Toward life, liberty and the promise of safe drugs

The volume of press coverage given lately to D.C. v. Heller, the Guantanamo Bay torture cases and John Yoo’s memo has unsurprisingly allowed more than a few other legal issues to escape public notice. The comparatively boring right of consumers to sue drug companies hinges on a relatively obscure doctrine known as pre-emption. The legal interpretation of pre-emption potentially affects everyone who will ever use an FDA-approved medicine (read: most Americans). And the Roberts Supreme Court, repeated avowals of “strict constructionism” notwithstanding, might be poised to make a significant change in existing law.

Advocates of pre-emption argue that the decisions of certain federal regulatory agencies — like the Food and Drug Administration — should effectively override state and local tort law permitting individuals to sue for damages because of the unique expertise required to make judgments about new medicines. Broadly at issue in upcoming pre-emption cases (Riegel v. Medtronic, Warner-Lambert v. Kent, Wyeth v. Levine and an as-yet unnamed case involving Johnson & Johnson) is the legal status of medical devices approved by the FDA that subsequently caused serious injury or death even when used properly. According to The New York Times, a Johnson & Johnson birth-control patch called Ortho Evra has killed 40 women.

To (over)simplify a bit: A multibillion-dollar drug company that (probably knowingly) marketed a defective product wants the Supreme Court’s help to absolve itself of all responsibility for more than three dozen deaths because of the actions of a federal regulatory agency. Never mind that Johnson & Johnson may have concealed data from the FDA. Never mind that the FDA is, in the words of The New York Times, “poorly organized, scientifically deficient and short of money” (not to mention the fact that it came under fire a few years ago for placing ideology ahead of sound medical judgment in its ruling on the morning-after pill). Think about the implications of a decision permitting drug companies to wash their hands of any vestige of legal responsibility if the FDA approves their product — even if the FDA does so with misleading or incomplete data.

Will drug companies protected from lawsuits have any incentive to double-check and triple-check the safety of medicines that they market? If they believe that lying to the FDA puts them on the fast track to legal immunity, won’t they have an even greater incentive to pass along doctored data to the harried agency? A ruling in favor of pre-emption would effectively place drug companies above the law, subject only to a regulatory body that has already shown itself to be prone to political bickering and conflicts of interest. The FDA — flawed as it is — would become our only protection from carelessly tested or outright dangerous medicines.

The cert petitions in Wyeth v. Levine list more than 40 cases as potential precedent. I can’t pretend to have any knowledge about the legal issues at stake in, say, Bowen v. Georgetown University Hospital. I can’t pretend to be any sort of expert on pre-emption. But from where I stand — as a citizen and a consumer — this case doesn’t need to rest on complex legal nuance. The issue of protection for drug companies whose products cause death is far simpler than that. Its simplicity rests on the fundamental legal notion, upheld explicitly in Marbury v. Madison and implicitly at the core of American jurisprudence, that every infringed right has a remedy. Every American harmed by a drug company willing to deceive the FDA for a quick buck has the right to seek compensation. An overly expansive view of pre-emption threatens that fundamental right.

Imagine that the Supreme Court held that the police have no right to search your home without a warrant, but if it happens, there’s nothing that can be done. Imagine that the Supreme Court upheld the right to a fair and public trial, but if someone happens to be convicted unfairly, the government cannot intervene. The very essence of our legal system would evaporate.

An overly expansive view of pre-emption does not threaten ordinary Americans to the same degree as those hypothetical cases, but it nonetheless presents a similar instance of denying remedy for a right infringed.

As Americans, we have a right to be confident in the safety of the medicines our government approves and the ability to seek redress if that right is violated. But if drug companies get their way in these upcoming cases, one seemingly obvious liberty could be severely degraded.

Xan White is a junior in Pierson College. His column runs on alternate Thursdays.

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