Court was wrong to give generic drugs pass on side effect warnings (Caplan/MSNBC)

[eppur_se_muova]

By Arthur Caplan, Ph.D.

The image of Justice blindfolded, holding her scales, is familiar from courthouses all over the United States and the world. Sadly, in its Thursday ruling in the case of PLIVA v Mensing, the U.S. Supreme Court made a decision that makes one wonder if that blindfold made the court unable to see the right thing to do.

The court ruled in a 5 to 4 decision that companies that make generic drugs, which account for close to 75 percent of all drugs dispensed in America, cannot be sued under state laws for not disclosing all the risks they know about the drugs they make.

Federal law says that generic drug makers have to use the exact same warning labels as name-brand drugs. Some state laws require changes or updates as new information about drug risks are discovered. That happens because generics come into use many years after name-brand drugs have been available, or because generic drug makers get more information from doctors and patients about risk since so many more people take the generic versions. The court said they did not care what the generic manufacturer might know. State law has to yield to federal requirements and federal law says the warning labels must be exactly the same, new knowledge or not.

This makes no sense at all. The intent of the federal law was to make sure that generic drug manufacturers did not get cute with their labels and “forget” to mention risks known from the name-brand versions of the same drug. It was not to hide new knowledge about risk from you and me.
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more: http://www.msnbc.msn.com/id/43526608/ns/health-health_care/

[indepat]

1. The decisions of the felonious ones seem to be getting feloniouser and feloniouser

:patriot:

[Blue Owl]

2. The invisible hand of Clarence Thomas is at work

n/t

[CrossChris]

3. I'm sure the court is all broken up about that. Meanwhile, people will get sick and die from this.

I'm sure they're all broken up about that, too.

[bluesmail]

4. I had a Doctor tell me the pharmacists get paid more

for pushing generic rather than brand.