EpiPen Lawsuits

Certain EpiPens and EpiPen Jrs were recalled by the manufacturer due to possible defects. This recall is critical. These devices are intended to provide lifesaving medicine in case of a severe allergic reaction. If they do not work properly, you could be severely injured or even die.

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Weitz & Luxenberg Attorneys Can Help You Investigate Your Defective EpiPen Claim

EpiPens and EpiPen Jrs can make the difference between life and death during a serious allergy attack. These devices contain epinephrine, which can help reverse life-threatening allergic responses, such as anaphylaxis. In worst-case scenarios, anaphylaxis can result in death.

Patients and their loved ones need to be confident that EpiPens and EpiPens Jrs will work when needed.

If you or your child was injured or required hospitalization because you believe that your EpiPen or EpiPen Jr malfunctioned, please feel free to contact Weitz & Luxenberg now. Our experienced attorneys may be able to help you.

We are currently investigating cases in which people required emergency room admission, were hospitalized, or died because their EpiPen or EpiPen Jr failed to work properly.

Certain Defective EpiPen Lots Recalled

The manufacturers, Mylan and Meridian Medical Technologies (the latter a Pfizer company), have voluntarily recalled 13 lots of EpiPens and EpiPen Jrs after receiving hundreds of complaints of EpiPen products failing to work properly in life-threatening allergic reactions. Mylan and Meridian Medical Technologies issued the recall at the end of March 2017.(1) (2) (3) (4)

A faulty component in the device “may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all.”(5)

If your EpiPen or EpiPen Jr came from one of the following lots and you or a loved one was severely injured requiring emergency room admission or hospitalization or resulting in death due to an EpiPen or EpiPen Jr failure to operate correctly, you may be entitled to file an EpiPen lawsuit.

Recalled EpiPen Lot Numbers
  • 5GM631
  • 5GM640
  • 6GM082
  • 6GM072
  • 6GM081
  • 6GM088
  • 6GM199
  • 6GM091
  • 6GM198
  • 6GM087
Recalled EpiPen Jr Lot Numbers
  • 5GN767
  • 5GN773
  • 6GN215

If an EpiPen or EpiPen Jr failed and your loved one died due to this failure, we urge you to contact us. We may be able to seek compensation from the manufacturers on your behalf.

“The manufacturers’ actions are incomprehensible. EpiPens are intended to save lives, and people must be able to rely on this medication when they are experiencing a severe allergic reaction,” said Paul Pennock, chair of W&L’s Defective Drug & Medical Device practice group.

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epipen 2-pak

What Is an EpiPen?

EpiPens and EpiPen Jrs are medications with auto-injector devices used to deliver the medication intramuscularly or subcutaneously. They contain a premeasured dosage of the prescription medication epinephrine. Epinephrine is a hormone (also called adrenaline) that can be used to treat serious or life-threatening allergic reactions.(6) (7)

Doctors may prescribe EpiPens or EpiPen Jrs to patients with severe allergies. Examples of potentially life-threatening allergies include insect bites or stings, and food allergies, such as nuts or eggs.(8)

Sometimes a patient with a severe reaction to an allergen may experience a life-threatening response known as anaphylaxis or go into anaphylactic shock. This response may occur within seconds or minutes of being exposed to an allergen.(9)

Signs of anaphylactic shock may include:(10) (11)

  • Hives and itchy skin
  • Flushed or pale skin
  • Low blood pressure
  • Tightening or constriction of airways
  • Swollen tongue or throat
  • Slurred speech
  • Wheezing and difficulty breathing
  • Weak, rapid pulse
  • Palpitations
  • Nausea, vomiting, or diarrhea
  • Dizziness or fainting
  • Unconsciousness

Anaphylaxis is an emergency. The Mayo Clinic instructs people not to “wait to see if the symptoms go away.” It notes if you are carrying “an epinephrine autoinjector (EpiPen), administer it right away.”(12)

According to Brown University, “Epinephrine is the only medicine that relieves all the signs and symptoms of anaphylaxis. It is most effective when it is given promptly, before symptoms become severe.”(13)

Some EpiPens and EpiPen Jrs Are Defective

At the end of March 2017, the U.S. Food and Drug Administration (FDA) and manufacturers notified the public about 13 lots of defective EpiPens and EpiPen Jrs. The manufacturers, Mylan and Meridian Medical Technologies, voluntarily recalled these defective devices.(14) (15)

At the end of March 2017, the U.S. Food and Drug Administration (FDA) and manufacturers notified the public about 13 lots of defective EpiPens and EpiPen Jrs.

