Court was wrong to give generic drugs pass on side effect warnings

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.

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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.

This is one lousy decision. Justice Clarence Thomas, who wrote for the majority said as much. He acknowledged that drawing a distinction about disclosing safety data between name-brand and generic versions of the same drug surely “makes little sense” to those who might get hurt as a result. Still, even in the face of common sense, he and the majority decided to put on their blindfolds and adhere to a pedantic interpretation of the relationship between federal and state law rather than protecting your health and mine. This might get a round of applause in business circles, but it stinks as public policy.

This horrid decision shouldn’t be the final word on setting the duties of manufacturers to warn those taking drugs about the latest and best information they have about risk. Congress should move quickly to amend federal law to make it clear that when it comes to disclosing risks, it should not matter who makes a drug.

The only thing that should matter is disclosing known risks about drugs on labels, websites and in communications to doctors. To do otherwise is to leave Justice blindfolded, unable to comprehend how the highest court in the land could not see clearly the need to protect consumers from harm.

Arthur Caplan, Ph.D., is director of the Center for Bioethics at the University of Pennsylvania.