There has been an important development in the handling of the numerous federal NaturaLyte and GranuFlo lawsuits over claims that the kidney dialysis products caused deadly side effects.
A large number of victims who suffered life-threatening health problems and people who lost loved ones to deaths they say were caused by the products are claiming that dialysis products manufactured by Fresenius Medical Care are defective and put patients at risk of suffering cardiac arrests, heart attacks or sudden death.
News reports show that Fresenius has agreed that all of the federal lawsuits that the company is defending itself against should be consolidated into what is called a multidistrict litigation.
It is not uncommon for large numbers of cases involving allegations of defective drugs, medical devices or products to be placed in such a status.
It is the first step in what sometimes leads to a judge approving a class-action status for lawsuits in which all plaintiffs may share in settlements. It is not unusual for such settlements to reach into the hundreds of millions of dollars, according to legal experts who have been involved in such cases.
Once a panel of federal court judges selects a single judge to oversee these cases, lawyers for the plaintiffs and defendants will be brought together and timetables and rules for evidence-gathering and other legal procedures will be adopted.
Normally, judges in such case also schedule what are called bellwether cases in which lawyers for both sides choose specific lawsuits in which the strengths and weaknesses of both sides can be tested.
Court records show that in 2011, one there was a filing with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking the consolidation of NaturaLyte and GranuFlo lawsuits before a federal judge in Massachusetts.
The records also show that a similar request was filed last year by two plaintiffs who claim in their lawsuit that they lost a loved one because of GranuFlo side effects.
Common to all of the NaturaLyte and GranuFlo heart attack lawsuits are allegations that Fresenius was negligent in warning patients and health care professionals about the dangerous risks for patients using the products.
Included in the allegations is information from a company internal memo that the plaintiffs claim shows that company officials were aware of these dangers and informed staff members at Fresenius dialysis centers while not notifying workers at independent centers.
According to the lawsuits, the internal memo to doctors at its network of dialysis centers informed the physicians that 941 patients had died of GranuFlo heart attack at Fresenius clinics in 2010.
Despite this alarming statistic, the plaintiffs claim, Fresenius failed to pull the products from the marketplace and put countless numbers of other dialysis patients at severe health risk.
Concerns about the safety of NaturaLyte and GranuFlo increased so severely that the U.S. Food and Drug Administration (FDA) issued a Class 1 recall in 2012 of the dialysis products.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences—or death.
FDA officials noted in the recall notice that NaturaLyte and GranuFlo could generate high bicarbonate levels that can cause metabolic alkalosis—a significant risk associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia, which can lead to cardiopulmonary arrest and death.