Fresenius Medical Care, a German medical company, has entered into a settlement agreement to resolve a landslide of cases brought against it involving its GranuFlo and NaturaLyte products used in dialysis treatments. Both of these products are dialysates and were used in thousands of dialysis clinics across the United States to treat patients experiencing kidney disease and kidney failures. Roughly one in every 500 Americans suffers from some illness that affects the kidneys and must undergo dialysis on a regular basis. Dialysis is a process that cleanses blood and eliminates toxins and wastes before returning it into the patient’s blood.
GranuFlo is a powder concentrate, and NaturaLyte is a liquid version of the same substance. The chemicals are used in dialysis machines to help neutralize the increased production of acid that can occur during the dialysis process.
In 2012, the U.S. Food and Drug Administration issued a Class I recall of both products after determining that the products posed severe threats to patients. Class I recalls are the most serious level of recall that the FDA can initiate and are appropriate when the product in question poses a substantial risk to patients, including the possibility of death.
Thousands of lawsuits were filed against Fresenius, including a substantial number of wrongful death actions. Eventually, the lawsuits were consolidated in a multi-district litigation, or MDL. This is a proceeding that helps promote the efficient use of judicial resources by allowing common legal issues to be resolved in a consistent manner. Unlike a class action, however, each plaintiff’s claim is subject to an independent analysis.
Litigation and investigations regarding GranuFlo and NaturaLyte revealed that the company knew about the dangerous nature of both products but failed to disclose the risks to patients and medical providers. According to an internal company document created in November 2011, over 900 patients suffered heart attacks in clinics maintained by Fresenius during that same year.
According to doctors retained by the company, patients with an excessive level of bicarbonate in their blood were six times more likely to experience a heart attack than patients with normal bicarbonate levels. According to the memo, GranuFlo increased the bicarbonate levels in patients’ blood and facilitated the resulting heart attacks.
To recover compensation from Fresenius, the plaintiffs needed to prove that the GranuFlo and NaturaLyte products were designed in an unreasonably unsafe manner that posed severe dangers to the patients. The plaintiffs could also recover damages by proving that the manufacturer failed to include appropriate instructions or warnings with the products. Now that the matter has gone to settlement, the litigation will not proceed.
If you or someone you love suffered injuries or lost their life due to GranuFlo, NaturaLyte, or another dangerous pharmaceutical, you may be entitled to compensation. At Moll Law Group, our dedicated and experienced team of mass tort lawyers has provided legal guidance to injured victims across the United States, including in Texas, California, Illinois, and New York. We offer a free consultation to help you learn about your situation and the legal actions that may be available to you and your family. Call us now at 412-362-1700 or contact us online to set up your appointment.