Manufacturers of Generic Drugs Preempted From State Claims

(July 5, 2011) A recent U.S. Supreme Court decision possibly leaves two wrongfully injured women no recourse. In a 5-4 split decision, the U.S. Supreme Court – written by Justice Thomas, with Justices Alito, Roberts, Kennedy, and Scalia joining – ruled that the manufacturers of generic drugs are preempted from state claims, regardless of what they may be.

Five years after the FDA approved metoclopramide, a drug used to treat digestive tract problems under the brand name Reglan, generic manufacturers began making their own versions of the drug. Eventually there was enough research done that proved long-term use of metoclopramide could cause tardive dyskinesia, a severe neurological disorder. Because of this, warning labels were strengthened several times, and eventually metoclopramide was awarded the black box warning label in 2009, which is the strongest label a drug can receive. This warning read “treatment with metoclopramide can cause tardive dyskinesia, an often times serious movement disorder which is often irreversible.”

When two people developed tardive dyskinesia after taking the generic drug for several years, they sued the manufacturers of the metoclopramide. They each alleged that the manufacturer was liable under state tort law for failing to provide adequate warning labels. In both suits, the manufacturers urged that federal statutes and FDA regulations preempted the state tort claims by requiring the same labeling instructions for generic metoclopramide and Reglan.

The manufacturers claim that it is impossible to simultaneously comply with both federal law and any state tort-law that required them to use a different label. State tort law places a duty directly on all drug manufacturers to adequately and safely label their products. The Federal law states that all generic drug labels must match their brand-name counterparts. The Supremacy Clause states that “federal law shall be the supreme Law of the Land… Where state and federal law directly conflict, state law must give way.” This means that Federal law takes precedence over the state law in this case.

Under the Hatch-Waxman Amendments, “generic drugs” can gain FDA approval by showing equivalence to a reference listed drug that has already been approved by the FDA. This loophole lets manufacturers develop generics without having to pay for any clinical trials. Generic drug manufacturers also have to show that their labeling is the same as the labeling approved of by the brand-name drug.

What is in dispute is whether – and to what extent – generic manufacturers may change their labels after initial FDA approval. The injured people say that the manufacturers could alter the metoclopramide labels, whereas the FDA says that warning of brand-name drugs and generics must always be the same.

The injured also argue that the FDA’s “changes-being-effected” (CBE) process should have also forced the manufacturers to change their labels. The CBE process allows drug manufacturers to add or strengthen a contradiction, warning, or precaution, and these manufacturers need not wait for pre-approval by the FDA. However, the FDA shoots down this argument, claiming that any change to strengthen the drug label would also violate the statutes and regulations requiring a generic drug’s label to match its brand-name counterpart’s.

The judges’ opinion states that “we find impossibility here. It was not lawful under federal law for the Manufacturers to do what state law required of them. And even if they had fulfilled their federal duty to ask for FDA assistance, they would not have satisfied the requirements of state law. If the manufacturers had independently changed their labels to satisfy the state-law duty, they would have violated federal law.” It’s basically a “damned if you do, damned if you don’t” scenario for the manufacturers.

Finally, the judges conclude that the federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, these state claims. In other words, based on the Supremacy Clause, the Federal laws take precedence over the state-tort laws in this case, and as long as the manufacturers comply with the Federal regulations that require it to match the brand-name labeling, it does not have to adequately warn on their labels.

So who really loses here? You do! I do! Any consumer does, because every generic-brand manufacturer basically just penetrated a loop-hole in our legal system. What this court decision means is that a generic-brand manufacturer of a drug like Reglan can produce a drug – knowing it can cause harmful symptoms, such as tardive dyskinesia – and because Federal laws take precedence over state-tort laws, not have to mention it at all. In other words, so long as the generic label matches the name-brand label, their work is done there, even if they know that there are further symptoms.

But can we blame them entirely? No! Legally they cannot do anything else after that, for complying with state-tort laws would violate Federal laws, which they surely do not want to do. The injured in this case argued that the manufacturers should have gone to the FDA for help on changing the name-brand warning label, which is a possibility, but it is not required. I think THAT is the problem; if they CAN go to the FDA they should be REQUIRED to go to the FDA! Does this seem like justice???

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