>A Texas resident has filed one of the newest lawsuits against Bristol-Myers Squibb and AstraZeneca, alleging that these drug manufacturers failed to adequately test Onglyza for potential side effects and also failed to warn patients about the increased risk of developing heart failure. Learn more:The Onglyza TV Commercial Makes It Seem Safer Than It Actually Is.
According to his case, which was filed in the United States District Court Southern District of Texas under case number 4:17-cv-00316, the plaintiff claims that both manufacturers were more concerned with the money they were making from the sales of Onglyza than the damage it was doing to patients.
In his complaint, the plaintiff notes that in December of 2008, the FDA informed pharmaceutical companies that were working on developing new drugs to treat patients with diabetes, that alterations to the natural incretin hormone cycle may result in an increased risk of cardiac events. Onglyza, which contains Saxagliptin, manipulates this incretin hormone cycle, extending the half-life of the hormone from two minutes to three hours. While the hormone helps to stimulate the production of insulin, it may be doing so at great risk.
The FDA even released an official guide for the industry titled “Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes”, which states that all companies seeking approval for new drugs should provide evidence that the drug does not significantly increase the chances of the patient developing heart disease.
According to the plaintiff, both Bristol-Myers Squibb and AstraZeneca failed to follow these recommendations and did not perform the clinical studies necessary, until five years after the drug was released and marketed to patients and even when they had the results of the study, which showed an increase in heart failure in patients taking Onglyza, they failed to warn the medical community or patients.
The study, which was published in the New England Journal of Medicine in 2013, prompted the FDA to request that the manufacturers submit clinical data to the administration for a panel to review. A total of two clinical trials were reviewed by a panel and that panel determined that a new warning needed to be issued regarding Onglyza, alerting the medical community and the public that heart failure was a serious risk associated with taking the drug. The warning was added to the product’s label starting in April of 2016.
Of course, this warning came too late the thousands of patients with Type 2 diabetes who had already been prescribed Onglyza. Now, many of those patients are choosing to pursue legal action against the manufacturers, hoping to recover the losses they have sustained as a result.
Almost everyone understands how serious it is for a patient to be diagnosed with heart failure, after all, the heart is a vital organ and without it, the patient doesn’t survive. Thankfully, advances made in medicine of the past few decades means that patients have more treatment options and are living longer and higher quality lives than ever before even after being diagnosed.
But those treatments can be expensive and many patients experience complications.
The complications that may occur in patients with heart failure aren’t as simple as an upset stomach or dizziness. In fact, many of the medical conditions that may arise are just as life-threatening as heart failure. This may include:
If the heart isn’t working properly it may cause a reduction in blood flow to the kidneys which, if not treated, can cause irreversible damage to both kidneys.
A buildup of fluid is common in patients with heart failure and this fluid can put pressure on the liver, causing damage.
Heart failure doesn’t necessarily mean that the valves are damaged, but with changes in blood flow and pressure, damage to the valves may occur, worsening the condition of the heart.
When a plaintiff files an Onglyza lawsuit, they are seeking to recover compensation through either a carefully negotiated settlement or successful verdict. This compensation can provide them with coverage of their:
Many plaintiffs are surprised to learn that emotional trauma is claimable but just like physical damage, emotional damage can cost a patient financial losses. Many patients with heart failure experience depression and anxiety, requiring therapy and potentially medication to get back into a healthier, happier place.
Until a case is reviewed, past and potential future medical expenses examines, and experts consulted, it is impossible to provide an estimate of how much a case may be worth. However, know that compensation is supposed to financially provide for a plaintiff so that they are able to return to their previous financial state.
It’s rare for a lawsuit to conclude quickly, most taking at least several months to reach an ending. Don’t let the amount of time it may take deter you - this may be the only way to recover compensation.
MDL stands for Multidistrict Litigation. It’s not uncommon for thousands of patients, learning that their medical condition may have been caused by a drug, to pursue legal action if they were not warned of the potential side effects. When dozens, hundreds, or thousands of lawsuits, all containing the same allegations are filed against the same defendants, it’s not uncommon for the court to join them into an MDL.
This consolidation is considered helpful not just to the courts but to all parties involved. It assigns all cases to one judge in one court, saving everyone involved time and money.
At this time, Onglyza lawsuits have not been consolidated into an MDL but it may be something that occurs in the future are more claims are filed.
Lawyers don’t just file the lawsuit paperwork and then disappear until the next time they are needed. Working with a client, an experienced attorney can review every aspect of the case, determine past losses, locate medical experts who can help determine future losses, speak with the insurance companies, review any settlement offers received, negotiate a higher settlement if desired by the client, and prepare both the case and the client for court.
Yes and one of the first questions our clients ask us is why.
The answer is teamwork. When filing lawsuits against major pharmaceutical companies, we realize that they have the funds to provide an almost unlimited network of resources and in order to create an extensive support network because it levels the playing field and provides our clients with additional resources, allowing a collective group of clients to benefits.
Continue Reading: Nearly 90 Onglyza Heart Failure Lawsuits Consolidated In Kentucky Court