So asks Megan McArdle. The argument runs as follows:
I don’t understand quite why FDA approval of drugs and medical devices
hasn’t long provided legal safe harbor for their manufacturers. The
defects that show up, such as the Vioxx and Fen-Phen problems, are
discovered long after approval precisely because they’re so rare that
they don’t show up in ordinary clinical trials. If the government
experts, who are presumably highly motivated to avoid catastrophes,
can’t spot the danger, why do we expect the drug companies to?
I can think of three possible rebuttals:
1. We simply can’t trust the bureaucrats to find the flaws with drugs. But note this is inconsistent with both the rhetoric of FDA defenders ("the FDA can work") and FDA critics, who argue we are overinvesting in drug safety as it is.
2. Lawsuits encourage the companies to look for problems once a drug is already approved. Regulation does not.
3. People need lawsuits as a way of emotionally striking back. If they are denied that privilege, they will demand ridiculously oversafe levels of regulation in the first place. In this view regulation is as much about building consumer confidence in a health care system as it is about protecting people.
I do not currently have a view on this matter. Do you? Kevin Drum is opposed.