There is much to admire about modern Germany. Their citizens enjoy protections and support systems such as guaranteed health care, six weeks paid vacation every year, green energy initiatives and support for industry that so far, Americans can only dream about (arguably, we came a small step closer this past election day). German mechanical engineering is legendary, and of course, Germany gave us the music of Bach, Beethoven and Brahms as well as the lovely actress Franka Potente.
On the dark side, there is the matter of companies such as Boehringer-Ingelheim and Fresenius, the latter of which produces the dialysis drug known as GranuFlo. The former of course brought us Pradaxa, the anti-clotting agent for which there is no antidote other than emergency dialysis.
What these two companies have in common are allegations that their executives were aware of potentially deadly side effects of their respective medications and, whether by oversight or design, failed to provide this information to patients and their doctors. In the case of Fresenius, an internal memo was issued to the company's own medical personnel in November 2011, stating that use of GranuFlo during dialysis caused a “significant risk” of alkalosis. This is a condition in which a patient's pH levels are elevated, leading to cardiac arrest. Essentially, Granuflo makes the patient's blood less acidic by introducing a substance into the bloodstream that is converted into bicarbonate - an ingredient in baking soda.
As you may recall from grade school science demonstrations, baking soda has a neutralizing effect on acids. The problem is that Granuflo contains more of this substance than similar medications – and may be making patients' blood too alkaline.
However, while this information was circulated within the company, it was not provided to other clinics or hospitals. Why not?
According to some of the product's defenders in the medical community, there was no need. One doctor, a professor of medicine at the University of Louisville, told the New York Times that the label “provides enough information for doctors to figure out how to adjust dosing appropriately,” adding that physicians bear some responsibility in determining how to use the medication safely.
An executive at Fresenius' North American division told the paper that his company had “no way of communicating with non-company clinics except through papers in medical journals,” adding that “the findings of the internal memo were too preliminary to warrant a publication.”
So, as is the case in most civil lawsuits of this nature, the question comes down to whether or not Fresenius had a duty to warn patients about possible adverse events. Since June of 2012, the U.S. Food and Drug Administration has been investigating Fresenius in order to determine if it violated federal law by failing to issue appropriate warnings. In the meantime, the legal community is gearing up for the lawsuits that will surely be filed as he number of deaths and injuries continues to mount.
It's worth noting that, like pelvic meshes and metal-on-metal hip implants, Granuflo was approved by the FDA using the highly questionable 501(k) Clearance Process – which allows the manufacturer to bypass the usual safety testing of a medical product that is “substantially similar” to a product already approved and currently on the market.
N/A. “Fresenius Naturalyte® Granuflo® Dry Acid Conccntrate 510(k) Premarket Notification
510K Summary.” U.S. Food and Drug Administration, 20 May 2003. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf3/k030497.pdf .
Pollack, Andrew. “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry.” New York Times, 14 June 2012.