This recall was initiated because these EpiPen products may contain a defective part. That defect may result in the devices’ failure to activate.(16)

A Pfizer company, Meridian Medical Technologies, and Mylan Specialty manufactured the defective EpiPen and EpiPen Jr lots. Mylan Specialty distributed them.(17)

According to the product label, “consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.”(18)

The recalled EpiPen and EpiPen Jr lots were distributed between December 17, 2015, and July 1, 2016.(19)

FDA Sends Warning Letter About EpiPen Product Violations

On September 5, 2017, the FDA sent a warning letter to Meridian Medical Technologies. In the letter, the FDA identified “significant violations of current good manufacturing practice (CGMP) requirements” regarding the company’s EpiPens and EpiPen Jrs.(20)

The FDA then instructed Meridian Medical Technologies to correct those violations.(21)

The FDA inspected Meridian Medical Technologies’ manufacturing facility from February 20 to March 24, 2017. The agency concluded that the company’s “methods, facilities, or controls for manufacturing, processing, packing, or holding” did not meet current good manufacturing practice requirements.(22)

The FDA also found that the company’s “combination products are adulterated…” referring to their EpiPen and EpiPen Jr products. These products are composed of both the drug epinephrine and the device, the part that delivers the drug.(23) (24)

EpiPen Products Failure to Activate

A defective EpiPen or EpiPen Jr might not work when needed due to a defect causing failure to activate.(25)

Another serious problem is that some EpiPens have activated spontaneously or leaked out without patients knowing. Then, the medicine was not available for use when the patient needed it.(26) (27)

According to the FDA, Meridian Medical Technologies, a company owned by pharmaceutical giant Pfizer, “failed to thoroughly investigate multiple serious component and product failures” for its EpiPen products. In fact, this negligence on the company’s part occurred even though failed EpiPen products were known by the company to be “associated with patient deaths and severe illness.”(28)

The FDA also noted in its warning letter that Meridian Medical Technologies, Inc. “also failed to expand the scope of [its] investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.”(29)

Hundreds of Complaints Linked with EpiPen Products

In its warning letter, the FDA noted that Meridian Medical Technologies, Inc. received hundreds of complaints regarding failure of its EpiPen and EpiPen Jr products. Consumers reported their EpiPen products had not activated or had activated with difficulty during life-threatening emergencies in spite of patients following the proper sequence of administration.(30)

According to some complaints, patients died because their EpiPen products failed to operate properly.(31)

To make matters even worse, Meridian Medical Technologies did not initiate a recall right away. Instead, the FDA had to discuss its concerns with the company numerous times. In the meantime, the company continued to make EpiPens and EpiPen Jrs until the FDA finished its inspection and investigation.(32)

FDA States Concerns About EpiPens

The FDA also stated in its warning letter that Meridian Medical Technologies, Inc. did not remove “potentially defective products from the marketplace” even though the company had “identified a defect in one of the critical components used to manufacture these products and even though [it] ultimately confirmed the same or similar component defect as the root cause for multiple complaints.”(33)

In one example, the FDA noted the company identified a failing EpiPen part from an auto-injector component in a sample from one lot of the devices. The FDA called attention to the fact that if that part is broken, the auto-injector may not work correctly and deliver the right amount of epinephrine. Although Meridian Medical Technologies rejected that lot and one other, the company did not bother to look for other possibly defective units in associated lots. Instead, the company continued to make EpiPens using that same potentially defective part, even though it “instructed [its] supplier to undertake a full investigation and corrective actions regarding the firing defect…”(34)

