Boston Scientific (NYSE:BSX) said the office of California attorney general Kamala Harris launched a probe this month of its transvaginal surgical mesh sales.
The Natick, Mass.-based medical device company also said a whistleblower lawsuit was filed against its neuromodulation business alleging violations of the False Claims Act "through submission of fraudulent bills for implanted device," according to a regulatory filing.
Boston Scientific said Harris’ office and "several other state attorneys general offices intend to initiate a civil investigation into our sales of transvaginal surgical mesh products."
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As of yesterday more than 2,500 product liability suits had been filed against BSX over the mesh devices, "alleging personal injury associated with use of our transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse," according to the filing.
"Generally, the plaintiffs allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims. Many of the cases have been specially assigned to 1 judge in state court in Massachusetts," Boston Scientific said, noting that lawsuits filed in federal courts have been consolidated into a single case before the U.S. District Court for Southern West Virginia.
Boston Scientific also said that a lawsuit unsealed in August alleges that its Valencia, Calif.-based neuromodulation business alleges that it ran a scheme to defraud Medicare and promote off-label use of its Precision Plus spinal cord stimulation system.
The lawsuit, filed in the U.S. District Court for New Jersey in March 2011, contains 29 counts alleging that the company sold the devices without certificates of medical necessity and faked diagnostic codes for the Precision Plus device. The suit also accuses Boston Scientific Neuromodulation Corp. of falsely certifying its truthfulness and compliance on claim forms. The company sometimes allegedly shipped the device before receiving orders from physicians, allegedly faking records to alter the shipping date.
The suit also alleges that BSNC also promoted the system for off-label uses, including treatment of phantom leg pain and urinary incontinence, and faked adverse event records "for the purpose of hiding such to [sic] the FDA," according to court documents.
Boston Scientific asked Judge Susan Wigenton in October to dismiss the qui tam case, which the U.S. government declined to join, according to the documents.
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