An Injectafer lawsuit plaintiff will be allowed to proceed with her injury claims, after a federal judge in Pennsylvania found that the defendants’ motion for dismissal was premature.
Injectafer is an intravenous medication approved to treat adults with iron deficiency anemia who are unable to tolerate oral supplements.
According to an Injectafer lawsuit pending in the U.S. District Court, Eastern District of Pennsylvania, Katherine Crockett was forced to take a leave of absence from work when she developed severe hypophosphatemia following her second infusion. Her complaint alleges that Luitpold Pharmaceuticals Inc. and other defendants marketed the medication as safe and effective while knowing or reasonably suspecting that it could cause dangerously low phosphorous levels.
In seeking to dismiss Crockett’s lawsuit, the defendants argued, among other things, that her claims of negligence were preempted by federal law because the U.S. Food & Drug Administration (FDA) had approved the Injectafer label and prescribing information. But in an order issued on January 28th, Judge Wendy Beetlestone noted that the drug makers had failed to provide any evidence that they had proposed a stronger warning or that the FDA would have rejected a different label.
“Accordingly, Defendants have not shown that they ‘fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning,’” Judge Beetlestone wrote. “Thus, a ruling on preemption with respect to Plaintiffs failure-to-warn claims would be premature.”
The FDA approved Injectafer in 2013, after previously rejecting the medication because of a potential association with “excess mortality and severe hypophosphatemia.”
Since its approval, however, evidence linking Injectafer to dangerously low phosphorous levels has only grown stronger. Most recently, for example, a study published in Alimentary Pharmacology & Therapeutics reported a significantly higher incidence of moderate‐to‐severe hypophosphatemia among Injectafer patients compared to those receiving another intravenous iron treatment called Monofer.
In December 2018, findings published in the Journal of Clinical Investigation suggested over half of those treated with Injectafer will develop severe hypophosphatemia. Just two years earlier, Austrian researchers reported that hypophosphatemia had occurred in 45% of those treated with Injectafer, while 32% developed severely low phosphorous levels.
Yet according to Crockett and other Injectafer lawsuit plaintiffs, the drug’s label barely mentions severe hypophosphatemia as a possible side effect, suggesting only that patients might experience transient decrease in serum phosphorus levels following an infusion.
Severe hypophosphatemia occurs when serum phosphorous levels fall below 1 mg/dl. Symptoms may include.
If allowed to remain untreated, severe hypophosphatemia may result in respiratory failure, muscle weakness, cardiac arrest, seizures, coma, and even death.