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January 28th, 2016

For Now, Federal Judge Keeps Steve Mostyn from Making a Mesh of Regulatory Authority

Medical device maker Boston Scientific Corp. this week successfully blocked — at least for the time being — a proposed class action that alleges it had smuggled cheap counterfeit material to use in its pelvic mesh products.

U.S. District Judge Joseph R. Goodwin ruled Tuesday that the Food and Drug Administration has primary jurisdiction to determine if the pelvic pesh product conformed to the agency’s standards.  Only after the FDA makes a determination will the court consider the proposed class’s allegations.

Steve MostynThe plaintiff’s attorney, Steve Mostyn, argued unsuccessfully against letting the FDA’s review even temporarily preempt this lawsuit.  Judge Goodwin disagreed:

“The FDA is in the best position to determine whether Boston Scientific’s mesh device is in compliance with the FDA’s own statutes, regulations and directives.  The FDA was the very agency that cleared Boston Scientific’s mesh device in the first place.”

ATRA has raised some questions about Judge Goodwin’s handling of multidistrict litigation that targets mesh makers in the nation’s biggest mass tort since asbestos.  But in this instance, the judge deserves kudos for appropriately deferring to FDA expertise and refusing Mostyn’s invitation to regulate from the bench.

Additional coverage can be found at Law360.

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