In 2012, the FDA issued a Class I recall for Naturalyte and GranuFlo after the agency found that the dialysis treatments, when inappropriately prescribed, could put patients at risk for low blood pressure, arrhythmia (irregular heartbeat) and sudden cardiac death.
Type of Lawsuit
Fresenius Medical Care is currently facing hundreds of lawsuits alleging that its hemodialysis treatments GranuFlo and Naturalyte caused patients or their loved ones to suffer serious cardiovascular injuries or death. These lawsuits allege that Fresenius knew since at least 2011 that its dialysis treatments were associated with serious cardiovascular side effects, yet failed to warn the public of these risks until an internal company memo outlining these risks was leaked to the FDA. While the FDA has since issued a Class I recall for GranuFlo and Naturalyte, this type of recall does not remove these treatments from the market.
Have you or a loved one suffered from a severe cardiac event after undergoing hemodialysis treatment? If so, you may be entitled to compensation.
What Are the Lawsuits Saying About GranuFlo and Naturalyte?
Lawsuits allege that the hemodialysis treatments GranuFlo and Naturalyte are defective and unreasonably dangerous. Patients who underwent dialysis treatment with these concentrates allegedly suffered from serious cardiovascular injuries including cardiopulmonary/cardiac arrest, heart attack, congestive heart failure and sudden cardiac death – all of which occurred during or shortly after treatment.
The lawsuits also allege:
Fresenius knew, or should have known, that GranuFlo and Naturalyte could put patients at risk for cardiovascular injuries
Fresenius failed to adequately warn physicians and patients about the risk of cardiac arrest or death with use of GranuFlo and Naturalyte
Top executives knew as early as 2011 that use of GranuFlo and Naturalyte carried a six- to eight-fold increased risk of cardiopulmonary arrest and sudden cardiac death
Fresenius concealed its knowledge of a link between the hemodialysis treatments and cardiovascular injuries in a wanton and willful disregard for the public’s safety
Plaintiffs are seeking compensation for past and future medical bills, lost wages, pain and suffering, emotional distress, loss of enjoyment of life, and in the event of death, funeral expenses and loss of earning capacity. They are also seeking punitive damages, which a judge may award to punish and deter other pharmaceutical companies from engaging in similar conduct in the future.
Is This a Class Action Lawsuit?
These lawsuits will not proceed as a class action. Rather, each patient who suffered an injury after using GranuFlo and/or Naturalyte will have to file an individual lawsuit with his or her attorney.
On March 29, 2013, the GranuFlo and Naturalyte lawsuits were consolidated to the U.S. District Court District of Massachusetts to be overseen by the Honorable Judge Douglas P. Woodlock in a procedure known as multidistrict litigation (MDL). This means that Judge Woodlock will be managing the pre-trial proceedings for the hundreds of federally-filed lawsuits against Fresenius. Even though an MDL has been formed, there is still time to file a lawsuit against Fresenius, and each plaintiff will retain his or her own attorney, suit and right to an individual award.
How Much Does a Lawyer Cost?
Most attorneys only charge their clients when their cases are successful. If your attorney is able to provide you with a favorable outcome, he or she may collect a percentage of your final verdict or settlement.
Why Were GranuFlo and Naturalyte Recalled?
In 2012, an internal memo to physicians at Fresenius’ dialysis centers was leaked to the FDA, revealing that if patients were inappropriately prescribed GranuFlo and/or Naturalyte they could be at risk for:
Low blood pressure
Hypokalemia (low levels of potassium in the blood)
Hypoxemia (low levels of oxygen in the blood)
Hypercapnia (elevated levels of carbon monoxide in the blood)
All of these injuries can result in cardiac arrest or death if left untreated, according to the FDA.
After reviewing the memo, the FDA issued a Class I recall for GranuFlo and Naturalyte, the most serious recall the agency can issue. According to the FDA, a Class I recall indicates that the product “will cause serious adverse health consequences or death.” It is important to note, however, that the recall did not take GranuFlo and Naturalyte off the market, but only required the manufacturer to update the concentrates’ labeling to include these risks.
How Can GranuFlo and Naturalyte Cause Cardiac Arrest?
It is believed that these patients are overdosing on a compound known as bicarbonate, a substance that neutralizes acid that accrues in the blood. GranuFlo and Naturalyte produce two times the amount of bicarbonate as other hemodialysis treatments, and plaintiffs allege that physicians were not warned to take this into consideration when administering the treatments. During dialysis, doctors will prescribe a dose of bicarbonate separately from GranuFlo or Naturalyte. As a result, patients can suffer from an overdose of bicarbonate, which has been linked to serious cardiovascular injuries.
Internal Memo On GranuFlo, Naturalyte Risks Leaked to FDA
An internal memo that spoke of “troubling findings” associated with GranuFlo and Naturalyte in Fresenius’ dialysis centers was leaked to the FDA in March 2012. According to the memo, nearly 1,000 patients suffered cardiac arrest in the manufacturer’s hemodialysis centers in 2010. Furthermore, patients using one or both of these treatments were six to eight times more likely to suffer cardiopulmonary/cardiac arrest and sudden cardiac death when compared to patients given other dialysis concentrates.
Despite claiming that the issue needed “to be addressed urgently,” Fresenius did not tell outside dialysis centers about the findings until an anonymous source leaked the memo to the FDA. Upon review, the agency launched an investigation into Fresenius looking to determine whether the manufacturer violated federal laws by failing to alert patients to the potentially dangerous risks associated with its products.
Were you or a loved one injured during or shortly after a hemodialysis treatment? If so, you may be entitled to compensation for past and future medical bills, pain and suffering, and in the event of death, funeral expenses. At ClassAction.org, we may be able to help you find a lawyer to assist with your claim.