Onglyza Litigation Ramps Up

Miami, FLYesterday, The U.S. Judicial Panel on Multidistrict Litigation (JPML) heard from Onglyza and Kombiglyze patients regarding whether to consolidate all federally-filed cases before one court for pre-trial proceedings.

Timothy Clark, one attorney representing the plaintiffs, said the 42 cases that are currently pending in federal courts across the country should be consolidated before U.S. District Judge Jon S. Tigar in San Francisco because he has already issued a few orders in some cases being coordinated in the Northern District of California. Clark pointed out that the case has more than doubled in size since filing the petition for consolidation to the JPML three months ago.

Representing another group of plaintiffs, attorney Alex Davis told the JPML that discovery is set to close in less than a month but they haven't received the discovery they need and he agrees with coordinating the cases in Northern California. (The lawsuits were originally filed in California in September 2016 before being refiled in New Jersey in February 2017.)

But defendants AstraZeneca and Bristol-Myers Squibb argued that the cases can continue to be litigated on an individual basis. For the past two years this has been going on, but plaintiffs say these complaints will soon grow to hundreds of similar complaints. Their attorney, Phyllis Jones told the JPML that centralization will “inject inefficiencies” and that “the creation of an MDL can attract cases that otherwise may not have been filed.”

Another Onglyza and Kombiglyze XR lawsuit filed

Earlier this month an Illinois man filed a complaint in the U.S. District Court, Central District of Illinois against AstraZeneca and Bristol-Myers Squibb, with similar complaints as plaintiffs above. They claim that during the development of the drugs, the pharmaceutical companies failed to perform adequate studies to determine if their drugs caused increased risks of adverse cardiovascular events, and they also failed to warn of the risks of heart failure and death.

Jerald Adams took Onglyza and Kombiglyze XR, both of which contain the active ingredient saxagliptin, to control Type 2 diabetes between April 2015 through December 2015. Adams says his diagnosis of heart failure was directly related to saxagliptin exposure. His complaint states that, “At all relevant times, Defendants had knowledge that there was a significantly increased risk of adverse events associated with Saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell, and profit from sales of Saxagliptin.”

Further, “Despite such knowledge, Defendants knowingly, purposely, and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers, and the public of the increased risk of serious injury associated with using Saxagliptin, including, but not limited to, heart failure, congestive heart failure, cardiac failure, and death related to those events.” (Case No. 1:18-cv-01015-JES-JEH)

Onglyza and the FDA

The first lawsuits that were filed in New Jersey claim that that Onglyza was sold in 2009 without conducting the clinical trials suggested in the FDA’s 2008 guidance. In 2016—one year after results of a trial conducted by AstraZeneca and ordered by the FDA—the agency released a safety announcement, warning that drugs containing saxagliptin may increase the risk of heart failure. The label for Onglyza was then changed to include a warning of an increased risk of pancreatitis and heart failure.

Onglyza Big Seller

When Onglyza was approved in 2009, the drug makers claimed it was “an important new treatment to help improve glycemic control.”

With almost 30 million people in the US diagnosed with diabetes and possibly over 8 million potentially undiagnosed and unaware of the condition (according to the CDC), the diabetes drug became a best seller for AstraZeneca and Bristol-Myers Squibb. Reuters reported that some analysts predict Onglyza sales could peak at $1.8 billion a year in 2018. They may be putting aside some of those profits to settle upcoming Onglyza lawsuits.