The U.S. Food and Drug Administration (FDA) has received reports of patients developing a serious risk of pancreatitis resulting from the prescribed medicine, Byetta. The FDA reports that two patients have died of the six reports of development of pancreatitis. The other four individuals are in varying states of recovery. The FDA is now warning patients and doctors to discontinue the use of Byetta immediately if they are developing signs and symptoms of acute pancreatitis. Pancreatitis is the swelling of the pancreas that can cause nausea, vomiting and stomach pain. Byetta is a drug prescribed for Type-2 diabetes.
Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. Apple’s Steve Jobs died of pancreatic cancer. In fact, pancreatic cancer is the most dangerous of cancers resulting in the lowest survival rate. Nine-four percent of pancreatic cancer patients die within 5 years of diagnosis. Seventy-four percent die within the first year of diagnosis.
Persons who have developed pancreatic cancer from the taking of Byetta have filed lawsuits around the country. These claims have been made against the makers of the drug, Amylin Pharmaceuticals, Eli Lilly and Merck & Co., Inc.
The first disclosure of Byetta’s relationship to pancreatic cancer was revealed before lawsuits were filed in 2009. The FDA made a decision in that year to revise the warning label for Byetta to include the recognition that there is a risk of acute pancreatitis when taking this prescribed drug. In 2011, researchers found that the risk of pancreatic cancer by users of Byetta was increased by almost 3 times. In 2011, a further investigation by researchers at UCLA showed that the serious and often deadly side effects of taking Byetta and another anti-diabetic medication Januvia were prevalent.
In April 2013, a further follow-up study was released by the Institute for Safe Medication Practices (ISMP) as to the medications used to treat Type-2 diabetes. This report concentrated on the five most widely used medications developed for Type-2 diabetes, which include Byetta, Januvia, Victoza, Onglyza and Tradjenta. The Quarterly Watch report that came from the ISMP revealed that in one calendar year, there were 1,723 instances of “serious adverse drug events” reported to the FDA coming from the use of these five medicines designed to treat Type-2 diabetes. The “serious adverse drug events” that were reported included pancreatitis, pancreatic cancer, thyroid cancer and renal failure.
The FDA recommended that the manufacturers of Byetta, particular, Amylin Pharmaceuticals and Eli Lilly, update its warning labels to include the risk of pancreatitis and these other serious illnesses. There are a variety and many pending lawsuits related to the use of Byetta, Januvia and these other Type-2 diabetes medicines. In one case filed in Minnesota, a jury returned a verdict of $1.8 million. In that case, the lawsuit was brought as a medical malpractice claim against the physician who prescribed Byetta.
The irony is that the U.S. Food and Drug Administration approved the use of Byetta, Januvia, Janumet and Victoza as far back as 2005. The FDA reapproved the use of the drugs in 2006, 2007 and 2010. The drugs are classified as incretin mimetics. More recently, the FDA has issued warnings to both patients and doctors associating these drugs to serious medical complications that include pancreatic cancer and other pancreatic diseases, but yet the products remain on the market making patients who use them at a much a greater risk of injury and death.
Many of the lawsuits that are pending have been consolidated in the United States District Court for the Southern District of California where groups of hundreds of Januvia and Byetta personal injury cases are in what is known as the Multi-District Litigation (MDL) pool. This is done for purposes of consolidated discovery. The cases that have been filed made the defendants of the Januvia makers Merck & Co., Inc. and its affiliates, which include the makers and marketers of Byetta, Amylin Pharmaceuticals and Eli Lilly & Company. Back in 2012, Bristol-Myers Squibb purchased Amylin Pharmaceuticals for more than $5 billion. That acquisition made Bristol-Myers Squibb another defendant in these cases.
As is often the case, many of the personal injury cases for patients injured by the use of these Type-2 diabetic drugs were first filed in state courts around the country. Most of those cases have been removed to the Federal District Court which is better prepared to manage the great number of lawsuits filed. The numbers of Byetta and Januvia lawsuits that have been filed are increasing. As of March 2014, there were 325 cases pending in the Multi-District Litigation. Additional lawsuits may be yet to be filed in the Federal District Court as well as in other state courts around the country.
The lawsuits that have been filed claim that the drug makers failed to adequately warn patients and doctors about the risks of harm and the dangers of the drug that have led to pancreatic cancer and death. One of those cases filed on behalf of an Ohio woman, alleges that the drug makers chose not to exercise reasonable care and created unreasonable risks for personal injury and death. The plaintiffs in these lawsuits claim that Merck, Amylin Pharmaceuticals and Eli Lilly as well as other contract manufacturers and marketers, knew or should have known that these drugs crated a high risk of developing pancreatic cancer. These drugs are widely used in Chicago and in Illinois.
If you or someone you know has been injured or harmed by using Byetta, please call us for an immediate free consultation. Robert Kreisman of Kreisman Law Offices has been handling pharmaceutical defect cases for more than 40 years.
With our years of experience in trying and settling pharmaceutical defect cases around the country, Kreisman Law Offices provides the best possible services to our clients. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online.