Pharmaceutical

federal prosecutors are moving forward against alleged counterfeit transvaginal mesh

2012 TVM serious complications federal prosecutors are moving forward against alleged counterfeit transvaginal meshThe Boston Globe reports that a criminal investigation against Boston Scientific has begun to get underway. This is different from the thousands of civil suits against Boston Scientific that are a part of the tens of thousands of transvaginal mesh lawsuits consolidated in multidistrict litigation (MDL) in West Virginia under U.S. District Judge Joseph R. Goodwin.

The civil suits involve individual plaintiffs who are suing the respective manufacturers of transvaginal mesh devices for alleged complications such as infections, bleeding, severe pain and discomfort, urinary and fecal incontinence, erosion of the mesh into the vaginal tissue, organ perforation, and painful intercourse. Many women have required multiple surgeries to remove the mesh. These plaintiffs have been finding favor with juries who are awarding multimillion dollar verdicts and holding the companies liable for these women’s injuries, for negligence in designing their products and for failure to warn patients and doctors of the products’ risks.

Besides these product-liability suits, Boston Scientific is also under criminal investigation for allegedly using counterfeit materials to make their mesh. Back in January the company was accused in a class action lawsuit of international conspiracy under the Racketeering and Corrupt Organizations (RICO) Act.

According to Boston Globe federal prosecutors have impaneled a grand jury in Charleston, W. Va., and in the past several months the grand jury has sent out multiple subpoenas collecting evidence relating to these allegations.

Boston Globe reported that “Among other things…investigators are examining whether the Marlborough medical device company engaged in deceptive trade practices by knowingly receiving substandard resins from China in packaging from a vendor whose materials had been approved by federal regulators, and whether it fraudulently sold defective products to health care providers.”

The FDA is also looking into these accusations. On April 1, the agency issued a safety warning acknowledging the accusations and saying that the mesh that had come under recent allegations was being tested to see if it was equivalent to the mesh originally approved by the FDA and that the tests would also address the safety and effectiveness of the final product.

Another site, Legal Reader, commented on this, saying, “BS is now working with the FDA testing the safety and efficacy of its mesh devices in an effort that is expected to go on for a few more months. An effort, by the way, that has drawn much criticism given the fact that BS has a motivated self-interest in showing the products are safe….(However) This investigation is good news for the thousands of women whose health has been all but destroyed by pelvic mesh products. While different from the civil suits over injuries caused by the mesh in general, criminal charges (and especially a conviction) could strongly bolster the civil cases by showing Boston Scientific’s utter disregard for patient safety.”

Sources:
Boston Globe
Legal Reader
Righting Injustice
Righting Injustice