Thursday, February 21, 2008

Supremes Strike Down Ability to Sue Over Devices

As explained in this New York Times coverage:

...the U.S. Supreme Court handed the Bush Administration and the medical drug and device industries a major victory on Feb. 20, ruling that consumers injured by one class of medical devices had no right to sue in state courts because the devices had received FDA approval. (Other devices that had gone through a less arduous FDA review process were not covered by this ruling.)

That was the bad news. The other bad news is that the court ruling was 8-1, unlike the very common 5-4 split one sees on this nearly-evenly-divided (conservative vs. moderate) court.

The good news is that Congress could readily fix this by passing new legislation, and two foes of the drug industry, Sen. Ted Kennedy and Rep. Henry Waxman, vowed to do so.

The basic claim in the majority ruling is that the law assigns to the Federal government, and not to the states, responsibility for regulating devices and drugs. So for the states to allow such suits in their courts is tantamount to setting up a separate, illegal level of regulation.

The opposing argument, which in my view has more merit given today's realities, is that such a restriction on bringing suit against a company presumes a more or less perfect FDA process. It also assumes that there is really an adversarial relationship between the FDA and the manufacturer--that the FDA sets the bar deliberately high, and the manufacturer really has to come up with considerable and reliable proof that the device is safe and effective. More recently, especially with the FDA getting half of its budget for reviewing new drugs directly from industry, we have seen the FDA often serving as industry lapdog rather than as adversary.

As I mentioned in HOOKED, there is another angle on whether or not these lawsuits should be permitted. I'm a physician by training, and share with my fellow physicians the terror of a malpractice suit. Given this nearly instinctive distaste for using the tort legal system as a means to seek redress, how can I then turn around and say that it's a good thing when rapacious lawyers and clients can set their sights on the drug companies? One of the realizations that has led me to view such lawsuits with more sympathy is that without them, I could never have written HOOKED. That is, many of the most damning documents, that reveal the behavior of the drug industry that is most damaging both to public interests and to medical professionalism, come to light only as a result of the legal discovery process. The company can keep these nasty e-mails and memos secret, and only has to cough them up if it is sued. Without damage suits we would know a good deal less about the inner workings of the industry--to our great detriment.

Those who oppose such lawsuits naturally fear that the future will be bleak, as we and our children die of horrible diseases because no new medical drugs and devices are being marketed, because no company wants to face the financial risk of rampant lawsuits. That ignores the way that companies today seem quite undeterred even by huge class action suits. A company like Merck with Vioxx, or (earlier) Wyeth with the diet drugs fen-phen, simply stashes away in escrow a few billion dollars that it has rattling around in its pockets as spare change, as its lawsuit defense and payout fund. The company then reassures stockholders that it has stanched any future flow of red ink, and goes merrily about its business.

Greenhouse L. Justices shield medical devices from lawsuits. New York Times, Feb. 21, 2008.

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