Medical devices are intended to improve our ailments and make our lives easier. Although this is achieved in many cases, there are some instances where medical devices do more harm than good due to design defects or a manufacturer’s failure to provide adequate warnings about the potential side effects.
Recently, Fresnius Medical Care won the first trial in the pending multi-district litigation (MDL) involving its GranuFlo and NaturaLyte dialysis drugs. These products were intended to reduce the level of acid in dialysis patients’ blood during treatments. According to the plaintiffs’ allegations, these drugs contain a high concentration of acetone, which created unusually high levels of bicarbonate in the patients’ blood during and after treatments. The products contain more bicarbonate than other comparable dialysis treatment aids on the market. The high levels of bicarbonate can lead to a variety of health problems including fatal heart conditions and strokes. In many of the MDL lawsuits, the plaintiffs are estates or surviving heirs bringing claims on behalf of a decedent, alleging that the decedent died soon after receiving a dialysis treatment involving GranuFlo or NaturaLyte.
In the most recent trial, a Massachusetts jury concluded that the plaintiff failed to prove its case. The trial was the first of its kind to go forward in the MDL. The plaintiffs rejected a proposed $250 million settlement roughly one year ago.
In another trial involving these products, a jury concluded that the plaintiff did not sufficiently prove that using NaturaLyte in the decedent’s treatments was the proximate cause of his death. The judge entered a verdict in favor of the defendants.
In March 2012, the US Food and Drug Administration initiated a Class I recall of GranuFlo after it received a leaked memo specifying a number of adverse events that may be associated with the improper usage of the two dialysis products. A Class I recall is the highest level of recall that can be initiated. Class I recalls cover situations in which there is a reasonable probability that exposure to or use of the product will cause a serious adverse health event. The memo allegedly cites a five-fold increase in the risk of suffering a heart attack after receiving GranuFlo or NaturaLyte. A week after receiving the memo, the FDA launched an investigation. Fresnius eventually sent a notice to its customers describing the risks associated with bicarbonate in its GranuFlo and NaturaLyte products.
If you or someone you love has been exposed to or received dialysis treatments involving GranuFlo or NaturaLyte, you may be entitled to compensation. At Moll Law Group, our dedicated and diligent team of dangerous medical device lawyers has provided seasoned legal guidance to injury victims and their families throughout the US, including Texas, Florida, and California. Knowing whether a medical device is responsible for your injuries and determining the best legal course of action to take can be incredibly stressful and confusing. We treat all our clients with the personalized and compassionate attention that they deserve and will help you obtain the compensation that you are due. To schedule your free consultation, call us now at 312-462-1700 or contact us online.