Injectafer is an intravenous medication prescribed to patients who suffer from iron deficiency anemia. Iron plays a significant role in the body because it facilitates the production of red blood cells. If you suffer from iron deficiency, your body may not produce enough blood cells, limiting the distribution of oxygen in the body. There are many forms of anemia, and the most common is iron-deficiency anemia. This condition affects a large number of Americans. Despite the effectiveness of Injectafer in treating anemia, Injectafer patients have a higher risk of developing hypophosphatemia. Hypophosphatemia often results in detrimental health complications. Many consumers have filled mass torts against Injectafer manufacturers due to the adverse effects of the disease. If you’ve experienced adverse side effects after using Injectafer, Consumer Alert Now can help you take part in mass tort and seek compensation.
Side Effects of Injectafer
The generic name for Injectafer is Ferric Carboxymaltose, an iron carbohydrate complex that comes in handy in treating iron deficiency in adults. Injectafer is associated with severe hypophosphatemia, a low level of phosphorus in the blood. Injectafer works best for adults with iron deficiency anemia who:
- Didn’t respond adequately to oral iron
- Can’t tolerate oral iron supplements
- Have a chronic kidney disease which is non-dialysis dependent
In 2008, the FDA (Food & Drug Administration) rejected Injectafer as a treatment for iron deficiency. The decline was after a clinical trial revealed that the drug led to severe hypophosphatemia and excess mortality. However, the agency finally approved Injectafer in 2013 but restricted its use to certain anemic adult patients.
In 2013, BMC Nephrology conducted a study on 447 patients with chronic kidney disease. This study revealed a significant decline in serum phosphorus in the patients only three weeks after receiving the Injectafer treatment. The phosphorus levels remained low twelve weeks after receiving the Injectafer treatment.
As research in Injectafer continues to develop, it’s evident that the drug could cause severe hypophosphatemia, unlike other iron supplements injected into people with iron deficiency. In an Austrian study conducted in 2016, it was evident that 45 percent of patients who received Injectafer treatment developed hypophosphatemia. Of all the patients who received Injectafer treatment, 32% developed extreme or severe hypophosphatemia. Only a small percentage of patients treated with other iron-deficiency drugs developed hypophosphatemia, and no patient developed severe hypophosphatemia like in the case of Injectafer treatment.
A recent study was published in the journal of Clinical Investigation. This study involved a clinical study on almost 2000 adults who received iron deficiency treatment between February 2016 and January 2017. Half of the patients received Injectafer treatments, while the other half received Feraheme treatment. Two and five weeks after receiving the treatment, the patients underwent a test for hypophosphatemia. The tests revealed that:
- Out of the patients who received Injectafer treatment, 50.8% of the patients exhibited severe hypophosphatemia signs, and only 0.9% of the patients who received Feraheme treatment showed similar signs.
- 1 in every 10 patients who received Injectafer treatment had signs of severe hypophosphatemia, while none of the patients who received Feraheme treatment developed severe hypophosphatemia.
- By the end of the study, 29.1% of the patients who received Injectafer treatment developed severe hypophosphatemia, and none of the patients who received Feraheme treatment had these signs.
The Nation’s First Injectafer Lawsuit
The first Injectafer lawsuit in the U.S took place on January 18, 2019, in Pennsylvania. The lawsuit was filed in the U.S. District Court in the Eastern District of Pennsylvania. This lawsuit was filed less than one month after the findings on the adverse effects of Injectafer were published in the Journal of Clinical Investigation.
Two years after the approval of Injectafer, FDA issued a warning letter to Luitpold Pharmaceuticals for issuing misleading claims about Injectafer, which did not disclose the drug’s potential risks. The video promoting Injectafer aired in 2014. This controversial video outlined that Injectafer was ideal for treating all patients suffering from iron deficiency anemia. According to this video, Injectafer could be used to treat anemic children as well.
However, FDA approved and limited the use of Injectafer to adults only who can’t use or are not responsive to oral iron use. FDA also approved the use of Injectafer by adults with non-dialysis dependent kidney illness.
