MDLs to Watch: Onglyza and Kombligyze XR

In February, the United States Judicial Panel on Multidistrict Litigation issued an order centralizing pre-trial proceedings in actions against the manufacturers of Onglyza and Kombligyze XR, medications used to treat Type 2 Diabetes Mellitus. When the centralization was ordered, the litigation, docketed as In Re: Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation, MDL No. 2809, consisted of 84 actions pending in 26 districts, with 41 actions pending at the time of the motion. However, since the Panel filed the transfer order, the number of actions has increased to over 200. In light of this dramatic increase in lawsuits, and the overwhelming number of Americans diagnosed with diabetes each year, this litigation has the potential to become a huge mass tort in the context of products liability.

The Lawsuit Allegations

Onglyza and Kombligyze XR are medications that help Type 2 diabetes patients lower their blood glucose levels. Both drugs contain the active ingredient, saxagliptin, which is a DPP-4 inhibitor. DPP-4 naturally occurs in the body and is responsible for breaking down, GLP-1, an incretin hormone that is released into the blood after a person eats and alerts the pancreas to produce insulin. Since diabetics make less GLP-1, DPP-4 inhibitors help the body retain GLP-1 and signal to the pancreas to produce more insulin. The medications also control blood sugar by reducing the amount of glucagon, a hormone that causes the liver to produce glucose. Kombiglyze XR also contains metformin as an active ingredient and is an extended release formula. Onglyza and Kombiglyze XR, both manufactured by AstraZeneca, were approved by the U.S. Food and Drug Administration in 2009 and 2010, respectively.

All of the lawsuits filed against Onglyza and Kombiglyze XR allege similar injuries caused by the drugs, including a significant, increased risk of heart failure, congestive heart failure, myocardial infarction, and other cardiovascular injuries that could lead to death. The lawsuits also similarly allege that the companies failed to properly warn doctors and patients of these risks. In its motion to centralize the pending actions against the companies, one of the plaintiffs, Carolyn Williams, asserted that AstraZeneca did not perform adequate clinical studies to determine the extent of this risk, despite the Food and Drug Administration issuing a recommendation in 2008 that clinical studies be conducted by all manufacturers of diabetes medications that pose a cardiovascular threat. Williams alleged that AstraZeneca sold Ongylza for nearly five years before completing the study and that the results found that patients given the drug had a statistically significant increased risk (27%) in hospitalizations for heart failure as well as an overall increased risk of all-cause mortality. In response to these results, the Food and Drug Administration voted to add a heart failure warning label on Ongylza medication.

MDL Centralization

As a result of the growing number of lawsuits, the United States Judicial Panel on Multidistrict Litigation issued an order centralizing pre-trial proceedings against Onglyza and Kombiglyze XR in the Eastern District of Kentucky. The Panel found that all actions involved common questions of fact concerning the allegations that both drugs caused plaintiffs or their decedents to develop heart failure and other cardiovascular injuries. The Panel held that centralization in the Eastern District of Kentucky would serve the convenience of the parties and witnesses while promoting judicial efficiency. This venue was chosen based on its accessibility to defendants and certain plaintiffs, with the Panel noting that the longest pending action in this matter (Taylor, et al. v. Bristol-Myers Squibb Company, Inc., et al., C.A. No. 5:16-00260) was initiated before this district.

Defendants AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. opposed centralization but alternatively suggested the Eastern District of Kentucky as one of their preferred districts. Defendants opposed the transfer on the basis that plaintiffs’ allegations are supported by a study that only supports the heart failure claims and does not address other types of injuries. As such, defendants argued that the cases would likely vary as to specific injuries and present their own subset of unique issues. Defendants also argued that centralization is unnecessary and pre-trial proceedings could be addressed with informal coordination. The Panel rejected both arguments, holding that all cases involve allegations that are “squarely in line” with the cited study and label change of the drugs. To the extent plaintiffs’ claims lack scientific support, the Panel noted that centralization allows defendants a single forum in which to seek summary judgment that could apply to all other similar cases. The Panel further noted that informal coordination among 84 cases pending in over 30 districts (the number of cases at the time of the Panel’s decision) would not be feasible. With over 200 actions now pending, the Panel’s decision to centralize pre-trial proceedings is even more consequential.

The Future of Onglyza and Kombiglyze XR Litigation

The litigation surrounding manufacturers of Onglyza and Kombiglyze XR will undoubtedly require medical experts, most notably, cardiologists, to establish the effects these drugs have on the human body, the benefits and risks of the medication, and the proximate causes, if any, to heart failure. Both companies have an uphill battle in terms of clinical studies, as their own study has been cited against them in the complaints and by the Food and Drug Administration.

The prevalence of diabetes in the United States is alarming. With over 30.3 million U.S. adults living with diabetes – and another 84.1 million diagnosed as prediabetic – the disease is ranked as the seventh leading cause of death in the United States. According to the Food and Drug Administration, approximately 386,000 patients were prescribed Onglyza and Kombiglyze XR in 2015. Ongylza reached over $1.8 billion in sales in 2018, and Metaformin (one of the active ingredients in Kombiglyze XR) is among the top ten most popular medications prescribed in the United States. Between the prevalence of diabetes and the corresponding need for medication to treat it, the allegations against Onglyza and Kombiglyze XR will only continue to grow as more studies are conducted.