Not Accepting Cases

EpiPen Lawsuits

People who are suing the manufacturer of EpiPen and EpiPen Jr devices claim a defective part prevented them from working as intended, resulting in hospitalization, emergency room visits and death.

Lawsuits have been in the works since manufacturer Meridian Medical Technologies recalled more than 80,000 EpiPen and EpiPen Jr devices in March 2017. Leading up to the recall, there had been hundreds of reports that the devices had failed or malfunctioned resulting in life-threatening emergencies.

By the end of 2017, the FDA had received 720 reports of complications involving EpiPens, according to the FAERS Public Dashboard. That was more than double the number of the previous year and accounts for more than a quarter of all EpiPen complications reported since 1993.

The complications included more than 200 hospitalizations and at least seven deaths, Bloomberg reported.

Lawsuits Claim EpiPens Failed in Life-and-Death Situations

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. They claim the defective EpiPens were on the market from 2010 through March 2017.

Pharmaceutical company Mylan N.V. had redesigned the device in 2009 — two years after it acquired the rights to it. Mylan N.V. contracted Meridian Medical Technologies, a Pfizer Inc. subsidiary, to manufacture the product. In the years since the redesign, reports of complications filed with the FDA 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.

Companies named in EpiPen lawsuits:
Meridian Medical Technologies
EpiPen Manufacturer
Pfizer Inc.
Meridian’s parent company
Mylan N.V.
Marketer and owner of EpiPen’s rights

FDA Warning: EpiPen Maker Failed to Investigate Problems

In September 2017, the FDA accused of Meridian Medical Technologies of failing to properly investigate hundreds of claims about malfunctions and failures.

The FDA sent the manufacturer a warning letter on Sept. 5, 2017, citing “significant violations” of federal regulations.

“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.”

Source: 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 continuing 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.”

Packaging Problem Could Cause EpiPen Failure, Health Canada Says

In September 2018, Canada’s health regulator warned that a packaging problem with some EpiPens could delay or prevent quick emergency treatment. Health Canada warned that the labels on some of the devices were not applied properly. This could cause them to remain stuck in their tubes.

The affected devices had an expiration date between April 2018 and October 2019.

Pfizer Canada said there was no need to issue a recall. The company said patients should check to see that they can remove the EpiPen from its carrier tube before an emergency happens. The company said it should only affect a small number of devices. But it did not specify exactly how many.

The problem is not believed to affect EpiPens sold in the U.S.

Mylan Agrees to $465 Million Settlement over Prices

In August 2017, Mylan agreed to a $465 million settlement in a whistleblower lawsuit. The U.S. Justice Department and several states claimed the company overcharged Medicaid for EpiPens. As part of the settlement, Mylan did not have to admit any wrongdoing.

The settlement came as Mylan faced growing complaints about skyrocketing price hikes for EpiPens. Between 2007 and 2016, Mylan increased the price of a two-pack of EpiPens from less than $100 to more than $600.

By 2017, there were five class action lawsuits over EpiPen pricing. In August 2017, a federal panel closed all five and transferred the cases to U.S. District Court for the District of Kansas as part of a new multidistrict litigation (MDL). The Kansas MDL does not deal with injuries from malfunctioning EpiPens but with claims Mylan manipulated prices that hurt consumers.

The companies sought to have the MDL dismissed, but in August 2018, the judge allowed the action to go forward on many of the plaintiffs’ claims. As of September 2018, there were six lawsuits in MDL-2785: EpiPen Marketing, Sales Practices and Antitrust Litigation.

Please seek the advice of a medical professional before making health care decisions.

Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Medically Reviewed By
Dr. Joseph Palermo
Dr. Joseph Palermo Osteopathic Medicine

14 Cited Research Articles

  1. U.S. District Court, District of Kansas. (2018, August 20). In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation; Memorandum and Order. Retrieved from http://www.ksd.uscourts.gov/wp-content/uploads/2018/09/17-2785-Doc.-896.pdf
  2. Bell, J. (2018, August 21). EpiPen Class Action Lawsuit Against Mylan, Pfizer to Continue, Judge Rules. Biopharma Dive. Retrieved from https://www.biopharmadive.com/news/epipen-class-action-lawsuit-against-mylan-pfizer-to-continue-judge-rules/530600/
  3. Health Canada. (2018, September 28). EpiPen and EpiPen Jr Auto-Injectors May Stick in Their Carrier Tube. Recalls and Safety Alerts. Retrieved from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67860a-eng.php#you-vous
  4. U.S. Food and Drug Administration. (2018, March 28). FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm
  5. U.S. Department of Justice. (2017, August 17). Mylan Agrees to Pay $465 Million to Resolve False Claims Act Liability for Underpaying EpiPen Rebates. Retrieved from https://www.justice.gov/opa/pr/mylan-agrees-pay-465-million-resolve-false-claims-act-liability-underpaying-epipen-rebates
  6. Edney, A. (2017, November 3). EpiPen Failures Cited in Seven Deaths this Year, FDA Files Show. Bloomberg. Retrieved from https://www.bloomberg.com/news/articles/2017-11-02/epipen-failures-cited-in-seven-deaths-this-year-fda-files-show
  7. U.S. Food and Drug Administration. (2017, September 5). Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17; Warning Letter. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  8. U.S. Food and Drug Administration. (2016, May 2). Inspections, Compliance, Enforcement, and Criminal Investigations; 4-1 – Warning Letters. Retrieved from https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm#SUB4-1-1
  9. Palmer, E. (2017, September 7). FDA Slams Pfizer Unit Responsible for EpiPens that Failed During Fatal Emergencies. FiercePharma. Retrieved from https://www.fiercepharma.com/pharma/fda-slams-pfizer-unit-made-epipens-failed-during-fatal-emergencies
  10. U.S. Judicial Panel on Multidistrict Litigation. (2017, August 3). In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2785-Initial_Transfer-07-17.pdf
  11. Raymond, N. (2017, August 17). Mylan, U.S. Finalize $465 Million EpiPen Settlement. Reuters. Retrieved from https://www.reuters.com/article/us-mylan-epipen/mylan-u-s-finalize-465-million-epipen-settlement-idUSKCN1AX1RW
  12. U.S. Food and Drug Administration. (2017, December 31). FDA Adverse Events Reporting System (FAERS) Public Dashboard. Retrieved from https://fis.fda.gov/sense/app/777e9f4d-0cf8-448e-8068-f564c31baa25
  13. U.S. Food and Drug Administration. (2018, June 30). FDA Adverse Events Reporting System (FAERS) Public Dashboard; Search for EpiPen and EpiPen Jr. Retrieved from https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis
  14. U.S. Judicial Panel on Multidistrict Litigation. (2018, September 17). MDL Statistics Report. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-September-17-2018.pdf
View All Sources
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(888) 645-1617

To contact Drugwatch Managing Editor Kevin Connolly, call (855) 839-9780.