FDA investigators want answers from Fresenius (NYSE:FMS) after a dialysis website leaked a copy of an internal memo released to the company’s in-house dialysis centers.
The memo detailed adverse events possibly associated with improper use of its Granuflo dialysis concentrate, including a possible 5-fold increase in heart-attack risk associated with the compound.
More than 900 patients suffered sudden cardiac arrest at Fresenius dialysis clinics in 2010, according to the memo, and researchers found that patients with elevated levels of bicarbonate in the blood were 5 times more likely to suffer an attack.
Fresenius chief medical officer Dr. Franklin Maddux told reporters that he felt that the data shared with the company’s clinics was "not in a condition for general consumption" and that he had no mechanism to warn outside clinics without resorting to medical journals, according to the New York Times.
The Granuflo product contains a compound that creates bicarbonate to help reduce acidity in the blood. Because Granuflo contains a higher concentration of that compound than similar products, physicians must modify the standard bicarbonate prescriptions given to patients for outside-the-clinic use. Patients who receive the standard bicarbonate dose may end up with an excessive amount of bicarbonate in their blood, potentially increasing their risk of sudden cardiac arrest.
Fresenius eventually notified its customers of the bicarbonate risk in March. The 2010 internal memo made its way to RenalWEB, which first reported the story last month, and the FDA announced its investigation about a week later.
Read more medical device legal news from MassDevice.com
Texas man sues doc, Medtronic over pain management implant
John Kimbley files a lawsuit against Medtronic (NYSE:MDT) and the hospital that implanted him with a Medronic pain-relief drug-dosing device, accusing the hospital and an MDT rep of changing both the drug and the dosage Kimbley expected to receive, resulting in an overdose that left him with anoxic brain damage and multi-organ failure.
Read more
CryoLife closes the books on a pair of lawsuits
CryoLife Inc. (NYSE:CRY) closed the books on a pair of lawsuits this month involving a patent dispute with CardioFocus and a payment conflict with Medafor.
CryoLife will pay $4.5 million to settle with CardioFocus and $3.5 million to settle with Medafor, but the company may save $1 million in anticipated legal costs should the lawsuits have dragged on the rest of the year, according to Benchmark Capital analyst Raymond Myers.
Read more
