Byetta, Januvia, Janumet and Victoza are fairly new drugs designed to help regulate blood sugar levels in people with Type 2 Diabetes. They are in a class of drugs known as incretin mimetics, and they have all been associated with an increased risk of pancreatic cancer and thyroid cancer. The Code of Federal Regulations requires a pharmaceutical manufacturer to warn of a drug’s potentially dangerous side effect “as soon as there is reasonable evidence of a causal association with the drug.” 21 CFR 201.57(c)(6). To date, none of these drugs’ labels warn of their heightened cancer risks. In fact, the manufacturers continue to deny the existence of any association between their drugs and cancer.
Because of the volume of lawsuits filed across the nation by victims of pancreatic cancer and thyroid cancer, a multidistrict litigation (MDL) court has been established in the Federal District Court in San Diego, CA. A similar coordinated proceedings court (JCCP) has been established in California state court in Los Angeles. Our firm has cases pending in both venues.
There are several important hearings on the near horizon in both federal and state courts. The two primary issues in the forefront of the litigation involve preemption and general causation. In short, the manufacturers are claiming the current labels adequately reflect the state of the science and, thus, the FDA would not permit a cancer warning be added to the label, even if they were to submit one. Secondly, the Defendants claim the Plaintiffs are unable to proffer adequate evidence of causation to warrant the continuation of the lawsuits.
Both sides have retained experts on these issues, and dispositive hearings are likely to be held this summer. In the meantime, we continue to investigate and file cases involving pancreatic cancer and thyroid cancer diagnosed after the use of these incretin therapy drugs. If you have any questions about this litigation, contact David Dearing, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at David.Dearing@beasleyallen.com.