GranuFlo & NaturaLyte Medical Recall – Possible Injury Lawsuits to Begin
by, 07-24-2012 at 04:23 AM (1580 Views)
FRESENIUS MEDICAL DIALYSIS PRODUCTS PLACE PATIENTS IN HIGHER RISK
FOR LIFE-THREATENING CARDIAC PROBLEMS AND EVEN DEATH
Facts continue to become available regarding the communications and actions (as well as lack of communications or actions) on the part of Fresenius Medical Care, the manufacturer of two popular renal dialysis medications. These products, GranuFlo as well as NaturaLyte have been linked to dangerous side effects. It is coming to light and being alleged that Fresenius was aware of these side effects but did not notify customers or the FDA regarding early signs. Additional questions continue to be raised regarding patient safety.
Fresenius Medical Care is one of the largest providers for dialysis equipment including machines, medications, and other dialysis treatment services including dialysis centers. The FDA was notified anonymiously regarding internal communication showing that it well aware regarding the two dialysis medications GranuFlo and NaturaLyte, which place patients in a situation of being 6 times as likely to suffer serious heart conditions, death, and other cardiac health problems. Fresenius, however, failed in its duty to warn its customers--specifically with regards to customers which were not served by its internal dialysis centers.
Generally, when such alarming details come to light, immediate and decisive action comes in the form of follow-up research, notifications to the FDA and customers, as well as voluntary product recalls. Reviews from the FDA also generally follow and personal injury lawsuits from patients which are linked to dangerous side effects and conditions. These medical personal injury plaintiffs also fall into the unfortunate category of those who have lost loved ones due to use of Fresenius Medical Care's dialysis products.
The Food and Drug Administration has also affirmed to LegalHelp.org that it has confirmed the launch of an extensive investigation regarding Fresenius' potential violation of federal law whereby it may have “[failed] to inform customers [regarding serious] lethal risk [associated to one or more of its medical products].”
Renal dialysis refers to the medical process whereby the dialysis patient essentially receives care that clears toxic waste out of the patient's body. The dialysis takes on the role of the kidneys which are no longer able to adequately perform their bodily functions. This essential medical treatment for kidney patients necessitated the use of certain medications and dialysis products which included GranuFlo in the dry form as well NaturaLyte in the liquid form. These two products produced by Fresenius have proven to be among the most widely prescribed dialysis products.
That said, the FDA now confirms that Fresenius has acknowledged in their health alert regarding severe health dangers which have been reported due to the elevated levels for bicarbonate in the blood. This alkaline substance which is used to neutralize acid bloodstream buildup, unfortunately attained higher than acceptable levels and caused heart attack, death, and other serious and severe heart conditions.
The most damning evidence in the Fresenius injury lawsuit communication comes from their own internal memos, which showed a clear understanding regarding their products causing high levels for bicarbonate and that dialysis patients had been shown to be at 6 times the level of other patients for suffering heart attack, other severe heart conditions, or stroke.
Compounding the problems at Fresenius come the news that Fresenius selfishly notified only their own internally operated Fresenius dialysis centers regarding the issues yet failed to notify external clinics which purchased and used their medical dialysis products.
Soon after the New York Times published an article, the FDA quickly notified the public of a Class 1 Medical Recall for specific product lots of GranuFlo and NaturaLyte Acid Concentrate which have been used for treatment of chronic, acute and other types of kidney failure which are utilized in hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis.