An FDA mandated trial has shown that Invokana use doubles the risk of lower limb amputation. The FDA promptly (July 2017) ordered a black box warning, the most serious warning available. The drug had already been linked to other dangerous side effects – ketoacidosis, bone fracture and kidney damage. People who felt they had been wrongly injured by the use of Invokana started filing lawsuits against the manufacturer, Johnson and Johnson and its subsidiary Janssen Pharmaceuticals. Many of the federal lawsuits were consolidated in a Multi-District Litigation in the United States District Court, District of New Jersey (MDL 2750).
The lawsuits allege that the company failed to properly test the drug before it started selling it to patients and marketing it to doctors. The lawsuits also allege that the company knew of the serious side effects but didn’t adequately warn doctors and patients. If the allegations are true, many users of Invokana were likely injured unnecessarily. Knowing the serious side effects of Invokana, doctors likely would have prescribed a medication or alternative treatment with fewer serious risks. Also, had doctors and patients been properly warned, they would have been able to monitor early symptoms of serious side effects more closely. When side effects aren’t properly disclosed, both doctors and patients are kept in the dark with often disastrous consequences.
The law requires drug companies to be honest when disclosing risks of medications. Companies must tell the truth when they bring potent medications to market. People who have suffered a serious injury while on Invokana should know their legal rights. Once fully informed, they can make a decision whether to pursue a legal case against the manufacturer.