Drug Warnings: Supreme Court Allows Generics Manufacturers To Sidestep Label Accuracy Claims

Tags: SCOTUS, Generic Drugs, FDA, John Roberts, W Ned Livingston

W Ned Livingston by W Ned Livingston

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[CC-BY-SA-2.0], via Wikimedia Commons

Perfect for adaptation into a Hollywood blockbuster, the Supreme Court has just published the latest installment of the Drug Label Warnings trilogy.

The first installment, “Wyeth v. Levine”, takes Place in 2009, when the Supreme Court of the United States heard the case in which the Wyeth Pharmaceutical company asserted that, since it had complied with the U.S. Food and Drug Administration's (FDA) federal regulations regarding drug label warnings, it could not be held liable if a state required more specific labeling.

That tale ends with the Court ruling 6 – 3 against Wyeth. In their decision, the High Court declared two points as being critical to the case: first, drug companies should not be allowed to hide behind their federally mandated labeling in order to duck their liability in cases where a drug has a known issue, but the FDA has not yet specifically said to change the warning label. That was the subplot for the first of the series, but the main story arch involves state's rights and prerogatives.

In their 2009 decision, the Roberts Court declared that a state law requiring a higher degree of responsibility will take precedence over federal law. As stated by Levine's lawyer, in a 2009 Reuters article, “The court's opinion reaffirms the important role state laws play in promoting consumer safety and providing compensation for injuries.”

When the next installment was released, in 2011, it contained a reversing twist worthy of J.J. Abrams.

The plot in the 2011 release involves three levels of intrigue: “Pilva v. Mensig”, “Actavis v. Mensig”, and “Acatvis v. Demahy”. The story retains the theme of patients being harmed by the misapplication of improperly labeled drugs, but in this version, the “perpetrators” are not a huge pharmaceutical corporation, but rather, lowly generic drug manufacturers who make and market drugs that are no longer under patent protection, allowing them to sell what would otherwise be called knock-offs at a lower price. The thing with generic drugs, though, as opposed to knock-off watches is, they have to be exactly like the FDA approved original. Exactly. That includes labeling—with the name changed, of course.

In Drug Labels II  then, there is basically the same legal question: the state requires a higher degree of accuracy on the labeling than is required by the FDA. Just as in 2009, the manufacturer has only included the FDA mandated information so, of course, the High Court ruled 5 – 4 in favor of the drug manufacturers. Yes, the drug manufacturers.

In the 2011 Reuters article, they state, “Justice Clarence Thomas, in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.” That opinion rendered by the same Clarence Thomas who, in 2009, sat in agreement with the judges who said, “U.S. Food and Drug Administration labeling approvals do not pre-empt state laws and shield companies from damages as part of liability claims.”

Justice Kennedy, who often breaks an otherwise deadlocked court had a sudden reversal of opinion as well, switching from his state-based ruling of 2009 to a federalist stance in 2011.

So there's the movie and it's sequel but, these days, it's all about the trilogy. So, in June of 2013, the Supreme court released “

Mutual Pharmaceutical v. Bartlett”. Because the whole drug labeling story had been done to death, in this version, there's still the horribly mutilated patient; there's still the generic drug manufacturer, but this time the patient put the drug's very chemical design in question, under New Hampshire's design defect laws.

In what appears to be a grand finale, the Roberts Court has finally pointed out: “

Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce," the majority decision said.

By invoking “interstate commerce”, the Court deftly removes states' prerogatives, and brings the whole question into the federal arena.

In a bizarre twist of legal logic, the FDA, an agency which was put in place to protect U.S. Citizens from “snake oil salesmen”, has been turned into a haven for drug companies. Or, one final installment from Reuters, in their June 24, 2013 article: “Today's court decision provides a disincentive for generic makers of drugs to monitor safety of their products and to make sure that they have a surveillance system in place to detect adverse events that pose a threat to patients,” Michael Carome, director of Public Citizen's Health Research Group, said.


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