Transvaginal Mesh Lawsuit

FDA fails to track medical devices

A piece in the Denver Post faults the U.S. Food and Drug Administration’s minimal monitoring of medical devices, and says the existing system leads to injuries and deaths from faulty devices allowed to remain on the market.

According to the article, prescription drugs have unique codes that can be used to track problems. But medical devices have no such identifiers and the FDA doesn’t even know how many devices are implanted ...

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NPR examines $1B Johnson & Johnson fine

An NPR report on an Arkansas jury’s billion-dollar decision against Johnson & Johnson mentions that the company is most famous for its baby shampoo and wryly notes: “So much for no more tears.”

The federal court decision was in response to allegations that the company used misleading marketing for its antipsychotic drug Risperdal. The jury found that the company failed to properly disclose the drug’s possible side effects, like weight gain, ...

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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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