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FDA Issues Warning Letter Over EpiPen Post-Marketing Problems

In a warning letter sent to Pfizer Inc., the Food and Drug Administration (FDA) threatened potential legal action over their negligent manufacturing of the emergency allergy treatment, EpiPen. The letter was drafted due to violations of “good manufacturing practices” at Pfizer manufacturing plants in Missouri between February and March of 2017. However, there are many more underlying issues, according to the letter. Pfizer subsidiary, Meridian, had been ignoring complaints about the functionality of the device. Their inaction had led to a number of serious injuries and deaths, although the exact number was not specified.

The pens’ distributor, Mylan, is the company that came under fire recently for unnecessarily hiking the price of the EpiPen six-fold.

The FDA’s initial interest in Pfizer was peaked in early 2016. Meridian found that a crucial component of the EpiPen, the portion that delivers the antihistamine, was defective. In some cases, the drug would leak out of the pen, rendering it useless. Other times, the drug simply would not inject properly or at all. The company continued to manufacture the same, flawed product while they were investigating the issue. They would later have to recall 260,000 EpiPens in the March of 2017 after being pressured to do so by the FDA.

Not surprisingly, both Meridian and the FDA received complaints during the period of this investigation concerning the drug not administering properly. Meridian dismissed these because they felt they were infrequent and, therefore, did not require attention. Pfizer also stated that “…it’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals”.

Between 2014 and 2017, the company received 171 complaints of improper injection, but they investigated “very few” of the claims and disassembled just as many potentially-broken product samples. Meridian did not offer an explanation for this inaction.

The letter was sent to Pfizer on September 5th. They must have a plan to address safety risks fifteen days from when the letter was sent. Not doing so could lead to legal action and other adverse consequences.

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Our experienced Wyoming personal injury lawyer, Jason E. Ochs will fight to help you recover proper compensation in a class action, pharmaceutical, and medical cases throughout multiple states. Contact us today.

Jason E. Ochs

Jason began his legal career in 2002 with a national multi-district litigation law firm in Newport Beach, California. There he worked on a variety of high-profile, complex-litigation projects including pharmaceutical and medical-device litigation across the country.

The Ochs Law Firm epitomizes professionalism and commitment to all of our clients, regardless of the size of the case or the might of the Defendant. We practice in Wyoming, Colorado, Kansas and California in personal injury litigation, medical malpractice, defective products, class action lawsuits, Qui Tam lawsuits, litigation across multiple districts, bad faith insurance, and civil litigation.

We look forward to providing top quality service and representation for you and your family.