Being anemic is a widespread phenomenon found in children and frail individuals. The problem can be resolved by taking iron supplements. You may not be aware of it, but some people have allergies or are unable to respond to oral iron supplements.
Is there any alternative? Yes, there it is- the injectable iron replacement medication. How safe is it? Not sure? Then you might be in danger if you take it. Injectafer iron infusion drug is also one such thing.
Injectafer has many adverse side effects making the victims pursue Injectafer lawsuits. This blog is going to discuss the soon-to-be booming Injectafer lawsuits.
Table of Contents
- 1 What is Injectafer?
- 2 Injectafer Side Effects
- 3 History of Injectafer and FDA Approval
- 4 What is Hypophosphatemia (HPP)?
- 5 Studies Underpinning Hypophosphatemia Issues
- 6 Why are the Makers of Injectafer Held Liable?
- 7 Sparking Injectafer Lawsuits
- 8 Injectafer Lawsuits Update 2022
- 9 Are there any Other Iron Infusion Lawsuits?
- 10 Queries on Injectafer Lawsuits Answered
What is Injectafer?
Injectafer (ferric carboxymaltose) is an intravenous (IV) iron replacement medication used to treat Iron Deficiency Anemia (IDA). It was designed to gradually release iron once inside the human body, potentially reducing the risk of side effects and providing more iron in just two doses. There should be seven days between the two doses administration. It is prescribed for adult patients who are intolerant to oral iron, have an unsatisfactory response to oral iron, or have chronic kidney disease that is not dependent on dialysis.
Injectafer is the only intravenous iron product in the United States that contains the innovative ferric carboxymaltose (FCM) compound. FCM has the potential to cause severe Hypophosphatemia (HPP).
Injectafer Side Effects
Injectafer can cause severe allergic reactions such as itching, rashes, allergic skin reactions, wheezing, shock, low blood pressure, loss of consciousness, and death in the users. Other iron infusion side effects include
- Difficulties in breathing
- Flushing of the face
- Hypertension (high blood pressure)
- Increased levels of liver enzymes
- Injection site bruising or pain
- Overloading of iron
- Severe Hypophosphatemia (HPP)
- Staining with hemosiderin
History of Injectafer and FDA Approval
Let’s dig into the background information on Injectafer.
Injectafer is manufactured by Vifor Pharmaceuticals in Switzerland. It is sold under the brand name Ferinject in other countries. It is distributed in the United States by American Regent, formerly known as Luitpold Pharmaceuticals. This company is a subsidiary of Daiichi Sankyo, a Japanese pharmaceutical conglomerate.
It seems the Food and Drug Administration knew about the adverse effects of the drug prior to its approval in 2013. The New Drug Application (NDA) submitted for Injectafer by Luitpold Pharmaceuticals to the FDA in July 2006 was rejected by the agency. It was discovered that this injectable iron increased the risk of death, serious adverse effects, and severe Hypophosphatemia.
The application submitted in 2011, too was rejected by the FDA due to manufacturing concerns. Finally, only when Luitpold resubmitted the NDA again the FDA approved it on July 25, 2013.
Very soon after the approval from the FDA, many studies started coming from across the country proving the connection between Injectafer and Hypophosphatemia (HPP).
Despite the findings in the studies, the manufacturers found a sharp growth in their prospects with a manifold increase in the sales of the injectable iron supplement, Injectafer, as it is the first and only high-dose non-dextran intravenous iron drug to treat IDA.
The FDA approved the single-dose Injectafer in 1000 mg rather than the original 1500 mg over two injections in May of 2021. The two-dose treatment was found to be the most effective for patients weighing more than 110 pounds, but the new single dose was more convenient for those weighing less than that.
On December 16, 2021, they announced that the FDA had approved Injectafer for pediatric patients aged one and up with iron deficiency anemia (IDA). These two approvals, even after the pursuits of lawsuits and warning clinical studies, make the brows knitted.
What is Hypophosphatemia (HPP)?
The main allegation in the Injectafer lawsuits is that it is causing Hypophosphatemia. It is a medical condition where the phosphate levels in the human blood become low and makes the bones and muscles weak.
Why does our body need phosphate? Phosphate improves our energy, nerve function, and regeneration. It is also necessary for bone health. It is an electrolyte that aids your body’s energy production and nerve function.
The phosphate we get from foods such as milk, eggs, and meat aids in the formation of strong bones and teeth. Phosphate levels in the blood must be perfectly adjusted. It should not go too low or too high.
