The nationwide law firm of Bernstein Liebhard LLP is representing a New York woman who developed pancreatitis allegedly due to side effects associated with Viberzi.
Viberzi is manufactured by Allergan, Inc. and is currently indicated to treat Irritable Bowel Syndrome (IBS) with diarrhea.
According to complaint filed in the U.S. District Court, Southern District of New York, on May 16th, the plaintiff, a resident of Yonkers, was prescribed Viberzi and began using it as directed in May 2016. Then 56-years-old, she had previously undergone removal of her gallbladder. (Case No. Case 1:19-cv-04521)
On May 17, 2016, she was admitted to the hospital and diagnosed with acute pancreatitis. Her doctor stopped Viberzi treatment in the belief that it had caused the disorder. Nevertheless, she continues to suffer health issues related to this event and remains at risk for recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer.
The U.S. Food & Drug Administration (FDA) approved Viberzi in May 2015. At the time, the drug’s label recommended a 75 mg dose for patients who had undergone gallbladder removal.
In March 2017, however, the FDA advised doctors not to prescribe Viberzi to patients without a gallbladder. Apparently, the agency had received 120 reports of serious pancreatitis or death associated with the medication. At least 68 had their gallbladder removed before treatment was initiated, with the majority receiving the recommended 75 mg dose.
Allergan added this contraindication to the Viberzi label the following month.
According to Bernstein Liebhard’s new Viberzi lawsuit, Allergan failed to design premarket clinical trials that would determine the incidence of pancreatitis in patients without a gallbladder.
“Properly designed and executed clinical trials would have led the original May 2015 label to contraindicate use in patients without gallbladders,” the complaint states. “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.”
Prior to May 2016, the company received numerous reports of pancreatitis in patients taking 75 mg Viberzi, the dosage previously specified for patients lacking a gallbladder. In June 2016, the European Medicines Agency also informed Allergan that it would contraindicate Viberzi for patients who had undergone gallbladder removal.
“Plaintiff did not have the same knowledge as Defendants and no adequate warning or contraindication was communicated to Plaintiff’s physicians,” the complaint states.
“Had an adequate warning and/or contraindication been communicated to Plaintiff’s physician, her physician would not have prescribed Viberzi and/or her physician would have passed the warning/contraindication on to the Plaintiff and Plaintiff would not have used Viberzi.”