Texas Plaintiff Claims GranuFlo Side Effects Include Stroke

A Texas woman and her husband brought a GranuFlo lawsuit against Fresenius in the U.S. District Court for the District of Massachusetts on March 20, 2012. According to the legal complaint, the Texas woman suffered from a stroke and other injuries that were allegedly caused by receiving GranuFlo and NaturaLyte during her dialysis treatment. Due to the severity of the plaintiff’s injuries, she will require ongoing medical care. The Texas couple has joined more than a hundred other injured parties who have filed GranuFlo lawsuits in federal courts.

Based on medical studies and numerous adverse event reports submitted to the FDA, many dialysis patients who were administered the Fresenius products developed serious GranuFlo side effects such as metabolic alkalosis, heart attack, and stroke. In some instances, the complications were fatal. Fresenius Medical Care is accused of engaging in negligence and fraudulent concealment due to the manufacturer’s failure to warn patients and the healthcare community about the risks associated with using GranuFlo and NaturaLyte.

Plaintiff’s stroke allegedly caused by GranuFlo and/or NaturaLyte

On February 28, 2011, the plaintiff received her regular dialysis treatment at a Texas hospital. According to the lawsuit, GranuFlo and/or NaturaLyte were the acid concentrates administered to the plaintiff as part of her treatment. Within an hour after her dialysis was completed, the plaintiff started to experience symptoms commonly associated with a stroke. Some of her symptoms included slurred speech, uncontrollable twitching on the right side of her face, and mental confusion. The plaintiff was transferred to another hospital for testing and additional medical care. Results from the MRI and CT scan confirmed that she suffered a stroke. Since the plaintiff’s injuries were so severe, she was required to undergo extensive medical care that included physical therapy and speech therapy.

The lawsuit alleges that the plaintiff’s stroke and related injuries were directly caused by GranuFlo and/or NaturaLyte. The plaintiff continues to have difficulty speaking, cannot walk without assistance, and isn’t able to feed herself. The plaintiff’s husband states that he has suffered from a loss of consortium, comfort, support, and other services within the marriage as a result of his wife’s injuries. The married couple is seeking compensation for medical expenses, loss of income, emotional distress, legal fees, and other damages.

The complaint further asserts that the injuries and damages incurred by the plaintiff and her husband could have been avoided if Fresenius Medical Care adequately warned the healthcare community about the risks associated with using GranuFlo and NaturaLyte. The lawsuit alleges that the dialysis products are defective and Fresenius failed to diligently test the safety of the products prior to distributing them to healthcare facilities.

GranuFlo side effects

Fresenius sells GranuFlo and NaturaLyte to clinics that it owns and healthcare facilities owned by competitors throughout the country. After GranuFlo and NaturaLyte started being administered to patients, it was discovered that the products could cause the bicarbonate levels in patients to increase to a point that potentially jeopardized their health. Developing cardiac arrhythmia, stroke, and suffering a heart attack from GranuFlo are some of the allegations asserted by plaintiffs in the numerous personal injury lawsuits filed against Fresenius.

From January 1, 2010 through December 31, 2010, Fresenius conducted a medical study to evaluate potential risk factors for patients who underwent dialysis treatments at the medical facilities the company owned. The results of the study showed that 941 patients had cardiopulmonary arrests and the risk of developing the medical condition is six times higher if the patients had elevated bicarbonate levels. In November 2011, Fresenius submitted a memo to its dialysis centers and other employees within the company advising them of the complications associated with GranuFlo and NaturaLyte. Fresenius failed to disclose this information to the FDA, other healthcare providers, or the public.

The FDA received a copy of the internal memo from an anonymous source in March 2012. After the FDA contacted Fresenius regarding adverse GranuFlo side effects, a warning was issued to the non-Fresenius dialysis centers. The healthcare professionals were notified that GranuFlo and NaturaLyte could increase the risk of patients developing cardiopulmonary arrest, heart attack and other life-threatening complications.

FDA issues GranuFlo recall

On March 29, 2012, a Class I recall of GranuFlo and NaturaLyte was issued by the FDA. A Class I recall is the most serious type of recall since it indicates there is a reasonable probability the patients will sustain serious or life-threatening injuries by using the products. The FDA also started an investigation to find out if Fresenius violated federal regulations by withholding information regarding the medical risks for patients, according to an article published in the New York Times. When Fresenius failed to notify the public about the serious side effects associated with GranuFlo and NaturaLyte, it prevented patients from making an informed decision about their medical treatment.