The family of a Georgia man who died from a heart attack following hemodialysis has filed a lawsuit against Fresenius Medical Care, alleging that problems with two acid concentrate products commonly used during dialysis treatments caused the sudden death.
The complaint (PDF) was filed by the son of Harold Bolton, Sr. in the U.S. District Court for the District of Massachusetts on October 25, alleging that the fatal heart attack occurred as a result of Fresenius Medical Care’s failure to provide proper warnings and instructions about the potential side effects of Granuflo and NaturaLyte.
Granuflo and NaturaLyte are two acid concentrates that have been commonly used in recent years during hemodialysis. According to the lawsuit, the products are unique dialysis treatments in the industry, as they use sodium diacetate, which doubles the amount of acetate in dialysate compared to formulations made with acetic acid. When combined with the bicarbonate buffer prescriptions administered during hemodialysis, this may increase the risk of a heart injury or death.
According to allegations raised in the complaint, Bolton began receiving Granuflo and NaturaLyte three times a week beginning in approximately 2006. Following treatment at a Fresenius dialysis center located in Clarke County, Georgia on October 24, 2010, the lawsuit indicates that Bolton suffered a sudden heart attack and died on October 26.
Bolton’s son alleges that Fresenius concealed or misrepresented information about the risks associated with their hemodialysis treatments, and failed to adequately warn about the increased risk of cardiovascular injury and death.
Fresenius Hemodialysis Problems
Fresenius is the largest provider of dialysis services and products in the world, owning thousands of dialysis clinics and manufacturing many of the products used during treatment at clinics owned by other companies, including machines, dialyzers, blood lines, needles and dialysis concentrates.
In November 2011, more than a year after Bolton’s death, Fresenius issued a detailed internal memo to their own clinics, warning about the risk of problems with Granuflo and NaturaLyte used during hemodialysis.
The company advised physicians at their own clinics that it was particularly important to monitor pre-dialysis bicarbonate levels and adjust buffer prescriptions to reduce the risk of heart problems and death during hemodialysis.
According to an internal analysis conducted by Fresenius Medical Care, the company acknolwedged that there were at least 941 instances where individuals suffered a cardiac arrest during hemodialysis treatments between January 1, 2010 and December 31, 2010.
Lawsuits Over Heart Attacks, Cardiac Arrest, Wrongful Death Following Hemodialysis
Bolton’s complaint is one of a growing number of Fresenius hemodialysis treatment lawsuits filed on behalf of individuals who received Granuflo or NaturaLyte at one of the manufacturers own clinics, or other clinics that used the Fresenius products.
Although lawsuits allege that Fresenius knew or should have known about the problems long before the internal memo was issued in November 2011, the same warnings and information about the risk of heart attacks with hemodialysis involving Granuflo and NaturaLyte were not provided to outside clinics until March 2012.
The FDA has determined that these warnings consituted a Class I medical device recall for Granuflo and NaturaLyte, which means the agency believes the products are likely to cause severe injury and death without the new warnings.
In May 2012, the FDA issued a safety communication warning about the risk of dosing problems during hemodialysis with Granuflo and NaturaLyte, urging doctors to consider the impact of the acetate levels in these dialysate concentrates when ordering or administering hemodialysis treatments.
Bolton’s hemodialysis lawsuit and other similar complaints filed by individuals throughout the U.S. are pursuing both compensatory and punitive damages against Fresenius, alleging claims for failure to warn, strict liability, negligence, wantonness, fraud, wrongful death, breach of warranty, and unjust enrichment.