Class Action Claims Mylan, Pfizer Manipulated EpiPen Expiration Dates to Increase Sales [UPDATE]

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A proposed class action alleges the makers of EpiPen have intentionally manipulated expiration dates in order to force consumers to refill their prescriptions for the potentially life-saving device more often.

According to the case out of Kansas, defendants Mylan N.V.; Mylan Specialty L.P.; Pfizer, Inc.; and Meridian Medical Technologies, Inc. have artificially shortened the EpiPen’s shelf life while aggressively pushing a misleading marketing campaign designed to encourage consumers to replace their EpiPens every 12 months in line with the “back to school” retail season. The suit says that in truth, the EpiPen’s shelf life is far longer than merely one calendar year.

The 47-page complaint begins by explaining that the EpiPen, an epinephrine autoinjector device used to treat severe allergic reactions known as anaphylaxis, was originally released with a 27-month shelf life. In 2001, the suit says, EpiPen manufacturer and Pfizer subsidiary Meridian submitted to the FDA a supplemental new drug application (sNDA) in which the company proposed that EpiPen’s shelf life be reduced to 20 months. Nowhere in the sNDA or its supporting studies did the company cite “any reason or justification at all” for the 25-percent shelf life reduction, the lawsuit alleges.

The case claims EpiPen’s shelf life was further reduced to 18 months sometime between 2001 and 2016. It was during this time frame, the lawsuit says, that Meridian and Mylan, which markets and sells EpiPens in the U.S., began communicating the 18-month shelf life to doctors and patients and marking such on the products’ packaging.

In August 2018, however, EpiPen’s expiration dates were extended by four months in response to an epinephrine injector shortage that fell during the “back to school” retail season, the suit says. In response to the shortage, the defendants allegedly produced data in support of a 22- or potentially 24-month shelf life, which the case avers was contrary to earlier representations but in line with the companies’ desire to beat out competitors and take advantage of the boom in sales.

“In other words,” the complaint reads, “EpiPens appear to suddenly have a longer shelf life when it serves Defendants’ interests.”

The lawsuit alleges that the EpiPen’s seemingly mercurial shelf life was motivated not by internal data and studies but by the companies’ desire to increase revenue at the expense of customers. The plaintiff states in the lawsuit that the vast majority of EpiPens purchased by consumers—“somewhere well above 95%”—are never used, as the device is intended for rare, life-threatening allergic emergencies. Therefore, the case argues, most consumers only purchase new EpiPens when the old ones are about to expire. In essence, a reduction in the length of time before the product reaches its expiration date would force customers to buy EpiPens more often and in turn line the defendants’ pockets, the suit alleges.

As the complaint puts it, “Defendants were motivated to put profits and revenue ahead of lives and medicine.”

In reality, the suit says, EpiPen’s expiration date is “much longer than 12 months.” Citing several studies, the case alleges that EpiPens have been known to retain effective doses of epinephrine “well beyond their expiration dates,” and can even provide a beneficial pharmacologic response up to 50 months beyond expiration. The suit claims this evidence “strongly supports” a shelf life longer than the 18-month timeframe pushed by Mylan and Pfizer.

Emphasized in the complaint is the fact that the price of EpiPens has skyrocketed since Mylan first acquired the brand, rising from $93.88 per two-pack in 2007 to $608.61 in 2016. The lawsuit notes that Mylan and its CEO have been under fire over the alleged price-gouging, which has become the subject of multiple class action lawsuits. 

The case claims that by deceiving patients into replacing the life-saving medication before it was truly necessary, the defendants have “extracted hundreds of millions of dollars of excess profits every year, year after year, for over the last decade.”