Some of our friends suggested that we honor the NCAA basketball tournament by engaging in a little bracketology. Presumably, they want us to run some legal concepts, cases, or personalities through brackets, ultimately selecting an overall champion. For those five or six of you who did not fill out March Madness sheets, bracketology is a way of deciding a winner by pairing off items, deciding winners, with winners advancing to confront other winners until there is one ultimate winner. Theoretically, bracketology can be as useful as, say, a decision-tree in evaluating alternatives or determining a course of action. Mostly, it's a harmless diversion. Our favorite recent example was a bracketology treatment of characters from the late, lamented HBO series The Wire.Bracketology can be fun. But it doesn't really work for our purposes. Creation of an intial bracket requires a seeding of the contestants. That is, at the outset you first make an assessment of relative value or merit. The excitement of the NCAA tournament is how reality can play havoc with the seeding. (Ask anyone who picked Duke or Missouri to make it to this year's Final Four.) Injuries, sudden and surprising ineligibilities, 19 year-olds calling timeouts when all timeouts have been used up, screwy turnovers, and miracle shots can all create improbable results. But an abstract exercise is different. It lacks the fluidities and frictions of real life. Doesn't the initial assessment pretty much predetermine the outcome? How can there be any upsets? In fact, that is what happened with The Wire bracket. Everyone knew right away that Omar would likely win as best character. President Obama picked Omar. And, indeed, Omar won. When people practice bracketology, the major issue is the extent to which one follows or departs from the "chalk." The "chalk" means picking the favorites. It is a boring strategy, but is mostly effective. For every amazing underdog success story, such as Butler, George Mason, and VCU, there are way more Kentuckys, North Carolinas, and Michigan States. Odds are that this year's Final Four will include at least three number 1's or 2's. Maybe one surprise team will sneak in. If one followed the chalk for The Wire bracket, one simply had to pick either Omar or Stringer Bell to triumph. (If you haven't seen The Wire, shame on you. It certainly makes our Final Four of the best television dramas of all time.)All of which is to say that we won't be doing Drug and Device Law bracketology. We would simply end up going with the chalk. Plus, we're not sure how to do the graphics for the brackets. If we were to pair off legal defenses, we're fairly sure that TwIqbal, Daubert, Preemption, and Statute of Limitations would be our Final Four. A couple of posts ago we discussed how preemption is so strong because it can preclude cases that otherwise possess substantive merit. That is also true with the statute of limitations. We like TwIqbal because it gets rid of junk pleadings, and we like Daubert because it gets rid of junk science. It would be nice if courts followed the chalk and applied these doctrines to send the bad cases away, like Kentucky dispatching an inferior opponent.Last week we saw two cases where courts followed the chalk. First, we have a straightforward application of TwIqbal in Reed v. Pfizer, Inc., 2012 WL 859729 (E.D.N.Y. March 14, 2012). The plaintiff alleged injuries from ingesting an oral contraceptive. In an early court conference, "plaintiffs acknowledged that the complaint allowed room for further factual details." Reed, 2012 WL 859729 at *1. Leave was given to file an amended complaint. That amended complaint alleged the usual claims: failure to warn, manufacturing defect, design defect, and breach of warranty. All flunked TwIqbal. The failure to warn claim did "not plead facts indicating how the provided warnings were inadequate." Id. at *3. "In contrast with their thorough recitation of Ms. Reed's claimed injuries, plaintiffs plead nothing about the content of Lybrel's warnings. This is likely because, as defendants note by reference to the FDA's website, Lybrel's FDA-approved warning labels warn of the very injuries plaintiffs have pled." Id. The manufacturing defect claim offered mere conclusions about negligent manufacturing, violations of regulations and "appropriate standards of care," and failure to test, but without an ounce of fact or a hint as to how the product differed from its design. Id. at *5. The design defect claim did "not plead facts alleging the existence of a feasible alternative design that would make the product safer, as is required to establish a design defect, under either New York or West Virginia law." Id. Finally, the warranty claim missed the mark: "Plaintiffs' unsupported conclusions that Lybrel differed in some defective manner from what was warranted lack the required factual content identifying that difference and making its existence plausible." Id. at *6. All of these rulings follow TwIqbal faithfully and are predictable. Not quite as predictable was the Reed court's allowance of another opportunity to amend the complaint. We would have thought that the court's reasoning, particularly on the failure to warn claim, demonstrated that further amendment would be futile. But the plaintiffs will now get a third chance to plead a viable complaint. At least the NCAA tournament is single-elimination. Lose and go home. Maybe folks in Durham, North Carolina right now would like another chance, but there is something to be said for finality.In the second case, Judge Mayer in New Jersey granted summary judgment for Novartis because Virginia’s two-year statute of limitations barred the case in its entirety. Irby v. Novartis Pharm. Corp., No. MID-L-1815-08 MT, slip op.
read more: No Bracketology for Us: Chalk Up Wins for TwIqbal and Statute of Limitations