Lawsuits over EpiPen and EpiPen Jr. claim the devices failed to operate as designed, resulting in hospitalization, emergency room visits and even death.
Lawsuits were filed after consumers suffered from the following conditions when an EpiPen or EpiPen Jr. failed to deploy:
Number of Lawsuits Litigation in early stages, cases still being accepted
Plaintiff Injuries Hospitalization or death after an EpiPen device malfunctioned
Defendants Meridian Medical Technologies (a Pfizer company), Mylan N.V.
Litigation Status Active
MDL Status 7 lawsuits (over pricing), U.S. District of Kansas
Class Actions None at this time
Top Settlement $465 million to settle lawsuits brought by state and federal governments over pricing
Lawsuits over EpiPen injuries have been in the works since Meridian Medical Technologies recalled more than 80,000 EpiPen and EpiPen Jr. devices in March 2017. There were hundreds of reports that the devices had failed or malfunctioned in life-threatening emergencies.
By the end of the year, the U.S. Food and Drug Administration had received 660 reports of complications involving EpiPens – more than double the number of the previous year. Reports included more than 200 hospitalizations and at least seven deaths associated with the devices. People who were hurt or who had a loved one die because of the faulty devices began filing lawsuits.
Attorneys are currently accepting cases involving injuries resulting from malfunctioning EpiPens. Litigation is still in the early stages. There have been no trials or large settlements so far.
Because there is the potential for a large number of lawsuits, lawyers for the people injured or for the companies being sued may seek to have the cases consolidated in a multidistrict litigation (MDL). MDLs allow several similar lawsuits to move more quickly and efficiently through the legal process.
Separate lawsuits over steep price hikes by EpiPen marketer Mylan N.V., have been consolidated in an MDL in Kansas.
People who were hospitalized or who had a loved one die because an EpiPen malfunctioned have filed lawsuits over the devices. They claim a defective part in the devices prevented EpiPens from working as intended.
Lawsuits Claim EpiPen Malfunctions Caused:
Emergency Room Care
EpiPens are designed to inject a precise dose of epinephrine when people experience a life-threatening allergic or asthmatic attack called anaphylaxis. Lawsuits claim that in some cases the devices either failed to deploy a needle for the necessary shot or the devices emptied the medication before it could be injected.
Lawsuits claim defective EpiPen and EpiPen Jr. devices caused injuries to people between 2010 and March 31, 2017. The devices are manufactured by Meridian Medical Technologies, a Pfizer subsidiary, for Mylan N.V.
Companies Named in EpiPen Lawsuits include:
Mylan acquired the rights to EpiPen in 2007. In 2009, the company redesigned the devices. In the years since the redesign, reports of EpiPen complications filed with the U.S. Food and Drug Administration have been significantly higher. In the 16 years before the redesign, the FDA received a total of 256 adverse event reports. In just the first two years after the redesign, there were 311 reports filed.
Lawsuits over EpiPen and EpiPen Jr injuries are in the very early stages. Attorneys are taking still taking cases. People who think they may have been injured by a defective EpiPen or EpiPen Jr may wish to talk to an attorney about their legal options.
Attorneys who specialize in drug and medical device lawsuits generally do not charge a fee for consultations. They usually do not charge any fees unless they win a case.
Lawsuits over injuries from malfunctioning EpiPens are still in the early stages. There have not been any large settlements or verdicts in those cases yet.
However, in August 2017, Mylan agreed to a $465 million settlement in a joint state and federal lawsuit filed over its pricing practices. That case was filed by the U.S. Department of Justice over rebates Mylan charged to state Medicaid programs. The government claimed Mylan misclassified EpiPen as a generic medical product, but priced it as a brand-name device.
As part of the settlement, Mylan did not have to admit any wrongdoing.
There are currently no class action lawsuits over injuries caused by EpiPens. At least five class action lawsuits over EpiPen price hikes were closed in August 2017. All the cases were transferred to U.S. District Court for the District of Kansas as part of a new MDL.
As of January 2018, there were seven lawsuits in MDL-2785: EpiPen Marketing, Sales Practices and Antitrust Litigation.
The Kansas MDL does not deal with injuries from malfunctioning EpiPens but with claims Mylan manipulated prices that hurt consumers. Between 2007 and 2016, Mylan increased the price of a two-pack of EpiPens from less than $100 to more than $600.
In September 2017, the U.S. Food and Drug Administration accused of Meridian Medical Technologies of failing to properly investigate hundreds of claims about EpiPen malfunctions and failures.
The FDA sent the Pfizer subsidiary a warning letter on September 5, 2017, citing “significant violations” of federal regulations. Warning letters are the agency’s chief means of seeking swift, voluntary compliance with federal law. They are issued “only for violations of regulatory significance.”
“Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.”
- FDA Warning Letter to Meridian, Sept. 5, 2017
The agency accused Meridian of being aware of problems with the devices for more than a year, but continued to distribute potentially defective devices.
The FDA also said it had found similar problems in a 2014 inspection of Meridian’s factory, and that the company’s response to correct them had been “inadequate.”
Please seek the advice of a medical professional before making health care decisions.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.