The maker of EpiPen devices failed to address known inaccuracies in its epinephrine injectors even as hundreds of customer complaints rolled in and the failures were linked to deaths, according to the Food and Drug Administration.
The allegations came to light today when the FDA filed a lawsuit a warning letter It was sent on September 5 to the manufacturer, Meridian Medical Technologies, Inc. The company (which is owned by Pfizer) produces EpiPens for Mylan, which owns the devices and is notorious for raising prices dramatically by more than 400 percent in recent years.
Auto-injectors are designed to be used during life-threatening allergic reactions to provide a rapid infusion of epinephrine. If they fail to fire, people who experience a reaction can die or suffer serious illnesses. According to the FDA, that’s exactly what happened to hundreds of consumers.
In the letter, the company wrote:
In fact, its own data shows that it received hundreds of complaints that its EpiPen products failed to work during serious emergencies, including some situations in which patients later died.
The agency continues to lambast Meridian Medical for failing to investigate problems with devices, recall bad grades, and follow up on problems found. For example, a customer complained in April 2016 that the EpiPen failed. When Meridian disassembled the machine, it found a damaged component that was causing the problem—the exact defect it had discovered in February when another unit failed.
The FDA writes:
However, on May 3, 2016, he concluded that the defect was not uncommon, although he did not examine all of his storage samples to determine the extent of the defect among many finished products, nor did he extend his investigation to another Most… He has closed his investigation and decided that “no market action will be taken.”
The agency went on to note that, during an inspection earlier this year, Meridian employees said they did not assemble the “vast majority” of failed devices that customers had sent back to them. Meridian received 171 such “complaint checks” between 2014 and 2017. But officials said they were allowed to take apart devices if “approved by management.” However Meridian notes that dissection is the only way to determine the cause of a machine failure.
Days after the inspection, Mylan recalled thousands of injections.
In a statement today, Pfizer responded to the FDA letter, saying:
Patient safety is a top priority to Pfizer. We stand behind the quality, safety, and efficacy of the products we make. We will continue to work with the FDA to resolve the points raised in the letter.
A spokesperson for Mylan told CNBCPfizer is continuing to work with the FDA to resolve the issues raised in the letter regarding Pfizer’s manufacturing of the EpiPen Auto-Injector, and Mylan will do whatever it can to support this process.” The company does not expect any EpiPen supplies because of the letter.