Prescription drugs Januvia, Janumet, Byetta and Victoza are popular Type 2 diabetes treatments. But reports of dangerous side effects, including pancreatitis and pancreatic cancer, raised questions about whether the drugs’ risks outweigh their benefits.
In May 2013, the U.S. Food and Drug Administration issued safety communications linking the drugs, collectively called incretin mimetics, to serious complications such as pancreatic diseases. The agency also advised the public it was investigating the drugs’ link to pancreatic cancer.
People who suffered from these side effects filed hundreds of lawsuits against the makers of these drugs: Merck & Co. (Januvia and Janumet); Amylin and Eli Lilly and Co. (Byetta); and Novo Nordisk (Victoza). The lawsuits landed in courts across the country and claimed the drugmakers failed to warn about the risk.
In 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated these cases in California federal court in multidistrict litigation (MDL) No. 2452, In Re: Incretin Mimetics Products Liability Litigation.
In 2015, the trial judge dismissed all the cases. But an appeals court reinstated them. As of Sept. 17, 2018, there were 948 cases pending in the reopened MDL.
Litigation History and Status
In August 2013, the Judicial Panel on Multidistrict Litigation transferred the first 53 cases against Merck, Amylin, Eli Lilly and Novo Nordisk to MDL No. 2452. The original cases came from state courts in Arizona, California, Colorado, Kansas, Missouri, Oklahoma and Pennsylvania.
Since all of the lawsuits claim the drugs caused pancreatic cancer and pancreatitis, the court felt it would be more efficient to centralize the cases because they all would likely use the same experts and go through the same discovery process.
According to a complaint, “Defendants willfully, wantonly, and with malice withheld the knowledge of increased risk of pancreatic cancer in users of the Drugs to prevent any chances of their product’s registration being delayed or rejected by FDA.”
- The faulty formulation of Januvia, Janumet, Byetta and Victoza increased the risk of pancreatic cancer.
- The drugs are defective and cause “unreasonable and dangerous side effects.”
- The manufacturers failed to adequately test the incretin mimetic drugs and monitor side effects before selling them.
- The manufacturers should have known about the side effects but didn’t warn doctors or patients about the risks.
- The drugmakers concealed the risks of pancreatitis and pancreatic cancer from health care providers and the public.
- Drugmakers do not specifically include the words “pancreatic cancer” on the drugs’ labels.
- Current warnings for Januvia, Janumet, Byetta and Victoza are inadequate.
Defendants Argue Preemption
In November 2015, the presiding jurist, U.S. District Judge Anthony J. Battaglia, granted the manufacturers’ request to dismiss all the cases in the MDL. Defendants argued that the plaintiffs had no failure-to-warn case because there was no way the FDA would have approved a label warning for pancreatic cancer. Therefore, drugmakers claimed they should not be held liable for failing to warn about pancreatic cancer.
This concept is called preemption. According to preemption, state law can’t impose requirements in areas regulated by the federal government. In this case, the argument is that failure-to-warn claims are void when there is clear evidence that the FDA — a federal agency — would not have approved a label change.
“Defendants have demonstrated by clear evidence that the FDA would have rejected a reference to pancreatic cancer in the product labeling during the time in which Plaintiffs’ claims accrued,” Battaglia said in his order. “Plaintiffs’ challenges to the FDA’s conclusions regarding pancreatic cancer risk are insufficient to overcome preemption in light of the extensive regulatory history of the drugs at issue.”
Battaglia also disqualified the plaintiffs’ expert witness, Dr. Thomas Fleming, and did not permit a substitute expert.
Appeals Court Reinstates Lawsuits
In September 2016, plaintiff’s attorneys filed an appeal on behalf of the MDL. According to the brief accompanying the appeal to the Ninth Circuit U.S. Court of Appeals, Battaglia misinterpreted the U.S. Supreme Court preemption law.
In an appeal, plaintiffs argued that Battaglia “misunderstood the lessons” of preemption case law.
The appeal said the judge also failed to properly interpret a U.S. Supreme Court decision called Wyeth v. Levine.
Under that ruling, the defendants failed to provide evidence that the FDA would have rejected a label update by the manufacturers. Drug manufacturers are allowed to strengthen safety language without prior FDA approval, the appeal said.
The judge also should not have disqualified Fleming, the plaintiffs’ expert, or deny additional discovery, according to the appeal. Battaglia disqualified the expert without proper facts and this resulted in “extraordinary prejudice” to plaintiffs, the appeal stated.
The Ninth Circuit Court of Appeals overturned Battaglia’s ruling in December 2017. The court held that the trial judge had improperly limited the plaintiffs’ ability to obtain discovery from the drugmakers. The discovery in question was “directly relevant to whether any causal connection existed between incretin use and pancreatic cancer,” the appeals court wrote in its opinion.
The court also concluded that Battaglia should not have disqualified Fleming as an expert. The defense had not met its requirement to prove Fleming should not be allowed to testify because he has previously consulted for another pharmaceutical company, the court ruled.
- Guy Riley
Guy Riley is a Maryland man who sued Merck, Amylin and Eli Lilly in California state court. His wife, Kathleen, was prescribed Januvia and Byetta to manage Type 2 diabetes beginning in 2005. Doctors diagnosed her with pancreatic cancer in 2009, and she died later that year. Riley filed a wrongful death claim in California state court in October 2012. His complaint also includes several claims filed on behalf of his wife’s estate, including, among other claims, strict liability, negligence, deceit by concealment and misrepresentation. He alleges that the drugs caused his wife “severe mental and physical pain and suffering prior to her death, along with economic loss.” The case was removed to the U.S. District Court for the Southern District of California, where it is now pending.
- Regina Kelly
The estate of Regina Kelly filed a suit against Merck, Amylin and Eli Lilly. She developed pancreatic cancer after taking Januvia and Byetta. Her estate alleges that the drugs “permanently and severely injured” her, ultimately causing her death. The estate seeks relief for her physical and mental injuries, the cost of her medical expenses, economic damages, punitive damages and other damages. The case is pending in federal court in California.
- Joel Whitley
Joel Whitley’s mother, Marcia Whitley, took Januvia in August 2007. The following month, her doctor also prescribed Janumet. She died of pancreatic cancer in August 2009. Her son filed a personal injury claim on behalf of her estate as well as a wrongful death claim. The case is pending in the federal MDL.
- Linda Jean Howard
Linda Jean Howard of Alabama developed acute pancreatitis after her doctor prescribed Victoza and Byetta. She alleged that if she or her doctor had known about the risk of developing pancreatitis, she would never have taken the drugs. She filed a lawsuit in federal court in August 2013. Her complaint alleged that the defendants conduct caused her to incur expenses for “physicians, surgeons, nurses, hospital care, medicine, hospices, X-rays, medical supplies and other medical treatment.” She also claimed it caused her to lose “actual and future income.”
Please seek the advice of a medical professional before making health care decisions.