(Bloomberg Law) — Daiichi Sankyo Co. and its unit American Regent Inc. must keep defending a woman’s suit alleging an injectable iron deficiency anemia drug caused a serious blood chemistry imbalance, after the Eastern District of Pennsylvania rejected its preemption arguments.
Katherine Crockett alleges Injectafer caused her severe hypophosphatemia, a low blood phosphate level, which led to pain, weakness, and constant fatigue.
Daiichi and American Regent failed to show that federal drug labeling law preempts Crockett’s state-law claims alleging inadequate warning and design defect, the U.S. District Court for the Eastern District of Pennsylvania said.
The drugmakers argued that Crockett’s claims are barred by impossibility preemption principles because she essentially alleges lnjectafer should have been labeled and designed differently despite the Food and Drug Administration’s approval of the existing label and design.
A drugmaker, to prevail on a preemption argument, must show that it “fully informed the FDA of the justifications for the warning required by state law” and that the FDA, in turn, informed the drugmaker that the agency wouldn’t approve a change to the drug’s label to include that warning, the court said, applying a recent U.S. Supreme Court decision.
Here, the drugmakers didn’t meet that threshold, the court said. They didn’t point to any “evidence” that they proposed a stronger warning to the FDA or that the FDA would have rejected a different warning label, it said.
As for the design claim, the court said the drugmakers haven’t described their relevant duties under state law, or established how they conflict with their federal obligations.
A ruling on preemption would be premature, the court said. But it said dismissal on impossibility preemption grounds “is particularly tricky.”
Crockett also has adequately alleged a claim for punitive damages, the court said. She alleges the defendants had actual knowledge, from scientific literature and clinical studies, that Injectafer causes severe HPP and that they suppressed this information from patients and the medical community in Injectafer’s labeling and marketing.
But Crockett’s strict liability and breach of implied warranty claims aren’t viable because Pennsylvania law doesn’t recognize those claims against drugmakers, the court said.
The court also dismissed her claims under the state’s consumer protection law.
Pogust Millrood LLC and Hausfeld LLP represented Crockett. Drinker Biddle & Reath LLP and Bowman & Brooke LLP represented Daiichi Sankyo Co., Daiichi Sankyo Inc., and American Regent Inc., former known as Luitpold Pharmaceuticals Inc.
The case is Crockett v. Luitpold Pharm., Inc., 2020 BL 29246, E.D. Pa., No. 19-276, 1/28/20.