Undercutting State Protections for Health, Safety and the Environment
Article VI of the U.S. Constitution makes clear that where federal and state laws conflict, federal law takes precedence. But what happens when state laws conflict not with federal law, but with federal regulations? Can a regulation adopted by a federal agency trump a law passed by a state legislature? Can it preempt citizens' right to sue in court under state law?
Such questions of “federal preemption” might once have been little more than interesting topics for an undergraduate constitutional law class, but in recent years they have taken on much greater importance. During the Bush years, various agencies of the federal government sought to use federal regulations to trump state environmental, health and safety protections that the Bush political appointees apparently regarded as too costly to industry, and to undercut citizens’ right to sue under state tort laws for damages resulting from industry irresponsibility.
The Bush Method
In some instances, federal agencies simply asserted in the text of regulations that the regulations preempt state standards or citizens’ right to sue for damages under state laws. In other cases, agencies sought out opportunities to file legal briefs on behalf of corporations sued under state laws, arguing that citizens do not have a right to sue for damages in areas covered by the federal regulations in question. For example, on the issue of drug and medical-device labeling – a critical area because labels are required to reflect the ways that drugs and devices can be prescribed safely and legally – the Bush Administration delivered a one-two punch. In 2006, the Food and Drug Administration inserted a last-minute provision into the preamble to a drug-labeling rule declaring that it preempts lawsuits filed under state law over inadequate warnings about the risks posed by a prescription drug – thus denying citizens’ right to sue when harmed by industry misbehavior.
Separately, the Bush Administration intervened in a Supreme Court case arguing that companies could not be sued under state law over FDA-approved device labels. Significantly, the Court ruled in favor of the manufacturer, essentially accepting the Administration’s argument that the manufacturer of a balloon catheter that exploded inside a patient during a routine angioplasty procedure could not be sued under state tort law because the device had won FDA approval. However, in March 2009, the Supreme Court ruled against the Bush/industry position. In Wyeth vs. Levine, the Court upheld the right of a Vermont woman to sue pharmaceutical giant Wyeth after its anti-nausea drug Phenergan, administered cautioned against but not barred on the Wyeth-written and FDA-approved label, killed sufficient tissue in her arm that doctors were forced to amputate. Wyeth argued that state tort laws were preempted by the FDA's regulatory action -- the approval of the label -- and that they could not be sued. A 6-3 majority on the Court disagreed.
When the pro-preemption position has prevailed in court, industry and its allies have sought to protect their gains by arguing that Congress has no authority to undo the decisions. A July 2009 white paper, Congress’s Authority to Correct the Courts’ Preemption Decisions, by CPR Member Scholars William Buzbee, William Funk, Thomas McGarity, and Sidney Shapiro, and CPR Policy Analyst Matthew Shudtz, dismantles the argument, noting that the Supreme Court's preemption decisions have rested on statutory, not constitutional grounds:
Courts’ decisions in these cases are, in essence, statutory interpretation decisions since their goal is to discern what Congress’s intent was or would have been had Congress considered the issue before the court. Unlike constitutional interpretation decisions, which can only be overturned by means of a constitutional amendment, statutory interpretation decisions invite congressional critique. As with any judicial interpretation of a statute with which Congress disagrees, Congress may amend the statute to make its intent clearer. Even if Congress does not disagree with the court’s interpretation of the original statute’s preemptive effect, it may decide that it wishes to change the law’s preemptive effect.
On May 20, by the stroke of a pen, President Obama reversed the Bush administration's preemption policy, ending the Bush attempt at stealth tort reform. In a memorandum to heads of executive departments and agencies, President Obama recognized that federal and state laws have historically operated concurrently to provide independent safeguards to the public, with state laws often providing greater protection than federal law. In unusually strong language, he also noted that, despite the Executive Order on Federalism that existed throughout the Bush administration, agencies had often declared that their regulations preempted state law, including state tort law, without either explicit congressional authorization or a factual basis in their record for such a claim. Most important, President Obama directed that agencies should no longer include statements in their preambles claiming their intent to preempt state law unless the actual regulation itself contains provisions that explicitly preempt state law. Moreover, agencies should only promulgate such preemptive regulations when they would be legally justified under traditional policies, including those in the Executive Order on Federalism, which in essence restates the presumption against preemption.
Read what CPR Member Scholars have had to say about the federal preemption issue:
The Truth About Torts. CPR's "Truth About Torts" series of looks at preemption policies at the Federal Railroad Administration, Food and Drug Administration, Consumer Product Safety Commission, and National Highway Traffic Safety Administration; looked at inflated claims about the "lawsuit crisis," and proposed a number of solutions. Read the Truth About Torts series.
How Many FDAs? CPR Member Scholars and staff rebut drug and medical device industry arguments that without wholesale federal preemption of state tort laws, they will face what amounts to 50 FDAs.
Senate Testimony: Medical Devices. CPR's Thomas McGarity testified before the Senate HELP Committee on August 4, 2009, declaring that current FDA regulation of medical devices was inadequate in the absence of a the right to sue for damages in state civil courts. Read the news release. Read the testimony.
Undoing the Supreme Court's Damaging Preemption Rulings. Read CPR's July 2009 white paper, Congress’s Authority to Correct the Courts’ Preemption Decisions, by CPR Member Scholars William Buzbee, William Funk, Thomas McGarity, and Sidney Shapiro, and CPR Policy Analyst Matthew Shudtz, rebutting arguments that Congress lacks the authority to undo Supreme Court decisions upholding preemption.
Wyeth vs. Levine. In March 2009, the U.S. Supreme Court handed down its ruling in Wyeth vs. Levine, rejecting an argument from pharmaceutical giant Wyeth that a woman harmed by one of its drugs could not bring a lawsuit against the company because the FDA's approval of the drug's label effectively preempted litigation under state tort law. Read a pre-decision op-ed by Member Scholar Thomas McGarity, "Court Takes Up Preemption Doctrine," in the November 28, 2008 Austin American Statesman. Read a post-decision op-ed by McGarity, A Rare Win for Consumers" (91 kb download), in the March 6, 2009 Dallas Morning News. The same op-ed was also published in the Houston Chronicle, March 7, 2009, "A Victory for Consumers in Pre-emption War," and in the March 9, 2009 Austin American-Statesman, "Wyeth vs. Levine is a Rare Win for Consumers." Read McGarity's editorial memorandum in advance of oral arguments before the Supreme Court, issued October 29, 2008. Read a post-decision editorial memorandum (56 kb download) by McGarity and fellow Member Scholar Nina Mendelson, issued on March 6, 2009. Read a day-of-decision press statement by Nina Mendelson.
Read Alexandra Klass and Sandra Zellmer's op-ed on why Exxon should pay punitive damages for the Exxon Valdez disaster, despite its claim before the Supreme Court that maritime law and the Clean Water Act preempt punitive damages in tort cases. The op-ed was published the in the March 1, 2008 Minneapolis Star-Tribune, before the Supreme Court's decision in the case. Or read their ACSBlog entry on the same subject, also before the decision. Read Alexandra Klass's post-decision blog entries on the subject: on ACSBlog and ScotusBlog.