Lawsuits Continue Against Makers and Users of Granuflo and Naturalyte
Hundreds of lawsuits have been filed against Fresenius Medical Care North America (FMC), the makers of Granuflo and Naturalyte. Both Granuflo and Naturalyte are products intended for use in dialysis, a medical procedure which cleanses the blood and rids it of toxins in people whose kidneys are not capable of performing this otherwise natural function. Granuflo is a dry acid mixture, while Naturalyte comes in a liquid form, but both products must be carefully mixed and delivered properly at the dialysis center in order to be used safely and prevent alkali dosing errors. These errors could cause metabolic alkolesis, a condition which may cause heart attack, stroke or death.
Naturalyte and Granuflo Acid Concentrate were in use from 2008 until 2012, when they were recalled by the U.S. Food and Drug Administration (FDA). During that period and since, more than 300 lawsuits have been filed against FMC – which not only manufactures the drug but also operates a network of dialysis centers – and DaVita Healthcare Clinics, a competing operator of dialysis centers which also used the FMC products. A particularly disturbing feature of this litigation is the fact that FMC conducted a study in its own dialysis clinics and found nearly 1,000 cardiac arrest cases in 2010. Although FMC sent an internal memo to its own clinical directors regarding the safety issue, it did nothing to inform DaVita or the thousands of other clinics serving 125,000 dialysis patients nationwide.
The Granuflo recall was only one of 49 medical device recalls issued by the FDA in 2012. Although recalls for 2013 have not yet been collected on the FDA website, it looks to be a bigger year for recalls than 2012. The list of Recent Medical Device Recalls on the website contains 68 recalls at the time of this writing in mid-January. Stryker Spine, Stryker Orthopaedics and DePuy Orthopaedics, Inc. are among the companies with recent recalled devices. DePuy and Stryker both had hip replacement recalls in recent years which led to class action lawsuits, although the current recalls are for other devices. Several other companies have also been identified for over half a dozen drug infusion pump recalls. Shoulder pain pumps, insulin pumps and other similar drug delivery systems have been linked to permanent debilitating conditions such as the deterioration of cartilage between joints, causing severe pain and reduced range of motion due to cartilage loss and bone rubbing on bone.
If you or a loved one has suffered an adverse event that may be due to a dangerous drug or defective medical device, contact a personal injury attorney with experience handling complex personal injury matters. In Los Angeles and Southern California, contact Magaña, Cathcart & McCarthy for a free consultation.