A type of brain injury, called progressive multifocal leukoencephalopathy (PML), can occur as a result of complications from use of Tysabri (natalizumab) by patients suffering from multiple sclerosis (MS). PML was first identified in immunocompromised patients, such as AIDS and cancer patients. However, it can arise when Tysabri reactivates a dormant viral illness called JC Virus (also known as John Cunningham virus or JCV). An article published in the journal of the American Academy of Neurology explains how injury from this complication can be avoided.
The Neurology article explains that PML is rare. However, when MS patients receive Tysabri, they are at increased risk for developing PML. PML develops in MS patient who have underlying JCV. JCV is common, but it typically is not symptomatic.
The Neurology researchers pointed out that once PML becomes symptomatic in MS patients, it is fatal 25% of the time. Asymptomatic PML is detected through a screening MRI. So, the researchers recommend that MS patients using Tysabri should be screened for JCV. If they have it, they should undergo serial screening MRIs to catch PML in its earliest stages.
As a medical malpractice attorney, this article was interesting to me in two regards. First, I have tremendous admiration for researchers who take the time to identify a problem and come up with a solution to it. High-minded scientists like them are truly a credit to the medical profession. My second reaction was, unfortunately, an “uh oh” moment. This came when I realized that this scenario carries many ingredients of a medical negligence claim: a rare complication, new guidelines, the need for preventative measures, and potentially catastrophic results (i.e., wrongful death).
Rare conditions are frequently involved in medical malpractice litigation because doctors often fall into the trap of ignoring important recommendations that pertain to less common conditions. New guidelines are a problem because the medical community is notoriously slow in adopting new practice patterns. The need for screening to prevent the complication invokes another dangerous medical bias: doctors are more geared to treating illness once it arises rather than taking steps to prevent it in the first place.
A devastating brain injury from PML can be avoided through proper screening. If an Ohio physician fails to take proper precautions while treating a patient, and the patient dies as a result, there may be grounds for a lawsuit. On the heals of the Neurology article, and subsequent warnings included in Tysabri packaging, a doctor cannot claim that he/she was not aware of this serious complication or the steps needed to prevent it.
