FDA Announces Voluntary Recall of Defective EpiPens
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Published on April 27, 2017
On March 31, the U.S. Food and Drug Administration (FDA) announced a manufacturer’s voluntary recall of a popular brand of auto-injector medical device – the Epipen – used to treat patients with severe allergies. This announcement came nearly two weeks after a similar recall was issued for the same devices in seven other countries. The recalls were a direct response to consumer complaints that the devices failed to operate as marketed.
Mylan Acknowledges Some EpiPen, EpiPen Jr Units May Have Defective Parts
Mylan NV sells the EpiPen and EpiPen Jr auto-injectors, which are actually manufactured by Pfizer. Both devices are designed to inject epinephrine–adrenaline–into patients who suffer from severe allergic reactions. When a patient goes into sudden anaphylactic shock, pressing the EpiPen or EpiPen Jr into the thigh is supposed to deliver an instant dose of epinephrine.
But according to news reports, Mylan admitted there have been at least two cases where the EpiPens failed to work. The company said the two affected patients “were able to use different EpiPens” and did not suffer any permanent damage. Nevertheless, Mylan issued a voluntary recall on March 20 for approximately 80,000 EpiPens sold in Australia, New Zealand, Japan, Denmark, Norway, Finland, and Iceland.
The March 31 notice extended that recall to the United States. The FDA said that at the present time, 13 specific lots of EpiPen and EpiPen Jr distributed between December 17, 2015, and July 1, 2016, were under recall. This includes devices with the following lot numbers:
Mylan claims the defective EpiPens “may contain a defective part” that prevents them from activating correctly. If that happens, the FDA warns there is a “life-threatening risk” of an improperly treated allergic reaction. Mylan is offering free replacements of any defective units. Customers can contact Mylan online or call 877-650-3494 for more information.
Have You Been Injured Due to a Defective Drug or Medical Device?
Even before these recalls, Mylan was already facing public scrutiny for its marketing of the EpiPen. Last year, the per-pen price rose more than 600 percent–from $47 to $284–and since the company only sold the EpiPen in pairs, many consumers were paying more than $600 to fill a prescription. Following a Congressional investigation, Mylan promised to “reimburse consumers for some of their out-of-pocket costs.”
Regardless of cost, drug manufacturers have a legal and moral obligation to produce safe, effective products. If you have been injured due to a defective EpiPen or any other medical device, it is important to speak with a Boston defective drug lawyer as soon as possible. Call Thornton Law Firm, LLP today at 888-341-1405 to schedule a consultation with one of our attorneys, or tell us your story here and we’ll call you to discuss your legal options..