Byline: Lawrence J. McQuillan, Ph.D., SPECIAL TO THE WASHINGTON TIMES
The U.S. Supreme Court Monday heard arguments in Wyeth v. Levine, a case that could uphold a fundamental tenet of our Constitution. Or, it could send shock waves through the health-care industry, embolden personal injury lawyers, and no doubt cost lives. Central to the case is the concept of pre-emption. Article VI of the Constitution, commonly referred to as The Supremacy Clause, says that federal law and regulations outweigh, or pre-empt, any conflicting state law or regulation. In other words, where there are conflicting state and federal laws, the federal law always prevails. But Wyeth v. Levine challenges that clause.
The case involves a Vermont woman who was improperly administered a drug at her local health center and suffered a significant injury as a result. She successfully sued the health center and several staff members for her injury. Seemingly, justice was done, but she did not stop there.
The woman sued the drug's manufacturer, Wyeth Pharmaceuticals, claiming that the warning labels were insufficient and that the U.S. Food and Drug Administration (FDA) should not have approved the way in which the drug was administered to the woman.
FDA scientists approved the drug and its warning labels, which have been used safely since 1955. The drug's labels specifically warned about the exact kind of injury the woman suffered. A jury found in favor of the woman, second-guessing expert FDA scientists in the process. She was awarded more than $7 million.
Wyeth lost on appeal. Apparently, the Vermont Supreme Court believes that FDA regulations do not preempt state laws on labeling. But that is wrong.
The FDA consists of more than 8,000 scientists, researchers, doctors and other experts expressly charged with keeping us safe and healthy by evaluating and approving (or rejecting) drugs and their labels. The Vermont jury was not made up of medical specialists, but instead registered voters. Should 12 randomly selected laypersons determine health policy instead of highly trained expert scientists?
If the judgment against Wyeth stands, it will open the floodgates for lawsuits challenging the authority of the FDA to evaluate drugs and their labels. The impact will be devastating.…