Fresenius Medical Care is facing intense scrutiny because their dialysis products GranuFlo and NaturaLyte increase the risk of cardiac arrest. Even more troubling, there is evidence that Fresenius knew of these risks and actively hid the information from the public. The company distributed an internal memo to Fresenius-owned medical centers explaining that their products could be linked to an increased risk of patients dying from sudden cardiac arrest. But Fresenius did not distribute the memo outside of the company, and it wasn’t until the memo was anonymously leaked that the problem became public knowledge.
The timeline of events is particularly important in this case. Fresenius’ actions and other important events are explored in detail below.
January 1, 2010 – December 31, 2010
Information About Risk Emerges
Research carried out by Fresenius shows that 941 patients from 667 facilities suffered from cardiopulmonary arrest after using Granuflo or NaturaLyte. This figure is over six times higher than that of competing products.
September 15, 2011
FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to Fresenius after a government investigation reveals Fresenius is not properly addressing complaints filed by patients using the company’s products. The letter cites five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”
November 4, 2011
Fresenius Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with the GranuFlo and NaturaLyte products. The memo states that the “issue needs to be addressed urgently.”
Internal Memo Leaked to the FDA
Over four months after Fresenius circulated the original internal memo, the memo is anonymously leaked to the FDA.
March 29, 2012
Fresenius Issues Warning to Doctors
Fresenius releases a modified update to the original internal memo, warning of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate . . . . This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”
May 25, 2012
FDA Issues Update Warning Doctors of Dosing Dangers
The FDA releases an update, warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The FDA recommends that doctors exercise more caution when prescribing these products to patients and urges doctors to “be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels greater than or equal to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.”
June 14, 2012
The New York Times Reports that FDA is Investigating Fresenius
The New York Times brings the Fresenius issues to the nation’s attention by reporting that the FDA is investigating the company. The article includes a quote from Steven Silverman, the director of compliance for the FDA’s medical device division, stating, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
June 27, 2012
FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
The FDA announces a Class I recall of GranuFlo and NaturaLyte, citing “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls, and the move is considered an important development in the ongoing case against Fresenius.
Upton Law Firm is actively investigating the problems surrounding the Fresenius products Granuflo and NaturaLyte. If you or a loved one have been harmed by these products, contact Upton Law Firm today.