A federal judge has rejected a motion by the makers of Injectafer to dismiss a woman’s lawsuit over side effects of the iron deficiency drug, indicating that primary claims that the medication caused her to suffer life-threateningly low phosphorous levels are sufficiently sound to survive an early challenge by the drug maker.
The complaint was originally filed by Katherine Crockett in December 2018, and removed from state court in Pennsylvania (PDF) to federal court the next month.
Crockett indicates that she received two shots of Injectafer, which caused her to develop severe hypophosphatemia, also known as severe HPP. However, she claimed that the defendants failed to adequately warn users and the medical community about the potential side effects.
The defendants include Luitpold Pharamceuticals, American Regent, Daiichi Sankyo, and Vifor Pharmaceuticals, who filed a motion to dismiss the complaint on numerous grounds.
In an order (PDF) issued January 28, U.S. District Judge Wendy Beetle Stone cleared the case to proceed on its core failure-to-warn claims, while dismissing some of the 10 counts in the original complaint. In addition, Stone also allowed Crockett to continue to pursue potential punitive damages against Injectafer’s manufacturers.
“Taking Plaintiffs Complaint as true, she has alleged that Defendants had actual knowledge from scientific literature and clinical studies that Injectafer causes Severe HPP; that they were aware of the differences between mild or asymptomatic HPP and Severe HPP; and that they suppressed this information from patients and the medical community in Injectafer’s labeling and marketing,” the judge determined. “Read together under a motion to dismiss standard, these pleadings are sufficient to state a claim for punitive damages.”
Injectafer (ferric carboxymaltose) was approved for intravenous use by the FDA in 2013. It is an iron replacement by Daiichi Sankyo, meant to treat iron deficiency anemia in adult patients with an intolerance to oral iron supplementation and who have non-dialysis dependent chronic kidney disease.
In August, researchers from Norway published a study that reported side effects of Injectafer were linked to an increased risk of HPP.
Crockett’s original lawsuit indicates the manufacturers knew, or should have known of the risks of HPP, but failed to provide adequate warning to the medical community or patients. It also notes that with the failure to warn of HPP, the label also fails to warn of the potential injuries which could result.
Hypophosphatemia can lead to severe health complications, including:
- Cardiac arrest
- Respiratory failure
- Muscle weakness
The case was one of the first of a growing number of other Injectafer lawsuits now being pursued by individuals who have experienced problems or side effects after receiving the iron deficiency drug.