This case involves numerous patients on dialysis treatment who suffered cardiac arrest. It was alleged that the pharmaceutical company that distributed this dialysis treatment was aware of the potential causal link between treatment and heart attack and did not fully disclose these dangers to patients or physicians. An expert in pharmaceutical ethics was sought to opine on the business practices for large pharmaceutical companies and whether or not the company employed unethical business practices.
Question(s) For Expert Witness
- 1. Please briefly describe your experience as it relates to the professional ethics of pharmaceutical companies.
Expert Witness Response E-007856
I am a professor of management and global business at a large university in the Northeast where I have conducted research and taught courses in business ethics for two decades. I have also taught courses in business ethics at several international universities. I am a member of a business ethics society and serve on the editorial board of a business ethics publication and a human rights publication. I am a founding co-editor of a business and human rights journal. For the past 15 years, I have co-taught a course on the legal, regulatory, and ethical aspects of the pharmaceutical industry in an MBA program in pharmaceutical management. I serve on the advisory council and faculty of a professional certificate program in medical affairs and clinical development administered by a large research university. I am the co-editor of a pharmaceutical ethics journal and the author of other scholarly books and articles on business ethics. I served as an expert witness in a shareholder derivative suit against corporate officers and directors of a major pharmaceutical company regarding failure to disclose potential side-effects of a drug marketed to children.
Expert Witness Response E-010153
I am a former FDA Review Chemist, with 30+ years of career experience in pharmaceutical research and development, quality operations and regulatory affairs. I have been a consultant in my own pharmaceutical development advisory firm for 20+ years during which time I have furnished clients with services ranging from providing regulatory application filing strategies specialized in chemistry and manufacturing controls to current good manufacturing practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. I have contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve form 483, warning letter, and consent decree issues. For a similar case of pharmaceutical ethics, I testified regarding regulatory generic labeling requirements for a case involving the ethical duty of the drug manufacturer to change labeling in a timely fashion.