A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would approve an application for premarket approval (PMA). Greenleaf also advised the client’s lawyers on FDA regulation of the relevant medical device to assist them in formulating their legal arguments.
In addition to preparing an expert report and providing strategic advice, members of the Greenleaf team testified during the deposition and the trial.
The case resulted in a large judgment on behalf of Greenleaf’s client.