Bristol-Myers, AstraZeneca Defendants in Onglyza Lawsuits
In 2016, the U.S. Food and Drug Administration (FDA) called for increased heart failure warnings on the AstraZeneca Type 2 diabetes medication, Onglyza (saxagliptin), Now, AstraZeneca and its former partner, Bristol-Myers Squibb, are facing 14 lawsuits related to the heart failure risks associated with Onglyza.
The lawsuits were filed in the District of New Jersey and similarly allege that the drug makers neglected to warn users that Onglyza and a related combination drug known as Kombiglyze XR (saxagliptin and metformin HCl extended‐release) might lead to cardiac arrest, congestive heart failure, and death, the New Jersey Law Journal reported.
Most of the lawsuits currently filed were brought by plaintiffs
who were diagnosed with congestive heart failure or some other cardiac issues. Some of the lawsuits were filed on behalf of Onglyza patients who died allegedly due to their taking the medication. Plaintiffs filed the lawsuits following an announcement by the FDA indicating that more stringent warnings would be needed concerning the various heart issues, some deadly, on the saxagliptin labeling.
All of the lawsuits similarly allege that AstraZeneca Pharmaceuticals and Bristol-Myers Squibb began selling saxagliptin in 2009 without having ever conducted clinical trials-which is mandated by federal regulators-to determine if the drugs played a part in increasing cardiac risk in patients. The FDA issued a bulletin in 2008, which advised diabetes drug developers of the need to show that their products do not increase heart risks.
According to the lawsuits, in 2015 an FDA committee convened and recommended that the federal regulators mandated for the addition of a heart failure warning on the label for saxagliptin; this, after the agency research that revealed that the drugs are associated with a significant increase in the risk of being hospitalized for heart failure. In 2016, the FDA announced that individuals taking saxagliptin might have an increased risk of heart failure. The agency then required a revised warning label on the drug.
The plaintiffs also allege that AstraZeneca and Bristol-Myers Squibb knew about the various increased cardiac risks associated with taking saxagliptin but failed to notify doctors or consumers of these heart risks.
The lawsuits attempt to show the association between saxagliptin and heart failure and other adverse cardiac events and were originally filed in state court in San Francisco, California in September 2016. The lawsuits were re-filed in New Jersey after a judge there granted a motion on February 1 by Bristol-Myers Squibb and AstraZeneca to sever and dismiss the non-California plaintiffs from that case on grounds of forum non conveniens, reported The New Jersey Law Journal. According to Cornell University Law School, forum non conveniens “is a discretionary power that allows courts to dismiss a case where another court, or forum, is much better suited to hear the case. This dismissal does not prevent a plaintiff from re-filing his or her case in the more appropriate forum.”
The lawsuits allege a design defect and seek to recover on grounds of negligence, failure to warn, breach of warranty of merchantability, and breach of express warranty and implied warranty. The New Jersey Law Journal wrote. The plaintiffs also seek to recover for pain and suffering, economic damages, emotional distress, lost wages, and medical expenses. The lawsuit also contends that the accrual of any applicable statute of limitations should be tolled due to the defendants’ fraudulent concealment under specific circumstances.
About 150 to 200 Onglyza cases are pending across the country and it is likely that they may eventually number into the thousands. For example, a Texas man filed a lawsuit against the drug makers’ alleging that Onglyza caused heart failure, court documents indicated. According to the man’s complaint for damages that was filed on February 1, 2017 in the United States District Court for the Southern District of Texas. The man took both Onglyza and Kombiglyze XR between 2010 and 2015 and alleged that he suffered congestive heart failure; heart failure; and acute hypoxic respiratory failure, a condition in which there is insufficient oxygen in the blood. He charges the drug makers with negligence, manufacturing a defective product, and failure to warn of the risks.
“Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure, and other adverse effects associated with saxagliptin from the public, plaintiff, physicians, and other healthcare providers,” the lawsuit indicates. “These concerted efforts resulted in significant harm to those treated with saxagliptin, including plaintiff,” the lawsuit further indicates.
Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits over the past several decades. The firm continues to offer free legal consultations to anyone with questions about filing an Onglyza or Kombiglyze XR lawsuit.
Warnings Mandated for Onglyza and Kombiglyze XR
The FDA approved Onglyza in 2009 and Kombiglyze in 2010. Both drugs belong to a class of drugs known as DPP-4 inhibitors that work to control blood sugar by helping the pancreas to produce more insulin following meals, reducing the amount of glucose produced by the liver. The medications do not encourage weight gain like many other Type 2 diabetes treatments. According to analysts, Onglyza could make as much as $2.47 billion annually by 2018.
Astra Zeneca and Bristol Meyers Squibb began marketing Onglyza in 2009 prior to conducting clinical trials to determine if the drug increased patients’ cardiac risks, the plaintiffs allege. The drug makers also ignored FDA guidance from 2008 that pressed companies to “demonstrate that” new therapies “will not result in an unacceptable increase in cardiovascular risk,” according to FiercePharma.
Onglyza’s heart risks were brought up in April 2016 when the agency pushed for the drug’s label to include a warning to indicate the associated risk of increased heart failure. Onglyza was not the only medication that regulators targeted. The FDA also mandated Takeda updated DPP-4 Nesina and the combination Kazano and Oseni. “FDA evaluated two large clinical trials conducted in patients with heart disease,” the agency wrote. “These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo.”
Filing an Onglyza or Kombiglyze XR 9 Lawsuit
If you or someone you know suffered uncontrollable bleeding related to the use of Onglyza or Kombiglyze XR 9, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).