Unlocking Legalities: Gorsuch’s Impact May Be Felt On Free Speech, Preemption
Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.
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Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.
The case would have tested whether manufacturers could be held liable if an FDA-approved device injured a patient when the product was employed for an off-label, unapproved use. The Oklahoma Federal Court and the 10th Circuit Court of Appeals had both previously ruled in industry’s favor.
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.