Symptoms of Hypophosphatemia are as follows
- Altered mental state
- Bone pain or discomfort
- Bone thinning
- Decreased energy level
- Muscle weakness and muscle fatigue
- Joint pain
In severe HPP cases, deaths too can occur. Due to the weakness in the bones and muscles, respiratory failure can result. It can also lead to seizures and cardiovascular issues like arrhythmias and heart failures.
Many patients who suffered the adverse side effects of Injectafer had started reporting to the FDA’s Adverse events reporting system. In the approximately 5000 adverse event reports, many of them alleged that Injectafer caused severe HPP, respiratory failure, cardiovascular issues, and other side effects.
Studies Underpinning Hypophosphatemia Issues
Though we can allege that Injectafer is causing Hypophosphatemia, we need scientific evidence to reinforce that. As we have seen earlier, there are so much research, and studies started popping up indicating the adverse effect of Injectafer. Let’s navigate on the most important of them in short.
BMC Nephrology study 2013:
The study found that a single 1000mg dose of ferric carboxymaltose (FMC) in Injectafer caused cutbacks in serum phosphate levels that lasted three months in 47 patients with chronic kidney disease who were not on dialysis.
Endocrinology case report 2014:
A 45-year-old woman’s problems with Injectafer were described in Case Reports in Endocrinology after she complained of intense fatigue about ten days after the second dose. Phosphate plasma levels in the blood were found to be dangerously low. Researchers felt that patients should be monitored for a long to identify the adverse effects of the drug.
Belgian Hospital study, 2015:
The first study was conducted by the Journal of Rheumatology. This research on two iron medications, Injectafer (Ferinject) and Venofer, was carried out in a hospital in Belgium. More than 50% of the patients who used Ferinject (about 80 patients) and more than 23% of the patients who used Venofer (around 50 patients) experienced Hypophosphatemia. One-fourth of the Ferinject patients had HPP symptoms that were more severe.
Austrian study of 2016:
Unlike in the previous study, the researchers used another iron drug called Monofer in this one. Sixteen of the 55 patients who received Ferinject developed severe HPP, whereas only three of the 26 Monofer patients developed HPP after administration. A few of them who had mild HPP prior to the administration were not included in the final list of severe HPP patients. This study also demonstrated that Ferinject was more dangerous than Monofer.
AMAG- Pharmaceutical study 2018:
The study published in the Clinical Journal of Investigation included approximately 2000 patients from the United States, Canada, and Europe. Half of them received Injectafer injections, while the other half received Feraheme injections. When compared to 1% of Feraheme patients, approximately 50% of Injectafer patients experienced HPP within two weeks. Even after five weeks, more than half of the affected patients using Injectafer experienced HPP.
Norwegian study 2019:
A study on inflammatory bowel disease (IBD) patients who took Ferinject (Injectafer) or Monofer compiled and analyzed their medical records. The study of over 100 patients discovered that more than half of the Ferinject patients and only 6% of the Monofer patients had moderate to severe HPP. This also amplifies the negative effects of Injectafer in patients.
Clinical Pharmacology study 2020:
According to the research published by the Journal of Clinical Pharmacology, 25% of patients with heart failure who received Injectafer suffered HPP, which was categorized as “severe HPP,” and 2% were thought to have “extreme HPP.”
BMC Medicine study 2020:
The study was conducted with ferric carboxymaltose (FCM) and ferric derisomaltose. The researchers discovered that 75% of women treated with FCM had Hypophosphatemia when compared to the 8% of those treated with ferric derisomaltose.
All these studies have proved that when compared to other iron treatments (such as iron isomaltoside), Injectafer causes far more Hypophosphatemia.
Why are the Makers of Injectafer Held Liable?
Do you think the manufacturers and distributors of Injectafer were unaware of the danger? Definitely not. The initial rejections from the FDA and the various studies would have caught their attention. However, their greed to rake in revenue made them keep mum about the dangers of Injectafer.
They did not adequately warn the public or the physicians of the adverse effects of the drug. They did not add any warning to their labels to alert the public.
Only in 2020, when the FDA warned the makers to modify its warning label, did they add a note of -symptomatic Hypophosphatemia- to their label. It was a very late action as, in the seven years before that, it had done enough damage to multitudes of patients.
After the warning was added, there was a slight dip in the sales of Injectafer. Adding the warning to the label does not mean that they can escape the liability in Injectafer lawsuits.
