Parties to hundreds of Onglyza lawsuits undergoing coordinated pretrial proceedings in a Kentucky federal court have very different ideas as to how discovery should move forward in the multidistrict litigation.
Plaintiffs had previously suggested that case-specific discovery on a select group of bellwether trial cases should proceed at the same time as general causation discovery. They contend that concurrent discovery would avoid delays and facilitate resolution of the pending claims.
But in a Response filed with the U.S. District Court, Eastern District of Kentucky, on October 5th, defendant AstraZeneca proposed a bifurcated schedule in which general causation discovery would proceed ahead of case-specific discovery. The company maintains that a 2-phase discovery schedule would enable the Court to determine whether or not plaintiffs have sufficient evidence to support their allegations that Onglyza caused heart failure.
The judge overseeing the federal Onglyza litigation will likely address this matter during a quarterly Status Conference that is scheduled to be convened on December 18th.
There are currently 220 claims pending in the multidistrict litigation underway in the Easter District of Kentucky, all of which were filed on behalf of plaintiffs who allegedly developed heart failure or other cardiovascular injuries due to their use of Onglyza and Kombiglyze XR.
Both drugs are indicated to treat patients with Type 2 diabetes and contain saxagliptin as their active ingredient. Kombiglyze XR also contains an older diabetes medication called metformin.
The litigation surrounding Onglyza and Kombiglyze XR began to grow shortly after the U.S. Food & Drug Administration (FDA) announced it was reviewing a possible link between saxagliptin and heart failure in 2014.
The agency’s investigation was prompted by interim results from the SAVOR-TMI clinical trial that suggested patients exposed to saxagliptin were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
In April 2015, a panel of outside advisors to the FDA recommended that information about heart failure be added to the “Warnings and Precautions” section included in the labels of all saxagliptin-containing medications. The FDA ordered those updates the following year.
Federally-filed Onglyza lawsuits were centralized before a single U.S. District Court Judge last July. At the time, just 41 cases were transferred to the Eastern District of Kentucky.
In September, Bernstein Liebhard LLP partner Daniel C. Burke was appointed to the Plaintiffs’ Executive Committee in the federal Onglyza litigation.