February 21, 2008 The Pump Handle 4Comment

In an 8-1 decision in Riegel v. Medtronic, the Supreme Court has ruled that medical-device manufacturers whose products secured pre-market FDA approval are immune from liability for personal injuries. So, if you’re injured by a medical device (like a drug-coated stent or prosthetic hip) that’s received this approval, you won’t be able to sue the manufacturer.

This might not be such a problem if we could have faith in FDA’s approval process. But, as reports from the Institute of Medicine and the FDA’s own Science Board have made clear, the agency lacks the resources and scientific infrastructure to do its job properly. Under such circumstances, it’s important the people be able to turn to the courts, as David Michaels explained in a post about a Texas Vioxx case:

[L]aw suits are an important part of our de facto system to protect public health. If the tide has turned against the entire tobacco industry—and I believe it has—it is not due to actions by FDA or EPA, although the pioneering work of both these agencies raised public consciousness and helped reveal the workings of the tobacco industry. Rather, it is because the cigarette manufacturers have lost legal battles waged by the widows and widowers of deceased smokers, and by the states attempting to recoup the taxpayer money spent providing medical care for smoking-related diseases. As strong as it was and is, the strength of the science didn’t convince Philip Morris to admit that tobacco causes lung cancer. Only after being pummeled by so much detrimental and expensive litigation has the cigarette-maker come up with a new strategy that involves telling at least partially the truth.

Likewise, the asbestos industry was tamed not by OSHA and EPA, not by a frank acknowledgment of the science, but by lawsuits brought by victims of mesothelioma, lung cancer, and asbestosis brought against Johns Manville and other producers.

Years after the first cases of flavoring-related lung disease appeared in food workers, OSHA still hasn’t issued a standard protecting workers from diacetyl. But $100 million in court awards and settlements have convinced flavor manufacturers they have to address the problem.

The Drug and Device Law blog (via Pharmalot) gives the defense lawyers’ perspective on the Riegel v. Medtronic decision:

We defense lawyers retort that product liability litigation is horribly ineffective (given the influence of so many non-merits issues), inefficient (plaintiffs’ lawyers take 33% or more of most recoveries, and that’s not even counting defense costs), and downright counterproductive (deterring innovation, and punishing manufacturers for doing the right thing when they discover problems) compared to governmental regulation as a means of ensuring product safety.

Well, now we’re going to find out who’s really right.

In other words, the PMA medical device field is going to determine in practice whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public as we think it is – or if it’s as lousy a way of ensuring safe medical devices as the other side claims.

So, to the medical device industry – to the regulators at the FDA – and to our colleagues who practice FDCA regulatory law…. Don’t let us down, please.

So, it looks like we can all agree that this decision means that we’ll be relying on FDA more than ever before.

The question on a lot of people’s minds now is whether, following this medical device decision, the Supreme Court will decide that FDA approval can also shield drug manufacturers from liability claims. Gardiner Harris explains about a case the Court will hear in October, dealing with the listing of risks on a drug label.

As for the medical devices decision, it dealt with the Medical Device Amendments of 1976, and the intention of Congress in passing the amendments. Some of the lawmakers involved in that legislation don’t agree with the majority opinion about it, reports the NYT’s Linda Greenhouse:

“In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” [Senator Edward M.] Kennedy said in a statement. He added: “Congress obviously needs to correct the court’s decision.”

Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Mr. Waxman said. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

Congress may act to remove the immunity that the Court has now given to medical device makers, but in the meantime we’ll have to redouble efforts to strengthen the FDA.

4 thoughts on “The Supreme Court and the FDA

  1. But compensation claims play such a big part in our lives today.

    Won’t we be lost without the ability to sue somebody?

  2. What we’ve lost is a powerful incentive for medical-device manufacturers to make absolutely sure their products are safe, or to take them off the market as soon as it becomes clear that they’re unsafe.

  3. In the past I testified in a number of medical tort cases. This Supreme Court decision must be remedied by Congress. The FDA is clearly unable to police the devices and medications under its aegis. Inspecting the wrong heparin factory in China, delay in getting bad drugs off the market are the tip of the iceberg. It’s incompetence, too few experienced experts, political pressure or a combination of all three. The FDA must be restructured and freed from the interests of the pharmaceutical and device industries.

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