saves lives, but for some, their EpiPen did not respond when they needed it the most. Worse yet, the company that produces these injectables may not have properly responded once it was told about the possible defect.
Did a Manufacturer Ignore Defective EpiPen Lots?
Back in 2016, Meridian Medical Technologies—a division of Pfizer and manufacturer of EpiPen—made an important discovery. A critical component of the EpiPen auto-injector malfunctioned during testing of a sample unit. This led to the rejection of two lots of that component from its manufacturer. However, this didn’t stop Meridian from continuing production on the EpiPen line.
Several months later, the Food and Drug Administration conducted an inspection of Meridian’s Missouri factory. Its inspectors discovered the failed component and rejected sample lots, but they also discovered something more disturbing. Over 100 complaints that the EpiPen auto-injector had failed to operate in emergency situations.
What Did the FDA Do About Its Discovery?
After examining the facts, the government agency found that Meridian’s oversight and control of manufacture were inadequate. This led to Meridian launching a recall of potentially defective units, and the FDA issued a warning letter. The letter outlines how the company failed to properly investigate complaints about EpiPen, and how the company missed associating these complaints with the defects discovered back in 2016.
Meridian responded by saying that complaints about EpiPen were not unusual considering non-medically trained individuals often used the devices. Yet the FDA still identified records of problems dating back all the way to 2014. The agency has now demanded the company submit plans to improve its complaint investigation and quality assurance techniques.
When a product is found to be defective, it is the responsibility of a manufacturer to do something about the potential defect immediately. If that company does nothing, the consequences can be deadly. This is why anyone who was hurt by a pharmaceutical needs to contact a medication liability lawyer immediately. Cases like this can be complex to prove, and an attorney with proven experience is often the best option for those who have been harmed.