A recent lawsuit filed in the U.S District Court for the District of New Jersey by Charlotte Nerio, claims that Invokana manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals failed to warn patients consuming the diabetes drug about amputation risks of the medication.
Nerio developed severe tissue necrosis, dry gangrene, and blackening of the fingers when she was under Invokana treatment since 2015. In her lawsuit, she argues that adequate warning about the associated risks of the drug would have helped her to avoid such a disastrous effect and blames the drugmaker of hiding such critical information. In December 2015, the FDA ordered the makers to include diabetic ketoacidosis warnings to Invokana label. In May 2017, following several reports on leg and foot amputations, a warning label update for the same was ordered by the FDA.
The hand amputation case by Nerio will be consolidated as a part of the multidistrict litigation (MDL No.: 2750) for Invokana lawsuits presided by Hon. Brian R. Martinotti for coordinated pretrial proceedings in the District of New Jersey. The first Invokana bellwether trial is slated to begin in September 2018.