Consumer Rights Victory At SCOTUS?

The Supreme Court today ruled that Congress does not give drug companies immunity from prosecution by regulating drugs through the FDA.

Diana Levine was a successful musician, until a toxic drug took away her right hand. The drug, an anti-nausea medicine made by the company Wyeth, causes irreversible gangrene if injected into a patient’s artery. Because Wyeth failed to adequately warn doctors of this poisonous effect, however, a physician’s assistant used an unsafe method to inject the drug into Levine. Her hand and her livelihood were the casualties.

After a Vermont jury found that Wyeth was liable for failing to warn doctors of the dangers presented by its drug, Wyeth claimed that it was immune to accountability for its failure, and that Diana Levine was entitled to nothing as a result. Specifically, Wyeth argued that, because the FDA has to approve new drugs before they enter the market, FDA approval of a drug or its labeling “preempts” any state law which also effects drugs or labels. Needless to say, if Wyeth had won today, it would have been a massive giveaway for the drug companies—total lawsuit immunity.

Instead, today’s Supreme Court decision upheld the basic American value that no one is immune from the law.

It was a bit of a surprise verdict, especially considering that it was a 6-3 ruling, with Clarence Thomas siding against the radical right of Scalia, Alito and Roberts and with the majority. Thomas is the only principled conservative in this scenario, because he essentially argued that state law cannot be pre-empted by FDA aproval. What made it interesting to me is that the same Court recently ruled that medical device manufacturers could not be held responsible in lawsuits, using markedly different logic. It's good news that Henry Waxman and Ron Pallone hailed the ruling in this case by hearkening back to that one, and seeking to fix it.

“I am pleased that the Supreme Court has recognized the important right of patients to seek redress in court if harmed by a drug – this is a critical check that helps ensure the safety of pharmaceuticals," said Chairman Waxman. “I hope that the Congress will now move to level the playing field and act swiftly to enact legislation to reverse the Court’s earlier decision regarding medical devices and restore the ability of patients injured by medical devices to have their day in court."

"Today's Supreme Court decision is a giant victory for patients," Chairman Pallone said. "Drug companies must be responsible for the safety of their products, and this decision is likely to make pharmaceuticals safer for all Americans. The decision also highlights the need for Congress to pass legislation giving patients harmed by medical devices the same legal recourse now affirmed for pharmaceuticals. There should not be any distinction between the legal treatment of pharmaceuticals and medical devices, and without action by Congress this unfortunate distinction will continue to exist."

We've heard that these two would be introducing legislation to reverse the SCOTUS ruling on medical devices. Today's ruling gives them even more of an impetus to do so.