A Virginia woman has filed a product liability lawsuit against Amylin Pharmaceuticals and Eli Lilly & Co., alleging that she developed thyroid cancer from side effects of Byetta, a popular diabetes drug that has also been the subject of a number of pancreatic cancer lawsuits in recent months.
The complaint (PDF) was filed by Elizabeth Childress on May 9, in the U.S. District Court for the Southern District of California, alleging that the 23 year old was diagnosed with thyroid cancer in 2011, after using Byetta several years earlier.
According to allegations raised in the lawsuit, Amylin and Eli Lilly have known about the link between Byetta and thyroid cancer, yet failed to provide adequate warnings or issue a Byetta recall to withdraw the diabetes drug from the market.
“Despite undeniable knowledge of the risk, and with full appreciation of the deadly side-effects posed by ingesting Byetta, Defendants concealed their knowledge that Byetta can cause life-threatening thyroid cancer from Plaintiff, other consumers, the general public, and the medical community,” Childress alleges in the lawsuit. “Indeed, the Defendants who manufacture and market Byetta never even mentioned ‘thyroid cancer’ in their product’s inserts.”
Byetta Side Effects and Thyroid Cancer
Byetta (exenatide) is an incretin mimetic diabetes drug known as a GLP-1, which is a class of medications that also includes Victoza (liraglutide) and a longer-acting version of Byetta, which is marketed by Amylin as Bydureon (extended release exenatide). The twice-daily Byetta Pen injection was approved in 2005, and has grown to generate nearly $1 billion in annual sales.
When the competing diabetes drug Victoza was introduced in 2010, a “black box” warning was placed on the label by that drug’s maker, alerting consumers and the medical community about a potential risk of developing thyroid C-cell tumors. Although Byetta acts similarly in the human body, Childress points out in the complaint that Amylin and Eli Lilly never placed warnings on their diabetes drug about the potential Byetta thyroid cancer risk.
When the drug makers obtained FDA approval to market a longer-acting version of Byetta in 2012, they did add language to the Bydureon label indicating that the extended release version of Byetta caused thyroid tumors at clinically relevant exposures among rats. However, similar warnings were not added to Byetta itself, even though the drug makers have promoted that the medications are the same, with Bydureon merely lasting longer.
“While admitting that Bydureon and Byetta are the same, Defendants have been indifferent to the health and safety of Byetta users, having wholly failed to provide any warning whatsoever on the Byetta label related to its link to thyroid cancer,” according to the complaint filed by Childress.
Childress seeks damages from Amylin and Eli Lilly for failure to warn, defective design, negligence, breach of warranty, negligent misrepresentation, and fraudulent concealment. She is seeking both compensatory and punitive damages.
Byetta Lawsuits Over Pancreatic Cancer
The complaint joins a growing number of Byetta cases filed in courts throughout the country by individuals who have been diagnosed with pancreatic cancer after using the diabetes drug.
Earlier this year, the FDA launched an investigation into the potential risk of pancreatic cancer with all incretin mimetic diabetes drugs. In addition to Byetta, Victoza and Bydureon, other drugs involved in this review include Januvia (sitagliptin), Janumet (sitagliptin and metformin), Onglyza (saxagliptin) and Tradjenta (linagliptin).
The safety review was initiated after results of a recent study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European health officials have also launched a similar review.
In April, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all pancreatic cancer lawsuits filed by former users of Byetta, Victoza, Januvia and Janumet, asking that the cases be centralized before one judge in the federal court system for coordinated pretrial proceedings.
The U.S. JPML is expected to hear oral arguments on the motion at an upcoming session scheduled for July 25 in Portland, Maine. If an MDL is established for all Byetta lawsuits, Victoza lawsuits, Januvia lawsuits and Janumet lawsuits, filed in U.S. District Courts throughout the federal court system would be centralized. However, it is unclear whether such a proceeding would include any lawsuits over thyroid cancer from Byetta or the other drugs.