Some people who have iron deficiency anemia are unable to tolerate oral treatments for their condition. People who suffer from iron deficiency anemia do not have sufficient iron to make hemoglobin. Hemoglobin is a protein molecule that is located in red blood cells which moves oxygen from the lungs to the remainder of a body. In order to get the help that they need, there is an injectable treatment for them. Fittingly, this is called Injectafer. However, this treatment can be dangerous. Patients have experienced a condition called hypophosphatemia, which is a phosphate deficiency that causes problems with the bones and joints. Injured patients have filed lawsuits against Luitpold Pharmaceuticals, the maker of the drug that allegedly knew of these side effects yet failed to warn the public. Injectafer has been alleged to cause a severe medical condition known as hypophosphatemia (HPP). Injactafer victims diagnosed with hypophosphatemia are pursuing Injectafer lawsuits against American Regent and other entities. These injectafer lawsuits assert that Luitpold, American Regent and other entities did not warn victims of the potential for a hypophosphatemia (HPP) diagnosis.
Injectafer Has a Checkered History, Even Before it Was Approved
Injectafer was approved by the FDA for use in 2013. Even before the FDA approved the treatment, it seemed to have an idea of the dangers of this drug. It took Injectafer six years to gain FDA approval. Injectafer finally received approval on its third try. The FDA had found issues at Luitpold Pharmaceutical’s manufacturing plant. Even when the FDA approved Injectafer, it subjected the treatment to strict limits on the types of patients who could use it. Only patients who had to take an injectable treatment and could not tolerate the oral supplements for certain reasons could be prescribed Injectafer.
Update- 12-16-22- “An Injectafer lawsuit filed by a New York woman claims side effects of the iron infusion caused her blood phosphate levels to drop to critically low levels, resulting in severe and permanent injuries. The complaint (PDF) was filed by Allena Osorio in the Philadelphia Court of Common Pleas on November 16, claiming that the drug makers Luitpold Pharmaceuticals, Inc. American Regent, Inc., Daiichi Sankyo and Vifor (international) AG withheld information from users and the medical community about the risk that the iron infusion may cause severe hypophosphatemia (HPP).” About lawsuits
9-22-22- “In a pretrial scheduling order (PDF) issued on September 15, Judge Beetlestone announced that the first Injectafer trial will begin on June 5, 2023.The Court has directed plaintiffs to submit a Pretrial Memoranda by May 22, 2023, with the Defendants’ Pretrial Memoranda is due by May 29, 2023, each including 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. The Injectafer trial will involve a lawsuit filed by Katherine Crockett in December 2018. According to the complaint (PDF), Crockett, of Philadelphia, was prescribed Injectafer in May 2017. She received two injections that month, and shortly after her blood phosphorous levels plummeted.” About lawsuits
2/14/22- “Injectafer, the world’s most popular treatment for iron deficiency anemia (IDA), is now available for children one year old and up.” Legal Examiner
10/5/2020- MARY WOODFORD files a lawsuit in IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF PENNSYLVANIA against LUITPOLD PHARMACEUTICALS, INC, AMERICAN REGENT, INC. and other entities, alleging she suffered damages as a result of Injectafer.
Injectafer Has Been a Big Moneymaker for Luitpold Pharmaceuticals
Even with the limited market and the difficult FDA approval process, Injectafer has done well for Luitpold Pharmaceutical. Injectafer has had annual sales approaching $500 million. The product’s sales have remained relatively strong after reports of some of the side effects have emerged, falling only 6% in 2020. However, some of the public, knowing the full risks of the product, has now turned away from Injectafer for other types of iron supplements.
Patients are administered the Injectafer treatment in their doctor’s office. They get it either through an intravenous drip or an IV push. Injectafer can be administered in as little as eight minutes. In the past, patients needed two or more treatments. Now, the FDA has approved a single-dose version of the treatment. Injectafer is supposed to raise the patient’s iron levels. An iron deficiency can cause the following symptoms:
- Severe fatigue
- An inflamed or sore tongue
- Cold hands and feet
- Pale skin
Injectafer Can Lead to Severe Hypophosphatemia
Several studies have shown the extent of the danger that patients face from Injectafer. This is not an instance in which a handful of patients experience serious side effects. One study found that around half of patients who undergo Injectafer treatment can experience severe hypophosphatemia. Another study in BMC Medicine looked at women only, and it found that 75% of them suffered from some form of hypophosphatemia after Injectafer treatment.
Phosphate is a crucial part of your daily life. It gives you the energy that you need. Phosphate is a combination of phosphorus and oxygen. Most of your body’s phosphate is found in your bones. Not only does it give you energy, but it also helps build bone and muscle strength. A phosphate deficiency will leave you feeling tired and weak.
Hypophosphatemia is a serious phosphate deficiency. It can lead to the following symptoms:
- Muscle weakness
- Severe muscle fatigue
- Decreased levels of energy
- Weakening of the bones
- Bone pain
- Joint pain
- Altered mental state
Severe cases of hypophosphatemia can even lead to death. There have been cases where hypophosphatemia has affected the respiratory system, keeping patients from being able to breathe normally. At the very minimum, hypophosphatemia will keep you from living a normal life, as you will lack the energy that you need to make it through the day.
The number of reports of serious side effects from Injectafer continues to climb. Now, there are over 5,000 adverse event reports on the FDA’s system.
Luitpold Pharmaceutical Knew of the Risks but Did Not Warn the Public
Here, the problem with Injectafer is that the maker of the treatment completely failed to warn the public of the risk of hypophosphatemia, even as the studies and reports of injuries started to mount. Astonishingly, there was nothing whatsoever on the drug’s warning label, even though this was becoming a known risk. The FDA had to take action, ordering Luitpold Pharmaceuticals to change Injectafer’s warning label in February 2020 to alert the public of the possibility of hypophosphatemia.
Over five years elapsed from the time that the first study detailed the risks of hypophosphatemia until the time that the FDA ordered the change. In the meantime, Luitpold Pharmaceuticals did absolutely nothing, even though the mounting research should have put it on notice of possible risks. During that time. Luitpold Pharmaceuticals racked up around $2 billion in total sales of Injectafer.
Lawsuits Against Luitpold Pharmaceutical for Failure to Warn of Dangers of Injectafer
Now, public lawsuits seeking compensation for the harm caused by Injectafer are about to go to trial in federal court in Pennsylvania. The main allegation in these lawsuits is that Luitpold Pharmaceuticals did not warn of the danger of Injectafer. One of the ways that a product can be defective is in its marketing. If the maker of a drug knows or should have known of a specific danger, it has an obligation to warn the general public and let them make their own decision about whether the risks of the product are worth it.
Damages in an Injectafer Lawsuit
If Luitpold Pharmaceuticals loses the initial bellwether cases, it may look to settle future cases. Given the number of adverse event reports of injury, there could be hundreds or thousands of lawsuits in the future. If you or a loved one have been injured by Injectafer, you may be entitled to the following damages:
- Lost wages
- Pain and suffering
- Medical bills
- Emotional distress
- Loss of enjoyment of life
If your loved one died from their Injectafer injuries, you can file a wrongful death lawsuit against the manufacturer to recover your family’s own damages from losing a family member. First, you need to contact an experienced product liability attorney who knows how to take legal action against a company for defective drugs.