The Food and Drug Administration is not mincing words with Meridian Medical Technologies. This manufacturing unit of Pfizer has been contracted by Mylan to produce the ubiquitous EpiPen auto-injector, and the FDA has sent the company a warning letter. How did the manufacturer gain the administration’s attention? Is there something wrong with this major and important medical product? The answer may leave you dismayed.
Is There a Problem with Your EpiPen?
According to the FDA, this story starts back in February 2016. That’s when Meridian found a unit of EpiPen components that was not working. This particular component was responsible for delivering the proper dose of epinephrine to the user. The company rejected two lots after the discovery and started an investigation, but it also kept the manufacturing lines going during that investigation.
Later, complaints started to flood in. Consumers said that their EpiPens were failing, and some even claimed severe illness and death as a result. A May 2016 investigation into customer complaints revealed the same defect discovered in February may have been responsible. Yet officials at Meridian labeled the complaints as infrequent and avoided a recall.
How Did the FDA Discover this Problem?
When February of 2017 rolled around, the FDA sent inspectors to Meridian Medical Technologies. This inspection revealed what the administration claimed were violations of current good manufacturing practice. It also claimed that Meridian was failing to properly investigate EpiPen auto-injector failures. After the inspection ended on March 24th, Meridian recalled 13 lots of EpiPens that may have contained the defect.
Though these steps from Meridian may have been a good start, the FDA was not satisfied and sent a warning to the company. It asked for changes to the company’s procedures for handling product complaints. The administration also wants improvements to the company’s methods of quality control. But what about the people who complained about the malfunctioning pens?
There are many laws in place to help the victims of product defects such as this. To learn more, contact a product liability attorney to discuss what your legal rights if you were sickened by a medical product like Mylan’s EpiPen.