The Washington Post features a mind-numbing editorial today in which the authors demonstrate an utter lack of understanding of civil law, regulatory policy, and administrative compensation schemes.
In the wake of the Roberts Court's 8-1 decision in Riegel v. Medtronic that found the language in the Medical Devices Amendments of 1976 (MDA) expressly preempt state tort claims, some Democrats have suggested legislation to remove the express preemption language.
The Washington Post doesn't like the path of the conservative court, or the Democratic Congress, instead suggesting that,
Lawmakers should instead consider creating a government-run compensation fund for patients harmed by medical devices, similar to the one established for those harmed by vaccines. They should also continue to strengthen the FDA through increased funding and oversight muscle. And they should return to the task of fashioning comprehensive tort reform that would significantly reduce frivolous litigation while ensuring that the rights of real victims are safeguarded.
While this type of third-way reasoning is often popular in Washington discourse, it rarely makes for good policy.
Consider the Vaccine Injury Compensation Program that WaPo uses as a model. This program was developed to provide no-fault compensation to people who had adverse reactions to vaccines. The underlying theory is that, while it's inevitable that some individuals will have an adverse reaction to a vaccine, the public health benefit of administering them to the broad population justifies the risk. Rather than simply sacrifice those individuals who react badly, though, we provide some compensation to them for "taking one for the team", so to speak.
Medical devices, on the other hand, are not vaccines. A heart catheter, such as the device at the center of the Riegel case, may save a life, but it's not necessary to prevent a pandemic. In fact, "medical device" is defined rather broadly:
A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy.
According to the Washington Post, manufacturers should not be liable for negligence in the design of surgical tools, wheelchairs, or heart valves. Their concern, though, isn't public health so much as it's the old canard that there exists an excess of "frivolous litigation."
I will spare you the de-bunking of this well-worn myth as you can easily find that the empirical evidence is very different from the talking points generated by American Tort Reform Association lobbyists.
But I did find it particularly unattractive that the Washington Post chose to trash one of the bedrock institutions of our democracy - the jury.
This is a favorite pastime of corporate lobbyists and right-wing statists - conjuring up tales in which a jury of dolts puts the nation at risk, and the only thing to save us is the independent wisdom of the
A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with itsgreater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.
But, again, as with the myth of excessive frivolous litigation, the attack on the jury system is founded in corporate public relations and misleading anecdote. These claims, however, do not stand up to the scrutiny of strong empirical research.
The truth, as I've noted before, is that right now corporate lobbyists prefer the federal regulatory state to federalism or trial-by-jury because the regulators are increasingly former industry lobbyists. And even if that were not as pervasive a practice as it has become, it's easy to lobby the head of the FDA. Doing the same with a jury is called "tampering" and results in felony charges.
The Washington Post gets it wrong because they're trying to wrap up a complex, messy issue with one quick stroke. Their solution is wrong on the facts, and wrong on the law. The express preemption language in the MDA is clearly on a collision course with justice, but the idea that an industry as broadly defined as "medical devices" should be covered by a sprawling administrative compensation scheme is to prescribe amputation to cure a wart.
Corporations may save money by eschewing accountability, but the real costs in that trade off will be borne by our most vulnerable citizens. The American legal system may be frustrating at times, but it's the most just system in the world, warts and all.
* The cynical way so-called conservatives are lately singing the praises of the federal regulatory state is really more than one should have to bear.