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.

SCOTUS strikes again

By Joseph Nicholson

For the second time this summer, the Supreme Court of the United States has handed down a decision that weakens consumer protection. Justice Scalia, who also wrote the opinion in Concepcion spoke for the Court in Dukes v. Wal-Mart, the high-profile sex discrimination suit against one of the world's largest retailers. Class actions like the one in Dukes are an important tool for protecting the rights of individual consumers against wealthy and powerful corporations. The case, which may change the rules for certifying class actions in federal court and may represent the outer limit for the court system as a means for social justice, was decided along ideological lines with Justice Kennedy joining the Court's other conservatives to form a 5-4 majority.

The suit began more than ten years ago when Betty Dukes, pictured at left, joined forces with several other female Wal-Mart employees to bring a class action against the company for what they perceived to be a company-wide culture of discrimination. The culture fostered among Wal-Mart managers promotes discriminatory decision-making by store managers when it comes to pay and promotions, the women alleged in their suit. The women argued they should receive backpay to bring them in line with male employees, injunctive relief to change Wal-Mart's discriminatory practices and punitive damages to send a message to other large corporate employers. With more than a million women believed to be affected by Wal-Mart's policies, the case was heralded as the largest class action in U.S. history.

All of that changed on June 20, 2011 when the Supreme Court overturned both the district court and the Ninth Circuit Court of Appeals and ruled that the class decertified. Class actions in federal court are goverened by Rule 23, which imposes four prerequisites to certification. One of these, commonality, became the focus of the Court and the reason the class was decertified. To satisfy commonality, the class as a whole must share an essential issue of fact or law in common. Though the class alleged a single culture of discrimination at Wal-Mart, and provided evidence that sexual discrimination was the most likely cause of the disparate impact amongst Wal-Mart employees, the case should have to proceed with each woman showing how she was discriminated against individually, according to Justice Scalia.

"Title VII, for example, can be violated in many ways—by intentional discrimination, or by hiring and promotion criteria that result in disparate impact, and by the use of these practices on the part of many different superiors in a single company," he wrote. "[T]he mere claim by employees of the same company that they have suffered a Title VII injury, or even a disparateimpact Title VII injury, gives no cause to believe that all their claims can productively be litigated at once."

In a rare display of sloppy language, Scalia converted the "substantial" evidence needed to show a common issue of fact or law from a qualitative showing about the substance of the issue to a quantitative rule imposing a significant burden. Under Scalia's, and now the federal courts' approach, the Dukes class would basically have to prove its claims before it could proceed as a class action.

The ruling left civil rights organizations "deeply disappointed," but determined to continue the struggle for justice. "Equal treatment in the workplace is a civil rights issue," said Arcelia Hurtado, Executive Director of Equal Rights Advocates, an organization devoted to women's equality for nearly 30 years. "Today we may have taken one step back in the court system, but we are confident that we have taken several steps forward in raising awareness about pay inequity and in galvanizing a generation of women who are standing up and saying, Enough is enough! Pay us what we are worth!" Though the class has lost certification, individual claims of discrimination can still go forward according to the Impact Fund, an organization representing the women in the case.