Implementing the Mandates Imposed on Covered Entities By Section 1557 of the ACA

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  Exclusion of Evidence: The FDA’s 510(k) Process

  By Janice G. Inman

  In a drug or medical device injury case, one of the defense’s most potent arguments is often that the product in question underwent FDA approval, so the balance of its safety and efficacy has already been determined. But when a device is approved for sale to the public through the FDA’s 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.

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  Physician Extenders or Liability Expanders?

  By Kevin Quinley

  For health care services to serve an influx of patients, so-called “physician extenders” now carry out functions previously performed by doctors. The aim of this article is to examine factors driving the growth in physician extenders, identify liability “hotspots” and offer tactics for health care providers to use in managing professional/medical liability risks.

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  Paralysis Cases: Helping Your Client Cover Future Costs

  By Mitch Warnock

  Part Two of a Two-Part Article

  Your paralyzed client currently has many problems to deal with, but the future holds many more. In order to advocate for your client, you need to gain an understanding of his or her current and future challenges, and work to maximize the resources your client will need to deal with them.

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  When Lack of Informed Consent Is Not the Issue

  By Janice G. Inman

  When an injury occurs, the first reaction of those in the medical office might be to ask, "Did the patient sign an informed consent form?" When the answer is "Yes," and the harm that occurred is listed as a possibility on that signed form, everyone can breathe a sigh of relief. Right? Not so fast.

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