Injectafer lawsuits are mass tort claims against the pharmaceutical companies that make the drug Injectafer, a medication that treats anemia and kidney problems by increasing the amount of iron in a patient’s blood. However, studies have found that around half of people taking Injectafer develop hypophosphatemia, which can be fatal. Despite the risks, though, the drug companies behind Injectafer fail to warn doctors and patients.
In this article, our defective drug lawyers describe how Injectafer works and why it is often prescribed. We will then explain the serious risks it poses for patients, and the lack of risks present in other, similar drugs. We will then take a look at the lawsuits that have been filed over Injectafer, the compensation that victims can recover, and what you can do if you think you have suffered from the side effects of Injectafer.
- 1. What is Injectafer?
- 2. Does Injectafer increase the risks of hypophosphatemia?
- 3. What is the status of lawsuits over complications caused by Injectafer?
- 4. What compensation can victims of Injectafer get?
- 5. What do I do if I have been hurt by Injectafer?
- 6. Contact our defective drug lawyers
1. What is Injectafer?
Injectafer is a form of ferric carboxymaltose, or FCM, a medication that replaces the iron in a patient’s body. It is taken intravenously in a controlled medical setting over two sessions separated by at least seven days. The 1,500 milligrams of Injectafer gradually release iron directly into the patient’s bloodstream.
First used in the U.S. in 2013, Injectafer injections have frequently been prescribed to people who cannot take oral iron supplement pills, or who have not responded well to them.
The following pharmaceutical companies are behind Injectafer:
- Daiichi Sankyo and its U.S. subsidiary,
- Luitpold Pharma,
- American Regent, and
- Vifor Pharma.
People who get prescribed Injectafer are often suffering from medical conditions that inhibit the iron in someone’s bloodstream, like:
- Iron deficiency anemia (IDA), or
- Chronic kidney disease.
The most common kind of anemia, IDA is where patients have low levels hemoglobin in their red blood cells. Hemoglobin is necessary to carry oxygen carrier throughout the body. IDA symptoms include dizziness, headache, fatigue, and shortness of breath.
2. Does Injectafer increase the risks of hypophosphatemia?
Injectafer has been strongly linked to a shockingly high risk for a very serious side effect: The medical condition hypophosphatemia.
Hypophosphatemia is a dangerously low level of phosphate in the bloodstream – less than 0.81 millimoles per liter (mmol/L). When phosphate levels fall below 0.32 mmol/L, it reaches the level of severe hypophosphatemia (severe hpp), which can be life-threatening if untreated.
Symptoms associated with hypophosphatemia include:
- Mental confusion or delirium,
- Rhabdomyolysis, or the breakdown of muscular tissues,
- Muscle weakness and muscle pain,
- Rhabdomyolysis (muscle death)
- Fatigue and exhaustion,
- Difficulty breathing / shortness of breath,
- Respiratory failure,
- Osteomalacia, or bone softening,
- Bone pain and fractures,
- Arrhythmias, including fatal heart rhythm patterns,
- Heart failure and cardiac arrest, and
- Acute hemolytic anemia, or the destruction of red blood cells.
If not treated properly and quickly, severe hypophosphatemia can be fatal.1
Numerous medical studies have connected Injectafer and its iron supplement, ferric carboxymaltose, or FCM, with a shockingly high chance of developing severe low levels of phosphate.
One of these studies found that the chances of developing hypophosphatemia after a dose of FCM were an astounding 70%.2 Another only focused on women, but found the odds to be 58.8%.3 Others found similar risks.4
Still other medical studies have shown that the increased risk of hypophosphatemia was only present with FCM, the type of iron supplement used in Injectafer. Similar injectable iron prescriptions did not come with such significant risks for hypophosphatemia.
One study covered nearly 2,000 people and compared the rates of severe hypophosphatemia in those who took Injectafer with those who took a different intravenous medication for low iron levels, Feraheme.5 That study found that more than half of the people on Injectafer, 50.8%, developed hypophosphatemia.6 Meanwhile, only 0.9% of Feraheme patients developed hypophosphatemia.7
Another study compared hypophosphatemia rates in people who were taking FCM and in those taking another type of iron supplement, iron isomaltoside.8 While this study only covered 81 people, the results were similar: 45.5% of those on FCM developed hypophosphatemia, and 32.7% developed severe hypophosphatemia.9 Meanwhile, only 4% of those on iron isomaltoside developed hypophosphatemia, with no cases of severe hypophosphatemia.10
Nevertheless, Injectafer does not list hypophosphatemia as a side effect on its warning labeling or any of its advertisements.
3. What is the status of lawsuits over complications caused by Injectafer?
Lawsuits have begun to be filed against the makers of Injectafer due to the overwhelming body of scientific literature linking Injectafer and FCM to hypophosphatemia. These lawsuits claim that Injectafer was defectively designed in a way that drastically increases the risk of hypophosphatemia, and also that the drug was defectively marketed for not warning patients about these risks. The first of these lawsuits was filed in federal court on January 18, 2019 in the Eastern District of Pennsylvania.11
Drug companies, including those that make and sell Injectafer, have a legal duty to disclose the side effects and medical conditions that their drugs can cause. Patients rely on this information to make educated decisions about their health. Additionally, doctors rely on these disclosures to prescribe drugs to their patients and alleviate their symptoms without creating others.
