Judge boots Boston Scientific counterfeit mesh case to the FDA

A federal judge yesterday booted a purported class-action racketeering lawsuit filed against Boston Scientific (NYSE:BSX), accusing the medical device maker of illegally smuggling counterfeit resin made in China to make pelvic mesh.

The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.

Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.

Judge Joseph Goodwin ruled yesterday that the FDA has jurisdiction over the case, as “many of the factual allegations contained in the complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.”

“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 – particularly because the FDA was the very agency that cleared Boston Scientific’s mesh device in the first place,” Goodwin wrote.

The judge also stayed the case until Stevens gets a determination from the federal safety watchdog, retaining jurisdiction over the charges leveled under the Racketeer Influenced & Corrupt Organizations Act and West Virginia statutes, according to court documents.

The complaint charges Boston Scientific and co-defendants EMAI, Luxilon and Proxy with racketeering, mail fraud, wire fraud, intentional and negligent misrepresentation, unfair and deceptive acts and practices, fraud and unjust enrichment. Stevens asked Judge Joseph Goodwin for a jury trial, temporary and permanent injunctions barring the manufacture and sale of products using the allegedly fake Marlex, a warning to the public about it, punitive and consequential damages, legal costs, pre- and post-judgment interest and a temporary restraining order.

Goodwin declined to grant the temporary restraining order, ruling that Stevens’ counsel never told Boston Scientific’s attorneys that a motion for the TRO was planned, as strictly required by federal law, according to the documents. Goodwin reserved judgment on Stevens’ motion seeking a preliminary injunction.

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