An EpiPen lawsuit may be an option for people who experienced a reaction and suffered serious complications after the auto-injectors failed to fire. EpiPen and EpiPen Jr products are designed to provide life-saving epinephrine in the event of a serious allergic reaction, such as anaphylaxis. If an auto-injector fails operate as expected, patients could experience serious health consequences, including death. Affected patients and their families may be eligible to pursue compensation for damages with the help of a defective medical device attorney.
If you or a loved one purchased an EpiPen manufactured by Meridian Medical Technologies, Inc., contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
What is an EpiPen?
EpiPen and EpiPen Jr auto-injectors contain epinephrine, a synthetic version of adrenaline, and are most commonly used for the emergency treatment of severe allergic reactions caused by foods, insect bites or stings, medicines, or other substances. The pen-like devices are manufactured by Meridian Medical Technologies, Inc. and sold by Mylan, an American global generic and specialty pharmaceuticals company.
The devices were approved by the U.S. Food and Drug Administration (FDA) in 1987 and are one of the most popular epinephrine auto-injector on the market. According to the manufacturer’s website, epinephrine works by constricting “blood vessels to increase blood pressure, relaxes smooth muscles in the lungs to reduce wheezing and improve breathing, stimulates the heart (increases heart rate) and works to reduce hives and swelling that may occur around the face and lips.”
EpiPen Auto-Injector Warnings
On September 5, 2017, the FDA issued a warning letter to Meridian Medical Technologies, Inc. for reportedly failing to address known malfunctions in its epinephrine auto-injectors even after hundreds of customers complained about the devices.
According to the agency’s letter, some of those failures were linked to patient deaths after EpiPen and EpiPen products failed to operate in life-threatening situations.
The FDA’s letter went on to say that Meridian’s own records indicate that the manufacturer received 171 complaints between 2014 and 2017 for “products that failed to activate when the patient followed the proper sequence.” According to the FDA, Meridian reportedly “identified a defect in one of the critical components used to manufacture” the products and “confirmed the same or similar component defect as the root cause for multiple complaints.” However, the company failed to remove potentially defective products from the marketplace.
EpiPen Auto-Injector Risks
Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties.
Other serious risks associated with EpiPen and EpiPen Jr may include:
- Arrhythmias, including fatal ventricular fibrillation
- Angina, especially in patients with coronary heart disease
- Rare cases of stress cardiomyopathy
- Gas gangrene, a type of bacterial infection, when injected into the buttocks
Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Likewise, adverse events that occur as a result of accidental injections can include increased heart rate; local reactions including injection site pallor; coldness and hypoesthesia; or bruising, bleeding, discoloration, erythema, or skeletal injury at the injection site.
EpiPen Side Auto-Injector Side Effects
Common side effects may include:
- Fast, irregular or pounding heartbeat
- Feelings of nervousness or anxiety
- Nausea or vomiting
- Difficulty breathing
In some cases, patients who have used the devices may experience infections at the injection site within a few days of an injection. Symptoms of a serious infection may include redness, swelling and tenderness.
On March 31, 2017, the FDA issued a press announcement alerting consumers of a voluntary recall initiated by Meridian concerning 13 lots of EpiPen and EpiPen Jr auto-injectors. According to the FDA, a potentially defective part could keep the recalled auto-injectors from activating, possibly leading to serious patient risks if a severe allergic reaction is left untreated.
Recalled products were reportedly manufactured and distributed between December 17, 2015 and July 1, 2016. Although the number of reported failures has been low, the FDA encourages consumers to keep and use their current EpiPens if needed until they have been replaced. If a device fails to activate, patients are advised to seek medical help immediately.
Lauren A. on May 16, 2016
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EpiPen Class Action Lawsuit Claims
In addition to potential device failure, an EpiPen class action lawsuit filed in November 2016 in California claimed that Mylan, the owner of the EpiPen devices, committed price gouging. According to the lawsuit, Mylan’s unfair increase in the price of EpiPens potentially leaves thousands of California children and adults at risk of death because they are not able to afford the cost of the auto-injectors. Before Mylan acquired the EpiPen in 2007, the auto-injector was priced at $57 per injector. Mylan now charges over $600 per two-pack after having raised the price 15 times in just seven years.
How an EpiPen Lawsuit Attorney Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a medical device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by defective a EpiPen or EpiPen auto-injector may be eligible to recover money for:
Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.