Riegel v. Medtronic Is Bad Medicine

The Supreme Court’s Riegel v. Medtronic ruling, which protects makers of certain medical devices from being sued, endangers patients’ rights. Pro or con?

Pro: Preempting Lawsuits Diminishes Safety

The Supreme Court’s recent decision in Riegel v. Medtronic grants medical device manufacturers immunity from lawsuits if a product has gone through the Food & Drug Administration’s pre-market approval process. The Court ruled the FDA was superior to a jury in determining the medical device manufacturer’s required safety guidelines. In doing so, the justices have allowed the sale of defective devices.

Plenty of evidence questions the FDA’s expertise. As reported recently in the New England Journal of Medicine, despite knowledge of dangerous defects of an implanted defibrillator lead—used to regulate the heartbeat—the FDA allowed these devices to remain on hospital shelves for months, until the manufacturer voluntarily recalled the product.

As a result, the defibrillator leads fractured in 665 patients, and five patients died. The products in question were approved by the FDA with no human clinical testing. This is just one example of a manufacturer repeatedly and knowingly selling potentially defective devices despite the FDA’s oversight.

Similar atrocities have occurred with prescription drugs. Historically, the FDA has allowed drugs onto the market in return for the manufacturer’s promise to do follow-up studies, regardless of evidence of serious side effects. For example, in 1993 the FDA approved the drug Traysol for use in heart operations, despite a link to kidney problems. No follow-up studies were done. In November, 2007, Traysol marketing was suspended for, among other things, the increased risk of kidney failure.

Often, effective studies never take place. The agency as a whole has failed to fulfill its obligations largely because of politics and a lack of sufficient funding and resources.

A jury trial in a civil lawsuit takes a more balanced approach to making the right decisions. Competent lawyers for both sides ask questions and present arguments. Highly credentialed experts on both sides explain the science. There are no “cozy” relationships or conflicts of interest, and the jury is independent.

The results of such trials would not subvert the FDA’s authority but rather act as an incentive for companies to provide safe products and promptly report problems. In the big picture, this is more effective for protecting the public from negligent conduct than the FDA’s regulations.

Con: Riegel Benefits the Manufacturers and the Public

The Riegel ruling has been hailed by many as a victory for medical device manufacturers only. Such a view ignores the benefits derived from the regulatory scheme governing FDA pre-market approval of medical devices that was established by the Medical Device Amendments of 1976 (MDA).

The medical device industry and the public enjoy a mutually beneficial relationship. The aging of our population has led to an increased demand for new high-tech medical aids. Today’s devices allow people to lead normal lives, when only a few years ago their survival would have been in doubt. Vice-President Dick Cheney’s ability to endure the rigors of public office, for example, is directly attributable to the implantable cardioverter defibrillator he received in 2001.

Device manufacturers, in turn, require profits for shareholders and to reinvest in new technologies. Subjecting device manufactures to different states’ laws—where junk science often rules—is not the means by which to further meet the needs of the public or manufacturers. State courts have failed to apply consistently the legal standards governing the admissibility of expert testimony at trial, hence we need a regulatory scheme that provides predictability to manufacturers, fosters innovation, and ensures the utmost in protection to the public. The MDA accomplishes just that.

And let’s not forget that the Riegel ruling applies only to medical devices that received “pre-market approval,” a rigorous process during which the FDA spends an average of 1,200 hours reviewing each application.

To ensure patient safety, manufacturers gather extensive clinical and preclinical data over many years at a cost of tens of millions of dollars. Once a device receives approval, the manufacturer is forbidden to make changes in the product’s design, labeling, or manufacturing process. Furthermore, manufacturers must inform the FDA of new clinical investigations and studies and incidents in which the device contributed to death or injury.

The stringent requirements of the MDA provide protection to the public while advancing innovation. The inability of a few plaintiffs to pursue state tort claims is a small price to pay for great strides in medicine.

Opinions and conclusions expressed in the BusinessWeek.com Debate Room do not necessarily reflect the views of BusinessWeek, BusinessWeek.com, or The McGraw-Hill Companies.

Reader Comments

random

To say that in states junk science is the rule is being rather dismissive of the scientific and medical resources a state would have. And to hold the FDA's pre-market approval process as a hallmark of quality is also erroneous. In the last decade alone, we have seen many tales of strange, often politically motivated rulings and many drugs with bizarre and unstudied side effects being unleashed on the public. Nobody is perfect, but that doesn't mean that there shouldn't be consequences for playing around with people's lives.

Gregg Gruis

I have had two defibrillators recalled yet my insurance and I are liable for expenses. Guidant and Medtronic are the ones who supply the FDA with reports of faulty problems. Gee, the Coyote guarding the chicken coup.

Gregg Gruis

I have had two defibrillators. One was recalled and I replaced the other. Yet my insurance and I are liable for expenses. Guidant and Medtronics are the ones who supply the FDA with reports of faulty problems. Gee the coyote guarding the chicken coup.

