Posts Tagged 'transvaginal mesh'

Radiological devices had FDA whistle-blowers concerned

Six U.S. Food and Drug Administration doctors and scientists who claim the agency retaliated against them said they were trying to raise valid concerns about medical devices of unproven effectiveness, The Washington Post has reported.

The doctors and scientists, who worked in the office charged with reviewing medical devices, have filed suit in federal court alleging that the FDA monitored their personal e-mail accounts, and used information obtained that way to harass and improperly dismiss them.

According to The Washington Post, they ...

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FDA looks to get devices on market more quickly

The U.S. Food and Drug Administration has announced a plan to get medical devices through the federal approval process and on the market more quickly.

According to the Wall Street Journal, the plan is an expansion of the FDA’s Innovation Pathway program.

The report says the plan will weigh factors such as how much risk patients are willing to accept with new devices. It quotes an agency spokesman as saying patients dealing with terminal illness are generally willing to accept a higher ...

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Lawsuit: FDA whistle-blowers faced retaliation

A group of six doctors and scientists who worked for the U.S. Food and Drug Administration have sued the agency, claiming their personal e-mail was monitored after they warned Congress that the FDA was approving faulty medical devices, The Washington Post has reported.

All of the doctors and scientists who filed suit in federal court had worked in the office responsible for reviewing medical devices. They claim information gathered from the surveillance was used to harass and dismiss them, and their ...

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Lawsuit accuses Johnson & Johnson of deception

A lawyer representing the state of Arkansas claims that Janssen, a unit of Johnson & Johnson, misled thousands of doctors in the state about the risks accompanying the anti-psychotic drug Risperdal, Bloomberg reports.

Arkansas is seeking more than $1.25 billion in penalties for alleged violations of the state’s deceptive-trade practices law.

Lawyers representing Arkansas argue that the company hid Risperdal’s diabetes risks, defrauded the state’s Medicaid program by failing to properly disclose those risks on the warning label, deceptively marketed the drug ...

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Consumer Reports says tracking for implants needed

According to Consumer Reports, a major problem with medical devices in the United States is a lack of any systematic way to keep track of them.

The May issue of the magazine contains an investigation titled “Dangerous Medical Devices,” which examines the flawed federal approval process that allows potentially hazardous devices to go onto the market.

Some of those problematic devices are surgically implanted in patients’ bodies. They include metal-on-metal joint replacements for hips, and transvaginal mesh implants to treat patients suffering ...

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CEO may have ties to recalled implants

New Johnson & Johnson CEO Alex Gorsky is already facing some questions regarding his possible involvement with a recalled line of metal-on-metal hip implants, according to a recent report in the Newark Times Ledger.

Gorsky, who started with the company in 1988, is replacing outgoing CEO William Weldon.

Weldon’s departure follows a series of recalls, including medications and devices, that were very damaging for the company. But the Times Ledger article states: “Some critics have already questioned whether Gorsky, who ran the ...

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