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. People who suffered from these side effects filed lawsuits against the makers of these drugs, Merck (Januvia and Janumet), Amylin and Eli Lilly (Byetta) and Novo Nordisk (Victoza).
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.
After the agency stated some studies suggested a link between these drugs and pancreatic cancer, the first lawsuits alleging the drugmakers failed to warn about the risk landed in courts across the country.
In 2013, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated these cases in California federal court in multidistrict litigation (MDL) number 2452, In Re: Incretin Mimetics Products Liability Litigation.
In November 2015, the presiding judge, Anthony J. Battaglia, granted summary judgement in favor of the defendants. Summary judgement means the judge dismissed all cases in the MDL. Plaintiff’s attorneys filed an appeal in September 2016 claiming the judge misinterpreted the law.
So far, plaintiffs are awaiting the decision from the Ninth Circuit Court of Appeals, but some law firms continue to accept cases and some people still filed lawsuits after the judge’s decision.
History and Status of MDL No. 2452
In August 2013, the JPML 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.
The purpose of centralizing case is to conserve resources. Since all of the lawsuits involving Januvia, Janumet, Byetta and Victoza claim the drugs caused pancreatic cancer and pancreatitis, the court felt it would be more efficient because all cases would likely use the same experts and go through the same discovery process.
According to the Master 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.”
Lawsuits in the MDL list several allegations against manufacturers, including:
- 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, Judge Anthony J. Battaglia granted the manufacturer’s request for dismiss all the cases in the MDL under a motion called summary judgement. Defendants argued that the plaintiffs had no failure-to-warn case because there was no way the FDA would have approved their label change to warn of 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 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.
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.
So far, the Ninth Circuit has yet to return its decision. At the time the judge granted defendants summary judgment, there were 749 cases pending in the MDL. More plaintiffs joined the MDL after the decision. As of April 15, 2017 the case count was at 931.
Case Law in Plaintiffs’ MDL Appeal
In the plaintiffs’ September appeal, they argued that Judge Battaglia “misunderstood the lessons” of preemption case law. Two cases set precedents in preemption law that the judge overlooked or misinterpreted: Wyeth v. Levine and Buckman Co. v. Plaintiffs’ Legal Committee.
The plaintiffs argue Battaglia made a mistake when he ruled that newly acquired information on pancreatic cancer was irrelevant to the issue of preemption.
Battaglia made a mistake when he ruled that newly acquired information on pancreatic cancer was irrelevant to the issue of preemption. In Buckman, the Supreme Court ruled that newly acquired risk information is relevant.
The judge also failed to properly interpret Wyeth v. Levine. Case law from Wyeth showed that defendants in the MDL failed to provide evidence that the FDA would have rejected a changes-being-effected (CBE) label update by the manufacturers. CBE laws (21 C.F.R. §314.70(c)) allow drug manufacturers to strengthen safety language without prior FDA approval. The FDA reviewed “little, if any, of the new safety information possessed by the Defendants that could have supported a CBS,” plaintiffs state in their appeal.
The judge also should not have disqualified Dr. Thomas Fleming, the plaintiffs’ expert, or deny additional discovery. Battaglia disqualified the expert without proper facts and this resulted in “extraordinary prejudice” to plaintiffs, the appeal states.
Examples of MDL Lawsuits
People who filed lawsuits in the MDL claim the drugmakers overpromoted the drugs as effective and safe and failed to warn about the dangers of pancreatic cancer. In addition to an increasing number of lawsuits, Merck, Amylin, Eli Lilly and Novo Nordisk incurred criticism because patients and physicians were not adequately warned about serious, potentially fatal, health risks. Had they received adequate warnings, many of the patients who developed pancreatic cancer or acute pancreatitis could have chosen other diabetes treatments, lawsuits claim.
Plaintiffs who filed lawsuits against incretin mimetic drugmakers:
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.
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’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.”
Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.
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