The biochemistry of a living creature is a delicate balancing act. For example, the pH level of the blood – the balance of acidity and alkalinity must be just right in order for a person to remain in good health. Too much acidity in the blood results in acidosis, a condition that can cause an irregular heartbeat as well as an elevated hear rate. When the blood is too alkaline, it causes alkalosis, which may result in muscle spasms and cramps.
It's no secret that tort (personal injury) cases are often complicated – even though this is a subject studied by every first-year law student. It doesn't help when a manufacturer is involved in litigation with a competitor that is using its own defective product.
In recent months, the German pharmaceutical firm Frenesius has been taken to task over its dialysis drug, Granuflo, over allegations that the drug has caused patients to suffer heart attacks. This is caused by a number of conditions due to the fact that Granuflo contains a higher concentration of sodium diacetate than similar medications. Frenesius apparently failed to make doctors outside its own network of dialysis clinics aware of this. This “failure to warn” is at the heart of Granuflo lawsuits that have been filed over the past few years.
As lawsuits pile up against Fresenius N.A., the pharmaceutical company that manufactures the dialysis drug GranuFlo – implicated in the deaths of hundreds of patients – it's worth taking a look at exactly what is allegedly killing them.
According to the U.S. Food and Drug Administration (FDA), one culprit is metabolic alkalosis.
If a family member is a patient at a treatment center and the staff administers a medication that causes severe injury or death, who is liable? The facility that purchased the medication? The staff member who administered it? Or perhaps, the company that manufactured it in the first place?
It was just over a year ago (June 27, 2012, to be exact) that the U.S. Food and Drug Administration (FDA) issued its Class I Recall Notice for Fresenius' NaturaLyte and GranuFlo Acid Concentrates, which can dangerously raise patients' blood pH levels (somewhat like injecting baking soda into the bloodstream). The result can be metabolic alkalosiss, which can cause cardiovascular complications resulting in spontaneous cardiac arrest.
On June 17th, several media sources announced that Fresenius Medical Care North America had recognized one of its dialysis centers – located in the Southwestern Washington town of Walla Walla – for “achieving high standards in patient care in 2012.” The Center for Excellence Designation is given out by the company once every year to a particular Fresenius facility that has demonstrated a superior level of patient care.
The argument for the commoditization, commercialization and privatization of everything in America – including health care and medical services – that has been shoved down our collective throats for the past generation goes something like this: “free market competition forces providers of goods and services to offer the best products at the lowest prices.”
Founded in 1871 – before which it was a loose confederation of duchies and principalities – the modern nation of Germany was the first to guarantee all its citizens the right to low-cost or free medical care. This has been a constant from the time the country was an empire ruled by the Kaiser, during the Weimar period, under Hitler and the Nazis, and in the decades following the Second World War as Germany transitioned into a modern, progressive democracy.
At the end of March 2013, the U.S. Judicial Panel on Multidistrict Litigation (USJPML) consolidated all pending cases against Granuflo manufacturer Fresenius before the U.S. Federal Court for the District of Massachusetts. This accomplishes two things: it eliminates all duplication of efforts when it comes to the discovery process, and it moves the trial to a venue near Fresenius' U.S.