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.