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Federal Court Holds Manufacturer Of Investigational Drug And Medical Device Responsible For Clinical Trial Investigator's Allegedly Inadequate Informed Consent Form


7/18/2014 8:07:50 AM

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In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a clinical trial based on the allegedly inadequate warnings the clinical trial investigator provided to patients in obtaining their informed consent to the trial. If left unchanged, the decision could be applicable even outside the clinical trial context if it is alleged that a pharmaceutical or device manufacturer had knowledge of a physician’s warnings to his or her patients.

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