Eye drops / not product liability per se

NeuwirthLaw Medical Malpractice, Product Liability

There is a current recall on eye drops and eye ointments manufactured by Global Pharma Healthcare Private Limited, which is an Indian manufacturing company. Their over the counter eye products were detected to have bacterial infection and were intended to be sterile. So, if you use these products, you may be directly dropping harmful bacteria into your eye. Bad, huh? This is evidence of a manufacturing problem. However, without the FDA’s involvement and a resulting voluntary recall, infection cases are very hard to prove either as medical malpractice or as product liability. There are several reasons for this. The claim here is that the manufacturer’s procedures to ensure sterility failed and bacteria entered the drops before they were sealed and shipped to the US.

Unlike cuts to the skin or inhaled bacterial infections, the eye is very sensitive to bacterial infections. What may initially look like pink eye or conjunctivitis can rapidly lead to degeneration of the retina or delicate structures in the eye. While doctors can infuse antibiotics directly into the eye, the structures of the eye can permanently degenerate because you have a lot of bacteria in a small, enclosed space with limited circulation. So, infusing bacteria into your eye is bad and can and has already led to reports of blindness.

In general, however, if you develop an infection following surgery, that is a known complication of surgery. If you are not diagnosed with an infection and it gets worse, it is always very difficult to determine who was at fault for the infection and any interaction with the general public makes proving a case impossible. In the nursing home context during covid, a number of families contacted me to evaluate the possibility of bring cases against nursing homes, but none of them had viable cases because covid was spreading so rapidly in an immune compromised population. It would never be clear to what extent the nursing home was to blame, if at all.

Every now and then, an infection case is viable, but only if the patient dies. So, for example, you go to an urgent care complaining of a cold and chest pain. You are told that it’s just a virus and you are sent home. Or, you are a college student with a head cold and you are sent home. If the patient, you, ends up dying of pneumonia or bacterial meningitis, then blood work would likely have found an elevated white count and the urgent care doctors should have notified you to either return or prescribed antibiotics asap.  Most likely antibiotics will fix bacterial infections. Most infections are viral and not bacterial. But, the failure to rule out or exclude the possibility of a bacterial infection is often evidence of malpractice.