Devices

Jury Awards $1 Billion on Hip Implant Case

A federal jury in Dallas has returned a combined verdict of more than $1 billion on behalf of six people who suffered serious medical complications caused by allegedly defective Pinnacle metal-on-metal hip implants made by Johnson & Johnson and subsidiary DePuy Orthopedics. The verdict includes more than $30 million in damages and more than $1 billion in punitive damages.

The verdict is the third bellwether trial among thousands of similar lawsuits nationwide that have been consolidated in multidistrict litigation in the U.S. District Court for the Northern District of Texas, according to attorney Mark Lanier. In March, a Dallas jury awarded more than $500 million to five individuals who suffered similar physical and medical complications caused by the implant.

“The Pinnacle implant was designed with a metal, rather than a safer ceramic or polyethylene, socket,” Lanier says. “The metal-on-metal design causes the socket to rub against the ball head, which can lead to corrosion and can cause bone and surrounding tissue to erode over time. Each of the six plaintiffs in the trial had to undergo revision surgeries to replace the implants and repair the damage. Jurors heard testimony that Johnson & Johnson and DePuy aggressively marketed the implants and employed tactics that included paying kickbacks to surgeons for using the device although they were aware of safer alternatives.”

A fourth bellwether trial involving 10 patients has been scheduled in Dallas for 9/2017.

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