GranuFlo and NaturaLyte have been linked to alkalosis, which has been associated with cardiovascular death and catastrophic heart injuries in patients undergoing dialysis.
New York, New York (PRWEB) October 13, 2012
Potential GranuFlo and NaturaLyte heart attack lawsuits are actively being investigated by the attorneys at Bernstein Liebhard LLP. GranuFlo and NaturaLyte, acid concentrates used to neutralize acid that builds up in the blood during dialysis, were named in a Class I recall by the U.S. Food & Drug Administration (FDA) in June.* The New York Times recently reported that the agency has also launched an investigation of Fresenius Medical Care to determine if it violated federal regulations by failing to inform customers about the serious heart risks associated with GranuFlo and NaturaLyte.**
Bernstein Liebhard LLP, a nationwide law firm representing clients who have been injured by dangerous drugs and defective medical devices, is currently offering free and confidential GranuFlo and NaturaLyte lawsuit evaluations to dialysis patients who suffered serious heart side effects within 48 hours of undergoing a dialysis treatment with either of these products, including:
- Cardiovascular death
- Sudden cardiac death
- Cardiopulmonary arrest
- Heart attack
- Other catastrophic heart injuries
GranuFlo and NaturaLyte Recall
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. According to the FDA, GranuFlo and NaturaLyte have been linked 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.
According to a report published by The New York Times in June, Fresenius issued a memo 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.
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. In fact, 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. This was only done after the FDA received a copy of the company’s November 2011 internal memo, and questioned Fresenius about it, according to the Times. In June, the FDA designated the GranuFlo and NaturaLyte recall a Class I recall. Class I recalls are the agency’s most serious type of recall, and are only issued when there is a reasonable chance that use of a product could result in serious injury or death.
Dialysis patients who suffered heart attacks, sudden cardiac death, and other catastrophic heart side effects within 48 hours of a dialysis treatment with GranuFlo or NaturaLyte may be entitled to compensation for medical expenses, lost wages, pain and suffering, and more. Learn more about filing a GranuFlo or NaturaLyte lawsuit by visiting Bernstein Liebhard LLP’s website. For additional information, contact a lawyer at Bernstein Liebhard LLP today at (877) 779-1414.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
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10 East 40th Street
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ATTORNEY ADVERTISING. © 2012 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Amy L. Abate. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP