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 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.
In an attempt to head off costly litigation, warning labels will expand, attempting to cover every imaginable use or misuse of a given drug. This will lead to the phenomenon known as “overwarning,” where vital and relevant warnings are buried in a sea of outlandish and unnecessary warnings, diminishing the impact of the real safety information, or scaring patients from using drugs they need and costing lives.
Courtesy of tort abuse, we already have a form of this in absurd warning labels on products such as “do not use curling iron while sleeping,” or “harmful if swallowed” on a fishing lure. It will be much worse – and no laughing matter – if the high court rules against the FDA.
Faced with 50 different state standards and an avalanche of state lawsuits, drug manufacturers will simply stay away from developing new, life-saving drugs because they deem them too costly and risky to pursue. Or they might pull existing drugs off the market. Vaccine manufacturers are already doing so, thanks to the very real fear of facing lawsuits based on junk science.
And make no mistake, consumers pay the price for these frivolous lawsuits as the cost of defending and insuring against them is reflected in higher prices for health-care goods and services. If the FDA is found not to have the last word in drug approval, we will see a chaotic patchwork of state- and jury-written warning labels. Imagine the confusion if the same drug bore vastly different warning labels from state to state.
The goal of tort law is to deter wrongdoers efficiently and compensate unjustly injured victims. When implemented fairly, the system works. When corrupted, the system produces frivolous lawsuits and mind-boggling monetary awards that have a chilling effect on the economy and damage our quality of life.
If the U.S. Supreme Court allows a jury to supplant FDA scientists, we will be taking a major step backwards in the struggle for common-sense tort reform and better health care. Here’s a warning label for the justices: “An unwise decision may cause medical confusion, enrich personal injury lawyers, and increase health-care costs and deaths.”
Lawrence J. McQuillan, Ph.D., is director of business and economic studies at the Pacific Research Institute and coauthor of the 2008 U.S. Tort Liability Index.