The federal multidistrict litigation established for heart failure lawsuits involving Onglyza and Kombiglyze XR is moving forward, following the issuance of the first Case Management Order in the U.S. District Court, Eastern District of Kentucky.
Among other things, the October 24th Order indicates that discovery will commence in two phases. The first phase will focus on general causation to determine whether saxagliptin – the active ingredient in Onglyza and Kombiglyze XR – is capable of causing heart failure or other cardiovascular injuries alleged by the plaintiffs.
“General causation is a critical issue in this case, common to all actions. If the plaintiffs are unable to establish that Onglyza or Kombiglyze XR is capable of causing any person to develop heart failure or other conditions alleged by the plaintiffs, then the parties will not be required to undergo the time and expense of further discovery and litigation,” the Order states.
“Thus, addressing general causation before considering plaintiff-specific issues will best ensure the most efficient resolution of these actions and use of the parties’ and the Court’s resources.”
The Order also sets forth the following deadlines:
Saxagliptin belongs to a class of Type 2 diabetes medications called DPP-4 inhibitors, which work by increasing the amount of incretin hormones produced by the digestive system. Among other things, these hormones inhibit the release of glucagon and stimulate the production of insulin. Both actions lower the amount of glucose present in the blood.
Plaintiffs throughout the United States began filing Onglyza and Kombiglyze XR lawsuits shortly after the U.S. Food & Drug Administration (FDA) announced it was reviewing a possible link between saxagliptin and heart failure in February 2014. That review was launched in reaction to preliminary study results that suggested patients exposed to saxagliptin were 27% more likely to be hospitalized for heart failure. The study – known as SAVOR-TMI – also linked saxagliptin to a higher rate of all-cause mortality.
In September 2016, the FDA added new “Warnings and Precautions” to the labels of all saxagliption-containing medications that reflected the SAVOR-TMI findings.
Plaintiffs who have filed Onglyza and Kombiglyze XR lawsuits allege that AstraZeneca and other defendants were aware that saxagliptin could increase a patient’s risk for heart failure, heart attacks, and other cardiovascular injuries. They further claim that defendants intentionally withheld this information from the public and failed to warn doctors and patients about cardiac side effects associated with with their products.
The multidistrict litigation for saxagliptin-related heart injury claims was established in February, when just 41 cases were transferred to the Eastern District of Kentucky. However, the proceeding has since grown to include more than 200 Onglyza and Kombiglyze XR lawsuits.
In September, Bernstein Liebhard LLP partner Daniel C. Burke was appointed to the Plaintiffs’ Executive Committee in the federal Onglyza litigation.