Ropes & Gray is pleased to support the American Conference Webinar Series on Innovator and Generic Drug Manufacturer Liability. The seminar will focus on the growth of the generic industry and it's impact on many aspects of pharmaceutical law, most notably in the regulatory area. Discussions will also center on the recent case of Conte v. Wyeth, which held an innovator liable in an action where only a generic form of the drug was prescribed. The case has raised important questions on multiple aspects of pharmaceutical law, including preemption, the learned intermediary doctrine, and pharmacovigilance requirements under the FDAAA.
Ropes & Gray counsel Howard Dorfman will join a panel of veteran attorneys with first-hand experience in this litigation and the industry-shaking issues it raises.
Participants will obtain an in-depth understanding of:
- The background of the legal debate in innovator-generic liability, the arguments raised in support of innovator liability for generic products, as well as the legal theories raised in response
- The strategies employed by both innovator and generic manufacturers in the litigation arena
- The regulatory framework and its impact on the liability debate
- A critical overview of the case law in this area including Conte, Foster and Clark v. Pfizer
- The potential impact of the requirements of the recently enacted FDAAA on the liability debate
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