Chris

The government is incapable and unwilling to protect the public. Politicians and thus government are controlled, i.e. owned, by special interest groups, which do not have the best interest of the majority as their priority.

Paul

This administration is so biased in favor of industry that the health and well being of citizens is not even a secondary consideration. This is true in bailing out investors in the financial markets, and it is true in letting the pharma and medical device industries allow products with known issues on to the market.

"Government by and for the people..." I don't notice the phrase "industry" in there anywhere. And now, back to the war in Iraq, another excellent example of our government at work.

Beth

The court system is one of the checks and balances of our capitalistic and democratic system. Because lobbyists for wealthy industries such as found in the medically related sectors can become deeply involved in the legislative branch, and there is no consistent competition from the civilian (patient) sector, ultimately, big business prevails in favorable legislation. The courts only rule on the laws; they don't create the laws.
However, since all of them are politically appointed at the higher levels, they tend to represent a special interest perspective reflecting what political sector they originated from. So, the court decisions tend to reflect the appointments and confirmations majority. Therefore, it's all about when an issue is raised--during what composition of the court.

It is clearly not in the interest of the public for proprietary corporations to get a consequence-free road before them as they begin down the road of medical production and development. We know that all decisions are based on revenues, and if there can be an opportunity for revenues brought in without the potential for revenues taken away through civil court, there is no corporate motivation for high standards and ultimate concern for human safety and life. That is the reality of the corporate world.

Obviously, many systems in the U.S. are broken in terms of supporting the public interest.

Tom Mariner

Those writers whose libelous statements that a governmental agency is in bed with those governed ought to understand the facts before their fingers hit the keyboard.

The FDA reaction to a serious infraction is always swift and brutal--there is no lengthy legal battle, just literally within minutes an order to stop everything the plant is doing--right now. In medical devices, that is called "padlocking the door." Why would patients want to trade that for a years-long battle fought by high priced attorneys on both sides to get the bums out of the business?

The FDA treatment of medical device firms is somewhat different from their responsibilities for drugs. They are actually very effective in making sure that things doctors use for patients are "safe and effective".

The manufacturers have to maintain a strict system to not only design to the highest standards, but also monitor closely the results from the field to detect even the slightest blip that may mean something not right. In fact, in the rare case that something is reported to the FDA, they not only immediately and thoroughly investigate the individual product but also investigate the way everything is built at the facility or company. They know that it is virtually impossible to produce something that fails in the field if one follows their "good manufacturing process.
"
Here are the facts--the FDA is so effective in its enforcement that it is a rare event that any of the billions of medical devices in constant use today ever stop doing their job regardless of how they are mishandled.

Mark Baird

But when something does fail and society benefits because the product has been improved, should not my son who at 16 died not receive some compensation from society?

If big government does not work as so many conservatives claim, then why give the big government agency the last say?

If conservatives disdain experts/scientists or the elites, then why do they trust the scientist or experts of the FDA?

If conservatives are big believers of the free market and the wisdom of the crowd then why do they not trust a trial by jury?

BigTex

These comments from Mariner are so out of touch with the realities of device regulation that he is either misinformed or over exagerating the roll of FDA in medical device regulation: He states, "The FDA reaction to a serious infraction is always swift and brutal--there is no lengthy legal battle, just literally within minutes an order to stop everything the plant is doing--right now. In medical devices, that is called "padlocking the door." Why would patients want to trade that for a years-long battle fought by high priced attorneys on both sides to get the bums out of the business?"

Most device recalls are voluntary. The FDA seldom uses swift action to keep a product from continuing to harm people.

Mariner also writes, "The FDA treatment of medical device firms is somewhat different from their responsibilities for drugs. They are actually very effective in making sure that things doctors use for patients are "safe and effective."

These statements are completely misinformed and naive. Politics is the foundation for medical device policy. No congress member with a large device industry in their state will even dare to question the lack of safety in the medical device 510(k) notification system where impantable devices are green lighted to sell based on their similarity to another product on the market.

What's moer pathetic: Consumers who trust politicians like Al Franken to protect them are being betrayed by him. He should at least admit that device patients will be conmprimised due to his and others slavish unholy allience with device industry lobbyist. Jobs and innovation don't mean anything to disabled device victims living in excrutiating pain for the rest of their lives. If Franken and Klobuchar could experience one day of pain these crippled device victims endure, I hope they would have the decency to see the world through a consumers eyes instead of a lobbyiest.

Sentor Franken, please do the decent thing or go back to comedy because you've brought nothing but tragedy to victims of medical devices.

Join the Debate

 

Participate More!

Please send us your ideas for new Debate Room topics. If you're an academic, association officer, or other industry expert and would like to write a Debate Room essay, send us a query. Questions? See the

BW Mall - Sponsored Links

Buy a link now!