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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 scienti...
  • 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 violation...
  • 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 allo...
  • 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...
  • 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...
  • FDA panel on hip implants seeks public input
    A federal Food and Drug Administration panel examining the safety of metal-on-metal hip implants is inviting members of the public to comment on the devices. The FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has scheduled sessions for June 27 and 28 t...
  • 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 ...
  • Fatal heart attack blamed on faulty approval process
    CBS Sunday Morning did a report this week spotlighting the inadequate process by which the federal Food and Drug Administration approves medical devices. The report, titled “When Medical Implants Fail,” examined the case of 21-year-old Joshua Oukrop, who died of a heart attack in 2005. Oukrop su...
  • FDA schedules panel for hip implant review
    The U.S. Food and Drug Administration has announced an official review of all-metal hip implants, in response to growing concerns about their reported early failure rates. According to a Reuters report, the FDA has scheduled an advisory panel for June 27 and 28, which will gather input from scientis...
  • Consultant: Scrutiny forcing FDA to tighten standards
    The federal Food and Drug Administration is becoming stricter about its process for approving medical devices, according to a consultant for regulatory affairs. Those changes are coming about in response to scrutiny and criticism over a process that allows devices to be approved based on their simil...
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