A lawsuit was recently filed claiming a woman suffered “severe and permanent injuries” after using the iron deficiency anemia treatment Injectafer (ferric carboxymaltose).
The lawsuit alleges that the woman developed severe hypophosphatemia, a phosphate deficiency which can be life-threatening, after receiving two injections of Injectafer. The lawsuit claims the woman suffered from muscle spasms, diffuse pain, arthralgias, cramping, stiffness, bone pain, fatigue, weakness, nerve pain requiring surgery, paresthesia, rash and sleep disturbance as a result. The lawsuit says the woman “had to take multiple weeks off from work and her business suffered” as a result of the condition.
The lawsuit seeks to recover damages from defendants based on the counts of negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraud, strict liability failure to warn, strict liability defective design and gross negligence.
The lawsuit claims that the defendants knew or should have known that Injectafer could cause severe hypophosphatemia, yet failed to warn the public about this. The lawsuit cites several studies which it says the defendants knew or should have known about. One of those studies reads, “[t]he single most important risk factor for the development of hypophosphatemia appears to be the choice of intravenous iron preparations, where [ferric carboxymaltose] was associated with a 20-fold higher risk than [iron isomaltoside] and all 18 cases of severe and life-threatening Case 2:20-cv-02019 Document 1 Filed 04/24/20 Page 18 of 56 16 hypophosphatemia developed after administration of [ferric carboxymaltose].”
The most recent study the lawsuit mentions is from February 2020. That study reads, “severe hypophosphatemia was not observed in Monofer patients but occurred in 11.3% of Injectafer patients,” and “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 lawsuit accuses the defendants of ignoring or disregarding “years of data and reports” on the link between severe hypophosphatemia and ferric carboxymaltose, noting that Injectafer’s label should have warned about this link.
The lawsuit alleges that Injectafer is a product with a defective design. It reads, “Injectafer is inherently dangerous and defective, unfit and unsafe for its intended and reasonably forseeable uses.”
The lawsuit seeks to recover damages including damages for pain and suffering, emotional distress and anguish, personal injuries, health and medical care costs, as well as punitive and exemplary damages.