The video aired by Luitpold Pharmaceuticals did not portray the side effects of Injectafer. Instead, the video portrayed the side effects of Injectafer in tiny and hard-to-read text. The text outlining the side effects of Injectafer appeared at the bottom of the screen and aired for less than 30 seconds. The video highlighted the side effects of other anemia treatments but didn't disclose that Injectafer could also have similar side effects.
The basis of the FDA’s warning letter was the misleading information regarding Injectafer that the video portrayed. The video implied that Injectafer offered both therapeutic and non-therapeutic advantages over other treatment methods for anemia. FDA pointed out that it wasn’t aware that Injectafer provided significant advantages over other treatment options for anemia.
Identifying Symptoms of Hypophosphatemia
For you to be able to file a lawsuit and get compensation for the adverse side effects of Injectafer, it should be evident that you suffered the said side effects. Hypophosphatemia, which is the primary side effect of Injectafer, occurs when the serum phosphorus levels go below 2.5 mg/Dl. If the serum phosphorus levels go below 1.0mgdl, the effects are even more severe.
Other factors, other than the side effects of Injectafer, could increase your risk of developing hypophosphatemia. Some of the risk factors for hypophosphatemia are alcoholism, vitamin D deficiency, hyperparathyroidism, sepsis or blood infection, anorexia or malnourishment, and long-term use of medications like antacids, diuretics, corticosteroids, and other medications.
If you’re suffering from mild hypophosphatemia, you may not experience any signs of phosphorous deficiency. However, in a case of severe hypophosphatemia, you may experience visible signs of phosphorous deficiency like:
- Bone fractures
- Bone pain
- Muscle weakness
- Tremors, tingling, and numbness
- Bone fractures
What happens if you don’t seek treatment for severe hypophosphatemia? If you fail to receive treatment for severe hypophosphatemia, the condition could lead to more complications like:
- Respiratory failure
- Muscle death (Rhabdomyolysis)
- Fatal heart arrhythmias
- Acute hemolytic anemia (destruction of red blood cells)
People suffering from mild hypophosphatemia can treat the condition by adding foods rich in phosphorus into their diet. These foods include dairy products and milk. Patients suffering from mild hypophosphatemia may also benefit from taking phosphorus supplements. If vitamin D deficiency is also contributing to hypophosphatemia, taking vitamin D supplements could reverse the condition.
Cases of severe hypophosphatemia are not easy to reverse. In most cases, these cases can only be reversed through intravenous injections with phosphorus supplements.
Manufacturer’s Warning Regarding Injectafer Side Effects
Even though medical studies indicate that Injectafer has numerous side effects, the manufacturers and users of Injectafer did not issue ample warnings to Injectafer users. For a long time, the drug’s label didn’t mention the symptomatic or severe hypophosphatemia that could result from Injectafer treatment.
However, from February 19, 2020, the manufacturer updated the drug’s label to include a warning that Injectafer could lead to symptomatic hypophosphatemia. However, this label does not address the severity of the hypophosphatemia level that could result from the use of Injectafer.
The new warning on the effects of Injectafer does not address the severity of hypophosphatemia (HPP) that could result from using Injectafer. The warning does not state that using Injectafer could increase the risk of HPP more than other drugs that treat iron deficiency anemia.
The failure to warn about the actual effects of Injectafer forms the legal basis for filing lawsuits on the adverse effects of Injectafer. Victims have filed numerous lawsuits against American Regent, Inc., which is the company responsible for manufacturing Injectafer in the U.S. The American Regent Inc. is a subsidiary of Luitpold Pharmaceuticals Inc.
Drug attorneys across the United States work tirelessly as they investigate the Injectafer claims that revolve around patients who suffered severe effects after using the drug. In addition to experiencing HPP, other patients developed additional adverse medical conditions after using Injectafer.
Drugs don’t have to be completely safe, and it’s normal for drugs to have certain side effects. However, drug manufacturers have a legal duty to ensure that they warn doctors and consumers about the side effects of certain drugs. Warning people about the side effects of certain drugs gives them a chance to make informed treatment decisions.
