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Supreme Court Follows Law: People Are Upset. Blame Big Business for Not Lobbying

The Supreme Court on Thursday handed down a decision in PLIVA, Inc. v. Mensing in which the Court held that a person could not sue a generic drug maker for failing to warn of the dangers and side effects of a drug.

Gladys Mensing and Julie Demahy had sued Croatia-based PLIVA Inc. and other generic drug manufacturers in state courts in Minnesota and Louisiana over the labels for metoclopramide, the generic version of Reglan. The two women alleged that metoclopramide gave them a severe neurological movement disorder called tardive dyskinesia, but none of the generic drug’s manufacturers and distributors made any effort to include warnings on the label.

One would think that this is a clear case of negligence on the part of the drug makers.

So why didn’t the Supreme Court side with the two women?

There were two conflicting laws governing the labeling of the drugs. The first was at the state level, where the state said that the generic drug has to label and therefore warn consumers of the side effects of a drug. The second, conflicting law is a federal law that says that the label of a generic drug must be identical to that of it’s non-generic counterpart. Federal law requires that manufacturers of the non-generic drug maintain a data sheet on the effects of the drug. This allows them to update the data sheet with new side effects, drug conflicts, etc as the information becomes available. The non-generic drug does not have to put the side effects on the label.

Therein lies the problem. If the manufacturer of the generic drug fails to put a warning label on the drug, they are violating state law. If they put the warning label on the product, they are violating federal law because the generic and non-generic labels are not identical.

The Supreme Court, in a 5-4 ruling, said that federal law prevailed and the manufacturers had followed the law and were therefore barred from being sued.

The vote fell on conservative and liberal lines.

Sotomayor said the problem was the court majority, not lawmakers or agencies: “Today’s decision leads to so many absurd consequences that I cannot fathom” it is what Congress intended, she said.

Just because the manufacturers cannot add warnings on their own “does not mean that federal law permits them to remain idle when they conclude that their labeling is inadequate,” Sotomayor wrote. The companies should be protected from suit only if they tried to alter the labels and the FDA did not allow it, she said.

It appears that Sotomayer believes that companies should not be protected by law unless they lobby lawmakers. Aren’t business lobbyists hated for undue pressure and influence so much so that we have laws that regulate them? And Sotomayor thinks “lobbying” would be a good thing?

If you want to hold the drug makers responsible, why aren’t the liberal justices holding the plaintiffs responsible? If the justices truly believe that the manufacturers had some responsibility to lobby lawmakers, don’t the plaintiffs have a responsibility to ask their doctor of the possible side effects of a drug? Or their pharmacist? Don’t they have a responsibility to look up at the library or on the internet the drug and its possible side effects?

Don’t people have some responsibility for what they put into their bodies?

The liberal Supreme Court justices aren’t the only ones unhappy with the decision. Arthur Caplan of msnbc.com writes:

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.

The LA Times says:

If you suffer a complication from a generic drug, obviously you shouldn’t expect much help from the courts.

Both are right but for the wrong reasons. They see the decision as a failure. We see it as a success. If the Court had ruled that the genetic drug makers should have been held liable for following the law, then what good is the law?

You shouldn’t expect help from the courts. It is not the court’s job to “help you” or “protect you.” The court’s job is to follow the law.

It is the job of the legislature, not the courts, to make laws.

To emphasis this basic fourth grade civics lesson to the masses and the liberal justices, Justice Thomas writes in the majority opinion:

As always,Congress and the FDA retain the authority to change the law and regulations if they so desire.

“Lady Justice” is blindfolded, so she cannot see what party is more sympathetic or what party has more “power” than the other. Justice relies on the law, and the creation of law is not the purview of the courts.

Justice demands an impartial review of the facts. Period. Anything else is judicial activism. Anything else is “making law from the bench.”

The Supreme Court got this one right.



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