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Syracuse Surgery Mistake Lawyers Review FDA Informed Consent Rules

The Food and Drug Administration recently released a proposal to modify informed consent rules that apply to clinical trials. If the proposal is adopted, all clinical trials will have to be accompanied by a statement that “clinical trial information for such clinical trial investigations has been or will be submitted to the National Institutes of Health/National Library for inclusion in the clinical trial registry databank.”

Informed consent is a legal procedure where a doctor presents a patient with information about a procedure — including the potential benefit, risks, and available alternatives — so that the patient can make an informed decision about whether to undergo/forego a test, surgery or clinical trial. A patient must have legal or mental competency to provide informed consent. That is, minors cannot give consent, nor can people who are not competent because of duress, injury, drugs, alcohol, dementia and/or mental retardation. Where a doctor performs a surgery or procedure without securing informed consent he or she may be liable for professional negligence.

The trial lawyers at Bottar Leone, PLLC, have decades of experience investigating, prosecuting and trying to verdict all types of medical malpractice cases, including those concerning a lack of informed consent. If you recently underwent a medical procedure and suffered a complication that was not explained to you, or your doctor did more than what you gave he/she permission to do, you and/or your family may be entitled to compensation for lifelong health care, medical expenses, medical bills, loss of income, and pain and suffering.

To discuss your case or concerns with an experienced Central New York medical malpractice lawyer, contact Bottar Leone, PLLC now at (315) 422-3466, (800) 336-LAWS, or by e-mail at info@bottarleone.com.

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