In less than a year, the number of lawsuits consolidated under the Invokana Multidistrict Litigation (MDL) has grown from 55 to 865, according to the U.S. District Court for the District of New Jersey, where the MDL is located. The claims are against Invokana’s manufacturer Johnson & Johnson’s Janssen Pharmaceuticals alleging the drugmaker failed to properly test Invokana and warn of the risks and consequences of using the drug.
Beasley Allen has previously reported that the Food and Drug Administration (FDA) approved Invokana in 2013 as the first in a new class of type 2 diabetes drugs called SGLT2 inhibitors. The following year the agency approved Invokamet, a combination of Invokana and metformin. Within two years of being on the market, however, there were more than 100 reports of acute kidney injury in patients taking the drug. The reports led the FDA to order a stronger kidney warning to accompany several SGLT2 inhibitors, including Invokana and Invokamet.
Among the adverse side effects Invokana has been linked to is diabetic ketoacidosis (DKA). DKA is kidney damage caused by a type of acidosis that develops when insulin levels are too low or during prolonged fasting. Beasley Allen has previously explained that it can lead to difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. Beasley Allen also notes that the FDA has warned about other adverse effects, including serious urinary tract infections (UTIs), which can lead to a serious blood infection called urosepsis or kidney infection called pyelonephritis.
Earlier this year, results from an FDA-mandated clinical trial showed Invokana also doubled the risk of leg and foot amputations compared with outcomes of patients taking a placebo. The dangers were even present in patients who did not exhibit risk factors for amputation. The findings led some doctors to stop prescribing Invokana.
As evidence of the drug’s adverse side effects mounts, it is not surprising that the numbers of lawsuits are also climbing.
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Lawyers in Beasley Allen’s Mass Torts Section are investigating claims on behalf of individuals and families with claims they were injured by Invokana and Invokamet, specifically cases involving DKA, acute kidney injury, and amputations. If you would like more information, contact Danielle Ward Mason, a lawyer in our Mass Torts Section. She can be reached at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.
U.S. District Court for the District of New Jersey