Ruling in Wyeth v. Levine Hardly a Victory for Consumers

Happened upon this San Francisco Chronicle story report on the U.S. Supreme Court’s ruling in Wyeth v. Levine, the most prominent preemption and business case of the year. Although it’s a week old, the story’s worth taking a look at: “Ruling says patients can sue drugmakers.”

(03-04) 17:08 PST WASHINGTON — In a resounding victory for consumers over the pharmaceutical industry, the Supreme Court ruled Wednesday that patients harmed by medication can sue the drugmaker for neglecting to list known dangers on the label even if federal regulators haven’t required them to do so.

No! That’s not a fact. That’s a statement of editorial opinion about a matter of policy. We’d argue that the court’s ruling was in reality a resounding defeat for consumers because it will discourage innovation and the development of new prescription drugs that can save the lives of those very same consumers.

As L. Gordon Crovitz writes about Wyeth v. Levine in his Wall Street Journal column, “The Supreme Court and the Tyranny of Lawyers“:

The Food and Drug Administration had required Wyeth to distribute carefully worded warnings with its antinausea drug. The FDA told Wyeth to warn that “under no circumstances should Phenergan Injection be given by intra-arterial injection.” The warning label also included, in uppercase letters: INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY. Tragically, a physician’s assistant in Vermont ignored the clear warnings and injected the drug into the arm of Diana Levine, who then developed gangrene and lost the arm. She sued the hospital, successfully. But she also sued Wyeth.

The legal issue was whether the medical experts at the FDA had pre-empted state lawsuits by mandating clear warnings. A majority of justices said that such implied pre-emption could not block lawsuits. The case would have been different if Congress had specifically pre-empted state drug lawsuits. The simple lesson businesspeople took was that the drug maker could not have done anything to avoid being sued. This logic leads to every drug (and ladder, hammer and toaster) having to carry 50 different warnings, one for each state, updated by local juries from time to time.

More broadly, this case is Exhibit A for how our legalistic culture puts a drag on the innovation, transparency and risk-taking that our new era champions. The result will be higher hurdles for funding to start health companies. There will be less research and development for new drugs, at a time when genome and other path-breaking information should be breaking important new ground, curing people, and helping drive the economy. Prices for drugs will rise to cover future jury verdicts. Defensive medicine already accounts for 30% of doctor bills, an amount equal to the cost of covering the 50 million Americans without health insurance.

This system, worsened now by the court’s ruling, does not serve consumers. Or anybody…except litigants and their lawyers who happen to win individual lawsuits.

Leave a Reply