In a 6-3 ruling, the U.S. Supreme Court in Wyeth vs. Levine, struck down the Food and Drug Administration (FDA) pre-emption argument for FDA approved drugs. Basically, this means that companies will be held responsible for not updating their labels for side effects or face expensive law suits.
So, in the coming months, expect a slew of additional label additions describing every side effect that has ever happened to anyone taking a branded pharmaceutical.
Also, expect hundreds, if not thousands, of lawsuits to be filed against pharmaceutical companies.
In some respects, this ruling makes a stronger case for more physician and patient education. The patients reading the fifteen page long package insert and doctors interpreting them, will need to better understand what they say.
In the end, the patients and physicians will benefit from the education. Those who fail to read the lengthy label may actually suffer from the more common side effects which would have normally been avoided with a shorter label.
The winners are the trial attorneys and the losers everyone else.
To read more:
Supreme Court: Wyeth vs. Levine
The Wall Street Journal: High Court Eases Way to Liability Lawsuits
The Wall Street Journal Blog: Supremes Set Different Rules for Device and Drug Companies
CBS Market Watch: Wyeth Company Complied with Vermont Law
Scientific American: Supreme Court Strikes Down Pre-Emption Argument for Drug Maker Wyeth
Policy and Medicine: Pre-emption: Wyeth vs. Levine (insider’s view)