Injectafer Lawsuit (March Update) – Forbes Advisor – Forbes

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Injectafer is an intravenous infusion drug prescribed to treat iron deficiency anemia. Some patients treated with Injectafer claim that the drug caused them to develop hypophosphatemia—a condition that causes abnormally low phosphate levels and can lead to coma or death.

This article provides details on Injectafer lawsuits including why they are filed and how they are progressing.

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What Is Injectafer?

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Injectafer is prescribed for treatment of iron deficiency anemia (IDA) in adults and children over one year of age. First approved by the Federal Drug Administration (FDA) in 2013, Injectafer is administered by intravenous (IV) infusion and recommended for patients who are intolerant of oral iron supplements or who have chronic kidney disease that is not dialysis dependent.

IDA has been traditionally treated with oral iron supplements. This made Injectafer an appealing alternative for patients with an intolerance for oral iron supplements.

Injectafer can be administered in some doctor’s offices, but is most often given at an infusion center. An infusion takes approximately 15 minutes, followed by a 30-minute observation for allergic reactions.

Injectafer was produced by Vifor Pharmaceuticals (formerly known as Luitpold Pharmaceuticals) in partnership with American Regent. Vifor Pharmaceuticals is a company in the Galenica Group, while American Regent is a subsidiary of Daiichi Sankyo.


Why Are Injectafer Lawsuits Filed?

Several lawsuits have been filed by patients treated with Injectafer who have experienced hypophosphatemia (HPP). HPP is a condition that occurs when a patient experiences abnormally low phosphate levels in their blood. Severe HPP can lead to serious medical complications, including coma and death.

Plaintiffs in Injectafer lawsuits allege that the drug manufacturers defectively designed the drug in a way that caused an increased risk of HPP and failed to give adequate warning of that risk to physicians. The original FDA warning label for Injectafer did not include strong warning language for HPP.

Clinical studies, such as one published in BMC Medicine in 2020, found that a primary ingredient in Injectafer was linked to an increased risk of developing HPP. The first study to suggest this link was published in the International Journal of Rheumatology in 2015. It was not until February 2020 that an updated FDA warning label added HPP to the drug’s significant risks.

Symptoms of HPP

Injectafer lawsuits allege that patients suffered from HPP as a result of their Injectafer infusions.

Patients with mild HPP may not have any symptoms or may experience generalized muscle weakness. More severe HPP can cause symptoms that include:

  • Moderate to severe muscle pain or weakness
  • Bone pain
  • Numbness
  • Confusion, irritability, or other altered mental states
  • Seizures
  • Coma
  • Death

Severe HPP requires immediate medical treatment.


History of Injectafer Lawsuits

The first lawsuit regarding Injectafer was filed in January 2019. Since that time, numerous lawsuits have been filed with similar allegations of injury caused by the drug.

So far the cases have not been consolidated into a class action. However, several cases in the Eastern District of Pennsylvania were grouped together and one trial was scheduled. These appear to now have been settled together, as they have recently been entered in a single qualified settlement fund for 13 plaintiffs. No settlement or jury verdict has been made public in any Injectafer case.

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Injectafer Response

The defendant drug companies named in Injectafer lawsuits have not made a public statement regarding the cases, but have sought to dismiss some of the claims against them for failing to state a valid claim.


Recent Developments in Injectafer Lawsuits

Nearly 70 individual lawsuits have been filed citing damage from Injectafer infusions. To date, there have been no public jury verdicts or settlements announced in these cases.


Can I Still File an Injectafer Lawsuit?

You may still be eligible to file an Injectafer lawsuit if the date of your injury does not fall outside of the statute of limitations. The statute of limitations varies by state, but typically requires you to file a lawsuit within two to four years from the time of your injury or the time you became aware of your injury.

At this point, all Injectafer lawsuits are individual lawsuits, rather than a class action. This means that you need to bring your own claim instead of joining a large consolidated case. An attorney who is familiar with deceptive products and drugs laws would be best able to advise you on your options.

The Injectafer FDA warning label was updated in 2020 to include a direct warning of HPP effects. As a result, it is now more difficult to show evidence that an administering physician was unaware of those risks. This may make it more difficult to prove misleading marketing or negligence on the part of the drug manufacturers for more recent claims.


How to File an Injectafer Lawsuit

Your first step to file an Injectafer lawsuit is to speak with a qualified attorney. A personal injury lawyer will have the most experience with this type of case. While the current Injectafer lawsuits are all individual claims, a lawyer with mass tort experience could also be beneficial in case your claim is consolidated with others.

Your lawyer will work with you to gather evidence proving your claims. Common evidence for these types of cases include:

  • Medical records documenting treatments received
  • Hospital records
  • Professional medical opinions


Compensation for Injectafer

Without public settlements or jury verdicts on Injectafer lawsuits, it is impossible to say for certain how much compensation would be awarded in these cases. One estimate states that a patient who suffered permanent or serious health consequences from Injectafer could receive a settlement between $200,000 and $500,000. However, it is important to note that this amount is speculative and could vary significantly depending on your injuries.


Has there been a recall issued for Injectafer?

Injectafer has not been recalled, and has remained in consistent use since its original FDA approval in 2013. The FDA issued a warning letter to the drug manufacturer in 2015 citing improper promotion of the drug for non-approved uses and misleading claims in advertising, but took no action to limit the drug’s use.

In 2021, the FDA approved a new single dose version of Injectafer. Use of the drug was approved for new use in adult patients with heart failure in June 2023.

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The Last Word on Injectafer Lawsuits

The Injectafer lawsuits are still working their way through the legal system, making it impossible to gauge their effectiveness. The creation of a qualified legal settlement fund in Pennsylvania indicates that at least some cases will be resolved through settlement agreements soon.

If you or a loved one has suffered HPP symptoms or other complications from Injectafer treatments, speaking to an attorney is a good step forward. Your attorney can evaluate your potential claim and give you advice on whether filing a lawsuit could be beneficial.

Diagnosed With Hypophosphatemia (HPP) Or Low Phosphate Levels After Taking Injectafer?

You may be eligible for significant compensation. Get your free case review today.
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Frequently Asked Questions (FAQs)

Has Injectafer been proven to be dangerous?

As with all drugs, Injectafer has the potential to cause unwanted side effects. Since 2020, the FDA warning label on Injectafer has identified HPP as a potential severe outcome from Injectafer infusions.

Should I stop using Injectafer?

If you have experienced unwanted side effects from using Injectafer, you should discuss those concerns with your doctor. Changing or stopping Injectafer infusions could cause other medical problems. Speak with your doctor before making any changes to your medical treatment.

Who qualifies for an Injectafer lawsuit?

An Injectafer lawsuit is a personal injury claim. These lawsuits are usually filed by patients who received Injectafer infusions and then developed severe HPP that required significant treatment or hospitalization.

What percentage of Injectafer patients develop hypophosphatemia?

According to a 2020 study published in BMC Medicine, 11.3% of study patients treated with Injectafer developed severe HPP. The same study concluded that patients treated with a primary ingredient in Injectafer had an increased risk of developing HPP.

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