epi pen failtures

Due to advances in medicine, medical-related products from pharmaceutics to machines that assist in the diagnosis or treatment of illnesses have become essential in saving lives. One example of such a product is the Epi Pen. Designed to inject epinephrine, also known as adrenaline, into a human body, the Epi Pen is an essential medical product that can save lives of individuals who are having extreme problems breathing due to allergies to certain foods as well as to bee stings, insect venom and more.

When the drug is injected into the body, blood vessels compress causing an increase in blood pressure as muscles in the lungs relax. The result is the reduction of wheezing and improvement of breathing, increased heart rate and reduction of hives and swelling around the face and lips. According to the National Food Allergy Guidelines, the use of epinephrine is recommended as the only first treatment for an acute allergic reaction to an antigen.

The Epi Pen itself, also known as an autoinjector, includes:

  •      Four latch gears that secure a plunger
  •      A needle
  •      A loaded spring that propels the needle
  •      Adrenaline
  •      Outer cover
  •      Orange cap

When engaged, the Epi Pen’s spring-loaded needle partially exists the tip and penetrates the skin of the user to deliver medication through a process known as intramuscular injection. Once the medication has been delivered, the needle is removed from under the skin when the loaded spring pulls it back up into the pen.

History Of The Epi Pen

First approved by the Food & Drug Administration (FDA) in 1987, Epi Pen was invented by Sheldon Kaplan at Survival Technology in Bethesda, Maryland in the mid-1970s. In 1996, Survival Technology merged with Brunswick Biomedical and the new company was re-named Meridian Medical Technologies, Inc.

In 1997, Dey, a subsidiary of Merck, purchased the exclusive rights to market and distribute the Epi Pen.

In 1998, Meridian Medical Technologies called for the return of some Pens. The Epi Pen recall resulted in the return of about 1 million Pens due faulty injectors that may not have offered sufficient dosages of epinephrine.

By 2001, annual sales of the Epi Pen reached $23.9 million. Moreover, the device had achieved a market share of 75% in the United States. Perhaps as a result, King Pharmaceuticals acquired Meridian for $247.8 million in 2003.

In 2007 when Epi Pen experienced yearly sales of about $200 million and was about 90% of the market, Mylan purchased the right to market it from Merck.

As many as 4 million Epi Pens were disbursed in the United States in 2016

Epi Pen Failure

In 2017, reports started to appear concerning possible Epi Pen failure. People who used the pens claimed that the needle remained sticking out after delivery of the medication when it was supposed to return under an orange cap located inside the tip.

According to an article in Bloomberg News, the FDA received 228 reports from patients and physicians claiming that the Epi Pen or Epi Pen Jr. has failed so far this year. Seven people have allegedly died through mid-September and 35 have been hospitalized.

These failures caused Meridian Medical to recall some Epi Pens in March.

However, reports to the FDA show that there were malfunction issues going back to 2014.

The FDA reports do not describe the reason for the Epi Pen failure. However, according to Bloomberg News, in a warning letter sent out in September, FDA inspectors suggested that epinephrine had leaked out of some pens and that the injectors didn’t work properly on others. However, the FDA noted to Bloomberg News via email that it was unaware of any Epi Pen failure and suggested that consumers continue to use their prescribed pens.

Some tweaking has been performed on the Epi Pen in recent years including to the orange cap, noted Mylan, and it added that the fix improved the pen’s safety and function and helps to discourage competition from manufacturers who wish to develop a generic device.

In September, the FDA issued a warning letter that claims that Pfizer has failed to investigate reports describing malfunctions of its Epi Pens. Some of the reports apparently ignored by Pfizer said that patients had died or became “severely” sick after using a faulty pen.

Pfizer challenged the FDA letter saying that it was “very confident in the safety and efficacy of its Epi Pen products.”

Product Liability

Here at the Eichholz Law Firm, our Georgia product liability lawyers take aggressive action against insurance companies and demand justice for clients. If you or a loved one has been affected by Epi Pen failure, time is of the essence. A medical professional must be contacted as soon as possible. Following contact with a healthcare expert, Epi Pen failure victims must get in touch with the the Eichholz Law Firm.