Mark Herrmann: Regulation by lightning bolt

The following is a reader take by Mark Herrmann.

Last month, the Supreme Court held that manufacturers of medical devices approved for marketing by the FDA through the “pre-market approval” process generally cannot be sued by private plaintiffs. The medical device industry hailed that decision. At long last, companies that ran the regulatory gauntlet of FDA approval would no longer have the FDA’s decisions about appropriate product design and warnings second-guessed by lay juries sitting in the presence of an injured plaintiff.

The New York Times reports on a different subject, but it’s all of a piece. American courts permit juries to award punitive damages in some cases, but foreign courts are increasingly refusing to enforce those punitive damage awards. “Punishments,” those foreign courts say, “should be meted out by the criminal justice system, with its elaborate due process protections and disinterested prosecutors.” Lay juries should not be the gatekeepers of damage awards intended to punish wrongdoers.

These two recent developments grow out of different areas of law, but they point to the same underlying concern. Neutral government experts – either scientific experts at the FDA or legal experts in prosecutors’ offices – are the appropriate people to set public policy. Lay juries are not.

Juries serve important purposes. At the founding of the republic, criminal cases might ask whether the inhabitant of a log cabin had the right to shoot an intruder in self-defense or whether the owner’s response went beyond societal norms. A jury is the perfect decision-maker in that situation – who better knows societal norms than a small cross-section of local society itself?

And juries’ capabilities extend far beyond criminal cases. In many civil matters, a jury’s collective wisdom will resolve disputes more intelligently than many possible alternatives.

But juries are far less suited to decide whether complex medical devices have been designed appropriately, so society is right to limit a jury’s power to second-guess the FDA’s decisions on that score. Even if capable of making those decisions, jurors are sitting in the presence of an injured plaintiff and so are naturally sympathetic to that person’s plight. Juries are not weighing the risks and benefits of a product’s design in a neutral, dispassionate setting.

Juries’ decisions to award punitive damages suffer similar flaws. Juries rarely award punitive damages – but when they do, they occasionally do so in breathtaking amounts. Randomly imposing breathtaking damages is regulation by lightning bolt, not a carefully calibrated regulatory policy. If misconduct is to be deterred, people must know that it is likely to be uncovered and punished. Misconduct will not be deterred by rules that make it unlikely that the misconduct will be found, but, if it is, might be punished disproportionately.

Physicians, no less than other participants in the legal system, should work in an environment that deters negligence and compensates injured victims. But that system must be calibrated so that its results are predictable and layman are not forced to second-guess the decisions of neutral experts. In the field of medical malpractice, as in the fields of product liability and punitive damages, society is right to search for a system that regulates predictably, not erratically.

Zeus should dispense justice only in ancient Greek myths, not in modern American courts.

Mark Herrmann is the author of The Curmudgeon’s Guide to Practicing Law and blogs at the Drug and Device Law Blog.