Durham, North Carolina (PRWEB) November 30, 2012
The North Carolina dangerous drugs lawyers with the Law Offices of James Scott Farrin are now offering free case evaluations to patients who received the now recalled GranuFlo dialysis product, found to increase the risk of potentially fatal heart problems.
The Food and Drug Administration issued a Class I recall for GranuFlo, made by Fresenius Medical Center, on March 29. Class I recalls are reserved for the most dangerous or defective products that could cause serious health problems or death.
The FDA followed up the recall by launching an investigation in June that sought to determine whether Fresenius failed to inform customers of the potentially fatal risks connected to GranuFlo, including an increased risk of heart attack, low blood pressure, arrhythmia (irregular heart beat), stroke and other heart problems.
According to a New York Times article on June 14, 2012, Fresenius circulated an internal memo in November 2011 that warned its own network of doctors about these risks associated with the product. However, the company did not alert the public or doctors outside of its network.
The Fresenius memo said that failure to properly mix and administer the GranuFlo concentrate appeared to be contributing to “a sharp increase in the risk of patients dying suddenly from cardiac arrest” and that “this issue needs to be addressed urgently.”
The memo said that 941 patients had suffered from cardiac arrest in Fresenius clinics in 2010, and concluded that those with high levels of bicarbonate in their blood had a six-fold increased risk of cardiac arrest.
GranuFlo is the only dialysis concentrate that contains the powder form of acetic acid, sodium diacetate, which is converted into bicarbonate in the body and helps to neutralize acid in the blood. However, bicarbonate is also included as a separate ingredient in the dialysis solution, and if doctors don’t properly account for the amount of bicarbonate that is converted in the body, it could lead to bicarbonate overdose.
Incomplete instructions about how to mix and administer GranuFlo to account for this possibility has led to an increased risk of bicarbonate overdose, which increases the risk for potentially fatal heart problems.
Fresenius is the largest supplier of dialysis machines and products, and it treats more than a third of the estimated 400,000 Americans receiving dialysis.
About the Law Offices of James Scott Farrin
The Law Offices of James Scott Farrin is headquartered in the American Tobacco Historic District, adjacent to the Durham Bulls Athletic Park, in Durham, North Carolina, with 12 additional offices statewide in Charlotte, Fayetteville, Greensboro, Greenville, Goldsboro, Henderson, New Bern, Raleigh, Roanoke Rapids, Rocky Mount, Sanford and Wilson. The firm’s 31 attorneys focus on the following practice areas: Personal Injury, Workers’ Compensation, Social Security Disability, Bankruptcy, Eminent Domain, Intellectual Property, Civil Rights, Mass Torts and Products Liability. Three of the attorneys are North Carolina Board Certified Specialists in Workers’ Compensation Law, one is a North Carolina Board Certified Specialist in Social Security Disability Law and one is a North Carolina Board Certified Specialist in Business and Consumer Bankruptcy Law. The Law Offices of James Scott Farrin is involved in the community, including sponsorship of local philanthropic organizations.
280 S. Mangum Street, Suite 400
Durham, NC 27701