Liability when a failure to investigate costs lives

Last week, the Food and Drug Administration accused the maker of EpiPens with failing to investigate device failures thoroughly. For those who depend on an EpiPen firing mechanism to work when suffering a severe allergic reaction the news is troubling.

What is the responsibility of a manufacturer? For a drug maker of a product that is crucial during life-threatening emergencies, it is high. A manufacturer or seller of a product that causes personal injury because of a defective design is strictly liable.

Numerous complaints & recalled lots

What do we know? In a letter to the company, the FDA stated, “our own data show you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.” The issue is with the trigger mechanism. When it fails to fire properly, the patient does not receive the proper dose of epinephrine.

However, earlier, this year Pfizer and Mylan recalled units for exactly this same issue – “failure to activate or increased force needed to activate” the device. The issue was related to a supplier component and testing across other potentially affected lots did not identify the defect. With a known issues could failure of quality control be an issue.

Company reaction

The company response is that reported complaints are not unusual since they have shipped more than 30 million EpiPens since 2015 and non-medically trained individuals administer the drug. The company also challenged any causal relationship between EpiPen failures and patient deaths.

For a company, with a questionable record (i.e. $465 million settlement with Justice Department for overcharging related to price increases) a simple statement of we have “an unwavering commitment to quality and patient safety” cannot be taken on face value. Oversight from the FDA is important, but civil lawsuits that hold manufacturers responsible can also ensure change occurs.

If an EpiPen failed to activate or released the wrong dose when it did activate and you or a loved one suffered a serious injury, seek legal assistance. The law provides remedies, but going up against a large corporation requires the skill of an experienced products liability attorney.