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In a drug or medical device injury case, one of the defense’s most potent arguments is often that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. 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. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?
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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.
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.
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.
Maximizing Future Medical Damages in Paralysis Cases
By Mitch Warnock
Part One of a Two-Part Article
When you take a catastrophic injury case involving paralysis, it is important to have a thorough understanding of the problems and pitfalls. In this two-part article, I will explore, from personal experience, the different types of future expenses the client can expect to incur.
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