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EpiPen Lawsuits

Device failure may have caused hundreds of deaths

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Epipen risks

The Quick Facts
  • Epinephrine autoinjectors like EpiPen treat extreme allergic reactions
  • 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
1. What are the new 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.

2. 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.

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 WARNING STATS

EPIPEN FAILURES REPORTED TO FDA - 171 REPORTS
ESTIMATED ACTUAL NUMBER OF DEVICE FAILURES - 1,700
AMOUNT PAID TO SETTLE DOJ EPIPEN LAWSUIT - $465 MILLION
ANNUAL SALES OF EPIPEN FOR MYLAN - $1.6 BILLION
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The Timeline

EpiPen Failure Litigation Update
5
sep 2017

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.

3
apr 2017

Federal Class action lawsuit filed in Washington state alleges Mylan conspired with pharmacy benefit management companies to establish a monopoly and overcharge patients.

31
mar 2017

Mylan agrees to recall a total of 13 lots of EpiPens, only after urged to do so by the FDA.

20
feb 2017

FDA begins on-site inspection of EpiPen manufacturing plant due to concerns over device failure

1
oct 2016

Mylan pays $465 million to settle lawsuit from the Department of Justice over fraudulent rebates paid to states under the Medicaid Drug Rebate Program.

6
sep 2016

Lawsuit filed in Ohio alleges Mylan’s price increases for EpiPens violates consumer protection laws.

23
aug 2016

Federal lawsuit filed in Michigan claims that Mylan’s fraudulently markets EpiPen in pairs to increase profits, not for health reasons.

1
may 2016

Mylan raises price of EpiPen to $609.

28
apr 2016

Failed EpiPen device returned to manufacturer has similar defect as February 2016 lots, but company claims the problem is “infrequent.”

1
feb 2016

Manufacturer first identifies EpiPen defect that may cause failure to deliver dose, but only rejects two lots from supplier.

1
may 2015

Mylan raises price of EpiPens to $461

1
jul 2013

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

What to Know before Finding an EpiPen Lawyer

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.

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.