Devices

Kentucky Sues J&J Over ‘Inadequate’ Mesh Warnings

Kentucky’s attorney general says the state has filed a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its allegedly deceptive marketing of surgical transvaginal mesh. “In Kentucky, more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient information about the known hazards so women and their doctors could make informed treatment decisions,” a state news release says.

Attorney general Andy Beshear says the company failed to follow recommendations by its own staff to include more complete product risk disclosures. According to the lawsuit, in 2005 Johnson & Johnson’s medical director emailed the company to propose stronger warnings on the product for doctors and patients. Another medical director noted in 2006 that post-operative patients were reporting that they did not believe they were provided adequate information prior to surgery on the possible adverse complications and that additional disclosures might be needed. “Johnson & Johnson failed to fully incorporate this information into any of its marketing or promotional materials, according to the lawsuit,” Beshear says, adding that the company “purposely concealed and mispresented to doctors and patients many of the risks of adverse events associated with the devices, which include chronic pelvic pain, urinary and/or defecatory dysfunction, pain with sexual intercourse or total loss of sexual function.”

Beshear filed the lawsuit in Franklin Circuit Court.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome