SCOTUS textualists read consumer protection out of drug regulation

By Joseph Nicholson

Continuing the string of victories for massive corporations in the Supreme Court this summer, Justice Thomas published a majority opinion on June 23 that restricts the ability of sick people to sue manufacturers of the generic drugs that made them ill. The Court's majority opinion in Pliva, Inc. v. Mensing admits that it "makes little sense," and yet the conservative textualists of the court value a literal reading of statutes over protecting access to the courts for injured consumers.

Gladys Mensing and Julie Demahy were prescribed Reglan in 2001 and 2002, and their pharmacists filled the prescriptions with generic versions. Both developed a neurological condition called tardive dyskinesia -- now a known side effect of Reglan that was not listed on the warning label for the drug. Unfortunately for Mensing and Demahy, however, they could not sue the manufacturer of Reglan because neither ever actually took that drug. Instead, they were forced to sue the manufacturers of the generics, alleging that they negligently failed to warn them and their doctors of the known side effects of their products. They did so under a Minnesota law that requires drug manufacturers to update warning labels to include newly discovered side effects and health risks. Now the U.S. Supreme Court has said the two cannot even sue the generic drug manufacturers either.

The basis for the Court's decision lies in the regulation of drugs by the FDA, and in particular a rule that requires generic drug makers to place warnings on their products that are identical to those on the name-brand drugs they imitate. Under the new ruling, generic drug manufacturers cannot be sued for failure to warn under state laws even if they knew before they started marketing their product that it had a serious side effect that was not on the warning label . According to Justice Thomas, it would be impossible for a manufacturer of generic drugs to comply with the federal regulation requiring a label identical to the name-brand and also comply with stricter state laws that require updated labeling.

In 2009, the Supreme Court ruled in Wyeth v. Levine that name-brand drug manufacturers could be sued for failure to warn even though the FDA approved their product label. While that decision was viewed as a major victory for consumers, the Supreme Court has now stripped away most of the benefit of that ruling because 75 percent of all prescriptions nationwide are filled with generic pharmaceuticals.

In a dissenting opinion joined by the other four members of the Court, Justice Sotomayor wrote that she could not believe the intent of Congress was to base a person's ability to sue a drug manufacturer on the accident of whether or not their pharmacist filled their prescription with a brand name or generic pharmaceutical. Sotomayor's solution, and one supported by the current administration, would be for the generic manufacturer to notify the FDA and convince it include the new warnings on the brand name label so they could also be included on the generic label.

The opinion reflects a fundamental difference of opinion among members of the court. The majority in Mensing are textualists, meaning that they read the law literally as it is written and rely on Congress or executive agencies to correct mistakes and bad outcomes. Unfortunately, this approach means that the injured parties in the case that inspires the change never receive the compensation or justice they deserve. The dissent, on the other hand, looks to the likely intent of the drafters and renders a decision consistent with that intent. With the change of the Court's composition over time the textualist point of view has more often gained the majority, making it even more important that legislators vigilantly amend laws to restore access to the courts and other important consumer protections.