Legal experts say the legitimacy of GranuFlo and NaturaLyte heart attack lawsuits will certainly be boosted by the fact that the U.S. Food and Drug Administration earlier this year announced a nationwide Class 1 recall of concentrates used in the kidney dialysis products.
The FDA describes Class I recalls as the most serious type of recall and involve situations in which there is a reasonable probability that use of the products being recalled will cause serious adverse health consequences or death.
GranuFlo and NaturaLyte heart attack lawsuits are being filed by our experienced network of defective medical device lawyers who are continuing to accept cases and offer free consultations to kidney dialysis patients who may have suffered heart attacks, sudden cardiac death, or other catastrophic heart problems because of their treatment with GranuFlo or NaturaLyte.
These are serious health problems and the increasing number of incidents involving GranuFlo and NaturaLyte dangerous side effects leading to these conditions has caused these kidney dialysis lawsuits as well as the Class 1 Recall. The language in the recall notice involves complicated medical terminology but the severity of the danger is clear:
The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death. FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.
The FDA also noted that Fresenius sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the NaturaLyte Liquid and GranuFlo Acid Concentrate. The FDA also asked health care professionals and consumers to report adverse reactions or quality problems they experienced using these products.
According to a recent posting on the San Francisco Chronicle web site, Fresenius Medical Care is the largest operator of dialysis clinics in the country, and provides dialysis treatment to over 400,000 U.S. patients every year.
The posting cited the FDA’s warning about links between GranuFlo and NaturaLyte to alkalosis, a condition caused by high levels of bicarbonate in the blood. Alkalosis has been associated with cardiovascular death and catastrophic heart injuries in patients undergoing dialysis treatment, the agency said. Read more on the Granuflo lawsuits
Also cited in the posting was a report published by The New York Times that obtained a memo by Fresenius officials that was sent to doctors at its own clinics in November 2011 warning that improper dosing of GranuFlo appeared to be contributing to a sharp increase in the risk of dialysis patients dying suddenly from cardiac arrest. The memo found that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. Fresenius’ own medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels, according to the document.
The posting said that thousands of non-Fresenius owned dialysis clinics that are supplied by the company were not issued the November 2011 memo, according to The New York Times, and that it was not until March 29, 2011, that Fresenius finally sent an Urgent Product Notification to its customer clinics warning of possible heart risks associated with GranuFlo and NaturaLyte.