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Johnson & Johnson and it’s Janssen subsidiary failed to adequately warn about the risk of kidney failure associated with the side effects of Invokana, according to a lawsuit filed on behalf of a former user of the new-generation diabetes drug.
The complaint (PDF) was filed in the U.S. District Court for the District of New Jersey on April 21, by a representative of Jessica Calongne, who develop an acute kidney injury less than a month after beginning treatment with Invokana, which ultimately led to kidney failure..
Calongne was prescribed Invokana to treat diabetes in April 2015, and the lawsuit indicates that she required multiple days of hospitalization from April 29 through May 1, 2015. Only a few weeks later, she was hospitalized again between May 27 and May 29, 2015 due to total renal failure.
“Defendants misrepresented that Invokana is a safe and effective treatment for type 2 diabetes mellitus when in fact the drug causes serious medical problems which require hospitalization and can lead to life threatening complications, including but not limited to diabetic ketoacidosis and its sequelae, kidney failure and its sequelae, as well as serious cardiovascular problems,” according to the lawsuit filed by a power of attorney for Calongne. “[Plaintiff’s] injuries were preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”
The case joins a growing number of similar Invokana lawsuits filed in recent months, each raising similar allegations that earlier warnings should have been provided for consumers and the medical community.
In June 2016, the FDA required the drug makers to add a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
Since the drug hit the market, federal regulators have also required new Invokana warnings about a risk of diabetic ketoacidosis, which is a serious medical condition associated with elevated levels of acid in the blood.
The lawsuit filed on behalf of Calongne will be consolidated as part of the federal Invokana litigation, which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts. However, if the manufacturer fails to reach Invokana settlements or another resolution for the cases, hundreds of individual claims may be remanded back to U.S. District Courts nationwide for separate trials in the future.