Recalled in May 2012, GranuFlo was once the most popular acid concentrate on the market, designed to neutralize the build-up of acid in the blood that typically occurs during dialysis treatment for chronic kidney failure. Today, GranuFlo is best known for its link to a six-times increased risk of cardiopulmonary arrest and sudden cardiac death, which it turns out, GranuFlo maker Fresenius Medical Care knew about for years before alerting the public and the FDA. If you underwent dialysis treatment with GranuFlo or NaturaLyte, and you have since suffered a heart attack, stroke, or another serious cardiovascular side effect, consult a knowledgeable GranuFlo lawyer today to explore your possible compensation options.
Dialysis tends to be the go-to treatment for patients diagnosed with chronic kidney failure, and, before it was removed from the market, GranuFlo was one of the more popular dry acid concentrates used during dialysis. There are, however, a number of natural treatment options for patients at all stages of kidney disease, which may help achieve optimum health without the use of potentially dangerous pharmaceutical drugs. These treatments include the following:
GranuFlo is the brand name of a dialysis drug manufactured by Fresenius Medical Care (FMC), a company that operates about one-third of all dialysis centers for patients suffering from kidney failure in the U.S. FMC is also the leading supplier of dialysis machines and drugs like GranuFlo to other clinics in the United States and Europe. GranuFlo first entered the market in the U.S. in 2003, and is commonly administered to dialysis patients experiencing a loss of kidney function due to renal failure. According to the FDA however, GranuFlo can increase bicarbonate levels in patients who use the drug, leading to a condition called hemodialysis metabolic alkalosis, which is a major risk factor for a number of life-threatening heart and health problems, including heart attack and cardiac arrest.
Despite FMC’s claims that GranuFlo is superior to other similar products in the dialysis industry, the dialysis drug has been linked to a variety of major side effects, including cardiac arrest, heart attack, hemodialysis cardiac arrest, hemodialysis cardiopulmonary arrest, stroke, death, arrhythmia, altered mental status (confusion) and low blood pressure.
Bicarbonates are administered to kidney failure patients undergoing dialysis to neutralize the build-up of acid that occurs in the blood during this process. GranuFlo is a medication that allows for greater conversion of bicarbonates, and is used in FMC clinics as well as in an estimated 125,000 patients in clinics operated by other dialysis providers. In fact, GranuFlo has been marketed by FMC as the “most widely-prescribed dry acid product in the dialysis industry,” and has been touted by the German company as “the safest choice for onsite concentrate mixing,” given “GranuFlo’s distinctive proportional component blend in each bag.” According to an internal memo issued by Fresenius in November 2011, however, as many as 941 patients had suffered from sudden cardiac arrest in 2010 alone, due to the improper administration of GranuFlo.
According to research, adverse cardiac events may be four to six times as common in patients taking GranuFlo, compared to other dialysis patients, and doctors at FMC clinics became aware of this risk in November 2011, but failed to notify the FDA until months later, after the agency received a copy of the company’s internal memo from an anonymous source. Because of these deceptive actions, FMC is currently under investigation by the FDA for failing to adequately warn consumers and healthcare professionals about the potentially deadly heart risk associated with excessive doses of its GranuFlo dialysis drug.
September 4, 2012 – FMC faces two wrongful death lawsuits filed in the U.S. District Court for Alabama, on behalf of women whose husbands died of heart attacks after being administered GranuFlo or NaturaLyte during dialysis.
September 27, 2012 – A wrongful death lawsuit is filed in Georgia, on behalf of a woman who suffered a fatal cardiovascular event during dialysis treatment in 2010.
November 12, 2012 – Another wrongful death complaint is filed in Georgia, on behalf of a man who died of a heart attack during dialysis treatment in 2010.
November 29, 2012 – FMC faces a GranuFlo lawsuit filed in Ohio, on behalf of a man who suffered sudden cardiac death after being given GranuFlo in 2010.
January 22, 2013 – A wrongful death complaint is brought on behalf of a man from Texas who suffered sudden cardiac death after being administered GranuFlo and NaturaLyte acid concentrates.
