Another Class Action Claims Cos. Manipulated Shelf Life to Force More EpiPen Refills

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Pfizer and subsidiary Meridian Medical Technologies have artificially increased the number and frequency of EpiPen purchases to force buyers to prematurely get refills of the live-saving device while many were still safe to use, a proposed class action suit alleges.

According to the 57-page complaint, Pfizer and Meridian’s fraudulent scheme has banked the companies “at least hundreds of millions of dollars” in excess EpiPen purchases “every year, year after year, for over the last decade.” 

More specifically, the lawsuit says Pfizer and Meridian, working alongside non-party Mylan N.V., have since at least 2010 manipulated expiration dates for the EpiPen, an epinephrine auto-injector used to treat anaphylaxis, and engaged in other deceptive conduct in order to force proposed class members to buy the product more often than is medically necessary. To accomplish this, the case claims, Pfizer and Meridian: 

• Put forward shorter EpiPen expiration dates unsupported by either medical literature or the studies and data provided by the companies to the FDA;
• “Aggressively” pushed consumers to buy the EpiPen in 12-month cycles in lockstep with the “back to school” retail season; and
• Commenced deceptive marketing programs to manipulate consumers and schools into buying into the companies’ false annual retail purchasing cycle. 

As the suit tells it, the defendant’s EpiPen scheme began to unravel in August 2018 after the FDA extended the shelf life of certain lots of the device and its authorized generic equivalent by four months in response to an epinephrine auto-injector shortage during the back-to-school season. The FDA made the call to extend the EpiPen’s shelf life “based on stability data provided by Mylan” and reviewed by the agency, the case says, with Pfizer and Mylan jointly announcing the extension was made “based on a careful review of product stability data provided by Pfizer.”

“In other words, EpiPens suddenly gained a longer shelf life without any changes to the product, device, or medicine,” the lawsuit summarizes. “Indeed, this extended expiration data applied to lots of already-manufactured devices, demonstrating that the existing formulation had a longer shelf life than advertised.”

The suit says the four-month extension of the EpiPen’s useful life—from 20 months to 24 months—is proof enough that Pfizer and Meridian “were (and still are) engaged in a scheme to defraud” by manipulating expiration dates. 

“If the longer expiration date was unsafe the FDA never would (or could) have approved it—temporary or otherwise,” the suit says, alleging Pfizer and Meridian “put profits and revenue ahead of lives and medicine.”

Until 2001, the EpiPen’s approved shelf life was 27 months from the date of manufacture, the lawsuit continues. In November 2001, Meridian, after submitting a new stability protocol, bumped the device’s expiration date down to 20 months after its manufacture, the case says, even though the EpiPen’s pharmaceutical ingredient remained unchanged.   

According to the complaint, Mylan N.V. is not named as a defendant despite being a member of the alleged RICO enterprise with Pfizer and Meridian. The suit says Mylan will soon merge with Pfizer and Upjohn, Pfizer’s off-patent branded and generic medicines unit. 

The lawsuit represents the latest chapter in a long string of litigation centered on allegations that the companies involved in manufacturing and selling the EpiPen, Mylan in particular, have not been forthcoming when it comes to how long the device actually lasts and when buyers should re-up their supplies.

The case looks to cover:

“All persons or entities in the United States and its territories who paid any part of the purchase price of an EpiPen refill or replacement within 36 months of the purchase date and for consumption by themselves, their families, or their members, employees, insureds, participants or beneficiaries (and not for the purpose of resale) from November 1, 2010, through and until Class Notice is given (the ‘Class Period’).”

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