Sparking Injectafer Lawsuits
After the episodes of severe HPP cases spawning here and there across the country, many began to file Injectafer lawsuits.
The first of such Injectafer infusion lawsuits were filed in December of 2018. Katherine Crockett of Philadelphia filed a lawsuit against Injectafer. In May 2017, Crockett was prescribed Injectafer. Her blood phosphorus levels nosedived shortly after she received two injections that month.
Plaintiff was later diagnosed with severe Hypophosphatemia, which resulted in multiple hospitalizations, severe nausea, weakness and pain, and severe and constant fatigue.
In January 2020, in the Eastern District of Pennsylvania, one of the Injectafer lawsuits were filed by Maria Munroe. She took the drug in 2018 in two doses, had suffered low phosphate levels and had chronic Hypophosphatemia.
In the same year, in October, Gregory Yova filed a Pharmaceutical Product Liability Suit Against LUITPOLD PHARMACEUTICALS, INC, in the Eastern District of Pennsylvania. Yova reported receiving an Injectafer injection in November 2019 to treat iron deficiency anemia. His phosphate levels, however, dropped to levels indicative of severe and symptomatic Hypophosphatemia (HPP), a serious and potentially life-threatening condition, following the first treatment.
Yova’s lawsuit informs, “Despite aggressive IV Phosphate replenishment and oral supplementation, Plaintiff’s phosphate levels continue to be unstable.”
A Floridian woman, Alexis Todd, had filed an Injectafer lawsuit against the manufacturers. After her second dose of Injectafer, her blood phosphorus level dropped dangerously, and she was hospitalized in the same month in April 2018. She had to discontinue her cancer treatment due to this. Only after two years of the incident her physicians linked the incident to the Injectafer infusion.
In January 2021, Teresa J. Edwards filed her Injectafer lawsuit. From 2018 to 2020, she received around ten infusions of FCM. She suffered the HPP side effects like muscle weakness and fatigue, and severe pain.
In February 2021, Barbara Kessler sued the defendants for her serious physical injuries from the Injectafer drug.
According to two recent lawsuits, taking Injectafer, a drug used to treat iron deficiency #anemia, caused patients to develop dangerously low levels of phosphorus — a condition known as hypophosphatemia, or HPP. https://t.co/NlElpQDW9J
— Drugwatch (@Drug_watch) June 23, 2021
Injectafer Lawsuits Update 2022
More than 100 Injectafer lawsuits have been consolidated before US District Judge Wendy Beetlestone, who is preparing a small group of “bellwether” cases for early trial dates.
Earlier this year, Injectafer lawyers filed a motion to combine Crockett and Jennifer Krueger’s lawsuits for trial in order to save resources and improve judicial efficiency. However, according to an order issued by Judge Beetlestone in July 2022, the two women’s Injectafer lawsuits will be tried separately. Since both cases have significant and specific issues, they should be trialed separately to avoid prejudice and confusion for the jurors.
Since most of the iron deficiency drug Injectafer lawsuits were filed in the district court of Pennsylvania, they were not consolidated into an MDL or Injectafer class action lawsuits so far. If a settlement is not reached in the bellwether trials, the Court will consider the option to consolidate the Injectafer lawsuits into an MDL.
Judge Beetlestone announced on September 15 that the first Injectafer lawsuits trial would begin on June 5, 2023, in a pretrial scheduling order (PDF).
The Court has ordered the plaintiffs to submit the Pretrial Memoranda by May 22, 2023, and the defendants to submit the Pretrial Memoranda by May 29, 2023. Each of these includes a summary of the case, the parties’ respective contentions, any stipulations of counsel, an itemized list of any admissions, witness and exhibit lists, and other key case details.
Stay in touch with us to know the updates on Injectafer lawsuits 2022. We will update you soon.
Are there any Other Iron Infusion Lawsuits?
Other than Injectafer, many other iron infusion drugs are available in the U.S. like Feraheme, Infed, Dexferrum, Ferrlecit and Venofer.
When we consider Injectafer vs Venofer, Injectafer contains the active drug ferric carboxymaltose, whereas Venofer contains the active drug iron sucrose. Both Injectafer and Venofer are iron replacement products. It is also from the same manufacturers of Injectafer. Venofer was approved by the Food and Drug Administration (FDA) on November 6, 2000.
