Injectafer Lawsuit

This page is about Injectafer lawsuits. Our Injectafer lawyers look at what these lawsuits are about and what the settlement amounts could look like if these claims are successful.

 2023 Injectafer Lawsuit Update

A recently filed case, Spero v. Luitpold Pharmaceuticals, Inc. (22-cv-04876) is a good example of a recent Injectafer lawsuit. This case was filed last month in the Eastern District of Pennsylvania by Scottsdale, Arizona woman.

Spero suffers from iron deficiency anemia and was prescribed Injectafer for treatment of her condition. She got her first Injectafer infusion in September 2020 and a second infusion a week later. Following her second injection, Spero suffered severe hypophosphatemia causing extreme pain and potential long-term injuries. This Injectafer lawsuit alleges that Spero’s injuries were the direct result of the Injectafer and that the defendants negligently failed to warn about this risk.

About Injectafer

Injectafer® (ferric carboxymaltose) is a prescription iron replacement drug that is administered by injection. Injectafer is designed for people who suffer from iron deficiency anemia (IDA) and are unable to take oral iron supplements. Injectafer is also used to treat people with anemia resulting from chronic kidney disease. Injectafer was approved and released onto the U.S. market in 2013 by Vifor Pharmaceuticals (f/k/a Luitpold Pharmaceuticals), a subsidiary of Japanese pharmaceutical giant Daiichi Sankyo.

To get prescribed Injectafer, you should have a history and physical exam documenting kidney disease or iron deficiency anemia with intolerance to oral iron. Users should have lab values that demonstrate no increase in iron studies or hemoglobin after the administration of oral iron.

People who suffer from IDA have insufficient levels of iron which is very important to ensure that the body produces enough red blood cells. A shortage of iron can lead to a shortage of red blood cells and poor health.

Traditionally, IDA was treated with oral iron supplements. The pharmaceutical industry recently began to develop and introduce intravenous iron supplements for those unwilling or unable to take oral iron supplements. Injectafer is a member of the class of intravenous iron products available in the United States.

Injectafer Causes Hypophosphatemia in Some Patients

Injectafer was the first intravenous iron drug in the U.S. to use the unique ferric carboxymaltose (“FCM”) compound. Although it was initially believed to be safe, soon after the release of Injectafor it was discovered that FCM causes a condition called hypophosphatemia (HPP).

HPP is an electrolyte disturbance that causes an abnormally low level of phosphate in the patient’s blood. Phosphate is critically important and helps with bone growth, energy storage, and nerve and muscle production.

There are several levels of HPP, including mild, moderate, and severe. Additionally, there is a condition that has been coined as “persistent hypophosphatemia” in which an individual can suffer from HPP for a sustained period.  Mild and moderate HPP often occur with any meaningful injury.

Severe HPP is another matter. It can lead to serious medical complications including osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and/or potentially rhabdomyolysis. The dangers of these harms increase if there are long periods of severe hypophosphatemia.

Studies Showing a Connection

The causal link between Injectafer and HPP has been conclusively established by a series of scientific research studies. The first of these studies was published in 2015 in the International Journal of Rheumatology.

The study found that over half of all Injectafer patients suffered some level of HPP, nearly twice as high as those in a control group. In 2018, a study published in the Journal of Clinical Investigation tested Injectafer on 2,000 test subjects and found that half experienced HPP.

By contrast, only 1% of subjects in the control group experienced HPP after receiving another iron injection drug. In 2019 a Norwegian study yielded similar results, finding HPP in 56% of Injectafer patients.

Injectafer HPP Lawsuits

Since about 2019, a steady stream of Injectafer lawsuits have been filed by individuals who received Injectafer injections for IDA, developed severe HPP, and suffered permanent injuries as a result.

Injectafer lawyers allege that the manufacturers have known for years that Injectafer caused severe HPP and resulting health risks. Injectafer was available in the European market for years before it was released in the U.S.

During Injectafer’s time on the European and U.S. markets, dozens of case reports and important pieces of medical literature emerged revealing the link between the FCM compound and severe HPP. There is also evidence that clinical trials of Injectafer revealed clear evidence of the causal link with severe HPP.

Ferric Carboxmaltose Lawsuits Claim Failure to Warn

Despite knowing that Injectafer caused severe HPP, the iron supplement drug was brought to the U.S. market without any adequate warning labels or warnings to the medical community. Every Injectafer lawyer will make this the central claim in any lawsuit.

Injectafer’s label omits any reference to “severe HPP” and provides no information on how to monitor for signs of severe HPP after injections. Instead, the manufacturers of Injectafor consistently downplayed and covered up the risks of their drug and severe HPP. At core, that is what the ferric carboxymaltose iron replacement lawsuits are about.

