The GranuFlo/NaturaLyte Settlement

Defective Drugs

By David Carnes, Staff Writer

Fresenius Medical Care, a diversified German health care company, recently reached a large settlement in a class action lawsuit over the undisclosed health risks of its medical products GranuFlo and Naturalyte. Although the company has also settled several wrongful death lawsuits based on the use of these two products, the value of the class action settlement far exceeded the value of any of the wrongful death lawsuits.   

Failure to Warn

GranuFlo and Naturalyte are dialysates, which are chemical mixtures critical to the kidney dialysis process. In the class action lawsuit, plaintiffs’ attorneys alleged that Fresenius failed to timely warn dialysis centers of known dangers associated with these products, even though these dangers had previously resulted in at least several hundred deaths.

In November 2011, Fresenius issued an internal memo to dialysis centers in its network, warning that GranuFlo and NaturaLyte presented a heightened risk of sudden cardiac arrest and other heart problems if used improperly. At the time, the memo was not made available to dialysis centers that were not part of the Fresenius network. Four months later, in March 2012, the U.S. Food and Drug Administration (FDA) initiated a Class I Recall of these products due to the very risks that Fresenius had warned about in its memo. Only then did Fresenius notify dialysis centers outside of its network.

The Class Action Lawsuit

The class action lawsuit against Fresenius was based on the unnecessary risks that GranuFlo and NaturaLyte patients faced during the four-month period from November 2011 to March 2012, when Fresenius was withholding information about the health risks of these two products. Even the State of Louisiana joined the action, because it provided payments to Fresenius (through its Medicaid program) for the use of the products during the time that its risks were known to Fresenius-affiliated dialysis centers but not to outsiders. 

The defendants denied liability for its delay in issuing its warning, based partly on the fact that during the critical four-month period, both drugs had been approved by the FDA and had not yet been recalled. In recent years, U.S. courts have greatly restricted the ability of plaintiffs to win lawsuits over drugs that have already received FDA approval, on the reasoning that the FDA is the supreme authority over drug safety.

The Settlement

Fresenius eventually reached a class action settlement of $250 million, $220 million of which will be covered by insurance. Due to the quirky nature of class action lawsuits (a multitude of plaintiffs are represented, even if they are not directly involved in the case), the settlement will not be considered accepted by the plaintiffs unless it is approved by 97 percent of them. If approved, the settlement will take effect in July 2016.

GranuFlo and NaturaLyte litigation will continue even after the final resolution of the class action lawsuit. If you or your loved one believe that you have been harmed by either of these products, don’t hesitate to seek out the services of a skilled product liability lawyer in your home jurisdiction. 

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