Iron Deficiency Infusion Lawsuit Filed Against Injectafer Manufacturers

Injectafer manufacturers failed to disclose the potential adverse health risks for years, according to the iron deficiency infusion lawsuit.

A Florida woman has filed a product liability lawsuit against the makers of the iron deficiency infusion Injectafer, indicating that she suffered dangerous drops in her phosphate blood levels following two injections, which left her with permanent and disabling injuries.

The complaint (PDF) was filed by Shannon Murray on January 31 in the U.S. District Court for the Eastern District of Pennsylvania, presenting claims against Luitpold Pharmaceuticals, American Regent, Inc., Daiichi Sankyo, Inc. and Vifor International AG as the defendants.

Injectafer (ferric carboxymaltose) has been marketed as a safe and effective iron deficiency infusion treatment since 2013, which is typically administered to adults experiencing anemia, who are not able to manage the condition with an oral iron supplement or have non-dialysis dependent chronic kidney disease.

However, in recent years several hundred similar Injectafer lawsuits have been filed in courts nationwide, each raising similar allegations indicating drug makers knew or should have known about the risks of dangerous decreases in blood phosphate levels, which can lead to the development of severe and symptomatic hypophosphatemia (HPP) and leave patients with muscle weakness, joint and bone pain, fatigue, difficulty walking and other long-term health complications.

Murray indicates she suffered from iron deficiency anemia (IDA) and received two Injectafer infusions in April 2018, with the injections only a few days apart.

“Subsequent to Plaintiff’s Injectafer use, she suffered symptoms indicative of severe and/or symptomatic hypophosphatemia,” her lawsuit states. “As a result of her use of Injectafer, Plaintiff has suffered, and will likely suffer in the future, severe and permanent injuries and damages, including, but not limited to: severe muscle and joint pain, paresthesias, headaches, nausea and vomiting, muscle and bone stiffness, limited range of motion, dizziness, stress and anxiety.”

When the drug was first introduced in 2013, the Injectafer warning label described reports of serum phosphate drops as “asymptomatic” or “transient.” In 2018, that warning was upgraded, but only suggested hypophosphatemia side effects were mild and infrequent.

It was not until February 2020 that the warnings about Injectafer side effects (PDF) were updated to add more detailed information about the risk of symptomatic hypophosphatemia caused by the iron infusion. However, critics have said even those warnings remain inadequate.

Because of the manufacturers’ misleading actions in failing to adequately disclose the risks of their iron deficiency infusion drug, there was no way for Murray to know her illnesses were connected the Injectafer injections, according to the lawsuit.

2023 Injectafer Lawsuit Update

Several hundred claims over side effects of Injectafer iron deficiency infusions have been filed throughout the federal court system, which are all pending in the U.S. District Court for the Eastern District of Pennsylvania.

Since each of the claims raise similar questions of fact and law, the Court is preparing a group of representative cases for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

Last year, the U.S. District Judge presiding over the litigation indicated that the first Injectafer lawsuit will go before a jury in June 2023, involving a complaint brought by Katherine Crockett, who developed severe pain and fatigue after a series of two iron deficiency infusions in May 2017.

In December 2022, an order (PDF) was issued scheduling two other cases for early trial dates, which are expected to begin on October 2, 2023 and November 29, 2023.

While the outcome of these early trial dates will not be binding on lawsuits filed by Murray and other plaintiffs, the average Injectafer lawsuit payouts awarded may have a substantial impact on any iron deficiency infusion settlements the manufacturer may offer to avoid the need for each case to go before a jury in the federal court system.