Pending Legislation on Generic Drug Labeling

In 2011, the United States Supreme Court, in Pliva v. Mensing, ruled that generic drug manufacturers could not be sued for insufficient label warnings as “federal drug regulations, as interpreted by the FDA, prevented the Manufacturers from independently changing their generic drugs’ safety labels.” Since patients who are harmed by insufficient warnings on generic drugs now have no recourse in court, the Patient Safety and Drug Labeling Improvement Act was introduced to Congress on April 18^th to change the law regarding generic drugs.

This bill allows generic drug manufacturers to update their safety warnings on their labels instead of having to use the manufacturer’s safety warnings. As a result, victims would be allowed to file lawsuits against generic drug manufacturers for insufficient warnings contained on the drug label.

Supporters of the bill argue that the bill is necessary to fix a “troubling inconsistency in the law governing prescription drugs“. Opponents of the bill argue that this bill would result in conflicting warnings on the same drug.

Thompson and Tredennick Partner Joel Thompson comments

Approximately 80% of all prescriptions in the United States are filled with generic drugs. The Mensing opinion is just another example of the gradual erosion of consumer’s rights. The opinion was flawed and I believe the Court knew of the problems presented by their decision. Justice Thomas, who wrote the majority opinion, acknowledged that the distinction ‘makes little sense’ in the eyes of consumers. Justice Sonia Sotomayor, writing the dissent, predicted ‘absurd consequences’ depending on the ‘happenstance’ of whether a prescription was filled with a brand-name or generic drug.

The Court reached their decision based on the wording of the Hatch-Waxman Act of 1984. The Majority reasoned that the Act prohibits generic manufacturers from changing their drugs’ labels to differ from their Food and Drug Administration (FDA)-approved brand-name equivalents’ labels at any point in time.

The sponsor of that 1984 Act, Henry Waxman, contends that the act did not intend to pre-empt all failure-to-warn claims.

This outrageous denial of a patient’s right to recover fair damages makes it imperative that Congress or the Food and Drug Administration fashion a remedy.

Nick Bruno is a Legal Assistant at Thompson & Tredennick