Editorial: Supreme Court clarifies FDA not infallible

Not so long ago, fans and critics had the U.S. Supreme Court since the accession of Chief Justice John Roberts and Justice Samuel Alito as a reliably “pro-business” court, likely to side fairly reliably with corporations in disputes with employees or customers.

Several recent cases have called that description into question, but Wyeth v. Levine, decided last week, should send those who prefer a simple phrase scrambling. We’re not sure if there is a simple valid description, but “pro-business” definitely doesn’t fit.

To be sure, almost any sentient human would feel sympathy for the eventual winner in this case, Diana Levine, who played guitar and sang for children in Vermont. After going to a clinic for a migraine, she was injected with Phenergan, an anti-nausea drug made by Wyeth.

The drug’s packaging included this warning, approved by the U.S. Food and Drug Administration: “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.”

The medical assistant didn’t pay close enough attention and injected the drug into an artery, and Levine contracted gangrene. Eventually her right arm had to be amputated.

Levine sued the clinic and got a settlement. Then she decided to sue Wyeth, the drug manufacturer, arguing it could have put a more forceful warning on the label. A jury awarded her almost $7 million, Wyeth appealed, and the Supreme Court said the jury verdict should stand.

As is often the case, the issues involved are complex. Last year, in the Riegel case, the same court with the same members ruled that in the case of medical devices (not drugs) an FDA-approved warning was sufficient to protect a manufacturer from liability when a device was used improperly and caused harm.

The high court argued that drugs and devices are governed by different laws, and Congress had made it explicit in the law regarding devices that an FDA-approved warning would “pre-empt” state-level lawsuits.

That argument is valid, though it didn’t necessarily have to be controlling. It is also not necessarily a bad outcome that this decision, in effect, makes it clear that the FDA is not the infallible authority on drugs that it sometimes pretends to be. A bureaucratic agency influenced by politics and influence-peddling, the FDA has made mistakes in the past and will do so in the future.

On the other hand, this decision makes the jurisprudence governing drugs and medical devices inconsistent and will no doubt open the gates for a flurry of litigation. That will make the process of developing new pharmaceuticals, already quite expensive, at around $1 billion, largely because of regulatory hurdles that effectively keep all but the behemoths out of the game, that much longer and more expensive.

The result will not only deter innovation, it could well keep some promising drugs — that could help some people but have unfortunate side effects if not used properly — from ever coming to market.

It is not a bad sign that the high court in this case gave such high precedence to the law as Congress wrote it. Whether it will be consistent in paying such respect is another question.