However, drug companies know that divulging the most serious side effects of their products can deter consumers and make them look elsewhere. They frequently use any excuse possible to avoid making these disclosures and protect their profits, even if it means putting people at risk.
The Injectafer lawsuits claim that the companies that make and sell Injectafer breached their legal duty to warn people about the side effects of the drug. By failing to warn doctors and patients about the high risk of developing hypophosphatemia, Injectafer’s makers hurt innocent people. The claims aim to recover compensation for the victims who suffered from the Injectafer side effects, as well as to hold the companies behind Injectafer accountable for their actions.
Additionally, drug companies have a duty to use compounds that do not put the people who take it in unnecessary harm. The stark contrasts between the rates of hypophosphatemia in people taking Injectafer and those taking a similar iron supplement suggest that the makers of Injectafer may have breached this duty, as well.
The FDA has not recalled Injectafer. Though the FDA initially denied approval to the IV treatment back in 2008 and 2011 because of severe hpp. FDA approval was finally granted in 2013 but only to IDA patients who did not respond well to oral treatment or who have chronic kidney disease that does not require dialysis. And in 2015, Luitpold Pharmaceuticals got an FDA non-approval letter for a television commercial that minimized the drug’s risks.
4. What compensation can victims of Injectafer get?
Victims of Injectafer who have suffered from hypophosphatemia and who elect to pursue a lawsuit stand to recover compensatory damages for their losses. Compensatory damages aim to bring a victim back to where they were before they suffered their injuries by providing compensation for their losses.
Compensatory damages aim to cover:
- Medical bills already incurred during a victim’s recovery,
- Medical expenses that are reasonably foreseeable in the future,
- Lost wages,
- Missed business opportunities and other professional setbacks from the victim’s injury,
- A reduced ability to earn a living in the future, thanks to the injury,
- Physical pain from the injury,
- Mental anguish, suffering, and the loss of life’s enjoyments created by the injury, and
- The loss of consortium felt by the victim’s family and loved ones.
Additionally, defective drug lawsuits like these have frequently led to punitive damages being awarded. Punitive damages are rare, but seek to punish wrongdoers for especially problematic conduct, even if it means awarding victims far more than it would take to fully compensate them for their losses.
5. What do I do if I have been hurt by Injectafer?
If you have taken a dose of Injectafer and realize that you have developed the symptoms of hypophosphatemia, the first thing to do is see your doctor right away. Hypophosphatemia is a severe medical condition that can be fatal. Getting medical treatment is the most important thing to do.
If it becomes clear that you have developed hypophosphatemia, the next step is to talk to a lawyer for a free case evaluation and to learn your legal options. Filing a lawsuit against the companies behind Injectafer might be in your interests. If it is, your lawyer will help you put together the evidence you will need to show your losses, like your medical bills and calculations of the wages you have lost.
- Rajesh S, Khardori R, “Severe Hypophosphatemia: Pathophysiologic Implications, Clinical Presentations, and Treatment,” Medicine 79:1-8 (January 2000).
- Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT, “Large‐dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial,” Transfusion 49:2719-28 (2009).
- Wolf M, Koch TA, Bregman DB, “Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women,” Journal of Bone and Mineral Research 28:1793-1803 (March 16, 2013)(A randomized, double-blind clinical trial revealed a rate of hypophosphatemia was nearly six times higher in patients who received Injectafer versus a different iron injection. 50.8% of the patients had hypophosphatemia, while 0.9% of those who took ferumoxytol developed the condition.).
- See Schaefer B, Glodny B, Wolf M, Zoller H, Letter to the Editor, “Letter: inconsistency in reporting of hypophosphatemia after intravenous iron,” Alimentary Pharmacology and Therapeutics (August 14, 2017) (listing 6 studies covering FCM and comparing hypophosphatemia risk to 11 studies covering other iron supplements). See also Merche Prats, Ramon Font, Carmen García, Carmen Cabré, Manel Jariod, and Alberto Martinez Vea., Effect of ferric carboxymaltose on serum phosphate and C-terminal FGF23 levels in non-dialysis chronic kidney disease patients: post-hoc analysis of a prospective study, BMC Nephrol. 2013; 14: 167 (July 31, 2013)(study involved 47 subjects; after one dose of Injectafer, everyone displayed a significant decrease in phosphorus levels after three weeks, and 35 became hypophosphatemic.).
- Wolf M, Chertow G, Macdougall I, Kaper R, Krop J, and Strauss W, “Randomized trial of intravenous iron-induced hypophosphatemia,” Journal of Clinical Investigation 3(23):e124486 (December 6, 2018).
- Schaefer B et al, “Choice of High-Dose Intravenous Iron Preparation Determines Hypophosphatemia Risk,” PLoS One 11(12):e0167146 (December 1, 2016) (45% of people treated with intravenous iron injections became hypophosphatemic, with 32% getting severe hpp.).
- Crockett v. Luitpold Pharmaceuticals, Inc., No. 2:19-cv-00276 (E.D. Pa. filed Jan. 18, 2019).