In addition, according to the FDA, Meridian Medical Technologies received hundreds of complaints about its EpiPen devices. The company knew there were problems regarding EpiPen product failures. People reported that their EpiPens had failed to work during life-threatening emergencies.(35)

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In some cases, patients had subsequently died due to failure of their EpiPen products. Instead of thoroughly investigating these complaints, Meridian continued to make potentially defective EpiPens and EpiPen Jrs.(36)

Company Continued to Distribute Potentially Defective EpiPens

In some cases, patients had subsequently died due to failure of their EpiPen products. Instead of thoroughly investigating these complaints, Meridian continued to make potentially defective EpiPens and EpiPen Jrs.(36)

In another instance, Meridian Medical Technologies received a complaint about an EpiPen that failed to activate. According to the FDA, the company investigated this complaint and found the defective part that prevented the auto-injector from working.(37)

The FDA noted, “This was the same type of manufacturing defect … you confirmed” months earlier. Even then, Meridian Medical Technologies “concluded that the defect was infrequent, even though [it] had not examined all of [its] reserve samples to determine the extent of the defect within the same lot of finished products, nor did [it] expand [its] investigation to other lots.” It also failed to determine if this defect was linked to previously rejected lots, even though its supplier’s investigation was still ongoing. Instead, the company “closed [its] investigation and determined that ‘no market action would be taken.’”(38)

The FDA also noted that while the company “eventually expanded the scope of the investigation into affected product lots and recalled all 13 lots distributed to the United States containing potentially deformed (b)(4), you did so only after our inspection closed and after multiple discussions with FDA.”(39)

Ultimately, the FDA told Meridian Medical Technologies to promptly correct the numerous violations that were cited in its warning letter. Otherwise, it noted legal action “without further notice including, without limitation, seizure and injunction” against the company might be necessary.(40)

EpiPens

EpiPen Agrees to Pay $465 Million

Manufacturing defects are not the only issue that the federal government has had with the companies that make and distribute EpiPens.

Mylan, a manufacturer of EpiPens, has agreed to pay the federal government $465 million. The company resolved claims that “it overcharged the government for its EpiPen emergency allergy treatment…”(41)

The settlement with the Justice Department involved “claims that Mylan misclassified the EpiPen as a generic product” rather than a brand-name product, underpaying rebates to state Medicaid programs as a result.(42)

According to the U.S. Department of Health and Human Services’ Office of Inspector General, the federal government “may have overpaid for EpiPens by as much as $1.27 billion between 2006 and 2016.”(43)

EpiPen Prices on the Rise

According to The New York Times, EpiPen prices have been climbing for a decade. Back in 2007, “pharmacies paid less than $100 for a two-pen set.” Two years later, the cost was $103.50 for a set.(44)

Just four years later, the cost had more than doubled to $264.50. Then, by May 2015, the cost jumped by 75% to $461. Just one year later, the price climbed to $608.61.(45)

Those prices are what a pharmacy pays. What consumers pay varies considerably. The difference in what people pay varies based on their health insurance coverage and formulary plans.(46)

Those with high deductibles and consumers without health insurance may be paying more than $600 a set. Even patients with good health insurance policies have said “their copayments are as much as four times higher than in the past.”(47)

