Injectafer Lawsuits

As of November 2024, most lawyers have stopped accepting new Injectafer lawsuits. 

Several cases consolidated into mini multidistrict litigation in the Eastern District of Pennsylvania federal court entered into an apparent settlement with Luitpold Pharmaceuticals. These cases were before Judge Wendy J. Beetlestone. 

Status of Injectafer Lawsuits

• December 2023: Crockett was dismissed with prejudice.
• October 2023: Judge Beetlestone signed an Order to Establish Qualified Settlement Fund between Luitpold Pharmaceuticals and 13 plaintiffs in the Eastern District of Pennsylvania.
• April 2023: Judge Beetlestone vacated the order scheduling Crockett for trial on June 5, 2023. The litigation has been stayed, and the judge asked the parties to update her every 30 days.
• March 2023: Plaintiffs filed a motion to seal medical records and private information in the Crockett case.
• January 2023: Judge Beetlestone signed a second unopposed stipulation and ordered that Crockett is still scheduled for trial on June 5, 2023. Plaintiffs filed motions to exclude defendant’s expert testimony.
• December 2022: The second trial will be Atkinson v. Luitpold Pharma., Inc. et al., No. 19-277, which was scheduled for October 2, 2023. The third trial will be Krueger v. Luitpold Pharma., Inc. et al., No. 19-984 which was scheduled for November 29, 2023.
• September 2022: Judge Beetlestone set the first bellwether test trial, Crockett V. Luitpold Pharmaceuticals, Inc. et al., 2:19-cv-00276-WB, for June 5, 2023.
• August 2021: Judge Beetlestone denied the plaintiffs’ motion to consolidate cases for trial.

So far, there haven’t been any court-approved settlement amounts that have been made public and no jury verdicts. 

People who filed Injectafer lawsuits say the drug’s makers defectively designed the drug because it greatly increases the risk of hypophosphatemia.

In addition, though the drug has been on the market since 2013, drugmakers didn’t add a warning to the label until February 2020. Even then, lawsuits claim the warning added in 2020 is not adequate for patients and medical providers.

Plaintiffs claim physical, emotional and financial damages. Defendants include Luitpold Pharmaceuticals Inc., American Regent Inc. and Daiichi Sankyo.

As of November 2022, there are about 53 Injectafer lawsuits filed in Pennsylvania and Florida courts.

Maria and Anthony Munroe

Maria and Anthony Munroe filed their lawsuit in the Eastern District of Pennsylvania in January 2020. Maria Munroe began taking Injectafer in September 2018. After two infusions, she suffered from low phosphate levels and ended up in the hospital. She now suffers from chronic HPP.

Gregory and Margaret Yova

Gregory and Margaret Yova filed their lawsuit in the US District Court for the Eastern District of Pennsylvania in October 2020. Gregory Yoya received one injection of Injectafer in November 2019. Because of severe HPP, he was hospitalized and his phosphate levels have never recovered.

His injuries include: “Severe fatigue, brain fog, hip pain, muscle weakness and cramping, ongoing generalized weakness, chest heaviness and pain, unstable INR, and severe abdominal pain as a side-effect of phosphate supplementation.”

Teresa J. Edwards

Teresa J. Edwards filed her lawsuit in January 2021. She had received 10 infusions over the course of several months from 2018 to 2020. She suffered symptoms of HPP including: Severe muscle fatigue and weakness, severe fatigue and severe and extended pain.

HPP is typically rare and can be inherited or caused by medical conditions in adulthood, but some studies have linked ferric carboxymaltose, Injectafer’s active ingredient, to severe hypophosphatemia.

A key 2016 study published in PLoS One by Benedikt Schaefer and colleagues found Injectafer was associated with a 20-fold higher risk of HPP than iron isomaltoside 1000. Eighteen of the HPP cases studied were severe or life threatening. In contrast, only one patient who took iron isomaltoside suffered from a mild case of HPP.

Myles Wolf and colleagues published a 2018 study in JCI Insight that found 50.8 percent of 1,000 of patients who took Injectafer developed HPP versus only 0.9 percent of 997 of those who took Feraheme (ferumoxytol).

FDA Denials

In addition, the U.S. Food and Drug Administration denied Luitpold’s new drug application for Injectafer in 2006 and again in 2008 for clinical safety concerns.

Symptoms of Hypophosphatemia

Mild cases of hypophosphatemia in adults don’t usually cause symptoms. But prolonged severe hypophosphatemia can result in serious symptoms such as seizures or heart failure.

People who file Injectafer lawsuits may do so to hold Luitpold and other drug manufacturers accountable for failing to warn people about the risk of HPP.

Plaintiffs may also receive compensatory damages for physical, emotional and financial losses caused by an HPP diagnosis and treatment.

Anyone who had at least one administration of Injectafer in 2013 or later and suffered from symptoms of hypophosphatemia may contact an attorney for a free case review.

Only an experienced attorney can tell you if you qualify to file a lawsuit.

Family members who lost loved ones because of severe hypophosphatemia after taking Injectafer may qualify to file a wrongful death claim.

There are time limits to file a claim and these vary depending on the state. Talk to an attorney right away to preserve your right to file.

Despite studies linking Injectafer to hypophosphatemia, the FDA had not issued a recall for the drug.

In fact, the agency approved a new single dose formula of Injectafer in May 2021. The current formula is a two-dose course of treatment for a total of 1,500 mg. The new single dose is one injection of 1,000 mg.

In 2015, the FDA issued a warning letter to Luitpold for attempting to promote Injectafer for unapproved uses and for presenting misleading claims about the drug in a video ad.