A Viberzi lawsuit has been filed in California by a woman who was diagnosed with acute pancreatitis after initiating treatment with the Allergan IBS drug.
According to a complaint filed in the U.S. District Court, Central District of California, on September 17th, Erin Duncan was prescribed Viberzi in September 2016 to treat irritable bowel syndrome (IBS) with diarrhea. (Case No. 18-8047)
Duncan’s gallbladder had been removed before she began treatment with Viberzi. She was admitted to the hospital and diagnosed with acute pancreatitis after just one dose.
Among other things, Duncan claims that Allergan failed to properly test Viberzi. For example, her complaint points out that during the drug’s clinical trials, there were at least 40 cases of abdominal pain – half of which occurred within 24 hours of initiating treatment – that forced subjects to discontinue participation in the study.
“Allergan did not require biochemical or radiological testing to confirm suspected instances of acute pancreatitis during clinical trials,” the complaint states “The lack of biochemical or radiological testing during the clinical trials led to undiagnosed instances of pancreatitis, resulting in misleading and inaccurate trial results.”
In March 2017 – less than 2 years after Viberzi was approved – the U.S. Food & Drug Administration (FDA) warned that the medication had been associated with 120 reports of pancreatitis or death.
Of the 68 patients who reported their gallbladder status, 56 did not have a gallbladder. In all of those cases, the patient had been prescribed the recommended dose for individuals without a gallbladder.
76 patients required hospitalization, including two who died. Neither of those patients had a gallbladder.
Symptoms of Viberzi pancreatitis appeared with just one or two doses.
Health care providers were warned not to prescribe Viberzi to patients without a gallbladder.
“Properly designed and executed clinical trials would have led to the original May 2015 label to contraindicate use in patients without gallbladders,” Duncan’s Viberzi lawsuit asserts. “Because the FDA did not have the benefit of data from adequately designed and executed clinical trials, it did not require contraindication in patients without a gallbladder.”
Her complaint brings claims of strict liability (failure to warn, defective design), negligence, negligent misrepresentation, breach of express and implied warranties and punitive damages against Allergan.