When I started practicing law, I spent most of my time defending a pharmaceutical company in AIDS/hemophilia cases, litigation involving approximately 10,000 completely innocent people who contracted HIV from the use of Factor VIII and Factor IX blood products. Regardless of how you viewed the liability of the involved drug companies, everyone agreed on the magnitude of the tragedy (which was very underreported in the media). My experience in those cases eventually lead me to becoming a plaintiffs’ lawyer because I quickly realized I would be far more energized by representing innocent victims who needed my help than large pharmaceutical companies. After I became a plaintiffs’ lawyer, I thought I would never be involved in a mass tort lawsuit with facts as tragic as the AIDS/hemophilia cases, but the gadolinium MRI contrast litigation, while on a thankfully smaller scale in terms of number of patients, is in the same league of suffering – a cruel, progressive disease that you contracted through absolutely no fault of your own.
Gadolinium is the contrast given before a MRI (or MRA, magnetic resonance angiograph, although this practice was never FDA approved) to increase the contrast of blood vessels during an MRI procedure so that the reviewing radiologist can better diagnose abnormalities. While gadolinium did improve MRI diagnostics, nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD) resulted for many patients with kidney issues who received a gadolinium contrast MRI. NSF/NFD causes thickening or tightening of the skin and connective tissues, which severely limits a patient’s ability to move, and it also causes pain, muscle weakness, scarring of internal organs and difficulty bending joints. It seems that patients’ lives are potentially at risk because of the damage to their organs, and destroyed by their inability to move. What we can all hope for is that science will move quickly forward to find ways to make this NSF/NDF more manageable.
More than 215 cases of NSF/NFD have been documented in the last decade, but despite ongoing research, the etiology of the disease was originally unknown. Now, it is clear that use of gadolinium contrasting agents in patients with kidney failure is the culprit. In June 2006, the FDA first said that NSF/NFD can be caused by the use of gadolinium contrast MRI. Last year, on May 23, 2007, the FDA asked manufacturers to include a new boxed warning with gadolinium contrast informing health care providers that patients with severe kidney insufficiency who receive gadolinium contrast are at risk for developing NSF/NFD. Additionally, the warning states that patients with liver problems are also at risk for developing NSF/NFD if they are experiencing kidney problems.
The lawsuits against the five manufacturers of Gadolinium have a simple premise: these companies knew that gadolinium is toxic and, if misused, could lead to serious injury. Accordingly, these companies should have properly designed and tested the gadolinium MRI contrast and given more consideration to vulnerabilities of the different types of patients who would be using the contrast, in this case, patients with kidney disease or renal dysfunction.
I met recently with a confirmed NSF/NFD client here in Maryland. These cases are just absolutely heartbreaking. This client I met with is a wonderful woman who was struck down in the prime of her life by NSF/NFD. Thankfully, she is in better spirits than most people you meet. 2013 Update: Her case settled for millions. But she died. An unbelievable human tragedy.