A lawsuit filed in federal court in Pennsylvania alleges that a Georgia woman suffered “severe and permanent” injuries after receiving Injectafer injections 12 times.
Injectafer is an iron deficiency anemia treatment. There are many intravenous iron products available, according to the complaint, but only Injectafer is formulated with a unique ferric carboxymaltose compound. The complaint claims that Injectafer is the only intravenous iron product which causes a condition called severe hypophosphatemia (severe HPP) and possibly persistent hypophosphatemia (persistent HPP).
Hypophosphatemia (HPP) is a low level of phosphate in the blood. Severe HPP is a “dangerous diagnosis,” according to the complaint, which states that it can lead to osteomalacia, arrhythmias, respiratory failure, rhabdomyolysis or cardiac arrest.
The complaint claims that the defendants, who include Luitpold Pharmaceuticals, American Regent, Daiichi Sankyo and Vifor, “have known for years” that Injectafer causes severe HPP, yet failed to warn about this risk.
The complaint notes that a 2016 study found that ferric carboxymaltose use “is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.”
A separate study, according to the complaint, found that up to half of patients who received ferric carboxymaltose developed HPP, and that only ferric carboxymaltose patients developed severe HPP, not patients who took Monofer, another intravenous iron drug.
Another study, according to the complaint, found that 13 percent of ferric carboxymaltose patients developed severe HPP, and that the severity of HPP was correlated with the dose of ferric carboxymaltose.
Yet another study, according to the complaint, found that 58.8 percent of Injectafer users developed severe HPP compared to only 0.9 percent of Fereheme users.
The complaint alleges that Luitpold also knew about the link between Injectafer and severe HPP “from its own clinical studies, some of which it never warned the general public” about in its labeling.
A February 2020 study, according to the complaint, found that about 75 percent of Injectafer patients developed HPP compared to about 8 percent of Monofer patients, that only Injectafer patients developed severe HPP, not Monofer patients, and that “even a single course of Injectafer may adversely affect a person’s skeleton which may help explain why repeated dosing of ferric carboxymaltose has been associated with osteomalacia and bone fractures.”
The complaint notes that Injectafer’s labeling does not warn about the risk of severe HPP.
The complaint seeks to recover damages based on multiple counts, including negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraud, strict liability failure to warn, strict liability defective design, and gross negligence.