In a previous blog, we reported on an FDA Warning Letter that accused the manufacturer of the EpiPen, Meridian Medical Technologies, of failing to adequately investigate and handle reports of defects that caused the hand-held medical device to fail in its intended use. As the FDA reported, this defect resulted in numerous reports of patients becoming severely ill or dying after the EpiPen failed to work.
The warning letter and recall are of significant concern, as the EpiPen is a device carried by numerous people for treatment of serious allergic reactions. When patients purchase the product, they expect it to function as it is marketed when they need it most – during emergency situations.
How the EpiPen Works
As an auto-injector, the EpiPen contains epinephrine, a chemical that opens airways in the lungs and narrows blood vessels, which can reverse a number of adverse symptoms of an allergic reaction, including hives, severe skin irritation, low blood pressure, difficulty breathing, swelling of the tongue and mouth, and other life-threatening symptoms. In severe cases, symptoms may also be accompanies by chest pain, dizziness, and headaches, as well as a severe tightening of the throat and airways.
These severe and potentially life-threatening allergic reactions are known as anaphylaxis, which can occur within minutes of exposure to allergens. Additionally, roughly half of all patients who experience anaphylaxis may also experience anaphylactic shock, a condition that results from restricted blood flow to critical organs during life-threatening allergic reactions. Common allergens that can trigger anaphylaxis or anaphylactic shock include:
- Insect bites or stings
- Food allergies (i.e. peanuts or shellfish)
- Drug allergies
- Latex allergies
- Exercise-induced anaphylaxis
- Other pollutants and allergies
People who have severe allergies and a history of serious allergic reactions commonly keep epinephrine auto-injectors like the EpiPen on hand for use in emergencies. When they do experience anaphylaxis, they can administer the EpiPen as an injection into the muscle of the outer thigh. Given the fact that some allergic reactions can be severe enough as to cause serious illnesses or even death, the EpiPen can be invaluable to patients who use them during allergic reactions, as it rapidly controls symptoms and affords the time for patients to seek further treatment and observation from a medical professional.
Unfortunately, as the FDA has reported, Meridian Medical Technologies’ critical failures in investigating reports and addressing potentially hazardous defects resulted in numerous faulty EpiPens being available to the public. When those defective EpiPens failed to work when patients attempted to use them during anaphylaxis, serious injuries and death occurred.
At Spangenberg Shibley & Liber LLP, we have earned national recognition for our work handling complex and high profile cases involving serious injuries, wrongful death, and defective consumer products – including defective medical devices. Our product liability lawyers are currently reviewing cases from consumers across the nation who believe they or a loved one suffered as a result of a malfunctioning EpiPen.
To discuss your case personally with a member of our team, contact us for a FREE and confidential consultation.