The Onglyza lawsuit alleges that two drugs developed for people with Type-2 diabetes, namely Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin HCI extended-release), have caused severe cardiac complications and sometimes even death amongst patients.
This lawsuit is filed against the two drug manufacturers, Bristol-Myers Squibb and AstraZeneca, who, ignoring patient safety, began selling the two drugs. The Onglyza lawsuit claims that two companies began marketing and selling the drugs in 2009 before completing a study recommended by the Food and Drug Administration regarding the drug’s cardiac risks in Type-2 diabetes patients.
What is Onglyza?
Onglyza is a medication for Type-2 diabetes developed by Bristol-Myers Squibb and AstraZeneca Pharmaceuticals LP that controls blood sugar levels in patients by regulating insulin levels after food intake.
Onglyza received FDA approval in July 2009 and is used in combination with other diabetes medication or along with a treatment regimen that includes weight control, diet, and exercise.
Onglyza And Increased Risk Of Heart Failure
After selling the drug for almost six years, Bristol-Myers Squibb and AstraZeneca completed the study recommended by the FDA in 2016, wherein it was found that the drug, along with other drugs in the same class (such as Kombiglyze XR, Nesina, Kazano, and Oseni) increase the risk of heart failure amongst Type-2 diabetes patients.
The companies conducted a trial known popularly as SAVOR, wherein they found a “statistically significant” increase in the risk of heart failure in connection to these drugs. In the study, 35 out of every 1000 people in the trial were hospitalized due to cardiac complications instead of only 28 out of every 1000 people in the placebo group.
Thus, the report published in The New England Journal of Medicine states Onglyza is connected to a 27% increased risk of hospitalization due to heart failure and an increased risk of fatality from all causes.
The Onglyza lawsuit focuses mainly on the lack of adequate study regarding the risks of Onglyza and Kombiglyze XR. Bristol-Myers Squibb and AstraZeneca’s failure to conduct studies to determine whether Onglyza and Kombiglyze XR increase heart-related adverse events comes even after the issue of the 2008 FDA guidelines, which required all manufacturers of Type-2 diabetes medication to determine that their drugs do not increase the risk of heart failure.
As such, plaintiffs in this lawsuit allege that the two companies failed to warn doctors and patients about the increased risk of heart failure, congestive heart failure, cardiac failure, and death.
The lawsuit also alleges that the companies issued untrue, distorted information regarding the safety and effectiveness of the two drugs while actively concealing the risks from healthcare professionals and consumers and that the two companies continued to market Onglyza and Kombiglyze XR as safe and effective drugs during the period between 2009 and 2016.
The lawsuit also alleges that the manufacturers also made efforts to delay the issuance of a warning on the labels and reference material of the two drugs regarding their increased risks of heart failure, congestive heart failure, cardiac failure, and death.
Is The Onglyza Lawsuit A Class Action Lawsuit?
The Onglyza lawsuit is not a class-action lawsuit due to the simple reason that each plaintiff and their injury is different and is therefore going to be treated in the same manner. However, this is a complicated case involving several individuals, which is why individual cases have been grouped in the form of a Multi-District Litigations (MDL).
The helps the lawsuit move forward with sample trials to establish liability by allowing attorneys and judges to address common procedural issues initially.
Where Does The Onglyza Lawsuit Stand Currently?
Individual Onglyza lawsuits from 23 districts were consolidated into MDL number 2809 by a federal panel in a federal court in Kentucky. The MDL will be heard by Chief Judge Karen K. Caldwell.
There also exists a motion that seeks to consolidate the cases in California State Court. The lawsuit is expected to move forward with the bellwether trial soon.
How Will The Onglyza Lawsuit Help Injured Parties?
The Onglyza lawsuit aims to help those injured by providing financial compensation to the patients and families to help them recover from heart failure. Thus, your Onglyza lawyer will assist you with medical bills, as well as the income and benefits lost as a result of the injury.
The Onglyza lawsuit will also assist in removing dangerous drugs from the market. Thus, your lawyer will also act as a safety advocate, helping spread awareness to the public to prevent further injury.
To learn more about the Onglyza lawsuit and how we can help you out, contact us today.