An FDA Tightrope Act
The man had a heart pump, which extended his life for a few months after a heart attack that would otherwise have killed him. But then a suture came loose, and the subsequent complications killed him. His widow sued the heart pump manufacturer, claiming that the design of the device was defective. But the Food and Drug Administration had approved the device as safe and effective. So last week, a federal appeals court in Pennsylvania threw the widow’s case out of court.
This was a victory -- one of several recently -- in the Bush administration’s campaign to get courts to do what Congress won’t: limit lawsuits, especially lawsuits against big corporations. In this case, the administration is largely right. Companies that make drugs and medical devices should be held to a very high standard of care. But they are entitled to a uniform standard -- one that they can know in advance and rely on.
The FDA represents society’s best effort to set an appropriate standard. This is a balancing act. Too lax a standard, people get hurt. Too stringent a standard and not only are products kept off the market (even though they may benefit some), but future medical breakthroughs are discouraged.
The FDA is not perfect. But neither is any other mechanism for determining this balance. Lawsuits are especially bad: costly, inconsistent and prejudiced on the side of excessive caution. If the FDA is not doing an adequate job of assessing the dangers of new medical products, it should be reformed. But putting tomorrow’s medical miracles through an FDA process that many think is already too cumbersome, having experts certify these products as safe and effective and then allowing that question to be redecided again and again by non-expert juries across the country -- each coming up with a different answer -- make no sense at all.
Obviously, if a drug company has deceived the FDA or corrupted the approval process in some other way, victims of that malfeasance should be allowed to sue. And then there’s the issue of “post-market surveillance.” Sometimes the dangers of a drug or medical device become apparent only long after it has been approved and used by many patients. The FDA should do a much better job than it does on this. Now, it does not even require doctors to report problems with approved drugs and devices. But manufacturers should also be liable for negligence if they ignore, or go out of their way not to learn of, problems with their products that emerge only after FDA approval.
We will never have infallible heart pumps. Our choice is either to decide as best we can how much risk of failure we can tolerate or to let loose the lawyers and have no heart pumps at all.
