A new investigation from Business Insider found that a division of the medical industry giant Pfizer, Meridian Medical Technologies, has been receiving complaints about defective EpiPens as far back as 2013. Patients reportedly told the manufacturer that their product was hard to activate or activated before they could be used, were often leaky upon delivery, and frequently arrived with bent needles and solution that appeared to be the wrong color.
Inspectors from the U.S. Food and Drug Admiration, or FDA, admonished the company for failing to investigate patient complaints in 2014. Despite this warning from the FDA, Meridian Medical Technologies failed to change its investigation system for 3 years, until they issued a voluntary recall in April of 2017, withdrawing 260,000 EpiPens from market because of a defective part called the “Power Pak,” which was made by a third-party company. Several months later, the FDA sent another warning to Meridian, urging them to investigate reports of products failures.
EpiPen complaints from users in the U.R. rose 13% from 2012 to 2013. Meridian also recieved more reports of patients suffering serious side effects during that time, with the total going up from 3 in 2010 to almost 50 in 2013. This is in addition to the 200 complaints EpiPen users submitted regarding defective products between 2014 and 2017. In 2016, two EpiPen complaints were made about the Power Pak specifically. According to the FDA, the company also did not set a “meaningful” cap on acceptable manufacturing defects. Meridian’s investigations also not link issues with the product to the company’s manufacturing process, despite the FDA reporting that as many as 4,432 unites made during this period were found to be defective.
"You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness," the FDA claimed in its correspondence with Meridian in September 2017. "You 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 agency also stated.” Meridian’s struggle to change its manufacturing process following its self-issued recall and the FDA’s most recent warning resulted in a subsequent shortage of EpiPens which patients suffered from throughout 2018.
This is not the only controversy surrounding the EpiPen in recent years. The drug-maker Mylan raised the price of the product by over 500% in 2016, charging more than $600 for two devices, effectively pricing some patients who require EpiPens out of being able to afford them.
EpiPends are essential medical devices for individuals with severe allergies, who require the epinephrine they provide to stop allergic reactions. For 25 years, the EpiPen has been the top-prescribed allergic-reaction treatment product in the U.S., with roughly 3 million Americans using EpiPens today. These Americans are among the roughly 5% of U.S. children and 4% of U.S. adults affected by food allergies. EpiPens are also used to treat those who suffer serious allergic reactions from bee stings or insect bites.
When the Medical Establishment is Negligent, We Hold Them Accountable
At Bertram & Graf, L.L.C. our Kansas City defective medical device attorneys believe no one should suffer because a product they need to survive fails to work. We take product liability seriously, and are committed to facing the medical establishment in court if necessary. From dangerous drugs to misdiagnosis cases, we have the experience and the knowledge in this field to fight for you. If you have recently suffered an injury or health problem due to a defective EpiPen or other medical product, don’t be afraid to seek compensation. Contact the firm of Bertram & Graf, L.L.C., and hire a lawyer who will never stop advocating for you.
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