What Is the Lawsuit Against Injectafer? Claims, Trials, Filing

The Injectafer lawsuit is a mass tort in which hundreds of patients accused the makers of the intravenous iron drug Injectafer (ferric carboxymaltose) of failing to warn that it can cause severe hypophosphatemia, a dangerous drop in blood phosphate levels linked to broken bones, muscle weakness, heart problems, and other serious injuries. The cases were consolidated in federal court in the Eastern District of Pennsylvania as MDL No. 2948, and by 2024 many of them had reached settlements with the manufacturer. No settlement amounts have been made public, and no case has produced a jury verdict.¹

Why Patients Sued

Injectafer is an IV iron infusion approved by the FDA in July 2013 to treat iron deficiency anemia in adults who cannot tolerate oral iron.² Clinical studies have shown it depletes phosphate at rates far higher than competing IV iron products. The drug interferes with the body’s ability to break down a hormone called FGF23, which builds up and forces the kidneys to flush phosphate out through urine.³

The trial numbers are striking. In a randomized study of roughly 2,000 patients, about 51% of Injectafer patients developed severe hypophosphatemia compared to less than 1% of patients given ferumoxytol.³ In the PHOSPHARE trials, 74% of Injectafer patients developed hypophosphatemia versus 8% of those on ferric derisomaltose. The problem is not always brief. One chart review put the average duration of hypophosphatemia in Injectafer patients at six months, and some patients never returned to normal levels during a two-year follow-up.⁴

The injuries plaintiffs blame on that phosphate depletion include:

Osteomalacia (softening of the bones), insufficiency fractures of the ribs, pelvis, spine, hips, and feet, and persistent bone pain.⁴
Proximal muscle weakness, rhabdomyolysis, gait problems, and in some cases the need for crutches or a wheelchair.⁵
Cardiac events including heart failure, arrhythmias, and atrial fibrillation.
Respiratory failure and respiratory distress.
Seizures and coma.

FDA adverse event reports compiled as of April 2021 counted 47 bone fractures, 33 cases of osteomalacia, 62 cases of respiratory distress, 26 cases of cardiac failure, and 43 seizures linked to Injectafer and its international equivalent Ferinject.⁵

What the Complaints Allege the Manufacturers Knew

The core allegation is that the companies behind Injectafer knew about the hypophosphatemia risk long before patients did. According to the complaint in the lead case, Crockett v. Luitpold Pharmaceuticals, Inc., when Luitpold first sought FDA approval in 2006 and 2007, the agency itself flagged “clinically important hypophosphatemia” as a safety concern and issued non-approvable letters.⁶

When the drug was approved in July 2013, the label did not warn about severe hypophosphatemia. Decreased blood phosphorus appeared only as an “adverse reaction” in more than 2% of users, and the effect was described as “transient” or “asymptomatic.” Plaintiffs say that language mischaracterized a condition that affected a majority of patients in clinical trials, could persist for months, and could cause debilitating bone and organ damage. The complaint cites studies showing Injectafer’s hypophosphatemia rate was roughly 20 times higher than competing iron products.⁶

How the Label Changed

The Injectafer prescribing information went through several revisions:

From July 2013 through January 2018, the label referred to “asymptomatic reductions in blood phosphorous” and listed hypophosphatemia only as an adverse reaction.⁶
In January 2018, “asymptomatic” was removed, but no specific warning about severe hypophosphatemia was added.
In February 2020, the FDA approved a revised label adding “Symptomatic Hypophosphatemia” to the Warnings and Precautions section, noting postmarketing reports of cases requiring clinical intervention.²
In May 2023, the label was updated again to state that “serious outcomes including osteomalacia and fractures requiring clinical intervention” had been reported.⁷

Plaintiffs contend that even the 2020 warning came too late and continues to understate the risk.⁸

Where the Cases Were Filed and Against Whom

The federal cases were consolidated as MDL No. 2948 in the U.S. District Court for the Eastern District of Pennsylvania before Judge Wendy Beetlestone.⁹ Additional cases were filed in the Philadelphia County Court of Common Pleas. The defendants named in most complaints are Luitpold Pharmaceuticals, Inc. (now American Regent), American Regent, Inc., Daiichi Sankyo, and Vifor Pharma entities. Luitpold merged with American Regent in January 2019, and the combined company now operates under the American Regent name.¹⁰

The cases were structured as individual lawsuits within a mass tort, not a class action. Each plaintiff’s claim is evaluated on their own injuries, medical history, and damages.¹¹

Bellwether Trials and Settlements

The court picked three bellwether cases to test how juries might respond to the evidence. None reached a verdict.

Crockett v. Luitpold Pharmaceuticals (No. 2:19-cv-00276-WB), the first bellwether, was originally set for trial in June 2023. The trial date was vacated in April 2023 during a stay, and the case was dismissed with prejudice in December 2023.¹
Atkinson v. Luitpold Pharmaceuticals (No. 19-277), the second bellwether, was originally set for October 2023.
Krueger v. Luitpold Pharmaceuticals (No. 19-984), the third, was originally set for November 2023.

In October 2023, Judge Beetlestone signed an order establishing a Qualified Settlement Fund involving Luitpold and 13 plaintiffs, confirming that at least some cases had reached settlement agreements.¹ By May 2024, many of the lawsuits pending in the MDL had reportedly settled with Luitpold.¹² No settlement figures have been made public. The overall litigation remains stayed, with the parties required to provide status updates every 30 days.

Can You Still File an Injectafer Lawsuit?

The litigation appears to be winding down. Most law firms have stopped accepting new cases, and the federal MDL remains stayed while settlement work continues.¹ Anyone who believes they were injured by Injectafer and has not yet filed a claim should speak with a product liability attorney promptly, because statutes of limitations vary by state and the window to join the existing settlement process may already have closed.

1
Drugwatch. Injectafer Lawsuits
2
FDA. Injectafer Prescribing Information (2021)
3
JCI Insight. Ferric Carboxymaltose and Hypophosphatemia Trial
4
National Library of Medicine. Hypophosphatemia After Intravenous Iron Treatment
5
National Library of Medicine. Systematic Literature Review of IV Iron and Hypophosphatemia
6
Law.com. Crockett v. Luitpold Pharmaceuticals Third Amended Complaint
7
FDA. Injectafer Prescribing Information (2023)
8
Drugwatch. Injectafer Makers Face Lawsuits Over Hypophosphatemia
9
GovInfo. In Re Injectafer Products Liability Litigation, MDL No. 2948
10
American Regent. Our Business
11
Forbes. Injectafer Lawsuit
12
AboutLawsuits.com. Injectafer