FDA links EpiPen failures with 7 deaths in 2017

Many Kentucky residents who suffer from severe allergies rely on EpiPens to deliver potentially life-saving doses of epinephrine. EpiPens are designed to administer the drug quickly and simply to stave off anaphylactic reactions, but recent media reports reveal that the Food and Drug Administration has linked the device to seven deaths during the first nine months of 2017. Malfunctioning EpiPens have also caused at least 35 people to seek hospital treatment, according to the FDA.

The FDA has reported issues with EpiPens in the past, but the problem seems to be getting worse. The FDA received four reports about EpiPen and EpiPen Jr. failures in 2012 and 12 in 2013. However, 67 reports were received in 2014. The pharmaceutical company that manufactures EpiPens says that the defect responsible for the problems is extremely rare, and they point out that higher failure rates can be expected when products like EpiPens are used by individuals with no medical training under highly stressful conditions.

The higher number of reports could also reflect the media attention that the EpiPen has been receiving. Consumers reacted angrily when the price of the devices was increased from $50 to $300 in 2016, and the FDA sent a warning letter to the maker of EpiPens in September after inspectors found epinephrine leaking out of the devices at a Missouri plant.

Manufacturers are expected to take all reasonable precautions to ensure that their products are safe. The courts treat this duty of care extremely seriously when consumers rely on products to deliver crucial medicine. Attorneys with experience in this area may know that product liability lawsuits can cause great damage to corporate reputations, and they could urge the defendants in these cases to avoid the publicity and uncertainty of a public civil trial by settling quickly and quietly.