I’ve written much on this blog about the terrible consequences of the U.S. Supreme Court’s ruling in PLIVA v. Mensing. In that case, the Court found that victims of injuries from generic drugs may not sue the drug makers for failure to warn, because the drug makers are not permitted under federal regulations to change their labels unilaterally. That’s true no matter how blatantly the science showed that a warning was needed; as long as the drug maker followed the rule conforming its label to the name-brand drug’s label, there could be no liability. This made generic drugs makers not liable for injuries to their customers, even though the name-brand maker of the exact same substance would be liable for the same injury. Now, the Wall Street Journal reported last week, the FDA has announced a proposed rule that would fix this dangerous situation.
The FDA’s rule would permit generic drug companies to change their labels if they have had reports of injuries or illnesses that warrant a label change. That would be true even though the resulting label might not be exactly the same as the name-brand drug’s label. This would remove the quandary found by the U.S. Supreme Court in Mensing, where the majority said it was impossible for generic drug makers to comply with both federal regulations and state-court decisions. If a state court finds that a drug maker failed to warn the patient, the logic goes, it is making a state law saying the drug maker must change its label. But because federal regulations require generic drugs to have exactly the same labels as their name-brand counterparts, the court said, it would be impossible to comply with both. As always in cases of such conflict, the federal law must prevail.
This foreclosed all generic drug injury lawsuits alleging failure to warn. A U.S. Supreme Court decision earlier this year, Bartlett v. Mutual Pharmaceutical, added that negligence claims and others that were at heart about the label are also forbidden. The new rule would remove the “impossibility” problem that the court found, restoring injured people’s ability to get fair compensation regardless of whether the drug was generic or name-brand. This is important; as the Wall Street Journal notes, generics account for about 84 percent of the drugs sold in the United States. An FDA official noted that this would also level the playing field. Sen. Patrick Leahy, D-VT, praised the move; he had previously introduced legislation seeking the same outcome. Not surprisingly, however, big-business advocate the U.S. Chamber of Commerce criticized the move for driving up businesses’ costs by enabling more lawsuits.
Of course the change would enable more lawsuits, but as an attorney for people injured by defective drugs, I fail to see the problem with that. If drug makers have a chance to adequately warn patients of new and important research on safety, they should be able to make the labels adequate in the first place. This is the best outcome for everyone: it would create fewer injuries, requiring fewer lawsuits to make the victims whole, and thus lower costs. By giving generic drug makers the ability to change their labels, the FDA would do nothing more than put them on the same footing as their name-brand counterparts. And for the victims of generic drug injuries—which can be quite serious, as the Mensing and Bartlett plaintiffs can attest—it represents a chance to get financial relief that has been denied to them for reasons outside their control. I look forward to hearing more about this rule.