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The New Era of Clinical Trials: Adopting Electronic Informed Consent

HIT Consultant

Director, Product & Strategy, Patient Consent, IQVIA Technologies The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. These solutions deliver a myriad of benefits for trial sponsors, sites and patients.

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A Precautionary Approach to Touch in Psychedelic-Assisted Therapy

Bill of Health

He has contributed to public psychedelic research and harm reduction efforts through a variety of organizations and outlets since 2009. Lily Kay Ross, MDiv, PhD has been taking a feminist approach to theorizing psychedelic ethics since 2009, especially with regard to sexual misconduct, abuses of power, and gendered violence.

Bioethics 359
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Always Liability Increases (ALI)?  Not Yet with Medical Monitoring.

Drug & Device Law

Another motion reflected Bexis original position (but wasn’t Bexis’ motion), that the Institute should prepare black letter, comments and reporters’ notes for both sides of this issue, similarly to the manner in which the same draft handled the question of patient-oriented versus physician-oriented standards for informed consent.

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Doctors Without Burdens:  Another Mesh Court Goes Backwards

Drug & Device Law

Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry. Pfizer, Inc. , 3d 758, 769-70 (Ky. 2004), where the Kentucky Supreme Court adopted the learned intermediary doctrine. The second was the decision below.

Doctors 59
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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. years after [plaintiff] developed [the complained-of condition] and [prescriber] continues to prescribe [the drug] to his patients”); In re Zyprexa Products Liability Litigation , 2009 WL 5062109, at *14-15 (E.D.N.Y. July 8, 2009) (applying California law); Nix v.

FDA 59
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Scientific Opponents Cannot Be Sued Into Silence

Drug & Device Law

2009)] saying that the publication of scientific articles, per se, is protected by the right of free speech and can’t be the basis for a lawsuit. That’s why we’re pleased with the ruling in Informed Consent Action v. We’re pleased to find a decision [referring to Bracco Diagnostics, Inc. Amersham Health, Inc. ,

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Who Needs a Lawyer in the Eleventh Circuit?

Drug & Device Law

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. 2009 WL 3294873 (D. 14, 2009) (all plaintiffs having all claims dismissed as a matter of law). Mentor Worldwide, LLC , 2019 WL 6766574 (M.D. 341 (2001).