We’ve got a search with one of the services that notifies us whenever any new opinion cites Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).  Why?  Well, there’s preemption, of course – which is what Buckman’s all about.  But more generally, we like this search because cases that cite Buckman are just likely to be interesting cases.

We know….  That sounds nerdy, but that’s the kind of attitude that got this blog started in the first place.

Anyway, the Buckman search has been productive over the past couple of days, turning up a couple of interesting cases:  Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010), and Koch v. I-Flow Corp., 2010 WL 2265670 (D.R.I. June 7, 2010).  Beyond both citing Buckman, Phillips and Koch have something else that we think is a common thread.  We think, in both of them, the defendants tried to do a little bit too much with Rule 12 motions to dismiss, and in both it came back to haunt them.

Don’t get us wrong.  We’re not giving up our love affair with TwIqbal or anything.  We still think that enforcing Rule 8 according to its terms is a good idea – and nothing’s been developed in our legal lifetimes that’s a better way of quickly getting rid of lousy cases that should never have been brought (or that plaintiff’s counsel didn’t bother to investigate).

It’s just that, as much as it pains us to say it, not every case is such a poor case that it should get thrown out under TwIqbal.

Take the first of the two cases, Phillips.  It involves a Class III PMA device.  Just saying that sets off Riegel preemption alarms in our heads.  And we’re right.  The particular device, a “Trident” prosthetic artificial hip, has been the subject of a lot of attempted litigation – we suspect that’s because of widespread solicitation of plaintiffs after a January, 2008 recall.  For the Trident litigation TwIqbal has been an excellent way of combating the sort of litigation cesspool that results from indiscriminate solicitation.  A lot of downright bad Trident cases have been KOed by the one-two punch of TwIqbal and PMA preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008):  Lewkut v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 1544275 (S.D. Tex. April 16, 2010); Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010); Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. March 23, 2010); Lemelle v. Stryker Orthopaedics, ___ F. Supp.2d ___, 2010 WL 996523 (W.D. La. March 15, 2010); Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009); Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009); Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009); Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. 2008); Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), reconsideration denied, 2009 WL 2827954 (N.D. Ill. Aug. 31, 2009).  Every one of these cases was canned on a motion to dismiss for failure to plead any non-preempted claim.  Certainly using the motion to dismiss route saved that company a lot of money.  That’s what TwIqbal was designed to do – the decisions arose from the Court’s sense that too much is spent on discovery in lousy cases.

The only real black mark had been Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009), which was simply a horrible opinion.  Stuff happens, in litigation as elsewhere.  We’ve already posted about how most other courts (like us) consider Hofts to be a real stinker of an opinion and don’t follow it.

But there’s such a thing as too much of a good thing, and Phillips is where that point was reached.  As we said, not every case is so weak as to warrant slamming the courthouse doors in the plaintiff’s face.  Many are – where there’s been solicitation, most are – but not all.  And defense attorneys need to exercise discretion and not pursue a one-size-fits-all strategy simply because it’s worked in prior cases.

Now we know that, after Riegel, just about the only way a plaintiff in a case involving a PMA device survives is to plead a violation of the FDCA.  The alleged violation must also be “parallel” to an existing state cause of action, so that it isn’t really a disguised private FDCA enforcement claim that’s barred under Buckman (that’s why these sorts of cases tend to come up in a Buckman-based search).  Here’s a collection of our parallel violation posts, if you’re interested in exploring these concepts in more depth.

In the Trident litigation there was a recall (hence the lawyer solicitation), and also some adverse FDA letters/inspection reports, so plaintiffs have at least something to work with.  But as that Lewkut string cite we just graced you with demonstrates, that “something” usually hasn’t been enough.  So what distinguishes a lousy PMA device recall case from one that survives TwIqbal?  The key allegation is this – “[t]he recall applied to plaintiff’s hip device,” 2010 WL 2270683, at *2.  That simple allegation of causation was pleaded in Phillips, uniquely (as far as we can tell) of all the decisions in the Trident litigation.

In our opinion (and in a lot of judicial ones, too) a plaintiff purporting to plead a “parallel violation” claim who can’t even allege that the supposed violation relates to his/her device richly deserves to get TwIqballed.  But a plaintiff who is able to plead causation probably clears that hurdle, if the violation claim isn’t just a disguised FDCA private right of action.  And the sort of claims made in Phillips look “close enough” to a run-of-the-mill, common-law manufacturing defect claim that we can’t say the court was clearly out of bounds in letting that one go on, at least for a while.

