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Who Knew? Admissibility Of Subsequent Remedial Measures When Defendants Are Without Knowledge Of The Injuries, Mark G. Boyko, Ryan G. Vacca
Who Knew? Admissibility Of Subsequent Remedial Measures When Defendants Are Without Knowledge Of The Injuries, Mark G. Boyko, Ryan G. Vacca
Law Faculty Scholarship
Federal Rule of Evidence 407 prohibits the introduction of subsequent remedial measures for the purposes of demonstrating negligence, culpable conduct, or product defect. But the rule breaks down, in application and purpose, when a defendant undertakes the new safety measure after the plaintiff's injury, but before the defendant had knowledge of the loss. Such a situation is not uncommon. Would-be defendants frequently improve their products and product safety for a variety of reasons. Toxic exposure cases, where exposure often predates diagnosis of the injury by a decade or more, represent a prime example of cases where defendants are likely to …
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Law Faculty Scholarship
This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.