Patients who used Onglyza to control their diabetes are filing litigations after experiencing heart attacks and pancreatic cancer. The U.S. Food and Drug Administration (FDA) recently placed a new warning label on this medication; this comes after countless people became injured and were never made aware of the life-altering side effects.
Pharmaceutical companies who manufacture Onglyza such as AstraZeneca or Bristol-Myers Squibb often make millions by marketing dangerous drugs that have never been tested properly. Saxagliptin reached $786 million in sales in 2015, an outstanding amount of money that can reach up to $2.47 billion in 2018 according to market analysts .
Medication Type: Diabetes
Injury: Heart Attack, Pancreatic Cancer.
Manufacturer: AstraZeneca, Bristol-Myers
Total Cases: 16,000
Settlement Amounts: EST – $100,000 over $1,000,000
Bellwether Trial Start Date: April 2017
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What is Onglyza?
Onglyza (saxagliptin) is an oral anti-diabetic drug manufactured by AstraZeneca and Bristol-Myers Squibb that was approved by the FDA in 2009 . Kombiglyze XR is a combination of saxagliptin and metformin HCl (extended-release) and was approved in 2010 . Both these drugs are used to help control hyperglycemia (high blood sugar) in people affected by type 2 diabetes, and may be used in combination with other oral hypoglycemic drugs such as sulphonylureas.
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Why are Onglyza and Kombiglyze dangerous medications?
Several clinical trials pointed out that the use of saxagliptin is associated with a life-threatening risk of heart failure. This side effect is so severe that in April 2016, the FDA changed the medication’s label to add a new warning after a safety review was issued. 14 out 15 members of the Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of the updated label, while the last member of the board recommended a full product recall since he deemed it too dangerous for the U.S. market .
On October 2013, a first study published in the New England Journal of Medicine found a 27 percent increase in heart failure hospitalizations in diabetic patients who took the DDP-4 inhibitor . Data analyzed included more than 16,000 subjects from the SAVOR TIMI-53 trial, which was funded by AstraZeneca and Bristol-Myers Squibb. Two large systematic meta-analyses published in 2014 confirmed the risk, which may even be greater in some sub-populations of patients [6, 7].
Plaintiffs Principal Accusations Against Onglyza
- Falsely advertising their product despite having knowledge of inherent dangers
- Failure in warning doctors and patients about dangerous adverse reactions
- Failure in conducting adequate pre-market trials
- Negligently or fraudulently marketing their medication
- Marketing a defective or harmful drug according to the product liability law
- Conspiracy and malicious conduct
Gibson v. AstraZeneca Pharmaceuticals LP
On October 29, 2015, Rochelle Gibson, a resident of Chicago, filed a litigation against AstraZeneca Pharmaceuticals in Cook County Circuit Court (Case No. 2015-L-010969). The woman is accusing the pharmaceutical company of negligence for failing to warn the public about the risks of their dangerous medication, on behalf of her mother, Lillie Ree Gibson. According to the complaint, Mrs. Gibson died of a cardiovascular attack on October 31, 2013, while she was hospitalized. She was diagnosed with heart failure in June 2011, shortly after her doctor prescribed her saxagliptin to treat her diabetes .
Often the pharmaceutical companies offer out of court negotiation to shut down the litigations before the legal system is involved. The pre-trial discovery phase of the upcoming litigation trial will require lengthy depositions and adequate time. Our lawyers’ strong legal skills and tireless determination will provide you with all the right weapons to fight this battle. With dozens of years of experience in this field, we know what’s the best approach to guide our clients to success.
Class Action or a Multidistrict Litigation Lawsuit?
Currently, only individual litigations have been filed against AstraZeneca’s medication, thus, no Class Action is available. Since most proceedings are still very recent, no Multidistrict litigation has been consolidated yet. An MDL is usually centralized in order to eliminate any delay in the pretrial discovery phase and avoid conflicting rulings from different judges.
Litigations filed against drugs with properties similar to saxagliptin ones like Victoza, Byetta, Januvia, Nesina and Janumet have already been centralized in a Multidistrict Litigation in the Southern District of California overseen by the U.S. District Judge Anthony J. Battaglia. Although Onglyza is not officially part of this list, it is possible that new cases of pancreatic disorders where this DPP-IV inhibitor may have had a causative role are included among the about 800 allegations in the MDL no. 2452 due to the pharmacological similarities.
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