A Kombiglyze and Onglyza MDL for federal court lawsuits filed against AstraZeneca and Bristol-Myers Squibb will focus on heart failure cases among other side effects associated with these diabetes drugs.
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)
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 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….
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.
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.[Read article in full at original source]