Plaintiff Dottie Dodson is suing Novartis AG for dangerous drug injury compensation. In her products liability lawsuit, she contends that she developed kidney damage from taking Valturna.
Dodson claims that the drug maker did not adequately warn users about the possible side effects of the hypertension drug, which contains aliskiren, an active ingredient from Tekturna, which is also a drug. Novartis took Valturna off the market in 2012. Dodson started taking the medication in 2010.
Her Valturna lawsuit accuses the pharmaceutical company of inadequately testing the drug before it was put out into the market and aggressively promoting it. She is contending negligence, breach of warranty, strict liability, fraudulent concealment, and state consumer protection law violations. Dodson wants compensatory and punitive damages.
A long-term study of Tekturna and patients with impaired kidneys and type 2 diabetes showed that the risks of kidney impairment, raised potassium levels, low blood pressure, stroke, and death went up in patients that took the medication. Researchers found that it is the mix of angiotensin-converting enzyme inhibitors, angiotensis II receptor blockers, and aliskiren that is not safe for patients suffering from chronic kidney disease or Type 2 diabetes. (However, other patients might also be at risk of Valturna’s more serious side effects). The risk of injury to study subjects was so high that the testing had to be stopped. Novartis stopped marketing and selling the drug last year.
Other serious Valturna side effects may include: coronary artery disease, heart failure, nervous system damage, fluid retention, kidney stones, blurred vision, muscle damage, hepatitis, seizures, renal complications and breathing problems. Patients that have sustained permanent damage to their kidneys may have to undergo a transplant or dialysis. Less serious side effects can include nausea, slowed/less even heart rate, fainting, stomach pain, skin problems, heartburn, diarrhea, back pain, joint pain, and cold-like symptoms.
Signs that taking Valturna may be damaging your kidney:
• Problems excreting potassium • Metabolic acidosis • Arrhythmias • Hyperkalemia • Ventricular fibrillation • Ventricular tachycardia • Uremia • Pericarditis • Hypocalcaemia • Anemia • Lower red blood cell count • Appetite loss • Fatigue • Lethargy • Coma
Off-Label Marketing of Valturna
Novartis had marketed Valturna for off-label uses for patients with type 2 diabetes (meaning that the US Food and Drug Administration did not test or approve the drug for such purposes). Diabetics were persuaded that not only would the drug reduce their blood pressure levels but also assist them with their renal problems. However, no scientific evidence exists to show that the drug is safe for diabetics or that it can actually help their renal health issues.
In addition to a products liability case against Novartis, you may have reason to pursue medical malpractice damages if your physician prescribed Valturna to you despite knowing that you had a history of diabetes or kidney issues.
Novartis Didn’t Properly Test Hypertension Drugs, Suit Says, Law 360, April 16, 2013
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