Drug and Medical Device Lawsuits

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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Study: More research needed on hip implants, cancer

The BBC reports that a British study found no evidence of a link between metal-on-metal hip implants and cancer. But the analysis of 41,000 patients covered only seven years following hip replacement surgery, and researchers said follow-up will be necessary.

Medical professionals are concerned about the long-term impact of cobalt and chromium ions breaking off the implants and getting into patients’ blood and soft tissues.

Researchers in the U.K. have already drawn on data from the National Joint Registry of England and ...

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British health agency issues warning about metal hips

Britain’s Medicines and Healthcare products Regulatory Agency has issued a warning that surgeons should stop using a particular type of hip implant because of “unacceptably high” rates of follow-up operations.

The report mentions that metal-on-metal implants – consisting of both a ball and a socket coated with metal – have come under scrutiny in both Britain and the United States recently over concerns about their early failure rate, and metal particles breaking off and releasing toxic metal ions into the bloodstream.

The ...

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