New Jersey Plaintiff Claims GranuFlo Killed Her Husband

A Granuflo recall lawsuit has been brought against Fresenius, the pharmaceutical company behind the controversial dialysate. Filed late last month in Massachusetts, the complaint alleges that Fresenius failed to properly warn patients about the GranuFlo death risk posed by strokes and heart attacks. It is the latest in a string of lawsuits filed against the company, some of which have been consolidated into multidistrict litigation proceedings.

The decedent at the center of the case was a New Jersey resident. As of June 2011, he began receiving hemodialysis three times a week at one of Fresenius’ clinics. On the 28 June, 2011, he suffered a sudden cardiac arrest shortly after his appointment. His wife is seeking compensation for pain and suffering, medical expenses, funeral expenses, loss of earnings and future support, as well as punitive damages.

The lawsuit claims Fresenius knew or should have known the full extent of the risks associated with GranuFlo, which works by counteracting acid in the body with the production of alkaline. The treatment requires careful monitoring to ensure a stable pH balance in the body, and is now thought to cause dangerously high levels of bicarbonate in the blood. More than a quarter of a million patients have been treated with the dialysate, which has generated some $80 million for Fresenius. Hundreds are alleging serious injuries and after receiving Granuflo at the 1,080 nationwide Fresenius clinics, and the 3,300 clinics to which they supply GranuFlo.

According to the lawsuit, Fresenius knew of the GranuFlo death risk as early as October 2004, after the publication of a report in the American Journal of Kidney Diseases showed an increased risk of alkalosis. A Class I GranuFlo recall was eventually conducted by the FDA in March 2012.

GranuFlo recall lawsuit

The lawsuit has been added to Granuflo multidistrict litigation proceedings  (MDL 2428) now underway against Fresenius. The MDL will be heard before Judge Douglas P. Woodcock in the Massachusetts District Court.

The MDL was prompted by the high number of complaints involving similar allegations of Granuflo injuries and side effects. Led by two bereaved plaintiffs, the petition was filed on behalf of multiple complainants in 2012 following a study which linked GranuFlo to the deaths of 941 patients. Fresenius consented to the consolidated Granuflo litigation – which includes more than 300 lawsuits – in January of this year.

Fresenius memo presented to court

A key piece of evidence in the GranuFlo recall lawsuit is an internal memo indicating the firm’s knowledge of the high mortality rate associated with the product. The memo, issued to their own clinics in November 2011, warned physicians of the importance of closely monitoring bicarbonate levels in patients. But Fresenius failed to distribute this information to other clinics that treated patients with Granuflo. The memo clearly stated that the risk of cardiac arrest was as much as eight times higher compared to other dialysates.

Leaked to the FDA in March 2012, the publication of the memo forced Fresenius to issue a warning to the clinics they supplied. In 2012, the update was classified by the FDA as a Class I GranuFlo recall.