Vaccine Injury, Liability And Preemption: A Recap
8 CommentsBy Ed Silverman // October 16th, 2010 // 10:25 am
For those of you who didn’t have a chance to keep up with an important legal and health issue, the US Supreme Court the other day heard arguments about whether the family of an 18-year-old Pennsylvania woman should be allowed to proceed with a lawsuit against Pfizer’s Wyeth for defects with its diphtheria, pertussis and tetanus, or DTP vaccine.
At issue is the underlying notion of preemption - in this case, whether a federal law known as the National Childhood Vaccine Injury Act of 1986 prevents the family of Hannah Bruesewitz to press their lawsuit, which was rejected by a federal vaccine court that is empowered to provide compensation. In the video, Marcia Coyle of The National Law Journal explains the courtroom blow-by-blow (you can read the court transcript here).
Justice in MI
I don’t think this one will be close–falls somewhere between Riegel and Levine. I’d predict a 6-2 or 7-1 supporting Wyeth–Ginsberg the most likely dissent, as in Riegel–especially given admin. support for preemption in this case.
M Helm, MD
For anyone interested in the actual medical issues of the case (and the reason the Vaccine Court dismissed the complaint). More detail can be found here: http://www.uscfc.uscourts.gov/sites/default/files/MILLMAN.Bruesewitz2.pdf
It should be noted also that the vaccine formulation the child received is no longer used. For many years now, “acellular” pertussis vaccine formulations have been available. These are purported to have a lower likelihood of fever and seizure. I’m not old enough (in practice) to be able to validate that perception clinically, though I think the licensing studies and probably the VAERS do support that conclusion (for the clinician this is actually a moot point). Certainly the acellular formulations would be less prone to the risk of the presence of pertussis toxins.
A question in my mind is the durability of the vaccine response to the acellular formulations. In recent years there has been a resurgence of pertussis (whooping cough), not just in California. Not that I want to go back to the “purified” whole cell pertussis vaccines, but there is now more recognition of the need to revaccinate adolescents and at least one acellular pertussis booster for adults to age 65.
In the broadcast story, autism was mentioned a couple of times. This particularly bothers me when 1) no relationship is demonstrable between vaccines and autism, 2) autism has been increasingly used as a label for all kinds of things, from severe mental retardation to just “odd kid” behavior - it is simultaneously a terrifying diagnosis for most parents and a more desirable diagnosis than, for example, severe mental retardation (which itself has many causes), and 3) the child in question clearly does not have autism - instead there is some focal brain abnormality which followed after (or manifested as) a prolonged period of seizures.
Truly this is a sad case for the Bruesewitz family, just as it would be for any family where something interrupts the development of their apparently normal child. I’m afraid that the limits of both science and the law will not deliver the real remedy this family and Hannah’s cargivers would desire.
JaT
I agree with JiM, sadly.
One thing that would put an end to the mass intrusion would be mass home schooling. The fewer kids in public school - the less federal dollars doled to the states.
The other would be if it could be decided per state under the 10th Amendment. Then people might find they have a choice if they are willing to move.
Wouldn’t that be an interesting experiment.
Condor
Permit me to disagree — with both my own (prior) opinions on this topic, and JiM’s and JaT’s. . .
The way the case was actually argued, premption (as a doctrine) emerged as far less important — in most of the Justices’ minds (IMHO) — than the notion that the “free market incentives” normally present in drug (contra vaccine) manufacturing and research efforts are wholly absent in the Vaccine Court statutory schema, if one whole-sale accepts the government’s (and pharma’s) views of the schema. To wit:
I finally had a chance to listen to the live .mp4 file of the Supreme Court oral arguments (a little over an hour investment), last night. I came away surprised. Surprised, and convinced that this is a closer case than I might have earlier guessed — based solely on a reading of the briefs — and the current political makeup of the court.
Importantly, at various points, Chief Justice Roberts (generally a very “pro-free markets” justice), Justice Alito (ditto) and even Justice Scalia (truly shocking!) made remarks, or asked questions, that were suggestive of the idea that they felt the whole Vaccine Court statutory schema has blunted any free-market incentive to improve vaccines, once approved. And that could foreshadow a decision at least moderatley helpful to the Bruesewitz family. Fascinating — and yet more evidence (to remind me, personally!) that it makes sense to actually hear the arguments, not just read the cold, flat black and white legal briefs — in any closely contested case. . . .
More here.
Namaste
Anne PME
In my state, I’ve seen several doctors who are concerned about giving their patients vaccines. They are concerned that when vaccine makers are protected from liability, the providers who administer the vaccine may have increased liability. Also, certain vaccines cause them to loose money.
M Helm, MD
Anne, I don’t understand the concern about increased provider liability. It makes no sense to me (though to paraphrase “Dr. McCoy” from Star Trek, D***it Jim, I’m doctor, not a lawyer). A provider following the immunization schedule is essentially protected from liability (except if the vaccine is administered or stored incorrectly). The vaccine schedule defines the standard of care. MORE liability would be associated with declining to vaccinate (especially if requested) or discouraging vaccination in the event that the unvaccinated child acquired a vaccine preventable illness and suffered.
This “concern” sounds more like a smokescreen to cover that the MD doesn’t feel their profit on one or more vaccines is sufficient to bother with stocking it (or them). Providing vaccines is typically a source of revenue for a practice. That is assuming there is reasonable patient demand in the practice to justify the hassle and expense of acquiring and storing the vaccines, and having staff trained in counseling and administering them. The costs and opportunities vary by state, and based on how the vaccines are purchased.
If a doc only rarely seen newborns, then yeah, it is likely that they wouldn’t want to bother with keeping polio vaccine in stock (for example). But that should have more to do with inventory carrying costs, storage, and the possibility of spoilage than fear of liability.
As for guessing the outcome of the Supreme Court, Condor, I gave up on that long ago. However, I thought that we were out of the era of “activist” judges writing new law from the bench. Moreover, the facts on the ground relative to improvements in vaccines don’t suppport the idea that the vaccine court law and operation “blunt” free-market incentive to improve vaccines. We can accomplish immunization against all of the entities on the schedule with far fewer “jabs” than we used to. As I understand it, there do not appear to be more problems with the new combinations or preservative-free formulations(well accepted by parents and pediatricians) than with the vaccines they have replaced.
Condor
Hello M. Helm, MD (can’t help but see Dean Martin, circa 1967, in a white turtleneck, whenever I see your handle!) –
A small point, perhaps, but actually (in the case of vaccines) it was essentially conceded by the government lawyers at oral argument that there is no longer any free market incentive to improve given vaccine. The government (NIH, CDC and FDA along with HHS, later) essentially direct mist vaccine research and innovation.
Thus it at least seemed that the right wing of the Court might use this as a springboard to “improve” the Vaccine Court’s mechanics, via an unexpected construction of the statutes in question.
Finally, as to your suggestion that we are beyond “activist” judges making new laws — from the bench — I can assure you that we are not.
The recent Citizens United holding is proof of my position, here.
Namaste
Condor
Excuse the iPhone typos, I think you’ll be able to figure out the gist of my commentary. And the Dean Martin reference is to the spy character he played in a series of forgettable feature films — as a (very) poor man’s Bond — Matt Helm.
Cheers!