Devices

St. Jude Pays $27 Million Over Faulty Defibrillators

St. Jude Medical has agreed to pay $27 million to settle allegations under the False Claims Act that it knowingly sold defective heart devices to health care facilities. “The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” a Justice Department release says.

The government says the affected devices were marketed between 11/2014 and 10/2016. St. Jude was acquired by Abbott Laboratories in 1/2017.

The government alleges that St. Jude failed to disclose serious adverse health events related to premature battery depletion in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators. By 2013, St. Jude knew that lithium clusters formed on the batteries and caused a premature power drain, it alleges.

In 2014, St. Jude submitted a request to FDA to approve a change to prevent this, stating “no serious injury, permanent harm or deaths have been reported associated with this” issue, the government says. However, the government says St. Jude was aware at the time of two reported serious injuries and one death associated with premature battery depletion.

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

Read more

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