Prescription Drug Label Expert Claims Warning of Serious Side Effects Was Inadequate

This case involves a certain class of antibiotic drug and its alleged link to peripheral neuropathy. The class of drugs in question – broad spectrum antibiotics – have been linked in some research to a risk of permanent peripheral neuropathy. Accordingly, a group of Plaintiffs in South Dakota alleged that the drug should have carried a more visible warning of this potential complication on it’s packaging. They claim that, if they had know of this risk, they would have not taken the drug.

Question(s) For Expert Witness

1. Please briefly explain your experience with regards to labels and warnings for drugs from an FDA perspective. 2. Do you have experience with labels/warnings for drugs that may cause Peripheral Neuropathy? 3. Have you ever been published / lectured on the topic of FDA Labeling/Warnings or Peripheral Neuropathy?

Expert Witness Response E-010122

I am a former FDA Senior Medical Officer and I have almost 20 years of drug development and NDA review experience. I am a specialist in reviewing the FDA's adverse event database, and I track adverse events of commonly used drugs, including peripheral neuropathy. I have been a professor of pharmacology and additionally lecture on the topic of FDA regulatory affairs. I have served as an expert on the topic of drug adverse events and the complex litigation it produces. Given the seriousness of this complication, it is likely that the drug's packaging should have displayed a prominent warning to communicate the risk to potential patients.