The outcome of the trial will, no doubt, have important implications for the hundreds of other similar cases awaiting adjudication.
First approved for use in 2005 as an effective way to control glucose (blood sugar) levels in Type 2 diabetes patients in combination with diet and exercise, Byetta has been linked to acute pancreatitis, as well as pancreatic cancer, thyroid cancer and kidney failure.
In 2007, the FDA issued its first warning about Byetta. The federal watchdog advised that there had been a number of cases of acute pancreatitis observed in diabetes patients using Byetta.
Acute pancreatitis is an inflammation of the pancreas usually accompanied by abdominal pain and vomiting. It is a serious condition that can lead to death and is associated with an increased risk of pancreatic cancer.
Los Angeles lawyer, Brian Depew, from the firm of Engstrom, Lipscomb & Lack (ELL), represents a group of seven individuals (and their families) that allege they developed acute pancreatitis subsequent to the use of Byetta. Two of the plaintiffs died from complications related to pancreatitis. All of the plaintiffs in the Depew complaint were prescribed Byetta prior to the first FDA warning in 2007.
The complaint filed against Eli Lilly and Amylin Pharmaceuticals that manufacturer Byetta claims that the two companies misrepresented the facts, maintaining that “Byetta was safe, effective and fit for human consumption.” In addition, the lawsuit claims that the manufacturers were negligent and failed to warn Byetta users of the potential adverse effects.
All the plaintiffs required hospitalization related to pancreatitis. In addition, the plaintiffs incurred medical expenses, lost-time income and permanent injuries, as well as emotional suffering that will be outlined in detail at the trial in November, according to the statement of claim.
“At the trial, we will put on a whole series of internal documents to prove that they knew or should have known that there is a risk with this drug and it required a warning, and that they failed to do so,” says Brian Depew.
Also expected to testify at the trial is Dr. Edwin Gale, from the University of Bristol in the UK. Gale is an expert in diabetes research and in physiological effects of the drug Byetta on the pancreas and other parts of the digestive system. Gale points to “changes in pancreatic enzymes” as an important change to the function of the pancreas and a likely cause of pancreatitis.
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The workings of the digestive system are a complicated area. Much of the case will focus on helping the jury to understand a highly technical area of medicine. Sales of Byetta and similar glucose-control drugs are a multibillion-dollar industry.
The two drug companies both refute the allegations vehemently.
“I think an appeal is likely. It doesn’t matter what the outcome is. In modern litigation, there will be an appeal,” says Depew.
Allegations Byetta is linked to pancreatic cancer is also the subject of a number of lawsuits yet to be heard in court. The November case is important because it is the first of the Byetta cases to go to trial.