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Injectafer Lawsuits

Injectafer lawsuits claim the iron replacement drug, also known as ferric carboxymaltose, causes hypophosphatemia (HPP) or low phosphate levels. HPP can cause serious health problems, including bone pain, seizures and death. Plaintiffs say Injectafer’s makers failed to warn the public of the risk.

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If you developed hypophosphatemia after receiving Injectafer infusions, you may be entitled to compensation. Get a free case review.

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Last Modified: July 15, 2021
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Why Are People Filing Injectafer Lawsuits?

People who filed Injectafer lawsuits say the drug’s makers defectively designed the drug because it greatly increases the risk of hypophosphatemia.

In addition, though the drug has been on the market since 2013, drugmakers didn’t add a warning to the label until February 2020. Even then, lawsuits claim the warning added in 2020 is not adequate for patients and medical providers.

Plaintiffs claim physical, emotional and financial damages. Defendants include Luitpold Pharmaceuticals Inc., American Regent Inc. and Daiichi Sankyo.

“Defendants have known for years, even before the pursuit of a New Drug Application (NDA) for Injectafer, that ferric carboxymaltose — and by extension, Injectafer — causes Severe HPP.”

Maria and Anthony Munroe

Maria and Anthony Munroe filed their lawsuit in the Eastern District of Pennsylvania in January 2020. Maria Munroe began taking Injectafer in September 2018. After two infusions, she suffered from low phosphate levels and ended up in the hospital. She now suffers from chronic HPP.

Gregory and Margaret Yova

Gregory and Margaret Yova filed their lawsuit in the US District Court for the Eastern District of Pennsylvania in October 2020. Gregory Yoya received one injection of Injectafer in November 2019. Because of severe HPP, he was hospitalized and his phosphate levels have never recovered.

His injuries include: “Severe fatigue, brain fog, hip pain, muscle weakness and cramping, ongoing generalized weakness, chest heaviness and pain, unstable INR, and severe abdominal pain as a side-effect of phosphate supplementation.”

Teresa J. Edwards

Teresa J. Edwards filed her lawsuit in January 2021. She had received 10 infusions over the course of several months from 2018 to 2020. She suffered symptoms of HPP including: Severe muscle fatigue and weakness, severe fatigue and severe and extended pain.

Did you develop hypophosphatemia or other serious side effects after receiving Injectafer?

Studies Link Injectafer to Severe Hypophosphatemia (HPP)

HPP is typically rare and can be inherited or caused by medical conditions in adulthood, but some studies have linked ferric carboxymaltose, Injectafer’s active ingredient, to severe hypophosphatemia.

A key 2016 study published in PLoS One by Benedikt Schaefer and colleagues found Injectafer was associated with a 20-fold higher risk of HPP than iron isomaltoside 1000. Eighteen of the HPP cases studied were severe or life threatening. In contrast, only one patient who took iron isomaltoside suffered from a mild case of HPP.

“Treatment with FCM is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.”
Schaefer et al., PLoS One
Source: PLoS One

Myles Wolf and colleagues published a 2018 study in JCI Insight that found 50.8 percent of 1,000 of patients who took Injectafer developed HPP versus only 0.9 percent of 997 of those who took Feraheme (ferumoxytol).

FDA Denials

In addition, the U.S. Food and Drug Administration denied Luitpold’s new drug application for Injectafer in 2006 and again in 2008 for clinical safety concerns.

FDA did not initially approve Injectafer because of safety concerns, including:
  • More patients who took Injectafer versus controls died
  • More serious adverse events occurred in patients who took Injectafer versus oral iron
  • Clinically important hypophosphatemia

Symptoms of Hypophosphatemia

Mild cases of hypophosphatemia in adults don’t usually cause symptoms. But prolonged severe hypophosphatemia can result in serious symptoms such as seizures or heart failure.

HPP symptoms include:
  • Bone pain and fractures
  • Coma
  • Difficulty breathing or shortness of breath
  • Fatigue
  • Heart arrhythmias
  • Heart failure and/or heart attack
  • Irritability
  • Mental confusion or delirium
  • Muscle pain
  • Muscle weakness
  • Respiratory failure
  • Seizures
  • Softening of the bones

Reasons to File an Injectafer Lawsuit

People who file Injectafer lawsuits may do so to hold Luitpold and other drug manufacturers accountable for failing to warn people about the risk of HPP.

Plaintiffs may also receive compensatory damages for physical, emotional and financial losses caused by an HPP diagnosis and treatment.

Compensation may cover:
  • Decreased ability to earn a living because of fatigue, brain fog, pain or other symptoms of HPP
  • Future medical bills for chronic HPP and lifelong phosphate supplementation
  • Lost business or professional opportunities
  • Lost quality of life, suffering and mental anguish
  • Lost wages from hospitalizations or doctor’s appointments resulting from HPP, this may include family members’ lost wages
  • Medical expenses for diagnosis and treatment of HPP
  • Spouse’s loss of companionship

Who Can File a Lawsuit?

Anyone who had at least one administration of Injectafer in 2013 or later and suffered from symptoms of hypophosphatemia may contact an attorney for a free case review.

Only an experienced attorney can tell you if you qualify to file a lawsuit.

If you suffered the following injuries after taking Injectafer, you may qualify to file a lawsuit for compensation:
  • Acute renal failure
  • Cardiac arrest or failure
  • Cardiac arrhythmias or dysrhythmias
  • Death
  • Drop in blood phosphorus
  • Hypophosphatemia or Severe Hypophosphatemia
  • Osteomalacia (softening of the bones)
  • Renal Wasting
  • Respiratory Failure
  • Rhabdomyolysis (muscle breakdown)
  • Severe muscle fatigue or weakness
  • Severe or extended Pain

Family members who lost loved ones because of severe hypophosphatemia after taking Injectafer may qualify to file a wrongful death claim.

There are time limits to file a claim and these vary depending on the state. Talk to an attorney right away to preserve your right to file.

Is There a Recall for Injectafer?

Despite studies linking Injectafer to hypophosphatemia, the FDA had not issued a recall for the drug.

In fact, the agency approved a new single dose formula of Injectafer in May 2021. The current formula is a two-dose course of treatment for a total of 1,500 mg. The new single dose is one injection of 1,000 mg.

In 2015, the FDA issued a warning letter to Luitpold for attempting to promote Injectafer for unapproved uses and for presenting misleading claims about the drug in a video ad.

Please seek the advice of a medical professional before making health care decisions.
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