American Regent Inc. constantly boasted about the size of their safety database. However, the drugmaker was never willing to address the connection between Injectafer and the severe cases of hypophosphatemia.
Filing a Lawsuit
If you or your loved one has developed severe side effects after receiving Injectafer treatment, you can join other victims in the U.S. in filing a lawsuit against the drug manufacturers. You can file a lawsuit against American Regent Inc. and Luitpold Pharmaceuticals Inc. for:
- Failing to warn consumers and physicians about the potential risks of developing hypophosphatemia after undergoing Injectafer treatment
- Ignoring or failing to react to studies regarding the severe hypophosphatemia that results from Injectafer use
- Releasing the drug into the market despite knowing that Injectafer use could lead to low phosphorus levels in the blood
- Marketing Injectafer and portraying it as a safe and effective treatment of iron deficiency anemia without revealing the potential risks of the drug despite being aware of the risks
You can take part in a mass tort alongside other plaintiffs that have suffered harm due to the same drug. A mass tort includes a large group of plaintiffs who have suffered harm after using a certain product, mainly drugs. The plaintiffs have a common defendant or defendants who allegedly caused the said harm. The lawsuit is consolidated into one action.
In a mass tort, every plaintiff is treated as an individual despite being part of a large group. Therefore, facts regarding a plaintiff must be established, including the loss that the plaintiff has suffered due to the products issued by the defendant.
Possible Settlements for Injectafer Lawsuits
If you develop complications after undergoing Injectafer treatment, you can file a mass tort against the drug manufacturer to ensure that you get the compensation you deserve. Some of the possible settlements for Injectafer lawsuits are:
You may need to undergo medical testing and treatment after developing adverse side effects. If you need to seek medical treatment of any kind, including nursing home stays and hospital stays, the defendant should pay for your treatment costs. HPP may lead to bone fractures and muscle death. In this case, you may need to undergo many months of physical therapy to restore bones and muscles to normalcy.
The cost of seeking treatment may be high, especially if you develop severe hypophosphatemia. Some people fall into a coma after developing hypophosphatemia. You may need a lifetime of adaptive devices and other forms of expensive treatment. Your medical costs claim should include every medical expense that you have to pay in the course of receiving treatment for the side effects. Ensure that you consider both the current and future medical costs. You should also ensure that you consider the costs of all medication that you may require during treatment.
For you to be able to prove the extent of your medical costs, you should keep a record of all your expenses. Whenever you visit a doctor, request him or her to provide you with a copy of your medical report. This will make it easy for you to prove the extent of the medical costs incurred while seeking treatment for Injectafer complications or side effects.
Lost Wages and Loss of Earning Capacity
The adverse side effects of Injectafer may be extreme and make you take some time off work to undergo treatment. The liable party should compensate for the loss payment for any work that you had to miss because of the complications or while seeking treatment for the complications. The compensation for lost wages may vary depending on several factors. The court will consider your regular rate of pay. For instance, the court may consider your hourly rate of pay and multiply it with the total number of hours spent away from work. For example, if you earn $30 per hour, working for 8 hours a day and you end up spending ten days from work, your compensation for lost wages will be $30*8*10= $2,400
The court may also consider other factors like your vacation days and your sick time. While calculating lost wages, other factors that the court may consider include commissions and bonuses that you would have received. The court may request for your employment records as proof of your wages.
What happens if you’re not employed? If you’re self-employed, the court will consider the income you used to make before the complications and compensate you based on it. The court may request certain documents as proof of income, including your tax return documents.
The adverse effects of Injectafer may have life-time complications. Therefore, you may be permanently unable to work because of the adverse effects of the drug. In this case, you may seek compensation for loss of earning capacity. Loss of earning capacity is the inability to make some money in the future.
While calculating the loss of your future ability to work, the court will consider various factors, including the remaining period to your retirement. The court may also consider your life expectancy.