The failure to adequately warn about the risks of severe HPP associated with Injectafer amounts to clear negligence on the part of Vifor. This failure has formed the basis of the growing number of Injectafer lawsuits being filed in the U.S. by individuals who developed severe HPP from Injectafer and were seriously harmed as a direct result.

Example Injectafer Lawsuit

So far around 70 individual Injectafer lawsuits have been filed in the U.S. One of the most recent Injectafer lawsuits is the case of Alexis Todd v. Luitpold Pharmaceuticals Inc., et al. (2:20-CV-01759) that was filed in the U.S. District Court for the Eastern District of Pennsylvania.

The factual background and allegations in the Todd case are typical of most Injectafer lawsuits. Alexis Todd, a middle-aged woman from Ocoee, Florida, had low iron and received two injections of Injectafer at the Orlando Health University of Florida on March 26 and April 2, 2018. Following her second injection, the phosphorous levels in Ms. Todd’s blood suddenly dropped sharply. On April 16, 2018, she was diagnosed with severe HPP and had to be hospitalized. Her condition also forced Ms. Todd to discontinue her cancer treatments.

At the time this occurred, Ms. Todd and her doctors had no explanation for her sudden onset of severe HPP. None of her doctors were aware of the link between severe HPP and Injectafer because there was no adequate warning to that effect. It was not until 2 years later that Ms. Todd and her medical providers eventually became aware that her HPP was caused by the Injectafer doses she received just weeks before. In her Injectafer iron replacement lawsuit against Vifor, Daiichi Sankho, and other companies, Ms. Todd is asserting negligence claims based on failure to warn, design defect, and other theories.

FAQs – Injectafer Lawsuits

Is Injectafer safe?

Numerous scientific studies have shown that Injectafer causes a medical condition called hypophosphatemia (HPP). About half of all patients who receive Injectafer experience HPP and some of them suffer from what is classified as severe HPP.

Who qualifies for an Injectafer lawsuit?

This litigation mostly involved patients who received Injectafer injections for iron deficiency and subsequently developed severe hypophosphatemia (HPP) resulting in hospitalization or other severe health consequences.

What is the expected settlement compensation payout for an Injectafer lawsuit?

Injectafer lawsuit settlement amounts will depend on the severity of the plaintiff’s injuries resulting from HPP. Lawsuits involving Injectafer-induced HPP where the plaintiff suffered very serious or permanent health consequences could have an average settlement amount in the $200,000 to $500,000 range.

This is, of course, pure speculation and assumes these lawsuits will be successful. Could this estimate be too high? Absolutely.  We are not longer reviewing these cases. One lawyer who is handling these claims contacted us in July 2023 – years after this projection was first made – to offer the opinion that this number is too high.

Archived Injectafer Litigation Updates

July 25, 2022 Update: A total of 13 Injectafer product liability lawsuits have been filed in federal courts so far in 2022. All but one of these 13 Injectafer lawsuits were filed in the Eastern District of Pennsylvania; one was filed in the Middle District of Florida. There are now a total of about 40 Injectafer lawsuits pending in Federal courts and a similar number of cases pending in Pennsylvania state courts.

There is still no indication that an MDL consolidation may be in the works and unless the number of cases increases dramatically that is unlikely to change. The first Injectafer lawsuit is likely to be in Pennsylvania state court.

May 28, 2022 Update: Biofer SpA has sued Vifor Pharma AG.  The lawsuit alleges the process for making the active ingredient in Injectafer infringes a Biofer patent.

December 9, 2021 Update: A new case study report published in the Slovenian Medical Journal this month sheds new light on how Injectafer iron infusions can trigger dangerously low phosphate levels in the bloodstream. The report examines the case of a 33-year-old patient who suffered severe HPP after receiving an Injectafer shot for treatment of her anemia. The report highlights the dangers of Injectafer and the importance of carefully monitoring a patient’s phosphate levels after receiving it.

November 3, 2021 Update: Philadelphia County Court of Common Pleas is continuing to see new Injectafer lawsuits.

September 30, 2021 Update: Last month, a federal judge in Philadelphia rejected a motion to consolidate the trials of the first two Injectafer lawsuits scheduled to go to a jury. The two cases are part of a larger group of 80 Injectafer lawsuits that have been consolidated by consent for pretrial handling (sort of like a mini MDL). The judge ruled that consolidation of these first two trials was not appropriate because it would offer minimal gains in judicial economy. The judge also noted that the two cases involved somewhat different and specific issues that would create a likelihood of prejudice and juror confusion.

These two cases will be the very first Injectafer lawsuits to go to trial and they will function very similar to bellwether trials in a full MDL. The outcome of these cases will have a major impact on how the remaining group of over 80 cases are handled. It is not entirely clear, however, whether the results of these initial trials will be used as a basis for settlement negotiations or if they will be the first of many.

File Your Injectafer Lawsuit

Our lawyers are no longer handling these claims.  But other still are.