A married couple has sued the manufacturers of an iron product known as Injectafer, after one plaintiff allegedly suffered serious injuries and economic losses following two injections. Tuesday’s complaint, filed in the Eastern District of Pennsylvania, explains that Injectafer is an iron replacement medication manufactured by Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo, Inc., Daiichi Sankyo US Holdings, Inc., Vifor Pharma Ltd., Vifor Pharma Participations Ltd., Vifor (International) Ag, and Relypsa Inc. The drug is reportedly indicated “for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or in adult patients with non-dialysis dependent chronic kidney disease.”
According to the filing, Luitpold and American Regent brought Injectafer to the United States market in 2013, though it had previously been available in Europe and elsewhere. The complaint explains that Injectafer is made from ferric carboxymaltose (FCM), which unlike the other intravenous iron products available, is associated with a serious condition known as hypophosphatemia (HPP). HPP is reportedly an electrolyte disturbance in which there is an abnormally low level of phosphate in the body.
Allegedly, the defendants knew that during the time that FCM compound products were present on the European and United States markets, “dozens of case reports and other medical literature linked Severe HPP to FCM and revealed the dangers of Severe HPP.” For this and other reasons, the plaintiffs contend that the defendants knew that Injectafer posed serious risks to users, but failed to adequately warn them.
After receiving two Injectafer injections in early 2019, one plaintiff suffered symptoms indicative of severe and/or symptomatic hypophosphatemia. She reportedly experienced severe muscle pain and weakness, bone and joint pain, and extreme and persistent fatigue. Now, the plaintiffs seek a variety of damages for the injuries suffered. They bring several product liability and tort causes of action against the manufacturers.
The plaintiffs are represented by Robins Kaplan LLP.