Benjamin R. Gideon, trial lawyer and partner at Berman & Simmons

The Jury Trial's Last Stand: Wyeth v. Levine

The Seventh Amendment provides for the right to a jury trial in all cases “where the value in controversy shall exceed twenty dollars.”  It goes on to say that “no fact tried by a jury, shall be otherwise reexamined in any court of the United States,” other than as permitted by the then-existing rules of common law.

That the Constitutional right to a jury is so far reaching and inviolate reflects the Drafters’ belief that civil disputes should be adjudicated by ordinary citizens, not governmental elites.  This right, like so many of the others enshrined in the Bill of Rights, is rooted in the Drafters’ deep suspicion of authority and their belief that individual liberties could be protected only if there were meaningful checks on the powerful factions in government and society. As government officials, even Judges could not be fully trusted.  Only the lay jury—a group of ordinary citizens from the community—could provide the necessary bulwark against tyranny.
 
Over time, however, this fundamental role of the civil jury has been eroded by a gradual shift of authority away from juries and to governmental actors—judges, regulators and bureaucrats.  But all too often, these governmental actors are captive to the special interests and corporations whose power and influence the lay jury was supposed to check.

Current events reveal the dangers of reliance upon industry “self-regulation” and tepid oversight by government employees who may be closely aligned with the industries they are charged with regulating.  This problem was compounded by the Bush Administration’s policy of reducing regulation and ceding power and control to private industry.
 
The effect of such policies is evident in the failures of the SEC, which permitted fraud and irresponsibility to run amok and contributed significantly to the financial collapse.  It is evident in the lax oversight by the Food and Drug Administration, which has approved medications and devices that have caused injury and death to numerous consumers.  And it is evident in the failures of the National Highway Traffic Safety Administration, which has eschewed sensible, fact-based regulations that could have prevented thousands of motor vehicle injuries and deaths in favor of watered down, industry-preferred standards.

It is against this backdrop that the Supreme Court last Wednesday decided Wyeth v. Levine, a case which some rightfully viewed as a Last Stand for the right to a jury trial.  The case involved an appeal by pharmaceutical company, Wyeth, the manufacturer of an anti-nausea drug, Phenergan.  A Vermont jury found that Wyeth failed to warn adequately of the risks associated with injecting Phenergan directly into a patient’s vein, a procedure which, when used on Ms. Levine, caused gangrene in her right hand and required amputation of her entire right hand and forearm.  Wyeth was aware of this risk. Phenergan injections had caused similar injuries on at least twenty prior occasions.  The Vermont jury awarded $7.4 million to Ms. Levine to compensate her for pain and suffering, medical expenses and the loss of her livelihood as a musician (that amount was later reduced by the amount of Ms. Levine’s previous settlement with other defendants in the case).

The issue before the Supreme Court in Wyeth was whether the Vermont jury had the authority to decide the case at all, or whether its authority was preempted by the Federal law.  The stakes were high.  If Federal preemption applied, the historical power of States and juries to adjudicate these cases would no longer exist, and there would be no remedies available for individuals like Ms. Levine.

The concept of Federal pre-emption of State law is nothing new.  The Supremacy Clause of the Constitution makes Federal laws and treaties controlling over conflicting State laws.  But for most of our history, this was “supremacy” was in name only.  It was left to States to create and enforce laws governing an individual’s right to obtain relief for injuries and death resulting from corporate malfeasance or defective products.  The Federal government did not often intrude into that realm.

What is new about the recent Federal preemption cases is the stridency with which the governmental and business interests have sought to intrude into a field historically under State control, in a calculated campaign to dismantle the jury system.

And the strategy has worked.  Leading up to Wyeth, the business community had found in the Roberts Court a willing partner in their attack upon the jury system.  Most recently, in 2008 in Riegel v. Medtronic, the Supreme Court ruled 8-1 that the Medical Device Act preempted State common-law claims challenging the effectiveness of a medical device that had received pre-market approval by the FDA.
 
The decision in Riegel means that victims now have no remedy for injuries or death caused by defective medical devices.  The power to hold medical device companies accountable, therefore, has been transferred from citizen juries to government regulators. As Justice Ginsburg observed in her lone dissent, the Majority’s decision in Riegel has the “perverse effect of granting broad immunity to an entire industry that in the judgment of Congress needed further regulation.”  She wrote, “it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices.”  But as a consequence of Riegel, that is now the law.

If Riegel curtailed access to civil justice for a defined group of medical device consumers, Wyeth threatened to eviscerate access to jury trials in all federally-regulated industries.  This is because Wyeth argued that state-law claims should be preempted, not on the basis of an express statutory provision (as in Riegel), but on the grounds that allowing state-law claims would conflict with the broader purposes and objectives of FDA regulations as a whole. 

If Wyeth’s argument had succeeded, there would have been few areas of traditional common law tort immune from Federal preemption.  Today, there is hardly any sphere that is not, at least in part, under the putative regulatory authority of some Federal bureau or agency.  Could Bernard Madoff use the existence of the Securities and Exchange Commission as a defense against common law negligence or fraud claims?  Could Ford Motor Company use the existence of the National Highway Traffic Safety Administration as a defense to claims that it knowingly sold its Explorer SUV in a condition that made it prone to accidental rollover accidents?

In in a decision that came as a surprise to many, and as a relief to proponents of civil justice, Justice Stevens, writing for the Majority, held in Wyeth that the FDA’s regulatory role in approving prescription medications and labeling does not preempt State common-law claims for defective labeling.  It upheld the verdict of the Vermont jury.  Justices Robert, Scalia and Alito dissented.

The effect of Wyeth is to preserve the right to a jury trial, one of the few real checks that still exists on unfettered corporate power and greed.  But the trend toward the erosion of the jury trial in Maine and across the country continues, and the implications of an unfavorable decision in a single case like Wyeth show just how tenuous that right has become.

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Berman & Simmons is the leading personal injury and medical malpractice law firm in Maine. For more than 100 years, our trial attorneys have represented those who have been injured or harmed by the actions of others. These personal injury cases range from car and truck accidents to the most complex litigation involving defective products and malpractice by healthcare providers. We are known as the firm that will stand up and fight for injured Mainers in disputes against big corporations and powerful interests.