Posts Tagged 'transvaginal mesh'

Feds want to question new J&J CEO in Risperdal fraud case

In a motion filed as part of a fraud case against Johnson & Johnson, the federal government alleges that new company CEO Alex Gorsky “was actively involved in matters at issue in this case,” Forbes reports.

Government prosecutors charge that Johnson & Johnson paid kickbacks to Omnicare, the nation’s largest nursing home pharmacy, to get Omnicare to pick up the antipsychotic medication Risperdal and other Johnson & Johnson drugs.

The federal government ...

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FDA approval of transvaginal mesh based on device that was recalled

Lopez McHugh has learned that transvaginal mesh devices, which are causing women extreme pain due to mesh erosion, extrusion, and failure, was approved by the FDA because they were similar another device on the market that has been recalled due to problems.

Yet this approval process is not limited to transvaginal mesh devices. A number of consumer advocacy groups have criticized the U.S. Food and Drug Administration’s 510(k) approval process, ...

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Top Johnson & Johnson officials try to reassure shareholders

During Johnson & Johnson’s annual meeting, outgoing CEO Bill Weldon and successor Alex Gorsky both tried to reassure shareholders that the company is getting its act together, the Washington Post reports.

According to the Washington Post, shareholders were “upset over the health giant’s battered image amid unprecedented product recalls and ethical lapses.”

Weldon told them that the company started growing again last year after two years of sales declines, with revenue climbing ...

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Article says FDA approval process is flawed

In a recent article titled “Four Medical Implants that Escaped FDA Scrutiny,” Scientific American takes a critical look at a U.S. Food and Drug Administration approval process that allows dangerous medical devices to be sold in the United States.

The article states that the rate of recalls, faulty devices, and repeat surgeries is increasing in an industry worth over $100 billion per year.

The first two devices the articles spotlights are ...

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FDA issues guidelines for medical devices

The U.S. Food and Drug Administration has issued what the agency is describing as a “first-of-a-kind guidance” to help medical device manufacturers get through the review process for new devices.

The FDA is issuing the document, titled “Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” to address problems that have come up recently as a result of the agency’s approval process.

An FDA spokeswoman has been quoted as saying: “The devices center identified several ...

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Group says legislation ignores FDA loophole

According to a news release by the Consumers Union, a Senate committee is scheduled to discuss legislation that would fail to correct a loophole allowing dangerous medical devices to make it onto the market.

The Consumers Union is the policy and advocacy arm of Consumer Reports.

On April 25, the Senate Health, Education, Labor and Pensions Committee was scheduled to mark-up legislation to reauthorize the Food and Drug Administration Safety and ...

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