Venofer (iron sucrose) Injection is an iron replacement product used to treat iron deficiency anemia in people with kidney disease. In order to encourage the formation of red blood cells, Venofer is frequently administered along with another drug like Aranesp, Epogen, or Procrit.
Patients on Venofer have experienced severe hypersensitivity events, including anaphylactic-type episodes, some of which have been deadly. Shock, clinically severe hypotension, loss of consciousness, and/or collapse are all possible patient presentations.
For the time being, there are no Venofer lawsuits and only Injectafer is facing the lawsuits.
Queries on Injectafer Lawsuits Answered
Let’s analyze some hot queries regarding Injectafer Iron infusion lawsuits rattling the minds of the victims in the FAQs here.
How long has Injectafer been on the market?
2013 saw the FDA’s initial approval of Injectafer as a 1500 mg course of treatment, given in two doses of up to 750 mg each, spaced by seven days.
How long does Injectafer side effect last?
After taking your dose of Injectafer, the majority of its moderate side effects, such as nausea and dizziness, should go away in approximately 30 minutes.
Is Injectafer safe?
Patients receiving Injectafer have experienced severe hypersensitivity events, including anaphylactic-type reactions, some of which have been deadly and life-threatening. Shock, clinically severe hypotension, loss of consciousness, and/or collapse are all possible patient presentations.
Why are IV Infusion Treatments Given for Iron Deficiency Anemia (IDA)?
In most cases, patients who need IV iron cannot take oral iron. They consist of the following:
- Patients who require prompt iron replacement because they are bleeding in the GI tract (the gut). (IV iron is more quickly absorbed by the body than oral iron.)
- Patients who cannot take oral iron because it irritates their GI system due to inflammatory bowel disease.
- Patients with iron deficiency anemia need to take iron supplements before major blood loss surgeries.
- Sufferers of celiac illness (gluten intolerance).
- People with cancer who are anemic and taking an erythropoietin stimulating agent (ESA).
What causes the Injectafer risk of HPP?
Though Hypophosphatemia is a rare occurrence, it can occur due to the drug ingredient ferric carboxymaltose in Injectafer as a side effect. Some may inherit the disease from the family. Low levels of blood phosphorus can be dangerous to the human body if uncared. If a mild HPP is treated with Injectafer, it can make the situation worse.
What compensation can you expect in Injectafer lawsuits?
The size of the Injectafer lawsuit settlements will be determined by how much HPP injured the plaintiff. The average Injectafer lawsuit settlement amounts for cases involving Injectafer-induced HPP if the plaintiff experienced very severe or long-term health effects might be between $200,000 and $500,000.
What should I do if hurt by Injectafer?
If you experience milder symptoms, consult a physician and follow his advice to either stop taking Injectafer or take medicines to relieve your symptoms. In case of emergency call 911 or reach a nearby ER to get the issue taken care of.
If you feel that you are seriously injured due to the drug, never wait but contact an Injectafer attorney to discuss your case. Proceed with your lawsuit shouldered by your attorney.
What damages can be claimed under Injectafer lawsuits?
The damages that can be claimed in Injectafer lawsuits are as follows:
- Medical expenses incurred during the victim’s recovery
- Predictable medical expenses in the future
- Lost wages
- Lost job opportunities
- Professional setbacks due to the injury
- Loss of ability to earn a living in the future
- Physical pain and discomfort
- Mental anguish and suffering
- Loss of consortium
- Loss of social enjoyment
- Wrongful death (If the victim loses life)
Is there an Injectafer Recall?
In spite of research connecting Injectafer to Hypophosphatemia, the FDA had not ordered a medicine recall. In reality, the government authorized a new Injectafer single-dose formulation in May 2021.
The victims of Injectafer and their attorneys are expecting a positive outcome in the bellwether trials in Injectafer lawsuits scheduled in 2023. A plaintiff-favored verdict in those test trials can turn the wind in their favor towards a global settlement.
Those who are affected should check their medical records to make sure the dosage of Injectafer and the date of iron infusion are documented to pursue Injectafer lawsuits. The efforts you go through to have a top medical record review company review your medical records will be worth it because they are the crucial evidence that will support your Injectafer lawsuits. Your extensive medical records can be mined for crucial information that will persuade the jury to find in your favor with the help of a persuasive medical chronology report.
Brace up with all your evidence to bring the wrongdoers before justice.
Share your thoughts on Injectafer lawsuits and the legal proceeding, if you know any, to keep the victims informed.
Get more insights from our Linkedin account: