Epidemiology Expert Evaluates Peripheral Neuropathy from Fluoroquinolone Antibiotic

This case involves a number of incidents related to the administration and long-term use of a particular type of antibiotic therapy. The antibiotic in question belongs to a class of drugs referred to as fluoroquinolones, and is used to treat a number of different infections within the skin, kidneys, bladder, sinuses, and prostate. However, some patients have experienced permanent damage to their peripheral nervous system, even after using the drug for a limited amount of time. As a result of this damage, patients have experienced pain, numbness, burning, and reduced motor capacity. Patients continue to experience symptoms well after ceasing the drug, and show little improvement after a year. It was alleged that the pharmaceutical companies that developed the drugs had a responsibility to vigilantly report and address the negative side effects of the antibiotic, and that they failed to shield patients from potential neurological damage.

Question(s) For Expert Witness

1. Are you well versed in pharmaceutical epidemiological studies and Biostatistics?

2. Please explain why you are qualified to review this case.

3. Is it the responsibility of the drug company to make sure that there is proper pharmacovigilance analyses of their product?

Expert Witness Response E-008530

I have conducted several pharmacoepidemiological studies and teach pharmacoepidemiology at in my position at a major university medical center. I have training in medicine and epidemiology, with a focus on pharmacoepidemiology. I have conducted several studies in this area and am aware of the medico legal implications of this particular situation. The drug company does have a certain responsibility to make sure that the FDA approved product is safe. However other factors may also modify this scenario. I have published extensively on similar scenarios and other drugs and side effects. I have a history of collaborative work with the US FDA where I primarily conduct projects focused on advanced methods for benefit and risk assessment or advising companies on emerging issues in drug safety.