Last week we attended a Food and Drug Law Institute Conference in Our Nation’s Capital. Like other firms, we sponsored a table and, like other firms, we offered trinkets. Call it the Swag Battle. We tempted passersby with clips that magnetically stick to your refrigerator – the perfect way to preserve a bag of potato chips, assuming you don’t down all those sour cream crisps of goodness in one fell swoop. Two firms distributed flashlights (obvious symbolism there), another had whistles (potential creepy symbolism about whistle blowers), another had rubber brains (great for the kids), and one had weird magnetic pebbles that crashed together to make a sound like the beginning of the old Outer Limits television show. We were mightily impressed when one of the sponsors placed a white chocolate wafer with its name on top of the cheesecake dessert. Presumably when you actually eat the name you’ve made the ultimate oral commitment to the brand.
But the real benefit of the conference isn’t these crazy goodies. Rather, it’s in meeting colleagues, clients, and counterparts. Mostly, we met folks from the FDA. Many of the top personnel from FDA were there, as were a number of staffers and administrators and lawyers doing important work in CDER, ORA, etc. Confession: we liked and respected everybody we met. They all seemed like smart, well-intentioned, hard-working people. One of the speakers said that drug development is the most complex activity that humans currently do. Regulation of that activity is also complex.
That said, it got a little monotonous how almost every FDA speaker devoted time to fending off criticism of the FDA as being unfair and destructive. We wondered about that, but not because we disagreed. The fact is that we couldn’t think of any time when we criticized the FDA — and we’re plenty critical. What was there to be so defensive about? And then we remembered. Well, actually, we were reminded rather directly, because there was a presentation by two people from the GAO (and you’d better know that the A is for “Accountability” not “Accounting”) about findings that certain FDA practices and procedures regarding regulation of food and drugs created a high-risk of not completely fulfilling the FDA’s mission.
Where do we litigators hear about the GAO criticisms of the FDA? We hear it when plaintiff lawyers cross-examine our FDA experts. Even putting aside preemption, compliance with extensive FDA regulation can be a compelling defense. It has jury appeal. Smart plaintiff lawyers know this, so right after our expert explains FDA regulation and how bright and diligent FDA regulators are, we hear the plaintiff lawyer read snippets from the GAO and other sources about how FDA is undermanned and how it occasionally has hiccups. Let’s face it: the plaintiff lawyer doesn’t even care what our expert says. And let’s also face this: it’s a tremendously unfair criticism … and it is effective. We wish GAO and other nattering nabobs of negativity would add balance and context to their critiques. As Dr. Evil would say, can you give me a frickin’ bone here? How about an acknowledgment that FDA by and large does a fine job, and how it’s improper for litigants to cherrypick and render a distorted picture of FDA performance? Hey GAO: call us. We’ll help you write it.
Meanwhile, it became crystal clear at the conference that FDA is being asked to do more and more with less money. You might think that lends credence to the criticisms, but the amazing thing is how well FDA responds to the challenge. Globalization affects food and drug regulation (as it affects pretty much everything) and FDA is seeking harmonization and collaboration with sister regulatory bodies. FDA will increasingly look at importers and their ability to own up to the quality and safety of the products they bring in. Inspections and enforcement will be increasingly risk-based. FDA is developing new algorithms to decide who and how to target. Some of the tools discussed by the regulators involve collection and sharing of data. We know about adverse events, but the FDA Sentinel system represents a movement toward a much more active surveillance system. We also heard about Risk Evaluation and Mitigation Strategy, as well as the CPSC database, which recently went online. (http://www.saferproducts.com/).
These are, to be sure, regulatory, not litigation initiatives. But the implications for product liability litigation are undeniable. That is especially true in the wake of the Supreme Court’s Matrixx decision. As one of the speakers put it, the Supreme Court was nice enough to say that adverse events by themselves are not probative of causation, but was not nice enough to tell us what sort of context makes such adverse events material. It seems that if litigants and competitors are gaming the reporting system, then the adverse events should not come in at trial, but at this point we certainly have more questions than guidance.
Finally, while there was much more talk about regulation than litigation, everybody seems fascinated by the parallel requirements debate set up by Bryant (8th Cir) and Bausch (7th Cir). It looks as if a lot hinges on whether you buy Judge Melloy’s Bryant dissent, where he focused on confidential documents making it impossible for plaintiffs to satisfy TwIqbal. We’re already on record that such concern is overblown and that, in Bausch anyway, that concern was used to mask a number of other deficiencies in the plaintiff’s pleading. And, of course, right after returning from the FDLI conference, we saw the bad Burgos (EDNY) decision that followed Bausch rather than Bryant. It certainly made us miss our friends at FDA.