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. Injectafer increases the risks of hypophosphatemia
- 3. Lawsuits over complications caused by Injectafer
- 4. Compensation for victims of Injectafer
- 5. What to do if you 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 releases iron directly into the patient's bloodstream.
First used in the U.S. in 2013, Injectafer has frequently been prescribed to people who cannot take 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, or
- Chronic kidney disease.
2. Injectafer increases 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, which can be fatal.
Symptoms associated with hypophosphatemia include:
- Mental confusion or delirium,
- Rhabdomyolysis, or the breakdown of muscular tissues,
- Muscle weakness and pain,
- Fatigue and exhaustion,
- Difficulty breathing,
- Respiratory failure,
- Osteomalicia, 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 hypophosphatemia.
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 high 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 iron deficiency, 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 label or any of its advertisements.
3. 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 side effects of the drug, 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.
4. Compensation for victims of Injectafer
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 to do if you 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 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.
6. Contact our defective drug lawyers
Pursuing your legal rights after being hurt by Injectafer can recover compensation for your losses, and can hold the companies behind the drug accountable for their actions. Call the defective drug lawyers at the Shouse Law Office at 855-LAWFIRM.
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).
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).
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).
Crockett v. Luitpold Pharmaceuticals, Inc., No. 2:19-cv-00276 (E.D. Pa. filed Jan. 18, 2019).