EpiPen is probably one of the most important medical innovations of our time. It allows for a person suffering from an allergic reaction to treat themselves quickly and prevent the catastrophic consequences of not receiving timely treatment. This has saved lives worldwide, but could you imagine the chaos that could be caused if such a trusted medical device did not function when it was used? Recently, severe allergy suffers have had to face the results of an EpiPen failure, and now the FDA is doing something about it.
IF YOUR EPIPEN FAILS
When faced with an allergic reaction, patients are instructed to use their epinephrine auto-injectors (EpiPen) and call for immediate medical assistance. However, many emergency medical crews have shown up to those calls and found that some of these patients have either received the wrong dosage or no dose of the lifesaving drug. The malfunction was traced to an EpiPen component the Food and Drug Administration has labeled (b)(4) and how the manufacturers of the EpiPen have handled this defect has startled the administration.
Meridian Medical Technologies, a Pfizer subsidiary contracted by EpiPen owners Mylan, manufactures this important medical device. This company is in charge of making sure the product is manufactured properly, and that all defects are rooted. However, after receiving hundreds of complaints, the manufacturer failed to adequately investigate the product failures or even halt production.
This was discovered by FDA inspectors during an inspection that lasted from February 20th to March 24th. During this inspection, not only were auto-injector failures discovered, it was discovered the Meridian knew about the defects. According to the FDA, the manufacturer failed to identify the scope or cause of the (b)(4) component failure, nor did it review all its investigations, which left some defect complaints unlinked to the specific product defect.
After negotiating a recall with Meridian in March, the FDA would later send a warning letter to the manufacturer in September to demand that the EpiPen maker clean up its act. But this comes as little comfort to the families who have lost loved ones do to this apparent lack of foresight. The FDA just recently cited EpiPen failures in at least seven deaths this year.
This means families need to be particularly sensitive about whether their EpiPen injectors are ready for action. And for those who may have already fallen victim to any defects that could be in this product, contacting a lawyer may be a necessary to keep others from falling victim to this possible negligence of duty.