EpiPen maker accused of failing to investigate complaints of malfunctioning products that reportedly led to injuries and deaths

Regulators have made serious accusations that giant healthcare products manufacturer Pfizer are not investigating complaints made over alleged EpiPen device failures.

The lifesaving device contains epinephrine; a hormone that can relieve symptoms of allergic reactions, including opening airways to the lungs for easier breathing. For those who suffer from severe allergic reactions, the injection can mean life or death.

“This is a lifesaving product,” said Diana Zuckerman, president for the National Center for Health Research; but when considering if things go wrong, she said: “If it fails 105 times, that’s significant.”

Warnings issued

According to multiple sources, regulators have issued a warning letter to Pfizer for its alleged failure to investigate more than 100 complaints that the device malfunctioned when needed. A number of these complaints include situations where patients have become severely ill or died.

Between 2014 and 2017, Pfizer is accused of ignoring 171 complaints of failure.

Regulators conducted an inspection of the company and found defects including the device failing to activate during use, and leaking of the drug before use, meaning there was little or no medication left for when it was needed. Either way, failing to administer the epinephrine (also known as adrenaline) could cause a great deal of panic and risk for the patients. In the best case scenario, the patient can get to hospital or access treatment as soon as possible.

Denying blame

Pfizer are sidestepping any blame, noting that it was “not usual to receive product complaints.” They added that “we currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths.”

A regulatory spokesperson said Pfizer were reportedly aware of product defects and injuries / deaths that may be potentially linked, but failed to remove the devices from the market and disclose further information about the deaths.

One seller of the product said they are “confident in the safety and efficacy of EpiPen products being produced at the site.” Notably, this is also the company who reportedly hiked the prices of the life saving devices from $around £38.00 for a single pen to over £450 for a two pack in 2016 to apparently preserve its monopoly position in the market. Although they acknowledged the investigations, they noted that “even an appropriately administered dose of epinephrine from a fully functional device may not prevent a patient from dying.”

Deaths and complaints

Bloomberg reports that seven people have already died from EpiPen defects this year and complaints about the devices doubled since 2016. Regulators reportedly received 228 reports of the EpiPen failing from mid-September 2016. During this time, 35 people were taken to hospital.

In March, two recalls were issued and potentially defective Epipens should have been extracted from the market.

One mother described how she was faced with a bent needle after using an EpiPen on her toddler. Unsure if the drug was administered properly, she rushed to the hospital to make sure he was safe. Thankfully he was unharmed, but the mother certainly suffered a shock and a lot of distress whilst taking him to the hospital and awaiting results of his condition.