Kidney patients who have been seriously injured in a dialysis procedure with NaturaLyte may be eligible for a NaturaLyte lawsuit.
In May 2012, the FDA warned healthcare professionals of dialysis dosing errors with NaturaLyte and GranuFlo, two products made by Fresenius Medical Care. The agency noted that they received complaints concerning these products and their potential to contribute to cardiovascular side effects and even death.
Fresenius Aware of Potential NaturaLyte Side Effects
The potential risks concerning NaturaLyte and GranuFlo became known to the general public on May 18, 2012, when RenalWEB published an online notice concerning the potential hazards associated with NaturaLyte side effects. RenalWEB, an independent company providing key information to dialysis patients, noted that Fresenius was aware of the concerns regarding NaturaLyte side effects in 2010, but failed to warn doctors outside its own centers until 2012.
On November 4, 2011, Fresenius circulated an internal memo about the increased risk of cardiac arrest and death during hemodialysis procedures that used GranuFlo and NaturaLyte concentrates. These concentrates and others like them are used to help control acid buildup in the blood. According to the memo, however, Fresenius’ products can contribute to an elevated level of bicarbonate in the blood. Excess bicarbonate can lead to serious cardiovascular side effects.
Doctors were unaware of the increased risks associated with these products, and were failing to adjust dosage accordingly. The 2011 memo alerted Fresenius doctors to the problem, but the company failed to expand that warning to outside medical centers that also used these products. These patients may now be eligible to file a NaturaLyte lawsuit.
NaturaLyte Lawyer Likely to Blame Fresenius for Failing to Warn
It was not until the FDA anonymously received a copy of the November 2011 memo, and asked Fresenius about it, that the company issued another warning to outside medical centers and nursing homes concerning potential GranuFlo and NaturaLyte side effects. That warning was issued on March 29, 2012, nearly five months after the release of the internal Fresenius memo.
A NaturaLyte lawyer is likely to argue that Fresenius was negligent in warning outside doctors of the issue, and that the company should have taken more steps to ensure patient safety both in their own dialysis centers and in other treatment centers around the world.
A NaturaLyte Lawsuit May Help Recover Damages
In May 2012, the FDA issued its own warning to healthcare professionals concerning potential dosing errors with NaturaLyte and GranuFlo. They advised doctors to carefully read the product labels, and to adjust dosing where necessary for patients who have higher levels of bicarbonate in their blood.
Prior to this warning, however, potential dosing errors may have gone unnoticed in many dialysis clinics. Patients who were injured as a result may be able to recover damages in a NaturaLyte lawsuit.
On June 27, 2012, the FDA issued a Class I recall of both NaturaLyte and GranuFlo, noting that these products could cause serious adverse health consequences, including death.
Free Consultation with a NaturLyte Lawyer
If you or a loved one suffered a serious cardiovascular injury after going through dialysis with NaturaLyte, you may be eligible for recovering damages through a NaturaLyte lawsuit. A thorough review of your case with a NaturaLyte lawyer may reveal claims that can be made against the manufacturer. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.