Preempting your right to innovative drugsJOEL WHITE | CONTRIBUTING WRITER Jurors aren’t physicians. They’re regular people. So why would we entrust them with medical decisions best made by clinicians or scientists?
It sounds preposterous, but jurors could be given the responsibility for deciding how doctors should practice. That’s the scenario one woman is pushing before the Supreme Court.
Instead of expert scientists at the Food and Drug Administration having the final say on drug safety, people whose medical training consists of watching “ER” reruns could wield the power to pull the plug on a drug critical to your health.
The Court just heard oral arguments in Wyeth v. Levine challenging a legal doctrine known as “preemption,” which states that federal law trumps state law when they conflict. Rooted in the Supremacy Clause of the U.S. Constitution, this legal principle provides a way to resolve discrepancies between federal, state, and local statutes.
This legal battle began when a woman named Diana Levine was awarded $6.7 million in damages after she was accidentally injured by an intravenous administration of the anti-nausea drug Phenergan in April 2000. Approved in 1955 by the FDA, Phenergan is used to control severe nausea and vomiting. Over the past 50 years, millions of doses of Phenergan have provided relief to patients.
Levine sued both the supervising physician and the physician’s assistant who injected the drug. The providers settled out of court.
Levine also sued the maker of Phenergan, Wyeth, despite the fact that the error was caused by the physician’s assistant, who gave twice the recommended dose and accidentally exposed an artery to the drug. This caused gangrene and led to amputation of part of her arm.
Levine’s lawyers argued that Phenergan’s label contained inadequate warnings of the drug’s risks. But the label contained four prominent warnings about the risks of improper administration, including the method used on Levine, as well as instructions on proper dosage. The FDA and an expert advisory committee had reviewed the warnings multiple times. In fact, the FDA required Wyeth to maintain the label’s warnings. Wyeth would have been in violation of federal law if it changed the label that was approved by FDA scientists.
Levine’s lawsuit directly challenges the content of FDA-approved labeling and whether that labeling should protect manufacturers against law suits as fair warning to consumers and physicians about a medication’s risks and proper administration.
For more than half a century, the public has relied on FDA experts to approve labels that inform consumers of the benefits and risks of their medications. Companies spend about a billion dollars to develop and achieve FDA approval of a new drug. If lay jurors in 50 states are able to overrule this process, then the entire FDA approval scheme would become meaningless.
If Wyeth loses before the Supreme Court, consumers can look forward to a litigation free-for-all in which juries -- not scientists or clinicians -- are the de facto providers of information on drugs in this country.
A blow against preemption would also be a blow to America’s innovative drug pipeline. Drug manufacturers would have to divert funds from research to defending and complying with a dizzying spiral of litigation.
But if the Supreme Court stands in support of preemption, patients will know the warning labels posted on drugs are vetted by scientists with the medical insight and expertise necessary for making them.
Joel White is a Senior Fellow at the Galen Institute (www.galen.org).