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Category : Dialysis
Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.
Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.
January 1st – December 31st, 2010 – First Information Concerning Risks Emerges
Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.
September 15th, 2011 – FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses 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 4th, 2011 – Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”
March, 2012 – Memo is Leaked to the FDA
Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).
March 29th, 2012 – Fresenius Issues Warning to Doctors
On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors 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 25th, 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 press release 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 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care
An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “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 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “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 of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.
For more information, visit www.seegerweiss.com/granuflo-lawsuit.
Following a string of troubling findings concerning the risks involved with the use of GranuFlo and NaturaLyte dialysis products, Seeger Weiss LLP is advising that the Food & Drug Administration (FDA) has opened up an inquiry into the parent company Fresenius Medical Care (FMC), combined with a Class I recall of both products. The inquiry’s goal is to determine whether Fresenius violated federal regulations by omitting critical information concerning the potentially deadly risk associated with use of the products.
FMC, based in Germany, is the largest operator of hemodialysis centers in the United States, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. A memo that Fresenius issued in November of 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems.
The issue was first brought to public attention after an internal memo was anonymously leaked to the FDA earlier this year. In the memo dated November 4th, 2011, FMC warned doctors operating in their dialysis centers that their products may be causing dangerously high biocarbonate levels that would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products. The memo also stressed that “This issue needs to be addressed urgently.”
Despite the findings, it was only after the FDA opened an investigation into the matter that FMC issued a wider warning to other care centers, which it did in March of this year. In June, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products from Fresenius.
As more information becomes public, patients who have suffered injuries are seeking redress and exploring their legal options. Chris Seeger, one of the partners of the law firm Seeger Weiss LLP, said that the decision Fresenius made not to inform the public of potential dangers reflects a failing on behalf of the company. “By not advising the FDA, the medical community and dialysis patients as soon as possible about the dangers of GranuFlo and NaturaLyte, Fresenius made the decision to put profits ahead of patient safety. They aren’t the first pharmaceutical company to make that decision and, unfortunately, they won’t be the last.”
Additionally, Mr. Seeger says that the error is made all the more egregious due to the fact that much of the damage to patients was preventable if Fresenius had responded quickly and efficiently to initial reports of the problem. “You would not expect a company that makes millions of dollars a year from dialysis patients to knowingly put those patients at risk for serious injuries, including death, but that’s exactly what Fresenius did. Fresenius was in position to prevent these injuries but chose not to do so. They must be held accountable.”
Seeger Weiss LLP is offering free consultations to those that might have been affected by the products. If you suspect that you or someone you know has been injured after using GranuFlo and NaturaLyte products in dialysis, contact Seeger Weiss by visiting http://www.seegerweiss.com/ or by calling directly at 888.584.0411.