February 1, 2013 – A man from Louisiana files a product liability lawsuit against FMC after suffering a stroke, heart attack and debilitating pain following treatment with GranuFlo and NaturaLyte.
March 13, 2013 – Four separate class action lawsuits are filed against DaVita HealthCare, on behalf of patients who suffered injuries allegedly caused by GranuFlo or NaturaLyte during dialysis treatment.
June 13, 2013 – A panel of federal judges establishes a multidistrict litigation (MDL) to centralize all GranuFlo and NaturaLyte lawsuits into one court for coordinated pretrial proceedings.
June 19, 2013 – A GranuFlo class action lawsuit is filed in Pennsylvania.
July 2014 – The state of Louisiana files a claim against Fresenius Medical Care and nearly 100 of the company’s clinics, after its GranuFlo and NaturaLyte products were linked to fatal strokes, heart attacks and other serious problems.
January 9, 2004 – An adverse event report is submitted to the FDA involving a patient who received GranuFlo or NaturaLyte during dialysis, and suffered a fatal cardiac event as a result.
November 4, 2005 – The FDA receives an adverse event report highlighting a case where a patient experienced a cardiovascular event and died after being administered GranuFlo or NaturaLyte.
February 1, 2008 – An adverse event report is submitted to the FDA on behalf of a patient who was administered GranuFlo and/or NaturaLyte, and subsequently suffered a fatal cardiac event.
March 14, 2008 – The FDA receives an adverse event report involving a patient who experienced a sudden cardiac event after being treated with GranuFlo and/or NaturaLyte, and died on the same day.
Early 2012 – The FDA receives a copy of FMC’s internal memo from an anonymous source, and becomes aware of the potential for GranuFlo to cause severe cardiovascular problems and sudden cardiac death in patients.
March 2012 – The FDA issues a Class I recall warning the medical community about the potential for GranuFlo and NaturaLyte to cause metabolic alkalosis possibly leading to cardiopulmonary arrest and death.
May 25, 2012 – The FDA issues a safety recall for all hemodialysis dialysate concentrates containing acetate, acetic acid or citrate.
June 25, 2012 – FDA regulators issue a Class I recall of FMC’s NaturaLyte and GranuFlo dialysis products, due to the risk of bicarbonate overdose, heart attack, sudden cardiac arrest, metabolic alkalosis and death.
2010 – Fresenius conducts a confidential study involving patients undergoing dialysis treatment, and finds nearly 1,000 patients who suffered heart attacks allegedly caused by GranuFlo or NaturaLyte. The study also finds that patients undergoing dialysis were six to eight times more likely to experience heart attacks and sudden death if they had elevated bicarbonate levels.
November 2011 – FMC issues an internal memo to doctors in its own clinics, warning about the potential for GranuFlo and NaturaLyte to cause heart attacks, strokes and sudden cardiac death, but does not report this risk to the FDA.
Despite the fact that Fresenius Medical Care became aware of the link between GranuFlo and sudden cardiac death as early as 2010, it was several years before the company reported this risk to federal regulators, and the FDA is currently investigating whether Fresenius Medical Care intentionally misled consumers and the medical community about the safety and effectiveness of GranuFlo. Lawsuits brought against FMC over cardiovascular injury or sudden death from GranuFlo allege that the drug maker:
Chronic kidney disease affects more than three million people in the United States every year, and many of these people undergo dialysis in an attempt to manage advanced and permanent kidney failure. Unfortunately, those who have received GranuFlo or NaturaLyte acid concentrates during dialysis may now be at risk for complications like heart attack, stroke and sudden cardiac death. If you or a loved one has suffered serious injuries while undergoing dialysis, GranuFlo and its manufacturer, FMC, may be to blame. GranuFlo lawyers across the United States are investigating GranuFlo side effect claims filed by consumers who experienced heart complications after receiving the dialysis drug. Contact an experienced GranuFlo attorney as soon as possible to discuss your legal options.