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On February 2, 2018, the U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “panel”) ordered that all federally-filed Onglyza (saxagliptin) lawsuits be centralized in the Eastern District of Kentucky.  That means a total of 84 cases pending in over 26 districts will be transferred to the new Multidistrict Litigation (“MDL”).

The cases all involve plaintiffs who took either Onglyza (saxagliptin) or Kombiglyze XR (saxagliptin and metformin) for type 2 diabetes and then developed serious cardiac injuries including heart failure.

Plaintiffs Agreed with Consolidation of Onglyza Lawsuits

Plaintiffs in a case filed in the Northern District of California filed the initial motion last October to centralize all federally-filed cases together in one court for pre-trial proceedings. They noted that the cases all shared common questions of fact, had the same basic theory of liability, and would involve the same core discovery, fact witnesses, and experts.

Common questions of fact include:

  • whether Onglyza or Kombiglyze XR can cause heart failure or other conditions such as congestive heart failure, myocardial infarction and/or cardiovascular injury;
  • when the defendants first learned of the connection between the drug and heart failure;
  • whether they failed to warn patients and doctors about the risk;
  • whether Onglyza is defectively designed or unreasonably dangerous; and
  • whether it was sold without adequate warnings.

The plaintiffs argued that it was timely to coordinate now because none of the pending cases had made substantial progress toward trial and discovery hadn’t even started yet in most cases.

Some of the plaintiffs asked the court to send the MDL to the Northern District of California. They argued that the judge there had MDL experience, there were already two cases pending there, and that the location was convenient because the counsel for the defendants were based in San Francisco.  Other plaintiffs asked the JPML to send the cases to the Eastern District of Kentucky.

Defendants Disagreed with Consolidation of Onglyza Lawsuits

The Defendants—AstraZeneca Pharmaceuticals, Bristol-Myers Squibb Company, and the McKesson Corporation—filed a response in November 2017 arguing against centralization.  They argued that there were a limited number of filed cases and there was no evidence that the litigation would continue to grow.

They also argued that an MDL could “frustrate resolution” of the cases because they involve a “range of claimed injuries not well suited for consolidation,” including heart failure and other cardiovascular injuries. Defendants further claimed that informal coordination among the actions would be sufficient.

JPML Agrees that Onglyza Lawsuits Involve Common Questions of Fact

The JPML found that the Onglyza lawsuits did, indeed, involve common questions of fact, and that centralization would “serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” Significantly, the JPML found that a MDL would also eliminate duplicative discovery, prevent inconsistent trial rulings, and conserve the resources of the parties.

The panel rejected defendants’ position that informal coordination among the actions would be sufficient. The JPML noted that informal coordination among the 84 cases “scattered across the nation” would not be feasible. They also recognized that “[c]entralization also will provide a single forum where disputes about the sufficiency of defendants’ past and any supplemental document productions, as well as about expert discovery, can be handled in a streamlined fashion.”

In the JPML Order, they also noted that heart failure is the injury claimed in most of the cases, and that this injury is “squarely in line” with the results of the SAVOR study, evidence which the plaintiffs will use to link the drug to the injury. The panel added that the defendants’ move to update their label with a warning about heart failure in 2016 also supports this connection.

Finally, the JPML sent the MDL to the Eastern District of Kentucky, a venue that defendants and certain plaintiffs had argued was appropriate for the Onglyza MDL. The panel noted that it’s relatively accessible, and that the longest-pending Onglyza lawsuit is also pending in this district.  The panel assigned Chief Judge Karen K. Caldwell to oversee the proceedings.

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