Drugs

DePuy Synthes Pays $10 Million to Settle Kickback Scheme

Johnson & Johnson’s DePuy Synthes medical device unit has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to an orthopedic surgeon in Massachusetts to induce his use of DePuy products. The qui tam or whistleblower suit was originally filed by former DePuy sales representative Aleksej Gusakovs.

According to a Justice Department release, the company paid the unnamed surgeon kickbacks in the form of free spinal implants and tools for use in surgeries that the surgeon performed overseas to induce that surgeon to use DePuy products in surgeries performed in the U.S. As part of the settlement, DePuy admitted that from 2013 through 2018, now-former DePuy sales representatives gave the surgeon thousands of dollars’ worth of free DePuy implants and instruments, including cages, rods, screws, plates, and surgical instrumentation, it says.

“Today’s settlement makes it crystal clear that it is illegal for medical device companies to provide physicians with free medical products to win business and boost their bottom line through illegal kickback schemes,” said FBI special agent in charge Joseph R. Bonavolonta. “Every year, health care fraud costs taxpayers billions of dollars. It is not a victimless crime and this unscrupulous scheme orchestrated by DePuy is just one example of how the FBI and our partners are working hard every day to protect both patients and taxpayers.”

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