Injectafer is a drug used to manage iron deficiency anemia. It is one of the intravenous iron therapies designed to help patients with low tolerance to oral iron supplements.
However, Injectafer was recognized to be unsafe even before FDA approval. About half of those who have used Injectafer have experienced major problems due to high phosphate levels in the blood.
If you have been harmed after using Injectafer, you may hold the manufacturer, Luitpold Pharmaceuticals, liable by filing an Injectafer infusion lawsuit.
Injectafer Infusion Lawsuit Updates
January 2023 Update
Spero v. Luitpold Pharmaceuticals, Inc. (22-cv-04876) is the most recently filed Injectafer infusion lawsuit. The lawsuit was filed by an Arizona woman in the Eastern District of Pennsylvania last month.
Spero has iron deficiency anemia, and Injectafer was given to treat her illness. She had her first Injectafer injection in September 2020, followed by a second one a week later.
Spero experienced severe hypophosphatemia (HPP) after receiving her second shot, which resulted in excruciating pain and possible long-term complications.
According to this lawsuit, the drug directly caused Spero’s injuries, and the accused negligently failed to warn the public of this risk.
July 25, 2022 Update
So far, in 2022, thirteen Injectafer infusion lawsuits have been filed in federal courts. Of these cases, only one was filed in the Middle District of Florida; the rest were filed in the Eastern District of Pennsylvania.
About 40 Injectafer infusion lawsuits are now active in federal court, while a comparable number of lawsuits are proceeding in Pennsylvania state courts.
There is still no sign of a class action MDL consolidation, which is unlikely to change unless the number of lawsuits significantly increases. Pennsylvania state court will likely hear the first Injectafer infusion lawsuit.
May 28, 2022 Update
Biofer SpA has sued Vifor Pharma AG. According to this lawsuit, the creation of Injectafer’s active ingredient violates a patent owned by Biofer.
December 9, 2021 Update
A new case study published in the Slovenian Medical Journal offers insight into how Injectafer iron infusions trigger fatally low phosphate levels in the bloodstream.
In this report, a 33-year-old woman administered Injectafer to treat her anemia developed severe HPP. The study emphasizes the risk involved with using Injectafer and the need for closely monitoring a patient’s phosphate levels after administering the injection.
November 3, 2021 Update
New Injectafer infusion lawsuits are still being filed in the Philadelphia County Court of Common Pleas.
September 30, 2021 Update
A motion to merge the jury trials of the first two Injectafer infusion lawsuits was denied by a federal court in Philadelphia last month.
The two lawsuits are part of a bigger group of 80 Injectafer infusion lawsuits consolidated with permission for pretrial management (sort of a mini MDL).
Consolidating these first two cases was not suitable, according to the court since there would be no improvement in the judicial economy.
The court also mentioned the risk of prejudice and jury misunderstanding in the two cases because they addressed rather distinct and unique concerns.
These two cases—the first Injectafer lawsuits ever to get to trial—will function like bellwether trials in a complete MDL.
The outcome of these lawsuits will significantly influence how the other over 80 cases are addressed. However, it is unclear if the outcomes of these early trials will serve as the foundation for settlement discussions or if they are only the first of many.
What is Injectafer?
Injectafer (ferric carboxymaltose) is an infusion used as an iron supplement and is only available by prescription. The drug was designed for individuals with iron deficiency anemia (IDA) who cannot take oral iron supplements.
People with anemia caused by chronic renal disease can also be treated with Injectafer. This drug was approved and introduced into the American market in 2013 by Vifor Pharmaceuticals, a Japanese Pharmaceutical conglomerate Daiichi Sankyo subsidiary.
For a doctor to prescribe Injectafer, you must have a medical history and physical examination showing kidney disease or IDA with intolerance to oral iron. Users should have lab results showing no iron concentrations or hemoglobin increase after oral iron intake.
IDA patients have low iron levels, which is crucial to ensuring that the body creates adequate red blood cells. Red blood cell deficiency and poor health are two consequences of iron deficiency.
Traditionally, oral iron supplements were used to treat IDA. The pharmaceutical industry has just started to develop and offer intravenous iron supplements for people who are reluctant or cannot take oral iron supplements. Injectafer is just one of the many intravenous iron products sold in the U.S.
Studies Link Injectafer to Severe Hypophosphatemia (HPP)
Several scientific research investigations have convincingly shown a causal relationship between Injectafer and hypophosphatemia (HPP). The International Journal of Rheumatology published the first study on this in 2015.
According to the study, more than half of all Injectafer patients experienced HPP, which is about twice as prevalent as in the control group.
Injectafer was tested on 2,000 study subjects in a 2018 study published in the Journal of Clinical Investigation. It was discovered that HPP occurred in half of them.
In comparison, after administering another iron injection medication, only one percent of individuals in the control group suffered HPP.
Similar findings were obtained from a 2019 Norwegian study that identified HPP in 56% of Injectafer patients.
FDA Denials
Additionally, due to concerns about clinical safety, the U.S. Food and Medicine Administration rejected Luitpold’s new drug application for Injectafer twice, first in 2006 and then again in 2008.
- The FDA previously rejected Injectafer due to many safety issues, including:
- More individuals died while taking Injectafer compared to controls
- Those who used Injectafer experienced more severe side effects compared to oral iron
- Clinically vital hypophosphatemia
Symptoms of Hypophosphatemia
Adults with mild hypophosphatemia typically don’t have any symptoms. However, persistent severe hypophosphatemia can cause grave symptoms, including seizures or heart failure.
