EpiPens Malfunction Implicated In deaths. For those who suffer from severe allergies, the EpiPen is a miracle device. EpiPens are loaded with epinephrine (adrenaline), which is delivered through a needle after the device is pushed against an individual’s leg. The epinephrine stops anaphylaxis. EpiPens are quite common, with nearly 4 million prescriptions fulfilled in 2016.
In 2014, a 3-year-old named Charlie took a swig of milk from his friend’s sippy cup. His mother, Paulette, watched in horror, unable to get to her son before he swallowed the milk. Charlie has a life-threatening milk allergy. Paulette grabbed the EpiPen and slammed it into Charlie’s thigh. However, when she removed the EpiPen, the needle was protruding strangely-it looked crooked. After administering the medication, the needle is supposed to be under a protective cover. Paulette rushed Charlie to a nearby hospital, just to be safe. Doctors observed him for a few hours, and he was released.
Paulette commented, “He was okay, but it was nerve-wracking, to say the least, not knowing if the EpiPen had worked or not.”
Sadly, not all have been as fortunate as Charlie.
By the middle of September of 2017, seven deaths were blamed on failed EpiPens, according to reports submitted to the United States Food and Drug Administration. In total, 228 reports of EpiPen failures were submitted. Some of the failures also occurred in EpiPen Jr. devices. Approximately 35 individuals had to be hospitalized due to the EpiPen failures.
EpiPens have been a hot news topic in recent months. Mylan sells the EpiPen. In 2016, Mylan received a great deal of backlash after it announced tremendous price increases on EpiPens-from around $50 for one device to over $600 for a set of two.
Congress conducted hearings on the matter, and several government agencies launched investigations. Additionally, Mylan’s competitor, Sanofi, sued the company, arguing that Mylan was trying to “preserve the monopoly position of their $1 billion crown jewel” by using anti-competitive measures.
In March of 2017, some units of EpiPen and EpiPen Jr. were recalled, after failures were reported. The recall was initiated by Meridian Medical Technologies, which produces the pen that encases the epinephrine. Mylan commented that the issue was an “extremely rare” defect.
However, consumers have reported EpiPen issues to the FDA for several years. For example, in 2012, four reports were submitted, and 12 were submitted in 2013. In 2014, the number of reports shot up to 67.
These reports are known as adverse event complaints. The reports do not prove that the device is entirely to blame for any adverse incidents. However, the reports do not show the true nature of an issue, since many people do not even know that these types of reports can be submitted to the FDA.
Meridian’s parent company is Pfizer. Pfizer previously released a statement, explaining that complaints are not atypical when a device “is frequently administered by non-medically trained individuals.” It later added that it was “confident in the quality, safety, and efficacy of EpiPens manufactured by” Meridian. It continued, “In the case of EpiPen, adverse events can also be due to epinephrine itself, for a variety of reasons as reflected in the product label.”
Mylan commented it is “confident in the safety [of the EpiPen] being produced at Pfizer’s manufacturing site. Testing and analysis across lots impacted by the recall have not identified any units with a defect.”
The FDA reports do not clarify how the devices failed. The FDA sent investigators to one of Meridian’s plants to examine the products. In a warning letter, the FDA noted that some of the injectors had malfunctioned and that epinephrine trickled out of some of the EpiPens.
The FDA has commented, “We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto-injector. We have seen circumstances in which adverse event reports increase once a safety issue is publicized, like a recall. We continue to monitor and investigate the adverse event reports we receive.”
Survival Technology originally developed the auto-injector. Survival Technology now operates as Meridian. Originally, the device was used to deliver lidocaine in those who suffered from irregular heartbeats. The United States military reached out to Survival about implementing it to provide treatments for those who had endured chemical warfare attacks, and astronauts were interested in using it for nutrition.
In 2007, Mylan purchased the rights to market and sold EpiPen from Merck KGaA. Meridian has been the sole manufacturer of the auto-injector device for Mylan.
In the last few years, the design of the EpiPen has changed. For example, the orange cap-where the needle should go after administration has been changed. Mylan commented that the changes in the EpiPen are primarily for functionality and safety. However, until 2025, the updates also mean that companies interested in making a generic device cannot do so.
component and product failures
The FDA’s warning letter added that Meridian only began the recall after being urged to do so by government agencies. Inspectors reported that the company “failed to thoroughly investigate multiple serious component and product failures…including failures associated with patient deaths and severe illness.” The letter did not note how many people had been injured by EpiPen malfunctions, or how many had died.
Still, the FDA had received 105 reports of device failures in 2016. Diana Zuckerman, the president of the National Center for Health Research, commented, “This is a lifesaving product. If it fails 105 times, that’s significant.”
What happens if a medical device does not work the way it is supposed to?
If a medical device fails and injures a patient, the manufacturer may be liable for damages.
Medical device failure falls under the realm of products liability claims. In a products liability claim, a consumer alleges that a defect in a product has caused injuries.
There are three primary types of defects that may result in a products liability claim:
- Design defects, in which the way the product was designed is the root of the problem;
- Manufacturing defects, in which an error in the product’s assembly is the issue; and
- Marketing defects, in which the product’s labeling or packaging fails to warn of potentially dangerous outcomes suitably.
A products liability case may allege one, two, or all three defects.
What types of evidence are used in medical device products liability claims?
In a single products liability claim, some different types of evidence may be submitted, including:
- Medical records
- Medical bills
- Employer records that demonstrate lost wages
- Expert medical reports
- Internal company records from the medical device manufacturer
- Witness statements
- Video footage
- Advertising materials
Other types of evidence may also be used, depending on the nature of the claim.
To maximize your recovery, it is wise to seek the assistance of an experienced EpiPen Lawsuit Lawyer as promptly as possible. Your Parker Waichman LLP attorney will ensure that your legal rights are fully protected throughout your claim.