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The U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all federally-filed Onglyza lawsuits consolidated into the Eastern District of Kentucky back in February 2018. Since then, District Judge Karen K. Caldwell has been overseeing the pre-trial proceedings. There are currently over 200 cases pending in the litigation involving allegations that Onglyza’s manufacturers, Bristol-Myers Squibb and AstraZeneca, failed to warn about the risks associated with the drug, including the increased risk of being hospitalized for heart failure.

Recently, according to a case management order, the court determined that discovery in the Onglyza lawsuits will be conducted in two phases, with the first addressing “general causation,” that is, whether Onglyza or Kombiglyze XR are capable of causing a patient to develop heart failure or other similar conditions like congestive heart failure, heart attack, and other cardiovascular injuries.

Court Orders Discovery Proceed Only on General Causation

Judge Caldwell stated in the order that establishing general causation is critical and common to all actions, as if the plaintiffs are unable to establish that the drugs can increase the risk of heart failure and other heart problems, “then the parties will not be required to undergo the time and expense of further discovery and litigation.” If the plaintiffs are successful, the court will move on to considering plaintiff-specific issues.

In making this decision, the judge denied the plaintiff’s earlier proposal to conduct concurrent discovery on all issues. In addition, the court ordered that the plaintiffs must file a master complaint on or before November 19, 2018. The master complaint will serve as the operative complaint in every individual action for the rest of the proceedings.

The court also ordered that if the parties wish to utilize plaintiff fact sheets, authorization forms, and/or defendant fact sheets, they need to file those with the accompanying motions for approval by November 19, 2018. A master answer responding to the allegations in the master complaint, as well as the short form complaint, are to be filed by December 19, 2018.

In addition to the above matters, the judge also ordered that by January 15, 2019, the parties must file a proposed plan containing deadlines for filing additional claims, third-party complaints, motions, responses, and for the first phase of discovery on the issue of general causation.

FDA Requires Warnings Concerning Heart Failure

The FDA approved Onglyza (saxagliptin) for the treatment of type 2 diabetes in 2009. The drug helps lower blood sugar levels by stimulating the pancreas to release more insulin after a meal. A few years later, however, results of a clinical trial suggested that patients taking the drug were more at risk of being hospitalized with heart failure.

The FDA reviewed the data from the study and concluded that new warnings were needed on the medication label to alert doctors and patients to the potentially increased risk of hospitalization for heart failure. These warnings weren’t added until 2016.

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