Judge Denies Plaintiff Request for Source Data on Byetta, Januvia Problems

As discovery continues in the federal lawsuits over pancreatic cancer from Januvia, Janumet, Byetta and Victoza, the U.S. District Judge presiding over the litigation has denied a plaintiff’s require to obtain source data on adverse events held by the manufacturers of the popular diabetes drugs, finding that it is not the Court’s job to police whether the pharmaceutical companies were truthful with the FDA. 

There are currently more than 500 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits pending in the federal court system, which all involve allegations that the drug makers failed to adequately warn about the risk of pancreatic cancer associated with the class of diabetes drugs known as incretin mimetics.

The cases are centralized before U.S. District Judge Anthony Battaglia in the Southern District of California, as part of an MDL or multidistrict litigation, to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

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In an order (PDF) issued October 6, Judge Battaglia denied a motion to compel production of adverse event source documents and databases filed by plaintiffs.

Plaintiffs had sought “underlying documents for each pre- and post- marketing adverse event known to each Defendant; and the adverse event databases maintained by each Defendant,” indicating that the source documents are necessary to determine whether the drug makers misreported or under-reported information to the FDA about the connection between the diabetes drugs and pancreatic cancer.

Most adverse event reports involving prescription medications are filed directly with the drug maker, who is then required to report these incidents to the FDA. However, plaintiffs maintained that the summary reports provided during discovery are insufficient without the underlying source data. They also argued that the information may provide a clearer picture of how the drugs cause pancreatic cancer and that the manufacturers knew about the risk for some time.

In rejecting the motion to compel, Judge Battaglia ruled that not only would attempting to get the companies to turn over the source data be unnecessarily burdensome, but also indicated that there would be little the court could do with the information, which amounts to claims of fraud against the FDA.

The cases pending in the MDL all hinge on claims that drug makers failed to provide adequate warnings. Claims that the manufacturers committed fraud against the FDA by not giving honest adverse event reports would have little bearing on the failure to warn claims, Judge Battaglia noted. He maintained that determining whether drug companies had committed fraud against the FDA was expressly the job of the FDA.

“The conflict arises not within the context of federal preemption versus the FDA’s power to regulate, but within the fraud-on-the-FDA type arguments and Plaintiffs’ multi state law failure-to-warn claims,” he wrote. “Granting the discovery sought on the basis such claims are relevant to preemption would require courts to overstep the bounds placed in effect by the FDA’s federal regulatory scheme and Supreme Court precedent. This would result in a frustration of the statutory scheme for regulation in this field.”

The ruling came a day before parties filed a joint agenda (PDF) for a status conference scheduled for today, which will look at the state of depositions and the discovery process.

Ultimately, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different diabetes drugs, known as bellwether trials. While the outcomes of these trials will not be binding in other cases, they are designed to help the parties gauge the relative strengths and weaknesses of their cases, and may lead to Byetta and Januvia settlement agreements.

Pancreatic Cancer Claims

Byetta, Januvia, Janumet and Victoza are all part of the same incretin mimetic class of diabetes drugs, which work by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal.

Byetta (exenatide) was the first member of the incretin mimetic class approved by the FDA, introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Bydureon is an extended-release version of Byetta. Victoza (liraglutide) is a similar injectable diabetes drug introduced by Novo Nordisk in 2010 as a longer-acting daily injection.

The pancreatic cancer lawsuits have been filed against the makers of all four drugs following a number of studies that linked side effects of Januvia, Janumet, Byetta and Victoza to an increased risk of pancreatitis, which plaintiffs allege causes the development of pancreatic cancer in many cases.

It has previously been estimated that about three dozen Byetta thyroid cancer lawsuits are also pending against AstraZeneca, which are excluded from the MDL proceedings. The plaintiffs in those cases allege that the Byetta warning label should mention the potential risk of thyroid cancer, which has been added to the label for Victoza.


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