Luitpold Pharmaceuticals Sued Over Failure to Warn of Injectafer Risks

Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo, Inc., Daiichi Sankyo US Holdings, Inc., and Vifor International Ag were sued by Laquita Palmer, who is petitioning for both damages and a jury trial. Palmer claims that the Injectafer product she had been prescribed, which was administered and produced by the Defendants, caused her to develop severe hypophosphatemia, or HPP. Palmer’s claim is the latest in a series of claims concerning Injectafer. This suit was filed in the Eastern District of Pennsylvania

Luitpold and American Regent, which recently merged, are owned by the Swiss company Vifor Pharmaceuticals, the complaint said. Vifor administers and produces Ferinject, which is the international equivalent to Injectafer. The plaintiff explained that Vifor designed and developed Ferinject, which came before Injectafer hit the United States market. When Vifor licensed the design of Ferinject to Luitpold, Luitpold began developing Injectafer.

The U.S. product, which contains ferric carboxymaltose (FCM), is described as “an iron replacement injection medication,” and it is intended 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.”

Injectafer allegedly differs from other iron supplements in that it contains FCM, which the plaintiff says has been known to result in severe hypophosphatemia (HPP), “an electrolyte disturbance in which blood tests reveal that there is an abnormally low level of phosphate in the patient’s blood.” This lack of phosphate can negatively affect bone growth, energy storage, as well as nerve and muscle production. Severe effects of HPP are “muscle weakening, fatigue, severe nausea,” and even medical complications like osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and rhabdomyolysis.

The plaintiffs argued that “Luitpold had knowledge of the link between Injectafer and Severe HPP from its own clinical studies” and failed to warn the general public, “a complete derogation of Defendants’ responsibilities to properly warn of Injectafer’s known dangers.”

The plaintiff is alleging negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraud, strict liability failure to warn, strict liability defective design, gross negligence. They are represented by Pogust Millrood.