Granuflo Lawsuit: Dialysis Drugs caused Fatal Cardiac ArrestSep 27, 2012 | Parker Waichman LLP
A Georgia man has filed a wrongful death lawsuit on behalf of his mother who died after a faulty dialysis treatment involving the use of the drugs GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are acid concentrates commonly used in dialysis treatments. They are manufactured by Fresenius USA Inc., which also operates more than a thousand dialysis clinics nationwide and treats nearly 80,000 a year.
The lawsuit filed on behalf of Frances Carol Bishop is like several others involving victims of cardiac arrest or sudden death after undergoing a dialysis treatment in which either or both of these drugs were used. Bishop allegedly suffered a fatal cardiovascular event on Sept. 10, 2010, following her dialysis treatment that day. The complaint involving charges of wrongful death, negligent care, and a failure to warn the public about the known dangers of these drug products. It has been filed this month in U.S. District Court for the Southern District of Georgia by Bishop’s son, Waddell.
Bishop’s complaint alleges his mother suffered cardiac arrest during or after her kidney dialysis treatment. That procedure involved the use of GranuFlo and NaturaLyte and Fresenius, the makers of the drugs and operators of dialysis treatment clinics, was aware of this life-threatening side effect but failed to warn the public.
According to a report on the lawsuit at AboutLawsuits.com, Fresenius has known for some time about the potentially dangerous side effects of its drugs used in dialysis but did nothing to warn the public or health officials of this grave danger. The company allegedly distributed an internal memo on the known risk of side effects some time last year and in that memo it disclosed that it was aware of at least 941 instances in 2010, alone, in which a person receiving dialysis involving the use of these drugs suffered cardiac arrest after being treated at one of its clinics. And that review did not include records at nearly 500 of the more than 1,000 clinics it operates.
It was not until May of this year that the Food and Drug Administration issued any public advisories about the potential dangers of GranuFlo and NaturaLyte. The use of these drugs increases a persons bicarbonate levels to higher-than-expected levels and that could impact bufferin drug prescriptions a dialysis may be taking concurrently with their treatments. If a doctor is not monitoring these prescriptions when dispensing GranuFlo and NaturaLyte, a patient is more likely to suffer a cardiac event.
Bishop’s suit, like others already filed against Fresenius, claims there are no warnings about the need for increased patient monitoring during dialysis if a patient is taking these other drugs when they receive GranuFlo and NaturaLyte.
In its May 2012 advisory, the FDA said doctors should “consider the impact of the acetate levels in these dialysate concentrates when ordering or administering hemodialysis treatments.”