This post is from the non-Reed Smith side of the blog.
A long time ago in a town not so far away, a teacher offered a piece of advice to his students:
A word to the wise is sufficient. A word to the foolish is a great waste of time. If I had not been so foolish and listened to the wise, then I would not have to write this silly, silly phrase.
No inference should be drawn that simply because this blogger can recall that sentence from so long ago that she was ever compelled to write it – over and over and over again.
Sentence writing as punishment may be “old school,” but there is some truth to this adage. Whether they are words of admonishment, caution, praise, or suggestion – a wise person listens and contemplates before taking action. Of course, the source of the word plays directly into how closely we heed it. As litigators, we get such words from our colleagues, our clients, our experts, sometimes a sound word even emanates from our adversaries. And perhaps most importantly, we sometimes get “advice” from judges. They’ll couch it to be clear that they aren’t pre-judging an issue or offering an advisory opinion – but we all know too well that judges have their ways of “suggesting” approaches or “hinting” at potential problems. And we all know how important those cues can be.
What we’re pondering today is whether the plaintiff in Clements v. Sanofi-Aventis, U.S., Inc., 2015 WL 3648911 (D.N.J. Jun. 11, 2015) will take note of the cue left for her in this decision dismissing her case without prejudice.
This case involves a Class III, PMA medical device. In other words, it should be preempted. And for the most part, the court agreed – but with a little latitude. First, plaintiff originally filed her complaint in state court. Defendants removed it. So the judge was willing to give plaintiff some leeway on compliance with TwIqbal. Id. at *1. Second, some limited discovery had been conducted, so defendant filed a motion for summary judgment. Although plaintiff argued that she needed more discovery, she failed to file the appropriate affidavits and declarations under local federal rules – deficiencies which are usually fatal. Again, because plaintiff had not chosen federal court, the judge was lenient. Finding that really all of the arguments in the summary judgment motion were legal arguments, the judge converted the motion into a motion to dismiss (sort of a reverse twist).
Next the court pared down the plaintiffs’ case by dismissing the claims that are subsumed by the New Jersey Products Liability Act (NJPLA) – implied warranty, negligence, and strict liability. Id. at *6. That left plaintiffs’ breach of express warranty claim, NJPLA claim and a derivative punitive damages claim. On the NJPLA claim, the court undertook a straightforward PMA preemption analysis. Plaintiff alleged that defendant violated the NJPLA because the device’s design and manufacture were defective and its warnings inadequate. Id. at *8. However, “[b]y approving Sanofi’s PMA application, the FDA determined that [the device’s] manufacture, design, and warnings were safe and effective.” Id. Therefore, the claim is preempted and since plaintiff pleaded no “parallel” violation of a federal standard, the claims warranted dismissal.
But again, the judge decided to offer a bit of leniency. In her response to the motion to dismiss, plaintiff argued that her claims should survive preemption because she was alleging a parallel violation claim — defendant promoted its device for off-label uses in violation of federal regulations on misbranding. Id. at *9. On this point, the court could not ignore that plaintiff failed to satisfy even minimal pleading standards. None of plaintiffs’ allegations mention off-label promotion, they don’t cite the federal regulations, and most importantly “the Complaint contains no facts from which the reader could conclude that [the device’s] manufacture, design, warnings, or alleged off-label promotion actually violated any of the federal provisions [plaintiff] cites in her brief.” Id. So while the claims were dismissed, it was without prejudice to afford plaintiff an opportunity to amend to allege her off-label promotion claim.
This is where the word to the wise comes in. The court offered plaintiff some “guidance;” a little food for thought as plaintiff re-drafted her complaint: “An off-label promotion theory may fail to state a cause of action to the extent that it illegitimately shifts the risk of off-label use from prescribing doctors and patients to manufacturers.” Id. at *10. Here, much to our liking, the court cited the recent Tenth Circuit ruling in Caplinger v. Medtronic, which we talk about here.
The court appears particularly to embrace the Caplinger reasoning that there is nothing in §360k(a), the MDA express preemption provision, that suggests that preemption turns on how a device is used. Id. Coupled with the fact that Congress explicitly acknowledged and protected off-label use by physicians and thus understood the difference, the absence of a mention of off-label use in §360k(a) is “hard to ignore.” Id. The court went even further in analyzing plaintiff’s potential amended claim:
A hypothetical claim (not pled in the current complaint) that Sanofi’s design, manufacture, or warnings were defective because they ignored the possibility that doctors would prescribe [the device] for off-label cosmetic use, would not necessarily constitute a non-preempted, “parallel” state-law claim. It might well constitute a state law requirement that is
expressly preempted by § 360k(a). An allegation that a product’s warnings were inadequate, for example, may be tantamount to a requirement that Sanofi must do something “different from, or in addition to” what the FDA had already
approved. That is to say, a jury would have to find either that Defendants were required to include warnings beyond those in the FDA-approved label … or that Defendants were obligated to issue post-sale warnings about potential adverse effects of using [the product] in an off-label manner.
Id. We agree. As evidenced by the overwhelming case law developed in the InFuse litigation, simply adding off-label to your complaint doesn’t cut it. Further, we think the judge has more than fairly put this plaintiff on notice that her next complaint better be TwIqbal compliant – which is where the few off-label claims that have survived preemption often fall short.
We think these are astute observations by the court and signal that plaintiff’s pursuit of an off-label claim won’t be easy. We’ll just have to wait to see if the judge’s words will be sufficient or simply a waste of time.