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Healthy Skepticism Library item: 19176

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Vicini J
US top court to decide generic drug labeling issue
Reuters 2010 Dec 10
http://www.reuters.com/article/2010/12/10/genericdrugs-labeling-warning-idUSN1012728820101210


Abstract:

  • Drug at issue had been approved by federal regulators
  • Ruling expected before the end of June
  • Generic drug companies had appealed to high court


Full text:

The U.S. Supreme Court said on Friday that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects.

The nation’s highest court will consider whether federal law preempted such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA).

The high court agreed to hear appeals by Teva Pharmaceutical Industries Ltd, (TEVA.TA) Mylan Inc’s (MYL.O) UDL Laboratories and Actavis Inc, based in Reykjavik, Iceland.

The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc’s (PFE.N) Wyeth unit and its antinausea drug Phenergan.

The justices are expected to hear arguments in the generic drug cases in March or April, with a decision likely by the end of June.

In one case, a U.S. appeals court ruled that Actavis could face claims by a woman who said it should have warned her to risks of metoclopramide, a drug that treats symptoms such as heartburn, nausea and vomiting. The drug’s name brand is Reglan.

Julie Demahy sued Actavis under Louisiana law, claiming she developed a neurological disorder after the company failed to alert her to literature about the risks of using metoclopramide and failed to change the drug’s label.

In another case, a woman, Gladys Mensing, sued the three generic drug makers in federal court in Minnesota after allegedly developing a severe neurological movement disorder after taking generic versions of Reglan. A U.S. appeals court ruled her lawsuit could go forward.

The Obama administration supported the two women and said the appeals court in their cases correctly ruled their claims were not categorically preempted.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909