We mean “for a while,” because there are other ways that the purportedly “parallel” claim in Phillips can fail – and in our experience, they usually do.  Now the plaintiff in Phillips will have to flesh out the supposed violation claims. As we’ve discussed before, a violation claim must be “genuinely parallel” to survive preemption.  That means that the plaintiff must interpret whatever FDA regulations or Good Manufacturing Practices in the same way as how the FDA does. Plaintiffs tend to interpret these sorts of things much more rigidly than the Agency itself – and end up preempted as a result, something we discussed here when Sprint Fidelis first came down.

Also, the regulation that the plaintiff relies upon (21 C.F.R. §820.20(a), Phillips, 2010 WL 2270683, at *7), must be sufficiently specific to serve as a common-law standard of liability, and that standard must be found in the regulation itself, and not in some FDA document (such as a guidance document) that lacks the force of law.  We’ve discussed these issues before, here (force of law requirement) and here (vagueness).

Finally, the plaintiff in Phillips is now going to have to put her money where her mouth is and actually come up with scientific proof that one of the alleged bases for the recall (presence of “residue”) was actually the cause of the alleged “loosening” of the implant.  So there’s a significant Daubert hurdle that this plaintiff will have to surmount.

But these are the kind of points that get hashed out on summary judgment after the plaintiff has come forward with the necessary expert testimony.  At the TwIqbal stage, all the plaintiff has to do is allege the facts, not back them up with expert testimony.  Assuming that the plaintiff in Phillips isn’t lying through her teeth about the applicability of the recall, that squeezes by our “one fact” rule of thumb.

So we end up having to post a PMA preemption “loss” on our device preemption scorecard .

We don’t like doing that.

We’d rather that defendants use their discretion on TwIqbal.  We’d much prefer putting up a summary judgment win than a motion to dismiss loss.

The other recent case where a defendant went a bit overboard on Rule 12 is Koch v. I-Flow Corp., ___ F. Supp.2d ___, 2010 WL 2265670 (D.R.I. June 7, 2010) (don’t blame us for the F.Supp. designation, we didn’t say a word).  It’s one of these pain pump cases, and as we’ve discussed before, pain pump cases for some reason have tended to be even more atrociously pleaded than the usual pharmaceutical/medical device mass tort complaints.

So there was a history in this mass tort, like there was in the Trident litigation, of successful TwIqbal motions to dismiss.  We’ve got ’em collected here.  And in Koch the defendants did draw some blood with Rule 12 (2010 WL 2265670, at *5, dismissal of negligent misrepresentation) – just not enough.  The main issue joined in Koch was product identification.  The plaintiff sued several manufacturers of generic bupivacaine, the analgesic used in the pump, but didn’t know which (if any) of them actually made the stuff that hurt her – so she deliberately fudged her pleadings:

Plaintiff has not yet been able to conclusively identify the brand of bupivacaine that she received in her pain-pump. . . . Because she cannot identify which Defendant manufactured the product that harmed her, Plaintiff has fashioned her Complaint so as to address each allegation to all three bupivacaine manufacturers collectively as DEFENDANT ANESTHETIC MANUFACTURERS.

Koch, 2010 WL 2265670, at *2.  That piece of pleading tripe was what drew most of the TwIqbal fire.

Rhode Island doesn’t have much law in the drug/device product liability area, but one thing has been is the ringing reassertion that plaintiffs suing drug manufacturers have to identify the maker of the drug in Gorman v. Abbott Laboratories, 599 A.2d 1364 (R.I. 1991) (rejecting market share liability in DES case). So the defendants had decent legal grounds for filing the motion.

But as in Phillips, there were also grounds to lay off – the atmospherics were as bad for the defendants as the plaintiff’s pleading was for the other side.  Specifically, the plaintiff “ha[d] promulgated interrogatories to Defendants that will enable her to identify which particular bupivacaine brand was used by her orthopedic surgeon.”  2010 WL 2265670, at *2.  That means that the defendants were interposing a motion to dismiss on grounds of failure to identify the proper product manufacturer in order to avoid answering interrogatories that sought – to identify the proper product manufacturer.

That’s a little too cute, folks.  It looks overreaching.

Those interrogatories seem (at least as described in the opinion) like pretty narrowly targeted discovery – not an excuse for the kind of open-ended, out-of-control money vacuum that motivated the Supreme Court in TwIqbal.  It would have been a better idea for the Koch defendants to go ahead and answer that discovery without prejudice to the filing of a later motion.

