> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Court Punts Mesh Case to FDA
- URL: https://www.fdaweb.com/court-punts-mesh-case-to-fda/
- Published: 2016-01-27T12:00:00.000Z
- Updated: 2026-09-15T02:31:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134576

> The West Virginia federal court has invoked the doctrine of primary jurisdiction to [remand](http://www.fdaweb.com/download.php?file=bostscientific%5Fmesh.pdf) a potential class action [suit](https://www.fdaweb.com/boston-scientific-charged-with-racketeering/) against Boston Scientific charging violations of the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems, and other complications from the firm’s vaginal surgical mesh implants. The suit says the company participated in an international conspiracy to sell defective mesh made from counterfeit materials smuggled from China.  
>  
> The court noted that the complaint does not contain any discussion of FDA, its regulations or statutory authority, or its control over medical devices in a brief asking the court to retain primary jurisdiction. “The plaintiff argues that applying the doctrine of primary jurisdiction will not promote national uniformity in the field of regulation,” the decision says, “and the court will not benefit from agency expertise. The court disagrees.”  
>  
> For its part, Boston Scientific argued that FDA has specialized knowledge over at least part of the issues presented in the case and “is best suited to interpret its 510(k) authorization and to make the threshold scientific determinations necessary to do so.” The company also said that “not only does FDA have the peculiar expertise and authority to determine the merits of plaintiff’s essential allegations … FDA has specific experience and expertise to fashion remedial measures as necessary.” The court said it agreed with that proposition.  
>  
> The court said that FDA is in the best position to determine whether Boston Scientific’s mesh device complies with agency statutes, regulations, and directives, particularly since FDA cleared the device initially. Granting the temporary injunction that was sought would prevent FDA from taking the first action in an area in which the agency clearly has expertise and an interest in the uniform application of its regulatory framework, the court concluded.  
>  
> It noted that FDA has a remedial administrative process that the plaintiff can use to address the case’s issues. The court stayed the case pending plaintiff’s application to FDA for a determination on the allegations regarding the company’s mesh products, retained jurisdiction over the case, and ordered the plaintiff to file a status report with the court on or before 5/1\. Once FDA has taken any action relevant to the plaintiff’s allegations, the plaintiff is ordered to provide that information to the court within 14 days.