This column by ACRU Senior Legal Analyst Ken Klukowski was published June 26, 2011 on The Washington Examiner website.
Trial lawyers cannot sue drug manufacturers for defective warning labels on generics if labels were approved by the U.S. Food and Drug Administration, according to the U.S. Supreme Court.
The 5-4 Pliva v. Mensing decision announced last week was a defeat for class-action trial lawyers hoping to profit on litigation based on allegations that manufacturers violated state laws that aren’t pre-empted by federal laws or regulations.
The Supremacy Clause of the Constitution requires that so long as a federal law is constitutional, it pre-empts divergent state laws.
Pliva grew out of the fact that the medicine Reglan can cause certain neurological side affects. When Reglan’s patent expired, doctors began prescribing lower-cost, generic versions.
Two people who suffered this neurological disorder sued the makers of the generic equivalent, arguing that the warning labels were inadequate to inform them of the risk.
Federal law empowers the FDA to regulate the content of drug warning labels as part of the agency’s approval process for new brand-name drugs.
Generic and brand-name versions of drugs must include the same information about side affects on their warning labels, according to the FDA.
Two women sued over the generic version of Reglan, arguing they should have strengthened its warnings. The two claimed they would not have taken the generic version of Reglan if the generic makers had petitioned FDA to strengthen labels to satisfy tougher state laws.
The FDA’s petitioning process for brand-name makers obligates them to update warning labels as new facts become available, but that process doesn’t cover generics. The generic labels merely must be identical to the current version of the brand-name labels.
The Reglan generic makers were thus in a no-win situation. They were required to strengthen their warnings under state law, but they could not change their labels unless Reglan’s manufacturer first changed its label.
The court decided the generic makers are not liable. Writing for the majority, Justice Clarence Thomas explained that the lawsuit was pre-empted by federal law.
If these women had taken Reglan instead of its generic equivalent, they could have sued. But because the law for generics is different, taking the generic variation of Reglan derails their lawsuit. Whether the distinction FDA’s regulations draws makes sense or not, it still trumps state laws.
Thomas noted that the court held a lawsuit against a brand-name manufacturer was allowed to proceed in 2009. The difference here is the difference in regulations governing brand names versus generics.
In the former lawsuit, it was possible for the maker to satisfy both federal and state law. Here, the generic maker had to violate one or the other.
The four liberal justices argued in dissent that state law is not pre-empted unless Congress expressly declares such in a federal law. Suddenly rediscovering their inner federalists in a dissent authored by Justice Sonia Sotomayor, the four opined that public health and safety are matters entrusted to the states, and that these lawsuits concerned health and safety matters.
The majority disagreed, holding that state law is pre-empted whenever it’s impossible to obey state law without violating federal law. While the generic makers could have petitioned the FDA to reach out to the makers of Reglan to change the label for both the brand-name drug and the generic, they were under no obligation to do so.
In a classic showdown between business and class-action trial lawyers, business won this time. But just barely.