  1. U.S. Food & Drug Administration. (2017, March 31). News & Events. FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm
  2. U.S. Food & Drug Administration. (2017, March 31). Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector. Retrieved from https://www.fda.gov/safety/recalls/ucm550173.htm
  3. WebMD. (2017, April 1). Global EpiPen Recall Now Includes U.S. Retrieved from https://www.webmd.com/allergies/news/20170401/epipen-us-recall
  4. U.S. Food & Drug Administration. (2017, September 5). Inspections, Compliance, Enforcement, and Criminal Investigations. Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  5. WebMD. (2017, April 1). Global EpiPen Recall Now Includes U.S. Retrieved from https://www.webmd.com/allergies/news/20170401/epipen-us-recall
  6. Meridian Medical Technologies. Highlights of Prescribing Information. (2017, April). EPIPEN® (epinephrine injection, USP), Auto-Injector 0.3 mg, EPIPEN Jr® (epinephrine injection, USP) Auto-Injector 0.15 mg. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019430s067lbl.pdf
  7. Edney, A. (2017, November 2). EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show. Retrieved from https://www.bloomberg.com/news/articles/2017-11-02/epipen-failures-cited-in-seven-deaths-this-year-fda-files-show
  8. Meridian Medical Technologies. Highlights of Prescribing Information. (2017, April). EPIPEN® (epinephrine injection, USP), Auto-Injector 0.3 mg, EPIPEN Jr® (epinephrine injection, USP) Auto-Injector 0.15 mg. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019430s067lbl.pdf
  9. Mayo Clinic. (2017, February 14). Anaphylaxis. Retrieved from https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468
  10. Ibid.
  11. MedlinePlus. (2016, March 20). Anaphylaxis. Retrieved from https://medlineplus.gov/ency/article/000844.htm
  12. Mayo Clinic. (2017, February 14). Anaphylaxis. Retrieved from https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468
  13. Brown University. (2014, September). Anaphylaxis treatment and prevention. Patient Education Series. Retrieved from https://www.brown.edu/campus-life/health/services/sites/brown.edu.campus-life.health.services/files/Anaphylaxis%20tx%20and%20prev%2014.pdf
  14. U.S. Food & Drug Administration. (2017, March 31). FDA News Release. FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm
  15. U.S. Food & Drug Administration. (2017, March 31). Mylan Provides Update on Meridian Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector. Retrieved from https://www.fda.gov/safety/recalls/ucm550173.htm
  16. Ibid.
  17. Ibid.
  18. Ibid.
  19. Ibid.
  20. U.S. Food & Drug Administration. (2017, September 5). Drugs. FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm575245.htm
  21. U.S. Food & Drug Administration. (2017, September 5). Inspections, Compliance, Enforcement, and Criminal Investigations. Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  22. Ibid.
  23. Ibid.
  24. U.S. Food & Drug Administration. (2017, July 25). About Combination Products. Retrieved from https://www.fda.gov/CombinationProducts/AboutCombinationProducts/default.htm
  25. U.S. Food & Drug Administration. (2017, September 5). Inspections, Compliance, Enforcement, and Criminal Investigations. Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  26. Ibid.
  27. Edney, A. (2017, November 2). EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show. Retrieved from https://www.bloomberg.com/news/articles/2017-11-02/epipen-failures-cited-in-seven-deaths-this-year-fda-files-show
  28. U.S. Food & Drug Administration. (2017, September 5). Inspections, Compliance, Enforcement, and Criminal Investigations. Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  29. Ibid.
  30. Ibid.
  31. Thomas, K. (2017, September 7). F.D.A. Accuses EpiPen Maker of Failing to Investigate Malfunctions. Retrieved from https://www.nytimes.com/2017/09/07/health/epipen-fda-malfunction.html
  32. U.S. Food & Drug Administration. (2017, September 5). Inspections, Compliance, Enforcement, and Criminal Investigations. Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm
  33. Ibid
  34. Ibid.
  35. Ibid.
  36. Ibid.
  37. Ibid.
  38. Ibid.
  39. Ibid.
  40. Ibid.
  41. CNBC. (2017, August 17). Mylan finalizes $465 million EpiPen settlement with Justice Department. Retrieved from https://www.cnbc.com/2017/08/17/mylan-finalizes-465-million-epipen-settlement-with-justice-department.html
  42. Ibid.
  43. Ibid.
  44. Parker-Pope, T. & Peachman, R.R. (2016, August 22). EpiPen Price Rise Sparks Concern for Allergy Sufferers. Retrieved from https://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/
  45. Ibid.
  46. Ibid.
  47. Ibid.

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