Monday, April 18, 2011
FDA Regulation and the Eye of the Beholder
Last week we got all misty-eyed about FDA, especially how it occasionally gets unfairly criticized by GAO. And then we got ornery about how plaintiff lawyers exploit such criticisms. As if on cue, this week GAO submitted findings to Congress criticizing FDA oversight of medical device approvals. The GAO testimony was a follow-up to a 2009 report about high-risk devices entering the U.S. market through the less stringent 510(k) process. FDA took steps to enhance premarket device safety since GAO's 2009 report, but GAO thinks FDA hasn't done enough. One gets the feeling that, in GAO's eyes, nothing could ever be enough. You should become familiar with the GAO criticisms, and then make sure your expert is familiar, because these criticisms will soon be showing up in court courtesy of your friendly neighborhood plaintiff lawyer. Please enjoy these bullet points: * FDA has not routinely used recall data to aid its oversight of the recall process * FDA inconsistently assessed the effectiveness of recalls * FDA lacks specific criteria to determine whether firms have taken adequate steps to correct or remove recalled devices * FDA's recall termination process is compromised by weak procedures and may result in recalled medical devices remaining in the market. We're not saying that GAO is completely wrong about all this. But there's a nagging, sanctimonious, 'gotcha' tone to the criticisms. Do you ever deal with people who obsess over Process? People who don't see the forest and don't even see the trees, because they spend all of their time with their noses pressed up against the bark? GAO at one point says that "FDA officials examining similar situations sometimes reached opposite conclusions regarding whether recalls were effective." Well, as Steve Martin would say, "Excuuuuuuuse me!" Different people sometimes will reach different conclusions. Yes, sometimes there are government organizations where everybody says the same thing. Like Stalin's Politburo. Mind you, GAO's findings are only "preliminary." Why, then, the shrill tone? Especially, when FDA has taken actions to improve the premarket approval process. GAO acknowledges these "positive steps," but there is darn little context or proportion in the GAO findings. It's as if the report was written in the Lyric Center in Houston. (Look up the addresses of some of your favorite Texas plaintiff law firms to see what that means.) It is a pity and a disservice if things like the GAO "preliminary findings" inspire some people to draw the conclusion that FDA is a paper tiger. Just under the GAO testimony in our inbox is a report from FDAzilla on "Top Seven Strategies for Avoiding 483s." It's an interesting report with helpful tips. But before you get to the tips, the report lays out how vigorous FDA enforcement has been lately, with the number of 483s issued by FDA climbing to 10,000 per year. Moreover, the agency has become more aggressive about issuing warning letters. FDA has also developed guidelines for misdemeanor prosecutions and plans escalating penalties. Foreign inspections are increasing, and U.S. inspections are becoming more challenging. Avoiding 483s is also becoming more challenging. Finally, as litigators, completely excluding 483s, warning letters, etc., poses its own set of challenges. The point is that FDA regulation is not a joke. It's the most thorough regulatory regime in the world. It isn't perfect, but for any institution where the key assets go home every night (like law firms and movie studios), perfection is impossible. We're pretty sure that GAO's work isn't perfect either. As any jury consultant will tell you, the biggest problem in defending big companies is that jurors all too often impose, not just higher standards of care, but unrealistically high standards of care on the defendant. That's probably all the more true with the government. So the danger of misuse of things like the GAO findings is real. A portrait emerges of an incompetent government saluting a crooked company. It's a portrait that is more deceptive than any of the deceptions that plaintiff lawyers accuse defendants of perpetrating.