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Defective EpiPens – What Victims Need to Know

Written by Berkowitz

epipen with nuts in the back round

These injector pens contain pre-measured doses of epinephrine, which is a fast-acting medication that stimulates heart function, drops blood pressure, reverses the effects of hives, and reduces swelling. It can also instantly improve a person’s breathing if they suffer from a severe reaction.

Those suffering from serious allergies will carry EpiPens with them so that if they are out or even at home and suffer a reaction, they can administer the medication immediately. The injectors are provided through prescriptions, and they are meant to save a person’s life.

Unfortunately, over the past few years, there have been defects found in these devices – and seven deaths have been caused by their defects.

What Danbury Consumers Need to Know about Defective EpiPens

Whether you have severe allergies or a loved one, you might have heard of the recalls issued after defective EpiPens caused seven deaths in 2017.

EpiPens can make the difference between life and death during these attacks, and when the EpiPen fails to administer medication, a person can suffer from catastrophic, long-term consequences – and sometimes death.

What EpiPens Were Defective?

EpiPens manufactured by Mylan and Meridian Medical Technologies were voluntarily recalled. They included 13 lots in this recall after they received several hundred complaints about the pens failing to work and stop a severe allergic reaction. The recall was issued back in March 2017.

The defect forced people to have to use increased force to get the needle to work, and in some cases, people suffering from severe reactions did not have the time to use that force to administer the medication.

Both EpiPen and EpiPen Jr in specific lots were recalled and identified as potential defects.

Anaphylactic Shock Can be Fatal

A patient with a severe allergic reaction typically suffers from a response known as anaphylaxis. The response takes seconds in some cases, which means the administration of medication immediately is the only way to save that person’s life.

Anaphylaxis is an emergency, and when any of the symptoms appear, a person should contact 9-1-1 and use their prescribed EpiPen immediately. Epinephrine is the only medication that will stop anaphylaxis and anaphylaxis shock – if it is given promptly and before symptoms advance too far.

About the 13 Defective Lots

March 2017, the U.S. Food and Drug Administration (FDA) along with the manufacturers of the pens issued a recall for 13 lots identified as defective. The recall was first initiated because the products were found to have a faulty component that made them unable to activate.

These lots were sold between December 2015 and July 2016.

The FDA issued a warning letter to the companies in September 2017. In their letter, they cited both manufacturers for their violations of good manufacturing practices and requirements. The FDA then required that the manufacturers fix these mistakes.

The FDA has thoroughly investigated both facilities. In that investigation, the FDA concluded that neither facility processed, packaged, controlled, or held those products in a manner that satisfied the good manufacturing practice requirements (CGMP).

Why Did the Pens Fail to Operate?

The pens might not have worked when used because of a defective part preventing them from activating. Some of the pens also leaked without patients realizing it, which means they did not have the medication amount or any medication in the pen when they needed it.

The FDA found that the companies failed to investigate components and product failures, including those reported to them. The FDA also cited the companies for failing to expand their investigations when allegations of defects were made against them. They only acted after the FDA’s inspection, instead of correcting the issue before it causes unnecessary harm.

Not the First Time EpiPens Have been Defective

There have been EpiPen recalls in the past. In fact, this recall is the second in a two-year span that required manufacturers to pull faulty injectors off the market. Sanofi US had to recall their Auvi-Q injectors because they delivered inaccurate doses – and some did not deliver the medication at all.

The Auvi-Q pens were reintroduced into the market after going through multiple changes in management and design. While patients use this brand, most have minimal confidence that the pens they have in their possession will use when they need them the most.

Manufacturers Refuse to Take the Blame

Sadly, Mylan has expressed that they feel their pens are safe and that the defective pens were not identified. The company claimed that the complaints were investigated by their firm and reported to the FDA as protocol requires. They also stated that there was no connection between the fatalities of their EpiPen and those reported to the FDA.

Can Patients Sue for Defective EpiPens?

People that suffered serious injuries were hospitalized, or families who lost loved ones because of defective EpiPens have started to file lawsuits. In these lawsuits, they claim that the defective devices prevented EpiPens from administering life-saving drugs as intended.

Many victims were hospitalized, and while only a few have died, those deaths are entirely preventable.

Some companies named in the recent EpiPen lawsuits include:

  • Meridian Medical Technologies
  • Pfizer, Inc.
  • Mylan N.V.

How Much Compensation Can a Victim Receive?

If a defective EpiPen injured you, whether it comes from the tainted batches of the manufacturers above or another instance, you may be entitled to compensation for those injuries. Compensation depends on the severity of the injuries and the manufacturer’s role in the defect.

Lawsuits over these types of cases are currently in the early stages – and class action lawsuits have been created for injuries caused by the defective pens from Meridian, Pfizer, and Mylan.

What is a Defective Product Lawsuit?

A defective product is any product that malfunctions while being used as it was intended originally. If the defective product causes injury to the consumer while using it, then the consumer may be entitled to compensation for their injuries.

Defective product and defective medication lawsuits use state laws, and these laws allow victims to bring lawsuits against the manufacturer and third parties involved in the distribution chain. These lawsuits can allege that the manufacturer was negligent, strict liability applies, or there was a breach of warranty.

Deciding which allegation is best depends on the situation, and often requires an attorney experienced in defective medication claims to decide.

There are three main categories of defective product claims, including:

  1. Design Defect – In the EpiPen case, this would involve a defective design with the pen itself. That means that the design of the EpiPen was flawed before manufacturing and the conception itself has the defect.
  2. Manufacturing Defect – A manufacturing defect means that the product was fine by conception but flawed during manufacturing. That could mean a faulty component or contamination issue. In the case of the EpiPen, most were manufacturing defects. There was a component during manufacturing that was faulty and led to incorrect dosage, leaks, and the pens not administering medication at all.
  3. Marketing Defect – Defective medications sometimes have nothing to do with the design or manufacturing. Instead, it means that the product was marketed wrong. The manufacturer may have left out side-effects during marketing that cause serious injury, or they could have marketed the product for a group that the product was not authorized to treat.

Who is Liable in a Defective Medication Case?

When there are defective medications or medical products, determining liability can be complicated. Often there are numerous parties involved in the production, testing, and release of these products – making it more difficult to decide who is truly liable.

It is best to consult with an attorney if a defective medication or medical product have injured you. An attorney can review the case and help determine which parties are liable.

If you believe a defective EpiPen or other medication harmed you, you need to make sure your suit follows the specific criteria required in a defective liability lawsuit, including:

  • You used the product as it was intended – including using within the expiration date posted on the product.
  • The product’s directions were followed, and all warnings on the labels and pamphlets were considered before use.

What Compensation Could You Receive?

Compensation in a defective medical product case varies. Ultimately, it comes down to the evidence, but also state laws and how much the statute allows for recovery. Some of the damages you may be entitled to include:

  • Economic Damages – Economic damages focus on medical costs, lost wages, property damage and other tangible losses that you can easily prove through copies of receipts, medical records, and statements.
  • Non-Economic Damages – These damages are reserved for non-tangible losses, such as pain, suffering, loss of companionship, and so forth.
  • Punitive Damages – You will rarely see punitive damages unless the manufacturer or a third party conducted willful or gross conduct – such as purposely tainting a medical supply or knowingly releasing a deadly drug onto the market.