How Many FDAs?

Industry's '50 FDAs' Argument Falls Flat

Nobody likes to be sued, even big companies with lots of lawyers on retainer. Of course, big companies sue each other all the time – always have and always will. But the litigation that industry seems to fear most is the kind that involves individuals suing companies – specifically, individuals with a legitimate claim that they were injured by the company’s product.

That fear of litigation is strong incentive to make sure products are safe, of course, suggesting that the best way to avoid being sued is to make safe products. Many companies do just that. But a lot of take a different view:  that the best way to avoid losing such cases is to keep them out of court altogether. 

That’s the driving force behind “tort reform.” And in the case of the drug and medical devices industries, it’s also the motivation for a longstanding effort aimed at getting the federal government to shield them from lawsuits brought against them in state courts. Toward that end, they’ve championed an expansive view of federal “regulatory preemption,” a doctrine derived from the U.S. Constitution’s Supremacy Clause, which holds that federal law is supreme, and that whenever state law conflicts with it, federal law takes precedence. Industry has sought to expand the doctrine into a nearly impenetrable shield against liability under state tort law. If federal law called for that, that’d be one thing. But it doesn’t. The preemption industry has in mind relies solely on regulatory agencies asserting that their regulations – not the statutes upon which they’re based – preempt state tort laws.

In making their case for preemption, the drug and medical device industries often argue that in its absence, they are effectively subject to a “50 FDAs,” suggesting that allowing citizens to sue for harm done to them by defective products subjects companies to a wide-ranging, unpredictable and inconsistent set of standards.  They contend that a better approach would be for FDA to adopt regulations imposing unitary federal standards that would supplant the entire state tort law system. 

In an October 2009 white paper, “Fifty FDAs”: An Argument for Federal Preemption of State Tort Law that Is Less than Meets the Eye, CPR Member Scholars William Buzbee, William Funk, Thomas McGarity, and Sidney Shapiro, with CPR Policy Analysts James Goodwin and Matthew Shudtz, argue that the “50 FDAs” argument doesn’t pass the smell test. They argue:

• Despite industry assertions to the contrary, state tort laws are both uniform and predictable, and so are their application. If anything, the application of a unitary federal standard is more unpredictable than the application of state tort laws.
• State tort law is an essential part of the way government in the United States functions, making good on the Constitution’s promise of jury trials in common law suits – thus giving citizens a chance to recover damages when they are harmed.
• State tort laws help keep products safe. Fear of litigation makes a difference, as industry’s ongoing campaign to shield themselves from lawsuits demonstrates.

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