U.S. Supreme Court Deals a Low Blow to Consumers
It is no secret that the highest court in our country, the United States Supreme Court, is sharply divided along political lines. Currently, the Court is comprised of two Reagan appointees, one George H.W. Bush appointee, two George W. Bush appointees, two Clinton appointees, and two Obama appointees. Sadly, the decisions of the Court often come down to legal interpretations, which are heavily influenced by political ideology.
On June 23, 2011, the U.S. Supreme Court handed down an opinion in Pliva, Inc. v. Mensing, which arguably has far reaching consequences for drug safety. In that case, the Court considered the issue of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state law claims.” Justice Clarence Thomas for the plurality wrote an opinion holding that the state law claims are pre-empted by federal drug regulations.
The holding of the case came as a surprise to many who thought that the Supreme Court would uphold the rulings of the 5th and 8th Circuit Courts. Both of those courts rejected the manufacturers’ argument that federal law pre-empted any state tort claims and held that the plaintiffs’ claims were not pre-empted.
Justice Sonya Sotomayor wrote a dissenting opinion in which Justices Ginsburg, Breyer, and Kagan also took part. In her opinion, she noted that "...the majority's pre-emption analysis strips generic-drug consumers of compensation when they are injured by inadequate warnings." She also sharply criticized the plurality opinion for its contorted reading of pre-emption, arguing that Pliva “effectively rewrites our decision in Wyeth v. Levine.”
Because Justice Thomas’ decision was a plurality opinion, there was no clear majority of the Court that adopted Justice Thomas' reasoning. Anyone who is interested in consumer issues, drug safety issues, or in how the Court works should read Justice Sotomayor’s blistering dissenting opinion. As they say, “you don't really want to see how the sausage is made.”
So what does all of this legalese mean for consumers? The gist of the Court's opinion is this: if a consumer is injured by a drug’s inadequate safety warnings, his/her right to sue now depends on whether the pharmacist fills the prescription with a name brand drug or a generic drug. Under the plurality’s holding, the consumer injured by a name brand drug will be able to bring suit, but the consumer injured by a generic equivalent of a brand name drug will be left with no remedy for his injuries.
Unfortunately for consumers, generic drugs now comprise 75 percent of all prescription drugs dispensed in this country. The consumer usually has little control over whether the name brand or generic is provided. Oftentimes, large insurance companies control the decision about which drug a consumer receives. This decision is made in the board rooms of large insurance companies who negotiate with drug manufacturers for the cheapest prices.
According to Justice Sotomayor, "Today's decision eliminates the traditional state-law incentives for generic manufacturers to monitor and disclose safety risks. When a generic drug has a brand-name equivalent on the market, the brand-name manufacturer will remain incentivized to uncover safety risks. But brand-name manufacturers often leave the market once generic versions are available, meaning that there will be no manufacturer subject to failure-to-warn liability. As to those generic drugs, there will be no additional layer of consumer protection."
Look for more about this landmark case and how it affects consumers on www.vanweylaw.com.
