The number of drug recalls issued by the U.S. Food and Drug Administration (FDA), which includes one that has since prompted thousands of GranuFlo lawsuits, has increased substantially over the past few years, according to newly-public federal records.

A report published by the Regulatory Affairs Professional Society indicates that a total of 499 drug recalls were announced in 2012, when the federal regulator granted Class I status to a GranuFlo recall that affected acid concentrates used in dialysis. In 2013, at least 1,220 recalls were issued.

As of August 2014, information obtained through OpenFDA, a new initiative that grants public access to product recall information, shows 836 recalls already issued as of August 11th, which may suggest that this may be one of the biggest years for product recalls.

GranuFlo Lawsuits Follow FDA Recall in 2012

Court documents reflect the filing of numerous product liability lawsuits that have followed recalls from the U.S. Food and Drug Administration (FDA). In the case for the GranuFlo recall, thousands of claims have been filed by individuals who received the medication prior to June 2012, at which time the federal agency determined there to be a serious risk for the dialysis medications to cause serious injury and death. Since then, thousands of lawsuits have been filed by individuals who allegedly suffered strokes, cardiac arrest, sudden cardiac death and other serious cardiovascular problems following their administration of GranuFlo and NaturaLyte.

Plaintiffs accuse the drug manufacturer, Fresenius Medical Care, of failing to adequately warn about GranuFlo and NaturaLyte side effects prior to March 2012, when the company issued an Urgent Product Notification that warned of the medications’ alleged association with serious cardiovascular injuries. A Case List updated last month indicates that 1,942 lawsuits over GranuFlo and NaturaLyte have now been filed in the U.S. District Court, District of Massachusetts, where a federal litigation is underway.

According to court records, dialysis plaintiffs further accuse Fresenius of withholding safety information related to the medications months before alerting the general public. In November 2011, the company sent an internal memo to physicians in its dialysis clinics that mentioned 941 patient deaths stemming from NaturaLyte and GranuFlo. Doctors were advised to adjust dosages of the medications.

Pursue a GranuFlo Recall Lawsuit

Contact our Firm to learn more about the GranuFlo recall, and if you are eligible to file a claim against Fresenius. Call us now at (877) 779-1414.

Published August 14, 2014 by