The Con Game

I was absolutely astounded by this article in yesterday's NY Times.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

The doctrine would make sense, sorta-kinda, if the FDA were adequately staffed and adequately funded, but it's not. In fact, it's so understaffed and underfunded that it relies upon the pharmaceutical companies to test the drugs themselves and to report the results honestly to the FDA.

Here's a scenario. A member in good standing of PHARMA submits an application to market a new drug, a lotion which cures baldness in men. The clerk accepts the application and asks if the drug has been fully tested. The PHARMA member asserts that of course it has. Then the clerk asks if there have been any serious side-effects. "Nope, just some very happy men and some very excited women." The application is granted.

What the PHARMA member didn't disclose that while the lotion does cure baldness, it has some "rare" side effects: itchy palms which ultimately turn into psoriatic arthritis in only 2% of the test subjects. That's hardly worth mentioning.

That's essentially what Johnson & Johnson did with its birth control patch, and the side effects caused the deaths of some women and disabling conditions in others because the delivery system put too much of the drug into their systems, leading to blood clots. When their testing showed the danger, Johnson and Johnson doctored the test results.

Here's the tragic part. Most of the parties involved in this and similar litigation anticipate that this company and many others will get away with it, given this Supreme Court. This is what happens when we allow "the market" to regulate itself. This is also what happens when the wrong people are elevated to the Supreme Court without any protest.

All that dry powder sitting around has become dangerous.