Plaintiffs continue to come forward, accusing Fresenius Medical Care of failing to inform patients about the risks involved with GranuFlo. This medical powder used in kidney dialysis treatment to help clean the blood of patients. Now, there are around 5,500 GranuFlo injury cases, many of which were filed in U.S. District Court in Boston and Middlesex Superior Court in Massachusetts. Fresenius is based in Waltham, MA.
GranuFlo has been linked to a greater risk of heart attack and metabolic alkalosis, which involves the body fluids having too much bicarbonate in the blood. Metabolic alkalosis can lead to more serious health issues, including hypoxemia, hypokalemia, high blood pressure, and cardiac arrhythmia.
Many of the Massachusetts defective medical device plaintiffs have noted that when Fresenius eventually told dialysis clinicians about the risks, it initially chose to only notify its own clinics. Their claims point to a company memo that Fresenius sent to its clinicians warning that the powder may cause cardiac event-related risks. Product labeling, which can lead to dosing errors, appears to be the main cause of this problem.
Patients suffering from kidney disease or failure usually have a decreased ability to naturally filter the acid that accumulates in the blood. Dialysis is supposed to do this using an artificial kidney. The blood is removed, filtered, and restored to the body of the patient. Bicarbonate is the substance that is used in this process, and GranuFlo has this bicarbonate. Unfortunately, now many are saying that GranuFlo’s natural ingredients were getting turned into too much bicarbonate, which is when the serious health complications happened.
After the U.S. Food and Drug Administration found out about the memo, it led a Class 1 GranuFlo recall related to the medical product’s labeling. This type of recall is only issued when a product is linked to very serious health issues or death.
Recently, a federal judge approved a qualified protective order for Health Insurance Portability and Accountability Act information that prevents Fresenius or its employees from discussing protected health information about plaintiffs with their doctors. Plaintiffs had complained when Fresenius asked to perform ex parte interviews with medical directors who are independent contractors at its outpatient clinics. They said that if their doctor also happens to be a a Fresenius medical director, then letting the company have this contact would violate the plaintiffs’ confidentiality as it pertains to their health data,
Another Fresenius products used in dialysis that is also the subject of a Massachusetts drug defect cases is Naturalyte. This is also powder that is a component of dialysate.
Judge Orders Protection For HIPAA Information in Dialysis Suits, National Law Journal, July 17, 2014
More Blog Posts:
GranuFlo Lawsuits Seek to Give Patients and Families Compensation Over Dangerous Drug Injuries, Drug Injury Lawyers Blog, August 13, 2013
GranuFlo Dialysis Treatment Lawsuits Filed Over Cardiac Deaths, Drug Injury Lawyers Blog, July 23, 2013
Boston Dangerous Drug Lawsuit Over Meningitis Outbreak Linked to Massachusetts Compound Pharmacy Proceeds, Boston Injury Lawyer Blog, September 19, 2013