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Biologics and the Heeding Presumption

January 2015 - IADC Drug, Device and Biotechnology Newsletter
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by Mollie Benedict and Traci Shafroth, published in IADC's Drug, Device and Biotechnology Newsletter

Prescription medications all carry potential risks—risks the prescriber must weigh against the benefits associated with the therapy as well as the risks associated with not prescribing it. Where there are no risk-free alternatives and leaving the disease untreated exposes the patient to substantial harm, prescribing the medication may be the lowest-risk option. Nonetheless, courts in several jurisdictions apply a presumption that if a pharmaceutical manufacturer had provided an “adequate” warning, the physician would not have prescribed the medication. Cases involving biologics, which have revolutionized the treatment of many serious diseases, offer a particularly compelling illustration of why there is no place for such a “heeding” presumption in prescription drug cases, and present significant opportunities to fight it. To read the article, click here.

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