“Welcome to the Humiraverse”

from DavidHealy.org
August 15, 2013

Editorial Note: This post in the AbbVie series is by Johanna Ryan from the RxISK Community Advisory Board
http://davidhealy.org/welcome-to-the-humiraverse/
“You might think that Cynthia DiBartolo had an airtight case – unless you know about a feature of American law called the Learned Intermediary Doctrine. This doctrine, accepted in most U.S. courts, holds that in most circumstances a drugmaker has no duty to warn the patient directly of possible adverse effects.”

Worth the read-a numbly unsurprising verse but watch how that plays out.

from wikipedia:
“Learned intermediary is a defense doctrine used in the legal system of the United States. This doctrine states that a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a “learned intermediary” who then interacts with the consumer of a product. This doctrine is primarily used by pharmaceutical and medical device manufacturers in defense of tort suits.

In a clear majority of states, the courts have accepted this as a liability shield for pharmaceutical companies.”
https://en.wikipedia.org/wiki/Learned_intermediary

This would also strain patient/doc interaction because of liability. No one really wins. All this could be absolutely different by rethinking the “gold” standard clinical trials:
http://www.lindalliance.org/Current_Projects.asp

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