Pain and Suffering
Some of the leading symptoms of extreme hypophosphatemia include seizures, respiratory failure, muscle death, fatal heart arrhythmias, confusion, coma, delirium, and acute hemolytic anemia. All these side effects could have a toll on your life, leading to intense pain and suffering. Therefore, you may file an Injectafer lawsuit to seek compensation for pain and suffering.
Unlike economic damages that are easy to define and calculate, pain and suffering are not easy to calculate. You’ll need the assistance of a legal expert to determine the extent of your pain and suffering. The judge will use his or her discretion to determine the extent of your pain and suffering. The defendant’s insurer may adopt various techniques of calculating pain and suffering, including the pain multiplier technique.
You may also receive compensation for emotional distress arising from the complications and side effects of Injectafer. Hypophosphatemia could have emotional ramifications on you. To prove emotional distress, you may have to present psychiatric records explaining the extent of your emotional distress. Diagnosis of conditions like post-traumatic stress may indicate that you indeed suffered emotional distress due to the negative side effects of Injectafer.
Loss of Enjoyment in Life
In extreme hypophosphatemia, the symptoms may be so severe that you may no longer be able to lead a normal life. For instance, hypophosphatemia could lead to muscle death. In this case, it would be hard for you to continue taking part in your hobbies and other fun activities. You may fear visiting public places to avoid criticism. You may not have the physical strength to take part in sports and other physical activities. You can file a lawsuit against the manufacturers of Injectafer to seek compensation for loss of enjoyment in life.
Loss of Consortium
The adverse side effects of Injectafer could prevent you from enjoying a healthy relationship with your spouse. Therefore, your spouse may file a lawsuit and seek compensation for loss of consortium. Your spouse may also file a loss of consortium lawsuit if you succumb to the adverse symptoms of hypophosphatemia and other adverse complications of Injectafer.
Loss of consortium compensates your loved one for the loss of a relationship, companionship, and sexual relations. As long as your partner can prove that he or she can no longer have normal intimate relations with you due to your injuries, he or she will receive compensation.
Extreme cases of hypophosphatemia could lead to coma and even death. If you lose your loved one due to the side effects of Injectafer, you can file a wrongful death claim to seek compensation. As long as your loved one's death resulted from the negligence or the wrongful act of another person, you can seek compensation. In the case of Injectafer, you can hold the manufacturers liable for failing to warn about the drug’s negative side effects. The manufacturers may also be responsible for marketing Injectafer safe for people of all ages without highlighting that Injectafer could lead to extreme hypophosphatemia.
People who can file a wrongful death claim include the immediate family members of the deceased person, including the spouse, children including adopted children, and parents of the deceased. In some instances, the siblings and the grandparents of the deceased person may also file a lawsuit. The domestic or life partners of the deceased person may also file a wrongful death claim. Any financial dependent of the deceased may qualify to file a wrongful death claim.
Some of the damages that you may recover in a wrongful death claim include:
- Funeral expenses
- Loss of parental guidance awarded to the deceased person’s children
- Loss of spousal support and companionship
- Loss of decedents benefits
- Loss of future inheritance
- Pain and suffering experienced by the survivors after losing their loved one
- Pain and suffering of the decedent before his or her death
Stages of Filing a Mass Tort
To know whether you have a case, your mass tort attorney will review several records, including your Injectafer treatment records. The attorney will also review the statements of your injuries. Your attorney may also review your medical records to ensure that your symptoms are due to Injectafer use and not due to an underlying medical condition.
During mass tort litigation, the defendant may not be willing to accept fault. Injectafer manufacturers may claim that your symptoms are not arising from the drug but other medical conditions. Your symptoms need to match those of other plaintiffs who have suffered severe side effects of the same drug.
Have you suffered adverse complications after undergoing Injectafer treatment? There is a way for you to seek compensation for your damages. Consumer Alert Now can guide you on how to file mass tort and seek compensation for your damages. We have helped many people across the U.S to seek compensation. Contact us at 800-511-0747 and speak to us.