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FDA Issues Critical Letter to EpiPen for Failure to Address Product Failures

FDA Issues Critical Letter to EpiPen for Failure to Address Product Failures

In early September 2017, the U.S. Food and Drug Administration (FDA) sent a scathing letter to Meridian Medical Technologies rebuking the company for failing to investigate and address component and product failures in its EpiPen products. The FDA cited hundreds of customer complaints that were linked to life-threatening emergencies in which the EpiPen auto-injectors failed to operate correctly. 

Meridian Medical Technologies, owned by Pfizer, manufactures the EpiPen product. EpiPen is used by people who have severe allergic reactions to peanuts, shellfish, insect bites or stings, medications, and more. The product contains a shot of epinephrine, which can reverse the effects of potentially lethal anaphylactic shock. The failure of this device in an emergency situation can result in serious injury or even death. 

The FDA investigated a Meridian Medical facility in early 2017, and found that the manufacturer failed to fully examine and research reported EpiPen defects from its customers.  Meridian only issued a recall for certain lots of the EpiPen after the FDA had investigated its facilities and after several additional interactions with the FDA. Meridian had previously performed an internal investigation but determined that the defect was infrequent and did not justify taking market action. According to the FDA letter, dated September 5, 2017, “[Meridian] failed to thoroughly investigate component and product failures for…EpiPen products, including failures associated with patient deaths and severe illness. You [Meridian] also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.” 

The EpiPen manufacturer has had increasingly bad public relations issues recently, as government officials and consumers revolted over the more than 500% price increase in the EpiPen over the past 7 years. Additionally, Meridian was hit with a $465 million settlement with the U.S. Department of Justice for overcharging Medicaid for its EpiPen devices.

Contact Our Personal Injury Attorneys Today

If you believe you were the victim of a faulty EpiPen, you should contact a personal injury lawyer familiar with pharmaceutical liability to discuss your concerns. Attorney Brett Oppenheimer, of Brett H. Oppenheimer, PLLC, will be happy to consult with you at no charge, at your earliest convenience. Our legal team will work tirelessly with you to ensure you are taken care of until your case is resolved.

You can contact Brett by filling out the contact form on this website or calling (502) 242-8877.

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