Onglyza Lawsuit Court Issues Order Governing Plaintiff Profile Forms

Published on January 16, 2019 by Sandy Liebhard

The federal court overseeing coordinated pretrial proceedings for hundreds of Onglyza lawsuits has issued its second Case Management Order, which governs the production of Plaintiff Profile Forms.

There are currently 226 Onglyza lawsuits pending in the U.S. District Court, Eastern District of Kentucky. All of the cases were filed on behalf of patients who allegedly developed heart failure due to their use of saxagliptin, the active ingredient in the Type 2 diabetes medications.

Onglyza Lawsuits Plaintiffs to Submit Profile Forms by March 1st

According the January 9th Order, claimants in all currently pending cases must deliver a complete and verified Plaintiff Profile Form to the defendants by March 1st.

Those who file their cases after January 15th must do so within 75 days of the date their Onglyza lawsuit is added to the multidistrict litigation.

As part of the Plaintiff Profile Form, each claimant must also produce records proving their Onglyza use, such as:

  • Pharmacy record(s) demonstrating that a prescription for Onglyza was filled by a retail or hospital pharmacy for use by the plaintiff or his or her decedent.
  • Records showing that samples were given or provided by a physician for use by the plaintiff or his or her decedent.
  • Medical record(s) denoting a prescription to plaintiff for Onglyza or notation of Onglyza as a current medication
  • An affidavit from a healthcare provider attesting that he or she prescribed Onglyza to plaintiff.
  • Pill bottle(s) for use by the plaintiff or decedent

Plaintiffs must also produce medical records showing new, aggravating, or worsening heart failure that occurred after they began taking Onglyza.

Finally, the Order directs the parties to negotiate a Plaintiff Fact Sheets (PFS), as well as a Defendant Fact Sheets (DFS).

“During the period in which the Court is evaluating Daubert motions regarding expert witness testimony on the issue of general causation, the parties shall file the proposed PFS, the proposed DFS, and an accompanying proposed Case Management Order which will contemplate the submission of completed PFS and DFS shortly thereafter,” the Order States. “During this time period the parties plan to reach consensus on a pool of cases that will be required to submit PFS and DFS.

Onglyza and Heart Failure

The U.S. Food & Drug Administration (FDA) approved Onglyza in 2009. It is indicated to treat patients with Type 2 diabetes in conjunction with diet and exercise.

The following year, the FDA approved Kombiglyze XR, a combination drug that contains saxagliptin and metformin.

In 2014, the agency announced a saxagliptin safety review, after preliminary clinical trial results suggested patients taking the drug 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 2016, the FDA ordered the manufacturers of saxagliptin-containing medications to add information about heart failure to the “Warning and Precautions” section of their product labels .

Federally-filed Onglyza heart failure lawsuits were centralized in the Eastern District of Kentucky last February. At the time, just 41 cases were transferred to the multidistrict litigation.

Bernstein Liebhard LLP partner Daniel C. Burke was appointed to the proceeding’s Plaintiffs’ Executive Committee last September.

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