Protecting Big Pharma from its Victims

Dear George,

It really grinds my teeth on edge when your critics start carping about “crony” corporatism, because it is a buck-assed truth that cronyism plays no role in the corporatist world. What we have, instead, is a collegial corporatism, a far more civilized manifestation of capitalism. In its collegial form, corporatism restricts bare-knuckle competition to certain well-established parameters and puts its primary emphasis on a cooperative effort to shore up its power and influence by breaking down the firewall that has traditionally separated commerce and the state.

In the emergence of collegial corporatism we are seeing the emergence of a new Holy Roman Empire that promises the world the eternal peace that only resource wars and wars of conquest can bring. But instead of piety, this Holy Roman Empire pursues profits.

It was necessary to sketch in this background before getting to the meat of this letter, and that is the role of the courts as midwives to this new empire. An article in Sunday’s New York Times illustrated the importance of the courts in giving birth to our new Rome.[1]

Big Pharma, more than other industry, has for too long been the victim of frivolous lawsuits by individuals who suffered ill effects, such as death and permanent disability, from using its drugs. The plaintiffs, to a person, are individuals who lack the backbone to suffer death and injury with the stoic apathy that is the mark of the good citizen.

It seems that seven years ago, the FDA approved a Johnson & Johnson product, the Ortho Evra patch, that delivered a dose of estrogen to post-menopausal women. Even before FDA approval, company research showed that the patch delivered a pretty heavy dose of the hormone. It was one of those little oversights that can happen to anybody. In a humane act, Johnson & Johnson decided to withhold this information because it did not want to cause the patch’s users undue distress.

Consequently, a couple of heart attacks and strokes popped up, which resulted in a net body count of forty deaths.

As too often happens, 3,000 “victims” of the patch are suing Johnson & Johnson, forgetting that taking any drug involves an act of informed assumption of risk on the part of the user.

I’m happy to say, George, that if your cronies (sorry, I mean colleagues) on the Supreme Court do their duty, this could well be the last class action suit against a pharmaceutical we will ever see.

Your administration is vigorously backing up Johnson & Johnson’s claim that they have immunity from liability because the FDA approved the patch, even though the firm withheld information about the dangers posed by the high estrogen dosage. The legal doctrine is called pre-emption, and states that the FDA is the only agency with the expertise necessary to evaluate a drug, even if this evaluation is grounded on false or misleading data.

The beauty of it moves me. The FDA, like other agencies in your administration, if rift with cron---, whoops! colleagues whose sole function is to see to the care and feeding of Big Pharma. The most efficient way of doing this is to make FDA approval an automatic shield against liability suits, thus saving Big Pharma the millions it spends each year defending these frivolous suits.

If the court decides in favor of Johnson & Johnson, it will be an illustration of the law at its finest as a enabler of procedural larceny.

The old Holy Roman Empire use to burn heretics; the new one simply rules against them in court.

Your admirer,
Belacqua Jones

[1] Harris, Gardiner & Berenson, Alex. “Drug Makers Near Old Goal: A Legal Shield.” The New York Times, Page One, Sunday, April 6,2008.