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Injectafer Lawsuit

Injectafer Lawsuit

Injectafer lawsuits have been filed by people who received iron injections for anemia and suffered low phosphate levels (hypophosphatemia) and other severe side effects.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Injectafer induced injury cases in all 50 states. If you or somebody you know has been diagnosed with severely low phosphorus levels (hypophosphatemia), you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Injectafer® Iron Injection Lawsuits Being Filed Nationwide

Dozens of lawsuits have been filed by people who received Injectafer® iron injections for anemia and developed a severe side effect called Hypophosphatemia (HPP), which causes low phosphate levels in the blood, fatigue, muscle pain, bone pain, and other debilitating symptoms.

What is Injectafer?

Injectafer® (ferric carboxymaltose) is an iron replacement injection for adults with Iron-Deficiency Anemia who can’t take an oral iron pill, or adults with chronic kidney disease who are not receiving dialysis. It is injected in two 750-mg doses, at least 7 days apart, for 1500-mg total.

Injectafer vs. Other Iron Injections

There are several types of iron injections available in the U.S., but Injectafer is the only one with Ferric Carboxymaltose (FCM). Unlike other iron injections, FCM can dramatically reduce levels of phosphate (phosphorus) in the body, causing Hypophosphatemia (HPP), according to recent lawsuits.

FDA Questioned Safety Long Before Injectafer Approval

The Swiss pharmaceutical company Vifor Pharma achieved FDA approval for Injectafer in the U.S. on July 25, 2013. However, long before then, the FDA rejected approval twice due to safety concerns. The first rejection was in 2006, when the FDA was concerned about side effects like severe hypophosphatemia. The second rejection was in 2011, when the FDA had manufacturing concerns.

What Are Some Alternative Iron Injections?

Patients who develop low phosphate levels from Injectafer may need to use an alternative iron injection. Examples include:

What is Hypophosphatemia?

Hypophosphatemia (HPP) is a condition that occurs when the body does not have enough phosphate to function properly. In very severe or persistent cases, HPP can cause death.

Why Is Phosphate So Important?

Phosphate is an electrolyte in the body that contains the mineral phosphorus. It is essential in nearly every part of the body. You need normal phosphate levels for proper nerve signaling, building and repairing bones and teeth, processing foods to make energy, keeping a normal heartbeat, and many other functions.

Signs of Low Phosphate Levels in the Body

Noticeable signs of low phosphate levels only occur when the amount of phosphate in the blood becomes very low. Muscle weakness develops, followed by stupor, coma, and death.

People with mild long-term (chronic) hypophosphatemia can develop weak bones, resulting in bone pain, broken bones and fractures. Over time, people may also become very tired, weak, and lose their appetite.

Symptoms of Hypophosphatemia

  • Extreme fatigue
  • Bone softening (osteomalacia)
  • Bone fractures
  • Cardiac arrest
  • Muscle weakness (rhabdomyolysis)
  • Muscle pain
  • Respiratory failure
  • Seizures
  • Heart failure
  • Irregular heart rhythm (arrhythmias)
  • Confusion and delirium
  • Coma
  • Death

What is Iron Deficiency Anemia (IDA)?

Iron-deficiency anemia (IDA) occurs when there is not enough iron in a person’s body to make red blood cells. Iron is essential for the body to produce red blood cells, which carry oxygen throughout the body and perform other essential functions. In the U.S., there are an estimated 7.5 million people with IDA.

What Causes Anemia?

People normally get enough iron by eating a healthy diet — but when people have a poor diet or problems absorbing iron, they can develop a shortage of iron, and then, a shortage of red blood cells. Over time, anemia can cause a wide range of life-threatening health problems.

Injectafer Linked to Severe Hypophosphatemia

Studies have linked Injectafer to a dramatically higher risk of HPP compared to other iron injections, such as Monoferric.

For example, two clinical trials in February 2020 found that 75% of patients given Injectafer developed HPP (blood phosphate level of 2.0 mg/dL or less), compared to just 8% of patients given another iron injection called Monoferric.

Furthermore, the study found that ZERO patients on Monoferric developed severe HPP, versus 11.3% of patients who got Injectafer.

Source: Wolf M, et al., “Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials” JAMA. 2020; 323(5)423-443 (Feb. 2020).

FDA Updates Injectafer Label With Hypophosphatemia

In February 2020, the FDA ordered drug-makers to add a warning label for “Symptomatic Hypophosphatemia.” Even so, the label still does not address the severity of this condition — or the significantly higher rate of HPP that is linked to Injectafer vs. other iron injections.

Injectafer Lawsuits

A growing number of Injectafer lawsuits have been filed by people who were injured by low phosphorus levels. These lawsuits accuse drug-makers of failing to warn about the severe health risks of Injectafer.

For example, one of the first Injectafer lawsuits was filed by Christa C., a woman from Idaho who had to stop working due to numerous side effects, including pain, weakness, fatigue, sleep problems, and more.

Her lawsuit was filed on April 24, 2020 in the U.S. District Court for the Eastern District of Pennsylvania — Case No. 2:20-cv-02019.

Can I Join an Injectafer Class Action?

At this time, there are no Injectafer class action lawsuits for people who developed low phosphate levels. Instead, lawyers are filing individual lawsuits nationwide. If you decide to file a lawsuit, we may be able to help you seek financial compensation for your pain and suffering, medical expenses, and more.

Injectafer MDL (Multi-District Litigation)

In the future, these lawsuits may be centralized into a federal Multi-District Litigation (MDL). The MDL process is similar to a class action because many lawsuits are consolidated into one court, but unlike a class action, each person’s lawsuit remains independent.

Are There Any Injectafer Lawsuit Settlements Yet?

No. Because it is still early in this litigation, there are not yet any Injectafer lawsuit settlements. However, large-scale settlements for people who were injured by Injectafer may be a possibility in the future.

Do I have an Injectafer Lawsuit?

The Schmidt Firm, PLLC is currently accepting Injectafer induced injury cases in all 50 states. If you or somebody you know has been diagnosed with low phosphate levels (hypophosphatemia), you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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