The Supreme Court’s Medical Device Decision Misses the Point

Last week the Supreme Court ruled that medical device-makers are protected from personal injury lawsuits so long as their products have passed the most stringent FDA approval process. The principle that the Justices cited in their decision was “preemption”—the idea that the FDA stamp of approval is final, binding, and supersedes any problems or malfunctions that may subsequently occur.  This means, more or less, that if your pacemaker blows up the device-maker can shrug and say “sorry buddy, the FDA gave it the okay; you’re on your own.”

As harsh as this may sound, there is an argument to be made for preemption. The principle was pretty clearly written into a 1976 medical device law and the pro-business contingent has a point when it says that without some degree of preemption, competition is nigh impossible (it’s tough to navigate 50 different state codes, and the companies that can are the big, established ones).

But regardless of the principles behind the Court’s decision, the practical dimensions of the ruling leave much to be desired. Preemption only has teeth if the FDA does—but the agency is all gums.

For years, the FDA has been in a state of steady decline. According to a former FDA chief counsel, the agency's staff has shrunk 14 percent over the last 14 years. Experts say the FDA needs a 15 percent boost in funding per year for the next five years in order to be effective, and a November report revealed that the FDA barely has any computers or personnel infrastructure.

In short, the FDA is a mess, and the entropy hasn’t spared medical device regulation. To help fill its empty coffers, since 2002 the FDA has had a system in place that allows device-makers to pay fees in order to expedite product inspections. It is estimated that between 2007 and 2012, the FDA will collect $287 million in fees from medical device companies—just over a fifth of the total cost to the FDA to review new devices.

The obvious problem here is that the FDA has an incentive to churn through devices as quickly as possible: faster approvals mean more manufacturers will pay the fees, thus helping the FDA make up some of its funding gap. And rushed inspections are usually poor inspections.

The FDA’s medical device fee-system is almost identical to its drug inspection system and the results there have been less than promising. In October of last year, an inside source at the FDA told Maggie that the performance goals (e.g. targeted turn-around times for approval) associated with a fee-based system have compromised drug approval standards.

“For the drug-maker it’s a gamble,” said the source. “The company is betting that, because we want to make the 10-month deadline [for reviewing and approving new drugs], we won’t send the application [for approval] back. If you find a problem or there is something missing [from the application] and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process. “Now,” he says, “we send it back [only] if it’s really crappy.”

There’s no reason to believe that medical device regulation won’t fall into the same pattern of cutting corners—not just because of the fee system, but also because of the general impotence of the FDA. In 2005, The New York Times reported that the FDA issued an internal memo stating “that the agency had little idea whether device manufacturers were fulfilling their obligations to conduct studies on the safety of products once they were on the market.”

Late last month, the Government Accountability Office (GAO) issued a report condemning the FDA for failing to meet “the statutory requirement to inspect certain domestic establishments manufacturing medical devices every 2 years.” Instead, the FDA inspects U.S. device-making plants every 3 to 5 years and foreign manufacturers a startling one every 6 to 27 years. How comforting.

Granted, the Supreme Court’s decision doesn’t apply to manufacturing errors; patients can still sue if a device is manufactured to be out-of-synch with FDA standards. But the broader pattern is still very clear: the FDA is swiftly approaching rock bottom. 

What’s also troubling for any astute political observer is how the sides of the preemption controversy have broken down along political lines. Obviously device-makers are happy about the Court’s ruling—but so is the Bush Administration. A U.S. deputy solicitor general told the Court that the absence of preemption would amount to “serious undermining of FDA’s approval authority and its balancing of the risks and benefits.” You know something’s up when the anti-government crowd is celebrating the monopolistic authority of a federal regulatory agency.

So why the support? The Bush Administration knows better than anyone that there is more at stake than issues of authority here. After all, the FDA is an executive agency—the President has a first-row seat to its epic decline.

Thus the administration is well aware of the reality that the Supreme Court’s legalistic approach missed: the FDA has been made the final word on nationwide safety standards for medical devices as it slumps toward total paralysis. And if the FDA can’t do it’s job, then preemption is an empty doctrine—logically sound in the courtroom, but practically ineffective in the real world.

Comments

[JMT]

What if it is proved that a co/corp HID info from the FDA during the approval process?

[Jack Lohman]

If the FDA reviewing board had ZERO doctors on the panel who were not also taking consulting or other fees from the manufacturer of the product being reviewed, perhaps it wouldn't be such a problem. But in the case of Vioxx, as just one example, 9 of the 15 members of the reviewing panel were consultants for the drug company (or otherwise had a conflict of interest). The company surely got what they deserved, but only after a few patient deaths.

[Earl Butz]

An 8-1 SCOTUS decision and an attempt to pick it apart without a law degree? How like Mike Nifong and the Duke lacrosse team.

[Tom]

So, yet another example of the fedgov failing us. Amazing. Remember, you can't blame just Bush 43 as you cited a decline over the past 14 years.

(Aside from the snark =)) I have two questions.

First: How much money would it take to allow the FDA to do its job?

Second: Given this ruling, can the victim of a malfunctioning medical device sue the FDA?

[NG]

The sole dissenter, Justice Ruth Bader Ginsburg, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.

That was all that Congress had in mind, Justice Ginsburg said, not "a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices." She said that Congress had passed the 1976 law "to protect consumer safety," not to oust the states from "a domain historically occupied by state law." The decision was at odds with the "central purpose" of the 1976 law, Justice Ginsburg added.