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September|October 2005
An Uncivil Division By William R. Yeomans
Left to Their Own Devices By Theodore Ruger

Left to Their Own Devices

By helping to shield manufacturers from lawsuits, the FDA is pushing tort reform by fiat—and leaving potentially flawed devices on the market.

By Theodore Ruger

WHEN DANIEL HORN'S HEART GAVE OUT IN 1998, doctors at Hershey Medical Center near Harrisburg, Pa., determined that he would not survive without a new one. But as he waited for a suitable donor, Horn grew dangerously weak, and his doctors were forced to make alternate plans. They opened Horn's chest and implanted a device known as the HeartMate, a pump designed to help his blood circulate. The United States Food and Drug Administration had certified the HeartMate's "safety and effectiveness" in 1994, and the device kept Horn alive for several months. But then it fell apart inside his chest, releasing an air bubble that traveled to his head. Several days later, Horn was pronounced dead of a brain hemorrhage.

In April 2000, Horn's widow, Barbara, sued the HeartMate's manufacturer in United States District Court. She claimed under Pennsylvania law that her husband had died because the HeartMate's design was dangerously flawed and that the manufacturer had failed to warn doctors of the device's apparent defects. The case seemed unremarkable, one of thousands of lawsuits over the years to allege flaws in drugs and medical devices already approved by the FDA. Usually based on state tort law, the suits serve to compensate victims for injuries and to add a layer of oversight beyond the FDA's responsibility for determining that a drug or medical device is safe to sell. The agency has long endorsed this combination of regulatory approval and subsequent litigation, and the approach has arguably saved countless lives. As recently as 1997, the FDA acknowledged that its approval process alone could not "guarantee the safety of" devices on the market.

But in Barbara Horn's case, the FDA took a dramatically different tack. It argued that its prior approval of the HeartMate as safe preempted her state-law claims. Courts generally give great weight to the views of expert agencies like the FDA and, in November 2002, a federal district judge threw out Horn's claims. Last year, the Court of Appeals for the Third Circuit affirmed the ruling, relying largely on the FDA's brief.

SINCE THE BUSH ADMINISTRATION CAME TO POWER, the FDA has taken a hard line against product-liability lawsuits like Horn's, arguing that they hinder its ability to regulate by creating new and sometimes inconsistent safety standards for medical devices. But rather than make its case and risk opposition before elected officials in Congress, the FDA has engaged in the stealth tactic of intervening in private lawsuits.

The force behind the tactic has been Daniel Troy, a conservative legal activist who served as the agency's chief counsel from 2001 until last year. Before he arrived at the FDA, Troy was an energetic and effective thorn in the agency's side. He worked together with the Washington Legal Foundation, a "free enterprise" advocacy group, in pushing for deregulation of the pharmaceutical and tobacco industries. He represented companies in persuading courts to strike down limits on advertising and commercial speech. In 1998, for example, Troy stopped the FDA from issuing new restrictions on information about "off-label," or unapproved, uses of drugs. He has consistently argued that doctors should be allowed to make their own decisions about a drug's safety and effectiveness, a stance that seems at odds with his view that the FDA should be the sole arbiter of product safety. Underlying his public positions, though, has been a commitment to shielding doctors and medical companies from litigation and regulation, an agenda that reflects the Bush Administration's broader program of "tort reform."

Troy and the Administration seem to be achieving that goal despite what looks like extraordinarily bad timing. Recent events like the withdrawal from the market of Vioxx, a painkiller suspected of increasing the risk of heart attacks and strokes, have exposed serious flaws in the agency's process of approving and monitoring products. Congress, top medical journals, and the public have all called for reforms, and the FDA itself has acknowledged its shortcomings. Still, the agency remains adamantly opposed to lawsuits that allege defects in new medical devices.

The FDA has had little trouble persuading courts to accept its views, because the federal law regulating medical devices is so unclear. The law says federal "requirements" for the devices preempt state law "requirements," yet it fails to define "requirements." The FDA used to interpret the term to mean general rules for the proper functioning of devices. Now the agency argues that its mere approval of a device as safe constitutes a federal "requirement," and so all claims based on state law relating to safety are preempted. The agency contends that lay jurors and judges undermine its ability to regulate by making uninformed judgments about safety. Lawsuits "threaten the statutory framework for the regulation of medical devices," the FDA argued in the Horn case, and produce consequences that "can harm the public health."

But the agency is promoting bad policy and bad law. First, its stance threatens to allow unsafe drugs and medical devices on the market. The approval process cannot identify all the potential dangers of a drug or device, particularly hazards that are infrequent or can be confused with naturally occurring events. Under the best of circumstances, the FDA's review of studies containing a limited number of research subjects gives it an incomplete picture of what can go wrong with a drug or medical device. Some serious but hard-to-detect problems surface only after the research stage, when tens of thousands of patients use a drug or device. FDA approval means only that a product has been deemed safe and effective at a particular place and time, with limited information.

Much can go wrong after a product hits the market, and it is essential to track how a product performs once it gets into the hands of consumers. The FDA does not have the staff, the budget, or the ability to gather the information necessary to do the job competently. Critics have recommended that Congress create an independent body to act as a product monitor, or that the vast stores of patient data held by Medicare and private health insurers somehow be combed for signs of problems. But these proposals underscore why product liability suits are indispensable in identifying safety risks.

What's more, there is little evidence that lawsuits involving devices and drugs thwart agency goals or impose unreasonable costs on manufacturers and consumers. Drug and medical device companies typically cite the costs of research and development—not litigation expenses—as the reasons for higher prices. The lack of evidence to support the contention that litigation boosts prices has prompted lawsuit critics to get creative. A few years ago, Troy reportedly bemoaned the lack of hard data and asked a group of friendly industry lawyers to generate studies that would show how litigation hampers the drug companies. The agency's claim that state tort law subverts its regulatory obligations seems driven as much by ideology as by empiricism.

The FDA's method for advancing its agenda is also questionable. Throughout American government, agency officials exercise immense authority despite being unelected and generally unaccountable to the public. The law holds them and their agencies in check, though, with a rulemaking process that typically subjects important policy changes to public comment and approval. The FDA has skirted this relatively transparent process by seeking policy changes through the courts, intervening in significant cases about which the public knows little.

Numerous courts, including the U.S. Courts of Appeals for the Fifth, Sixth, Seventh, and Eighth Circuits, have accepted the views expressed by the FDA, failing to recognize that this is the wrong time and the wrong way to allow such a dramatic shift in policy. As Barbara Horn can attest, the safety issues at stake affect thousands of patients around the country, and they should be resolved through public debate rather than left to the machinations of a few bureaucrats and judges.

When the FDA argues that its decisions should trump court rulings that are based on state law, it raises issues that affect the balance of power between the states and the federal government. A decision to weaken state power in this area is too important to make without advice from a broad range of parties, including the states themselves.

Theodore Ruger is an assistant professor of law at the University of Pennsylvania Law School.

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