SCOTUS Sides with Consumers against Drug Companies


In a 6-3 decision, the Supreme Court dealt drug companies and their business lobbyists when they agreed that state juries may award consumers injured by dangerous drugs, even if the FDA has okayed the manufacturing regulations.

The case at the center of the ruling upheld a jury award of $6.7 million in favor of Vermont musician Diana Levine who lost her right arm after an anti-nausea drug injection. Wyeth, the drug’s manufacturer, argued unsuccessfully that the FDA’s labeling requirement should have been enough to shield it from lawsuits.

While pharmaceutical companies may be extremely disappointed in yesterday’s ruling, implications beyond drug manufacturing labels are apparent. Business groups and other companies have been looking to the federal government to shield them from litigation. A move is sort of ironic considering they don’t want federal oversight on anything they do.

While the Supreme Court has sided with big business in pre-emption suits, especially in the notorious Riegel vs. Medtronic case, yesterday’s decision looked at a different legal standard. The Riegel case looked at specific language laid out by Congress, while yesterday’s ruling looked at implied standards and policies set forth by federal regulation. Basically, if the FDA says it’s okay, then it’s okay.

Other companies who have tried to hide from oversight and litigation recently are those who manufacture fireworks, cigarettes, antifreeze, popcorn, and light bulbs. If they are basing their cases on the language set forth in Congressional language, as Medtronic’s lawyers did, then it is believed they may succeed because compliance with state laws may be impossible. Yet, Justice John Paul Stevens, writing for the majority in Wyeth v. Levine, stated that in this case, Congress “determined that widely available state rights of action provided appropriate relief for injured consumers.”

The other justices who joined Justice Stevens include Justices Ruth Bader Ginsburg, Stephen G. Breyer, Anthony M. Kennedy, and David H. Souter. Justice Clarence Thomas objected to Justice Steven’s reading of the law, but still voted with the majority.

Those who voted against consumers and state’s rights include Justice Samuel Alito, Antonin Scalia, and Chief Justice John Roberts. Justice Alito writing for the dissenters said, “This case illustrates that tragic facts make bad law.”

Wyeth v. Levine focuses on the drug Phenergan, which Levine was taking due to migraine headaches. She was given Demerol and Phenergan at a clinic by a physician’s assistant. Usually Phenergan is administered via intramuscular injection or IV drip because when it is exposed to arterial blood, the drug can cause gangrene. The physician’s assistant administered the drug using the “IV push” method, injecting into what she thought was a vein. A few weeks later, Levine had her right arm amputated above the elbow. The lawsuit she filed claimed the warning from Wyeth about IV-push administration was not strong enough.