An EpiPen lawsuit was recently filed against Myeplis, a medical supply company that produces the EpiPen, an emergency treatment for allergic reactions including anaphylactic shock. Myeplis does not sell the EpiPen directly to individuals but rather through a distribution system called “The Retardant Distribution System”. The distributor sells the EpiPens to pharmacies and doctors. A list of frequently asked questions about Myeplis’ product is also posted on their official website. One question that most customers ask is whether or not it is safe to take the EpiPens within the span of three hours of having an allergic reaction.
Myeplis was notified by the FDA (Food and Drug Administration) in July of this year that they have to formally certify that they provide the product to patients within three hours of having an allergic reaction.
This type of notifications is formal enough that they have to include a reference to a previous case in which a similar situation occurred, and again, the details of that case cannot be disclosed for obvious reasons of confidentiality. The formal notice itself tells the customer that they have to file a lawsuit within three years if they do not want the FDA to remove the product from stores. They also tell the customer that Myeplis will lose its Class-Action status if they are not formally certified. A Class-Action suit is when one person tries to represent a group of people similarly to the plaintiff in a lawsuit in which that person gets a settlement. So the basic concept of the lawsuit is if one person feels bad because a prescription medicine their doctor gave them caused them to have an allergic reaction, the whole class is entitled to monetary damages because their medical condition was caused by the defendant’s negligence.
So why did Myeplis fail to formally certify the EpiPen?
Some speculate that they didn’t want to put the class-action lawsuit in jeopardy; others think that the company simply didn’t feel comfortable enough with the FDA’s response to formally certify the product. Either way, the company has now officially acknowledged that the recall of the EpiPen was technically improper. They’ve also promised to make changes so that this type of product isn’t the cause of a potentially faulty product. Although the official recall isn’t out until next year at the earliest, the new warning letter can make sure that next time a consumer wants to get a hold of the EpiPen, it won’t be a problem.