New Hampshire Meningitis Warnings and Informed Consent – Breach of Obligation?

As many of you know, there was a warning of meningitis outbreak in New Hampshire last week for those who recently received steroid injections for back pain.

The drug is believed to be linked to what is known as a compounding pharmacy. Compounding pharmacies  historically make small batches for a patient so a medication can be more compatible for the specific patient’s needs. Most pharmacies do not do large scale manufacturing however. Large manufacturers operate much differently and have high standards regulated by the FDA. Compounding pharmacies do have quality and safety standards, but they are different than those at manufacturing operations.

So the problem we had here is that the compounding pharmacies are acting like a large manufacturer making big batches of drugs while not having the same safety standards and quality control that the big manufacturers have. The challenge for patients and doctors is was the patient given informed consent? In other words, did the doctor sit down with the patient and explain where their drugs were coming from?

” Patient, I have the opportunity of getting this steroid from a big batch manufacturer that will cost more money, or I can get you a steroid that I can inject in your back from a small compounding pharmacy in Massachusetts that is doing big batches of the drug for less money, and maybe more risk. Now that I have informed you, do you give me consent to use the cheap stuff?”

Every doctor assumes their drug is going to be clean, and we are by no means suggesting that any doctor has anything but the best of intentions for their patient. However if they were buying from this compounding pharmacy because it was cheaper instead of buying from a large manufacturer, and if the doctor did not have that discussion with the patient, the doctor may have breached his obligation of informed consent.

The class action lawsuits that will occur as a result of these outbreaks will most likely rest on this point.

-Jim Normand

Articles contained here are not intended to provide legal advice, only providing general information. We encourage individuals to consult with an attorney regarding individual circumstances.