GranuFlo Recall Prompts Subpoena, Growing Litigation
Fresenius Medical Care, already facing several GranuFlo lawsuits stemming from its recall of GranuFlo and NaturaLyte dialysis products last year, is apparently facing more heat over the debacle. According to a report from Reuters, Fresenius recently disclosed that it had received a subpoena from the U.S. Attorney, District of Massachusetts, for documents related to the case. The company says it is fully cooperating with the investigation.
GranuFlo and NaturaLyte are acid concentrates used during dialysis to remove toxins from the blood. The drugs are formulated differently than rival products in that they contain sodium diacetate, rather than acetic acid. As such, they have the potential to raise bicarbonate levels more than other dialysis concentrates. Last March, Fresenius issued an “Urgent Product Notification” to the thousands of dialysis clinics that use GranuFlo and NaturaLyte, warning that failure to account for this difference when determining the dosage to administer to patients could lead to serious heart problems, including cardiac arrest and sudden cardiac death. The U. S. Food & Drug Administration (FDA) later declared the notification its most serious class of recall, Class I.
In June, The New York Times revealed that the FDA was investigating Fresenius’ handling of the GranuFlo recall. It seems that in November 2011 Fresenius issued a memo to clinics in its own network warning that more than 940 people at its dialysis clinics had died from sudden cardiac arrest in 2010. The patients had been treated with either GranuFlo or NaturaLyte, and all had elevated bicarbonate levels in their blood. A study conducted by the company’s medical staff concluded that high bicarbonate levels were associated with as much as a 6-fold increase in the risk of cardiac arrest. The memo advised doctors at Fresenius clinics to adjust dosage of the drugs to avoid this danger.
Fresenius did not send a similar warning to its customer clinics at that time. According to The New York Times, the company did not issue the March Urgent Product Notification until the FDA was leaked a copy of the 2011 memo from an anonymous source and made inquiries to Fresenius. The FDA is now trying to determine if the delay between the November 2011 memo and March 2012 notification violated any laws.
GranuFlo Lawsuits on the Rise
Last month, a group of Plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed claims stemming from the GranuFlo recall in a multidistrict litigation for pretrial proceedings. The motion, dated December 12, 2012, asks the Panel to establish the proposed GranuFlo multidistrict litigation in U.S. District Court, District of Massachusetts, before either Judge Joseph L. Tauro or Judge Patti B. Saris.
All of the complaints filed since the recall allege that inadequate labeling and warnings for NaturaLyte and GranuFlo caused harm to patients. At the time the motion for consolidation was filed with the JPML, at least 11 GranuFlo lawsuits were pending in various federal courts throughout the U.S.