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  • Regulatory NewsRegulatory News

    Arizona Supreme Court Ruling Realigns State With Others on Drugmakers’ Warning Labels, Lawyer Says

    An Arizona Supreme Court ruling last week brought the state in line with a number of other states in terms of its use of the “learned intermediary doctrine,” under which drug manufacturers satisfy their duty to warn consumers about their products by giving appropriate warnings to a prescribing physician or other health care provider. The case under review, known as Watts v. Medicis Pharmaceutical Corporation, pitted Amanda Watts, who developed lupus and hepatitis after t...
  • In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication

    A Warning Letter to medical device manufacturer Shasta Technologies has highlighted major alleged deficiencies at the company's Sherwood, Ore., manufacturing facility, resulting in an unusual warning about the company's blood glucose testing supplies. Warning Letter According to the Warning Letter, inspectors from the US Food and Drug Administration (FDA) found serious problems during a December 2013 inspection of the Sherwood facility. For example, FDA said when its i...
  • Responsible Corporate Officer Doctrine Upheld by Appeals Court

    • 30 July 2012
    • By
    The US Circuit Court of Appeals for Washington, DC, has ruled in favor of an emerging enforcement technique used by the federal government to bar individuals from certain employment opportunities after being found guilty of defrauding programs such as Medicare and Medicaid. The technique could be of enormous consequence for the pharmaceutical and medical device industries, both of which do large amounts of business through Medicare, Medicaid, Tricare and numerous other g...
  • US Looking to Alternate Methods to Punish Drug Companies For Regulatory Non-Compliance

    US government officials are looking to clamp down on regulatory violations by the pharmaceutical industry-which has already paid $8 billion in fines over the last decade-by going after individuals within the companies more aggressively, reports USA Today. The US Department of Justice, in particular, is ramping up its use of the Park Doctrine-a legal doctrine that holds individuals within a company responsible for the actions of a company. Senator Chuck Grassley (R-IA) ...
  • New Insurance Product Covers Exposure to Health Fraud Cases

    • 05 March 2012
    • By
    Worried about your exposure to healthcare fraud? A new product is looking to protect employees at pharmaceutical, biotech and medical device companies-among others-that are worried about being the subject of health fraud investigation and subsequent action under the Park Doctrine, writes the Philadelphia Inquirer. The Park Doctrine holds that executives who fail to act in accordance with their responsibilities can be held personally responsible for fraud perpetrated ...