Lawsuit Alleges Iron Replacement Injection Resulted in Bone Pain, Fatigue and Other Problems From Low Phosphate Levels

According to allegations raised in a product liability lawsuit filed against the makers of Injectafer, side effects of the iron replacement injection caused a New York woman’s phosphate levels to become so depleted she developed a chronic condition that causes bone pain, fatigue and other serious health complications.

The complaint (PDF) was filed by Monique Benum and her husband, Eli, last month in the Court of Common Pleas in Pennsylvania.

Luitpold Pharmaceuticals, American Regent, Inc., Daiichi Sankyo and Vifor International are named as defendants in the lawsuit, which alleges Injectafer (ferric carboxymaltose) is so unreasonably dangerous that the risks far outweigh any potential benefits provided for users.

The iron replacement injection was first introduced in 2013, as a treatment for adults with anemia, who are not able to be treated with an oral iron supplement and have non-dialysis dependent chronic kidney disease. However, problems after Injectafer infusions have included reports of severe hypophosphatemia (HPP), which involves dangerous drops in phosphate levels and may lead to a number of severe health complications, including cardiac arrest, respiratory failure and death.

Injectafer is the only anemia treatment on the U.S. market which contains a unique ferric carboxymaltose (FCM) compound, which is known to cause severe HPP and potentially persistent HPP.

Benum indicates she was prescribed Injectafer for the treatment of iron deficiency anemia in June 2018, and received a total of 12 injections between June 25, 2018, and April 10, 2019. However, according to the lawsuit, her phosphate levels became “critically low” resulting in severe and/or symptomatic hypophosphatemia.

Although the drug makers knew or should have known about the risks associated with the Injectafer iron replacement treatment, warnings were withheld from users and the medical community about the risk of severe HPP, as well as the how the condition should be treated.

“Defendants at no times have attempted to warn users of these risks and have therefore violated their duties to warn and not misrepresent the benefits of a drug,” Benum’s lawsuit states. “Defendants also have a duty to explain to the medical community how to properly investigate and monitor a sharp drop in phosphorous levels. Defendants at no time have provided such warnings.”

Benum presents claims of negligence, failure to warn, design defect, negligent misrepresentation, fraud, strict liability, gross negligence, and her husband presents a claim of loss of consortium.

The case joins a growing number of other Injectafer lawsuits filed over the past year, each involving similar allegations of severe drops in phosphate levels after receiving the iron replacement injection.