This Diabetes Drugs Litigation Involves Heart Failure, Myocardial Infarction, And Other Cardiovascular Problems
In February 2018 the United States Judicial Panel on Multidistrict Litigation (JPML) established MDL No. 2809, IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION.
According the the February 2, 2018 Transfer Order issued by the JPML:
[W]e find that these actions involve common questions of fact, and that centralization under Section 1407 in the Eastern District of Kentucky will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions share numerous factual questions, inasmuch as plaintiffs allege that the use of Onglyza or Kombiglyze XR caused them or their decedent to develop heart failure or other conditions such as congestive heart failure, myocardial infarction and/or cardiovascular injury.
According to that JPML Transfer Order the Defendants -- AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. -- opposed centralization of approximately 80 Onglyza and Kombiglyze lawsuits into this new MDL:
Defendants oppose transfer by arguing that plaintiffs’ allegations are supported by a single study (the SAVOR study), which itself supports only claims regarding heart failure – not the various other injuries (congestive heart failure, acute hypoxic respiratory failure, coronary artery disease and cardiovascular injury) plaintiffs allege. They argue that, as a consequence, these cases likely will turn on unique issues that are applicable to, at most, a small subset of other cases. Defendants also assert that informal coordination among the actions is a feasible alternative to centralization. These objections are insufficient to overcome the significant advantages that centralization will afford.
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Continuing, this Kombiglyze / Onglyza MDL Transfer Order sets forth the JPML's take on that contention by AstraZeneca, Bristol-Myers Squibb, and McKesson:
Defendants concede that most cases involve allegations of heart failure, which is squarely in line with the results of the SAVOR study and the subsequent label change for Onglyza and Kombiglyze XR in April 2016. If defendants are convinced that plaintiffs’ claims regarding heart failure or other injuries lack scientific support, then centralization affords them a single forum in which to seek summary judgment, which might be applied to other similar cases.
As background, in April 2016 the FDA took regulatory action by mandating label changes with new warnings about an increased risk of heart failure for these relatively new diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs:
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
- Qtern (dapagliflozin and saxagliptin)
As indicated above, MDL No. 2809 involves only Onglyza and Kombiglyze lawsuits filed in the federal court system.
However, at the present time we are investigating heart failure cases for patients who used Onglyza or Kombiglyze as well as patients who used Nesina, Kazano, Oseni, or Qtern.
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