HPP symptoms include:
- Bone pain and fractures
- Softening of the bones
- Fatigue
- Heart failure or heart attack
- Heart arrhythmias
- Muscle weakness and pain
- Respiratory failure
- Difficulty breathing
- Irritability
- Seizures
Ferric Carboxmaltose Lawsuits Claim Failure to Warn
Injectafer was introduced to the U.S. market without proper warning labels or caution to healthcare professionals, even though it was known to cause severe HPP. Every Injectafer infusion lawsuit attorney will make this the main defense in any legal action.
The label for Injectafer does not mention “severe HPP” and gives no instructions on how to watch for symptoms of severe HPP following injections.
Instead, the Injectafer producers continuously understated and concealed the risks of their medication and severe HPP.
Fundamentally, this is what the cases over ferric carboxymaltose iron replacement are about. It seems obvious that Vifor negligently failed to appropriately notify customers about the dangers of severe HPP connected with Injectafer.
This failure was the foundation for the increasing number of lawsuits that people who got severe HPP from Injectafer and were badly affected as a result have brought in the United States.
Injectafer HPP Lawsuits
Individuals filing Injectafer infusion lawsuits claim that the drug’s producers created a defective product since it dramatically increases the risk of hypophosphatemia.
The manufacturers failed to include a warning on the label until February 2020, yet the drug has been available since 2013. Even then, plaintiffs contend that the 2020 warning is insufficient for patients and healthcare professionals.
The plaintiffs seek physical, financial, and emotional damages from Luitpold Pharmaceuticals and Daiichi Sankyo, the defendants. About 53 Injectafer cases were submitted to Pennsylvania and Florida law courts as of November 2022.
Maria and Anthony Munroe
In January 2020, Maria and Anthony Munroe filed a suit in the Eastern District of Pennsylvania. Maria Munroe started using Injectafer in September 2018.
But two infusions later, she experienced low phosphate levels, which led to her hospitalization. She has been suffering from chronic HPP since then.
Gregory and Margaret Yova
In October 2020, Gregory and Margaret Yova lodged their complaint to the Eastern District of Pennsylvania U.S. District Court.
Gregory received one Injectafer shot in November 2019. He suffered severe HPP leading to hospitalization, and his phosphate levels have never improved.
His symptoms include severe fatigue, hip pain, muscular weakness and cramping, chest heaviness and pain, persistent generalized weakness, brain fog, and severe stomach pain as a side effect of phosphate supplementation.
Teresa J. Edwards
Teresa J. Edwards submitted her complaint in January 2021. She underwent ten injections spread out over several months between 2018 and 2020.
She experienced acute weakness, fatigue in her muscles, and chronic and severe pain, all of which were HPP symptoms.
Reasons to File an Injectafer Infusion Lawsuit
Luitpold and other pharmaceutical manufacturers could be held responsible in Injectafer infusion lawsuits for failing to warn consumers of HPP’s risk.
In addition, plaintiffs may be awarded compensatory damages for losses they suffered due to an HPP diagnosis and related medical care.
Compensation may cover the following:
- Medical costs for diagnosis and treatment of HPP
- Reduced ability to earn due to HPP-related symptoms
- Current and future health costs for chronic HPP and lifelong phosphate supplementation
- Pain and suffering
- Reduced quality of life
- Lost wages from hospitalizations or medical visits brought on by HPP; may include lost pay for family members.
- Loss of companionship for the spouse
Punitive damages have also frequently been granted in lawsuits involving defective drugs.
Punitive damages are uncommon, but they aim to hold offenders accountable for bad behavior, even if it means giving victims far more money than they would need to compensate for their losses properly.
Who Can File a Lawsuit?
Anyone who received at least one dose of Injectafer anytime from 2013 and experienced hypophosphatemia symptoms may speak with a lawyer for a free case evaluation.
Only a skilled lawyer can inform you whether you can file an Injectafer infusion lawsuit. You might be eligible to claim for damages if you had any of the following harm as a result of using Injectafer:
- Acute kidney failure
- Renal wasting
- Hypophosphatemia or severe hypophosphatemia
- Cardiac arrest
- Cardiac arrhythmias or dysrhythmias
- Respiratory failure
- Severe muscle weakness or fatigue
- Severe pain
- Drop in blood phosphorus
- Osteomalacia (softening of the bones)
Families who lost loved ones following severe hypophosphatemia after using Injectafer may be eligible to pursue legal action for wrongful death.
There are deadlines for filing a claim, which differs from state to state. To protect your right to file, speak with a lawyer as soon as possible.
Is There a Recall for Injectafer?
Despite research studies relating Injectafer with hypophosphatemia, the FDA is yet to order a recall for the drug.
Shockingly, the government approved a new Injectafer single dosage formula in May 2021. The present formula is a double-dose 1,500 mg regimen. The new single-dose injection contains 1,000 mg.
The FDA wrote Luitpold a warning letter in 2015 for trying to advertise Injectafer for unauthorized uses and for making misleading statements about the medication in a video advertisement. But there’s not been further action since then.
Contact an Injectafer Infusion Lawsuit Attorney
Law firms are filing Injectafer infusion lawsuits against Luitpold Pharmaceuticals for the severe and long-lasting HPP that their clients experienced due to using the harmful drug.
You may be able to file a lawsuit if Injectafer has harmed you or a loved one. Drug firms and manufacturers of defective products and devices are required to compensate when their product causes you injury.
However, you must speak to an attorney immediately to file an Injectafer infusion lawsuit before the statute of limitations expires. Legal Giant can reduce the stress of hiring by linking you with a competent personal injury attorney.
Contact us for a free case evaluation today.
