Fraud-on-the-FDA

News & Analysis as of

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices....more

District Court Rejects Fraud-on-the-FDA Theory of False Claims Act Liability

In an opinion that continues a welcome trend in False Claims Act cases, Judge Saylor of the United States District Court for the District of Massachusetts has dismissed a relator’s FCA complaint for failing to plead facts...more

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