A thirty year old woman decided to sue the manufacturers of NuvaRing, a vaginal contraceptive implant, after suffering a severe stroke while using the device. Though she had no family or personal history of blood clotting, she was diagnosed with a stroke and multiple blood clots in her shoulders and heart after one full year of NuvaRing use. Neither the neurologist or cardiologist found anything structurally wrong with her physiology, and blood thinners were recommended after she lost the use of her left side, arm, hand, and leg. When every form of follow-up treatment was deemed inconclusive, her doctors suggested that the NuvaRing may have caused the blood clotting. Since the stroke, the woman has been able to regain the ability to slowly walk with difficulty, and has had to undergo physical, speech, and occupational therapy. Her doctors hoped that she would be able to regain some memory and verbal skills, though the chances of her regaining physical control were deemed improbable. The lawsuit required an expert in pharmaceutical branding to comment on the product and how regulatory warnings could have been changed by the manufacturer.
Question(s) For Expert Witness
- 1. Please discuss your experience in developing and marketing a drug like NuvaRing.
- 2. What is your experience in introducing a new drug and processing the information with government agencies?
Expert Witness Response E-009794
My company, RCCG, is a Regulatory and Clinical consulting firm and our partners and affiliates have significant experience and expertise in developing and marketing medical products – drugs, biologics and medical devices. The special area of our expertise is combination products. We are familiar with NuvaRing from the time this product was invented in Europe and followed the controversial history of this product in US (specifically, clinical studies), and other countries. We do have experience introducing medical products to US and other markets by developing regulatory and clinical strategies, conducting clinical studies, and handling all aspects of regulatory filing with government regulatory authorities. We are absolutely able to interpret clinical trials and translate the information onto a product monograph. We design and conduct clinical research and have clinical affairs experts, epidemiology experts and bio-statisticians on staff as well as network of clinical consultants to interpret and analyze the results of clinical trials.