Dozens of new product liability cases have recently been filed in the U.S. District Court for the District of Massachusetts against the manufacturer of the dialysis drugs GranuFlo and NaturaLyte, bringing the number to over 2,000 in the District of Massachusetts alone. Other suits are also pending in other courts across the country.
The plaintiffs in the lawsuits allege they or a family member suffered cardiovascular or other heart problems after being administered GranuFlo or NaturaLyte during dialysis.
In a 2012 recall of both Naturalyte and Granuflo Acid Concentrate, the manufacturer cautioned clinicians to be aware of the concentration of acetate or sodium diacetate in the products because of the possibility of high serum bicarbonate level in patients undergoing hemodialysis in certain situations. According to the recall, improper use of Naturalyte and Granuflo could contribute to metabolic alkalosis. Patients with metabolic alkalosis are at significantly higher risk for several serious medical conditions, including hypokalemia, low blood pressure, cardiac arrhythmia, hypoxemia, and hypercapnia. If not treated appropriately, cardiopulmonary arrest could result.
The Intended Purpose of the Drugs
Naturalyte and Granuflo were designed to aid in the treatment of renal failure, both chronic and acute, resulting from hemodialysis. They are supposed to be used with a three-stream hemodialysis machine calibrated for acid and bicarbonate concentrates.
What Went Wrong
It is alleged that the drugs in question may increase a patient’s risk of cardiac arrest if not prescribed appropriately. Many of the lawsuits against the manufacturer assert that it did not adequately warn doctors that the products contain a comparatively high level of a substance that the human body converts to bicarbonate, high levels of which may be linked to problems with the heart.
Earlier this year, a Class 1 recall of NaturaLyte Liquid Bicarbonate Concentrate was issued by the U.S. Food and Drug Administration (FDA). According to the FDA, Fresenius Medical Care North America issued the recall notice because bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The bacteria was identified as Halomonas (species 1, 2, 3).
How to Get Help if You Have Been the Victim of Dangerous Prescription Medicine
At the Law Offices of John C. Manoog, III, we understand that victims of defective products, such as prescription medications, have a lot of questions about not only their health and prognosis following their injuries but also what they can do about them in a court of law. We are here to help you as you work through the issues that surround your case. Call us at (888) 262-6664 or contact us online to schedule an appointment. We also handle medical malpractice and improperly filled prescription cases.
There is no charge for the first visit, and many cases are accepted on a contingency fee basis, meaning we don’t get paid until your case settles or a judgment is paid. We serve injured people throughout the Cape Cod area, including both Plymouth and Hyannis.
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