The court in Koch seemed to have the same thought:

Defendants’ assertion that Rhode Island products liability law requires product identification is mistimed.  Yes, the product must be identified, but failure to do so is not fatal at the initial pleading stage. . . .  In order to establish the liability of any one of Defendants herein, Plaintiff will ultimately be required to identify which of them manufactured the bupivacaine that was administered to her.  However, at this stage of the litigation, the Court determines that Plaintiff has made out facially plausible claims against each Defendant.

Koch, 2010 WL 2265670, at *4.

So the court denied the motion – even though in fact the pleading was garbage.  Id.

We think that’s the wrong way to reach a justifiable outcome.  We don’t think that deliberate mushing together of allegations against distinct defendants is a proper way to plead alternative liability – or any liability under TwIqbal.  Rule 8 isn’t an exercise in hiding the ball.  But the particular pleading problem, involving product identification, involves a discrete issue that doesn’t take all that long to clear up.  We think that a stay would have been in order pending answers to the pending interrogatories.  We’re not sure what they would have produced, anyway, since if the doctor couldn’t tell what drug he used from the plaintiff’s own medical records, we question what better information a remotely-situated manufacturer is likely to have.

Instead we get a lousy decision that lets plaintiffs get away with making broad allegations against multiple, differently situated, manufacturers.  That’s a terrible result, not only for defendants in litigation where it appears that product identification will be a recurring issue, but for all the rest of us as well.  All because somebody tried to be too cute with a TwIqbal motion.

The defendants did better with their fraud dismissal – proving that Rule 9(b) is still tougher than TwIqbal, which is as it should be, since that rule comes with an express specificity requirement.  Koch, 2010 WL 2265670, at *4-5.  But even there, the defendants couldn’t leave well enough alone.  These already-dismissed fraud counts included factual allegations about the FDA, thus giving rise to a Buckman-based argument that about fraud on the FDA was preempted (that’s how Koch came up in our Buckman search).

But for some reason, the defendants in Koch chose not to file a substantive motion to dismiss to the extent plaintiff was alleging fraud on the FDA.

No – they had to go and file a motion to strike the already-Rule-9(b)-dismissed-allegations.  Why, we don’t know.  Yeah, there’s an off chance that any allegation in a complaint could eventually get read to the jury or something, but that’s years down the road.  Not to mention that a partial motion to dismiss on Buckman preemption grounds would have neatly taken care of that remote risk.

Motions to strike are among the most worthless, time-wasting things around.  We went that route more than twenty years ago when we were young and inexperienced, and have never done it again.  Unless something’s libelous or confidential, courts won’t grant them.  Judges have better things to do than prune complaints.

And that’s exactly what happened in Koch – an entirely avoidable Rule 12(f) defeat for our team, even though the court agreed that Buckman preempted the claim:

[Defendant] is correct that Plaintiff’s claims that [it] defrauded the FDA are preempted.  Nonetheless, the Court refrains from striking these references in the Complaint for several reasons.  First, unlike the claims in Buckman, these allegations are not the focus of Plaintiff’s claims; they merely represent surplusage that accompanies Plaintiff’s “laundry-list” style of pleading.  In addition, because the Court dismisses Plaintiff’s fraud claims herein, any remaining references to the FDA are largely irrelevant to Plaintiff’s remaining claims.  The Court is confident that these issues will be satisfactorily narrowed as the litigation proceeds.

Koch, 2010 WL 2265670, at *7.

Thus, resort to Rule 12(f) rather than Rule 12(b)(6), winds up with the worst of both worlds – the allegations nominally remain in the complaint, and there’s no explicit ruling that they’re preempted that insulates the defendant from discovery, or anything else, about those allegations.  Admittedly, if the plaintiff tried for FDA-fraud-related discovery, after the statement quoted above, that would be a level of “too-cute” well beyond anything the defendants did – but why leave that door open?  There was very little up side.

The point of addressing Phillips and Koch together (other than that they happened to come across our desks on successive days) is this:  We know TwIqbal; TwIqbal is a friend of ours, and situations like Phillips and Koch aren’t TwIqbal (apologies to the late Lloyd Bentsen). The Supreme Court’s decision to put teeth back into Rule 12 is one of the best things that’s happened for defendants since we’ve been practicing law – right up there with the Amchem/Ortiz rout of class actions and Daubert’s curtailment of junk science.  But it’s still rather new and fragile, and we don’t want to see this get bollixed up.

So please – defendants and counsel – exercise restraint and good judgment in making TwIqbal motions. We’re not home free, at least not yet.