N.C. Judge Admits Evidence of 501(k) Clearance in BSC Transvaginal Mesh Action

STATESVILLE, N.C. — A North Carolina federal judge said he will allow evidence of the 501(k) clearance process for Boston Scientific’s Uphold transvaginal mesh device to be presented at an upcoming trial, but with an instruction to the jury that it does not constitute evidence that the FDA authorized the device as safe.

In a Sept. 21 order, Judge Richard Voorhees of the U.S. District Court for the Western District of North Carolina found the evidence may be admissible under the North Carolina Products Liability Act as compliance with “an applicable government standard.”

Martha Carlson sued BSC in connection with …