Defective EpiPens Cited in Deaths of at Least 7 Americans So Far in 2017
Bloomberg News recently submitted a Freedom of Information Act (FOIA) request with the FDA for information about deaths associated in any way with the
. The cases at the FDA are self-reported by patients and doctors, which means that it's a conservative estimate that probably under-counts the problem.
Bloomberg obtained data of EpiPen failures generally (with and without deaths), and the trend isn't good . While there were just four failures of EpiPens reported in 2012, those numbers jumped to 12 failures in 2013 and 67 failures in 2014. As of mid-September, the FDA has received a whopping 228 reports of EpiPens failing to work as intended in 2017. Of the 228 EpiPen failures so far this year, thirty-five people were hospitalized and seven people died.
Mylan, the maker of the EpiPen, would prefer not to take any substantial portion of the blame. The notoriously confrontational drug company has said that it's "confident in the quality, safety and efficacy of EpiPens" but seemed to have a tough-shit attitude about the news that people are dying while trying to use the product.
"One needs to keep in mind that an anaphylaxis event can be deadly and, sadly, even an appropriately administered dose of epinephrine from a fully functional device may not prevent a patient from dying," Mylan told Bloomberg News in a statement. "We have not identified any causal connection between any reported patient deaths and Mylan's epinephrine auto injector products."
Yeah, that sounds like the Mylan we all know and loathe.
The problem with the FDA reports obtained by Bloomberg is that they don't specify precisely how the EpiPens failed, nor do they directly say that the failure of the EpiPens to work was the direct cause of death. Strangely, this leaves consumers without any information about what they can do to protect themselves.
Did the people who died use the EpiPen incorrectly? Is there anything that consumers can do to make sure that their EpiPens work when they're needed most? Gizmodo has reached out to both the FDA and Mylan for comment and will update this post if we hear back.
Mylan has had one scandal after another over the past few years. First, the company jacked up the price of the product from $57 in 2007 to roughly $600 in 2016 and had to testify in front of Congress about why the company was participating in price gouging. Then the CEO lied to Congress about how much profit the company was making on each EpiPen . Then the company was exposed for over-charging the government by $1.27 billion . Then Mylan had to issue a worldwide recall for the EpiPen in March because the product wasn't working as intended .
And Mylan's response to consumers and the government about its price gouging has quite literally been go fuck yourself . America's regulatory agencies are clearly broken and drug companies like Mylan can do whatever the hell they want and only get slapped with a fine here or there.
I wish I had better advice for people with serious allergies who are worried about whether their EpiPen will work, but both the FDA and the drug companies seem to have just three words for you: Good luck, sucker.
[ Bloomberg ]