A lawsuit filed in October in federal court in Pennsylvania claims that Injectafer use led to a woman suffering severe, permanent injuries after developing Severe and/or symptomatic hypophosphatemia (HPP).
The lawsuit claims the woman suffered, and will likely suffer in the future, permanent and severe injuries including, but not limited to, shortness of breath, bilateral leg pain, wheezing, tachycardia, nausea and vomiting, malaise, achiness, increased fatigue, blurry vision, headache and stress.
The lawsuit claims that the defendants have known “for years” that Injectafer can cause Severe HPP.
“During ferric carboxymaltose’s presence on the European and United States markets, dozens of case reports and important pieces of medical literature emerged revealing the dangers of Severe HPP and linked the ferric carboxymaltose compound to Severe HPP,” the lawsuit states.
The lawsuit notes a comparison between Injectafer and Monofer found that Injectafer was associated with 20 times the risk of HPP compared to Monofer, and that all 18 cases of Severe HPP were associated with Injectafer. The lawsuit notes another comparison found that HPP occurred in up to half of patients who received Injectafer, and that only Injectafer led to Severe HPP.
The lawsuit notes another study found that HPP is “frequent” after Injectafer use “and may have clinical consequences.”
The lawsuit notes a more recent comparison between Injectafer and Feraheme found that 58.8% of Injectafer users versus only .9% of Feraheme users developed Severe HPP.
“In addition to the aforementioned reports and literature, Luitpold had knowledge of the link between Injectafer and Severe HPP from its own clinical studies, some of which it never warned the general public via its labeling,” the lawsuit states.
The lawsuit notes that a February 2020 study found that 11.3% of Injectafer patients developed Severe HPP.
The lawsuit notes that Injectafer was originally rejected by the FDA, partly due to concerns over “clinically important hypophosphatemia.”
The lawsuit notes that Injectafer’s label lacks any warning about Severe HPP.
The lawsuit states the labeling fails to warn about many conditions associated with Severe HPP, such as cardiac arrest, rhabdomyolysis, respiratory failure or cardiac arrhythmia.
The lawsuit argues that the failure to warn about Severe HPP “is a complete derogation of” the defendant’s responsibilities to warn of their product’s known dangers, violating state and federal laws in the process.
The lawsuit seeks to recover damages based on numerous 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.