On behalf of William Takacs at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A.
The manufacturer of two dialysis solutions is being sued for deliberately withholding side effect information from the public.
Leaked memo shows manufacturer warned its own clinics of risks, but not other clinics
The manufacturer of two dialysis solutions, GranuFlo and NaturaLyte, is facing thousands of lawsuits over allegations that it concealed dangerous side effects about its products from patients and clinics, according to the Boston Herald. The lawsuits stem from a leaked internal memo that showed the manufacturer had warned its own clinics and staff about health hazards of its dialysis drugs, but failed to share that information with non-company clinics that used the same products.
FDA issues Class 1 recall
According to DrugWatch, the manufacturer failed to issue proper directions concerning the use of GranuFlo and NaturaLyte. The improper use of the products can lead to an excess of bicarbonate, which in turn can lead to heart attacks, strokes, and even death in some patients. The company ran its own tests and found that patients with an excess of bicarbonates in their systems caused by the dialysis solutions were six times more likely to suffer cardiac arrest.
In an internal memo, the company shared its findings with its own clinics, but failed to inform the approximately 3,000 non-company clinics that also used the drugs about the results. The company also failed to issue a recall until the FDA discovered the memo and issued its own Class 1 recall for the drugs. A Class 1 recall is the most urgent type of recall the agency can issue, and usually means that exposure to a certain product risks causing serious health problems or death.
The manufacturer is now facing over 5,000 lawsuits in two Massachusetts courts, where the company is headquartered. The multidistrict litigation includes plaintiffs from all over the United States. The lawsuits allege that the manufacturer withheld vital information from clinicians and patients and that its actions led to the deaths of countless people.
The plaintiffs accuse the manufacturer of misleading the public and even continuing to sell the products after it knew about the risks. They also allege that the manufacturer failed to warn the FDA about the risks of its products and deliberately withheld health information from non-company doctors.
GranuFlo and NaturaLyte lawsuits
The above case is bound to affect many Americans, and it is likely that lawsuits against this particular dialysis manufacturer will continue to grow as more information becomes public. Patients expect that when they are treated for a medical condition, that doctors and drug manufacturers will have done everything possible to make sure that such patients are not placed at any undue risk.
Unfortunately, the above case shows that some medical manufacturers may fail to inform the public, doctors or safety authorities about the dangers of a particular product. Anybody who has been the victim of GranuFlo, NaturaLyte or any other dangerous product should contact a personal injury lawyer as soon as possible. Since such cases can become exceedingly large and complex, plaintiffs will want the best legal representation they can get when fighting for the compensation they are due from a potentially negligent manufacturer.
Keywords: dialysis drug manufacturer, GranuFlo, NaturaLyte, lawsuit, FDA, recall