Recall

Johnson & Johnson reaches deal with prosecutors

The Wall Street Journal reports that Johnson & Johnson and federal prosecutors have reached a settlement over allegations that the company illegally marketed its antipsychotic drug Risperdal and other medications.

That settlement will reportedly be about $2.2 billion, and include about $400 million in criminal fines.

But the settlement won’t be the end of Johnson & Johnson’s legal troubles. It’s still facing thousands of lawsuits from plaintiffs alleging that the company’sread more.... --> continue reading...

FDA spied on own scientists

The New York Times reports that the U.S. Food and Drug Administration conducted a wide-ranging surveillance operation against its own scientists.

The agency used “spy software” designed to help employers monitor workers, and captured screen images from the government laptops of scientists as they were being used at work or at home.

Though federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines ...

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FDA unveils plan to track medical devices

The federal Food and Drug Administration has unveiled a plan to track high-risk medical devices.

A Wall Street Journal report on the policy says that it would require the high-risk devices to carry identification numbers. Jeffrey Shuren, director of the FDA’s medical-device center, described the plan as “a major game-changer” and said the agency plans to ramp up efforts to identify malfunctioning medical devices early.

For a long time, public safety advocates ...

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Johnson & Johnson sold mesh after being ordered to stop

According to Bloomberg, Johnson & Johnson continued selling a vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered the company to stop.

In a letter from August, 2007, the FDA told Johnson & Johnson to halt sales of Gynecare Prolift until the agency decided whether the device was “substantially equivalent” to other products on the market. The letter cited the “potential high risk for organ perforation” ...

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Use of metal hip implants declining

Use of metal-on-metal hip implants has been declining in recent years, in response to concerns that they may pose a safety risk for patients who receive them.

According to a Bloomberg report, use of the devices peaked in 2006 and 2007, when the metal-on-metal variety accounted for an estimated 30 percent of the market. Now the all-metal implant, with both a ...

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FDA panelists wouldn’t recommend metal implants

According to a story on WLFI out of Indiana, most members of a U.S. FDA panel said they would not recommend metal-on-metal implants for patients who needed hip replacement surgery.

The report quotes a physician on the panel as saying: “I do not use metal-on-metal hips, and I can see no reason to do so.”

At the FDA’s request, the 18-member panel of experts met for two days this week to discuss ...

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