In this unique session, a panel of drug and medical device product liability litigators will share challenges they have faced in litigation and reflect on what they wished their regulatory counsel would have done during the FDA pre-approval, approval or post-approval periods to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the regulatory counsel done something differently with regard to:
- The drug or device review and approval process
- Product labeling
- Clinical trials
- Handling of post-approval challenges related to recalls and withdrawals
David Ferrera, Partner, Nutter McClennen & Fish LLP
Susanna Moldoveanu, Attorney, Butler Snow LLP
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