Epipen Lawsuits

Device failure may have caused hundreds of deaths

Epinephrine auto-injectors like EpiPen treat extreme allergic reactions. EpiPen manufacturer warned by FDA of ignoring product defects.

epipen lawsuit

FDA Warnings for EpiPen

Automatic injectors like EpiPen are crucial for patients with certain allergies in times of emergency. They quickly provide a measured dose of epinephrine (adrenalin) to treat life-threatening allergic reactions like anaphylaxis until a patient can receive professional care.

The EpiPen, which has been on the market since 1987, is the overwhelming market leader in epinephrine auto-injectors. However, The FDA recently warned the manufacturer that a significant number of their products may be ineffective.

In a September 5th warning letter to the maker of EpiPen, the FDA charged that they had received hundreds of reports of the injectors failing, sometimes causing death. However, the manufacturer didn’t completely identify the defect, and didn’t recall all the affected devices. Therefore, thousands of patients may have been affected.

In short, the FDA warned that the defective EpiPens may fail to activate, fail to properly disburse the epinephrine drug, or may have spontaneously released the drug early so that none remains when it is needed.

Here are the quick facts pertaining to the current litigation:

  • EpiPen in the news after 500% price hike in recent years
  • EpiPen manufacturer warned by FDA of ignoring product defects
  • Hundreds have reported device failure; some causing death
  • 1 million EpiPens recalled in the past for ineffectiveness
  • Drug maker already paid $465 million fine for Medicaid fraud
  • Lawsuits being filed over deaths caused by EpiPen failure.
Frequently Asked Questions
1. How can EpiPen failure lead to death?

EpiPen is used primarily to treat anaphylaxis, a severe allergic reaction caused by food allergies, insect bites, stings, or medication side effects. The reaction triggered by white blood cells can present as quickly as a few minutes after exposure and can cause death if not treated.

Anaphylaxis typically causes throat or tongue swelling, rashes, shortness of breath, itching vomiting, dizziness, or low blood pressure. It affects as much as 2% of the population, and, in medical emergencies, around .3% of victims die even with hospital admittance.

For those at risk of anaphylaxis, an emergency epinephrine injection is the first line of treatment. However, when the auto-injector fails to release the necessary medication, symptoms may continue to worsen to the point where breathing ability and blood flow are affected. This can be fatal in some cases.

Those who lost a loved one due to an EpiPen failure during an allergic reaction may be entitled to substantial compensation.

2. EpiPen death lawsuits: Does your family qualify?

EpiPen is used primarily to treat anaphylaxis, a severe allergic reaction caused by food allergies, insect bites, stings, or medication side effects. The reaction triggered by white blood cells can present as quickly as a few minutes after exposure and can cause death if not treated.

Anaphylaxis typically causes throat or tongue swelling, rashes, shortness of breath, itching vomiting, dizziness, or low blood pressure. It affects as much as 2% of the population, and, in medical emergencies, around .3% of victims die even with hospital admittance.

For those at risk of anaphylaxis, an emergency epinephrine injection is the first line of treatment. However, when the auto-injector fails to release the necessary medication, symptoms may continue to worsen to the point where breathing ability and blood flow are affected. This can be fatal in some cases.

Those who lost a loved one due to an EpiPen failure during an allergic reaction may be entitled to substantial compensation.

EpiPen Lawsuit Update

Latest news on EpiPen failure litigation.

2017
Sept 5
U.S. FDA sends warning letter to maker of EpiPen charging that they ignored complaints of device failure, didn’t determine the cause, and continued selling the devices after stating the issues were isolated.
2017
Apr 3
Federal Class action lawsuit filed in Washington state alleges Mylan conspired with pharmacy benefit management companies to establish a monopoly and overcharge patients.
2017
Mar 31
Mylan agrees to recall a total of 13 lots of EpiPens, only after urged to do so by the FDA.
2017
Feb 20
FDA begins on-site inspection of EpiPen manufacturing plant due to concerns over device failure.
2016
Oct 1
Mylan pays $465 million to settle lawsuit from the Department of Justice over fraudulent rebates paid to states under the Medicaid Drug Rebate Program.
2016
Sept 6
Lawsuit filed in Ohio alleges Mylan’s price increases for EpiPens violates consumer protection laws.
2016
Aug 23
Federal lawsuit filed in Michigan claims that Mylan’s fraudulently markets EpiPen in pairs to increase profits, not for health reasons.
2016
May 1
Mylan raises price of EpiPen to $609.
2016
Apr 28
Failed EpiPen device returned to manufacturer has similar defect as February 2016 lots, but company claims the problem is “infrequent.”
2016
Feb 1
Manufacturer first identifies EpiPen defect that may cause failure to deliver dose, but only rejects two lots from supplier.
2015
May 1
Mylan raises price of EpiPens to $461.
2013
July 1
Price of EpiPens reaches $265.
2009
EpiPens are priced at around $100.
1998
Over 1 million EpiPens are recalled after they are determined to be at risk of ineffectiveness.
1987
EpiPen first approved for sale by the Food & Drug Administration.

Financial Recovery

Families of those who died after their EpiPen failed to stop an allergic reaction may be entitled to significant financial recovery due to the FDA’s claim that the maker of the devices ignored glaring signs of safety risks. However, it is important to understand the unique nature of these cases, how they are handled, and how to select the right lawyer.

Lawsuits for defective medical devices and pharmaceutical drugs typically begin in local state or federal courts around the country, but are eventually consolidated to a central location for easier handling once a certain number of claims are filed.

Free Case Review

EpiPen MDL Court

These special venues, called multidistrict litigation (MDL) courts, oversee large volume cases similar to traditional class action lawsuits, but with greater advantages for the plaintiffs (victims).

Because of this, you can select your own lawyer and maintain greater control over your individual case, while enjoying the benefits of a large group claim.

However, while most normal personal injury lawsuits are best handled by a local law firm, these cases may benefit from larger firms that specialize in MDL litigation against multi-national drug companies.

Even if your lawyer is located in a different state, they will often come to you for meetings, gather all necessary evidence, and appear on your behalf at all required court events. All at no cost to you unless you receive an award from your case.

DrugNews works only with firms that have handled thousands of defective drug and medical device MDL cases, and can put you in touch with a lawyer in minutes at no cost. Contact us today for more information or to talk about your case. 

Sources of information

Get in touch with us.

Call, email or live chat with us today to see how we can help.

Need a quick answer? Call us!
Reach out to us by email.
We are here to help now