Tuesday, August 28, 2012

Off-label Promotion in California – Same Facts, Same Law, Different Results

            This post is solely on behalf of the Dechert half of the Blog.  The Reed Smith half is involved in these cases and they ain’t saying a word (not out loud, anyway).

            As litigators, we are all too familiar with the adage “you win some, you lose some.”  Unless and until an issue is decided by the Supreme Court (and all too often not even then), the law is subject to interpretation by judges, who after all are just people with their own outlooks and biases.  Hence, we often report on cases with very similar facts but very different results –often leaving us scratching our heads.  And that’s what happened in two recent California cases involving the same spinal fusion product.  Both plaintiffs alleged unlawful off-label promotion.  One court found the claims preempted, the other did not.  Go ahead, scratch away – we can’t figure out the difference either – other than one court got it wrong.

            You can guess which we think that was.

            First, we’ve said it before and we’ll say it again:  Off-label promotion is not a tort.  Courts have so held repeatedly, here’s just a sampler.  So while in some instances off-label promotion is not permitted by the FDA, “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 349 n.4 (2001).  This statute (21 U.S.C. §337(a)) is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at 352.  The California exemptions from §337(a) − see 21 C.F.R. §808.55 − have nothing to do with these cases or this device. 

            That brings us to the court that got it right:  Coleman v. Medtronic, 2012 WL 2335532 (Cal. Super. Jun. 13, 2012).  Under Riegel, that court had previously tossed plaintiff’s claims but  allowed plaintiff to continue to try and state a non-preempted claim by allowing leave to amend on two occasions. Plaintiff there focused on a “warning” claim alleging off-label promotion.  On motion to dismiss #2, the court took a second look at permitting the warning/off-label claim based mostly on dicta from a case in Minnesota.  Moving away from the dicta and looking at the totality of implied preemption law, the Coleman court concluded, properly, that plaintiff’s off-label promotion claims were “impliedly preempted because they would involve imposing a state requirement that is different from or in addition to the federal requirement and therefore preempted.”  Coleman, 2012 WL 2335532. 

The next court, in Cabana v. Stryker Biotech, LLC, slip op., (Cal. Super. Aug. 20, 2012), didn’t agree.  Before tackling the unfortunate preemption ruling, we should point out how little’s left of that case.  In response to defendant’s motion for summary judgment, plaintiff gave up strict liability manufacturing, design defect and failure to warn claims and her implied warranty claims.  Slip op. at 4.  That's 90%+ of most product liability cases.  All that’s left is general negligence, express warranty (which invariably vanishes the moment a plaintiff has to put up or shut up about what the warranty actually was) and fraud.  Plaintiff definitely has only a small playing field left. 

As to preemption – hey wait, we thought this was summary judgment − where are the actual facts?  For some reason, the court focused almost exclusively on mere allegations in the complaint, slip op. at 2-4, and not on whether plaintiff had any evidence to support those allegations, particularly as they concern off-label promotion.  Summary judgment, however, is supposed to pierce the pleadings; bare allegations are not sufficient:
Plaintiffs cannot simply incant the magic words that Defendants violated FDA regulations in order to avoid preemption.  Moreover, the nonmovant may not defeat a properly focused motion for summary judgment by relying on mere allegations without introducing definite and competent evidence.
Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 313 (D.P.R. 2011), citing, Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir. 1994); Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 282 (E.D.N.Y. 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1158 (D. Minn. 2009), aff’d 623 F.3d 1200 (8th Cir. 2010).  We could cite a lot more, but we think the point’s been made.

Too bad for the defense in Cabana, though; that plaintiff skated.

Reading Cabana as a whole, the court seems to hold that all a plaintiff needs to do is allege a violation of federal law – in this case off-label promotion – and that’s enough to create a triable issue of fact.  We call this a “magic words” approach.  Even though we don’t like all of the recent Cornett case (see last week’s post here), the New Jersey Supreme Court at least required facts to go forward.  Off-label promotion cases must not:
  • be nothing more than a private action to enforce FDA statutes and regulations;
  • be nothing more than a challenge to the approval of the device or label;
  • require proof of fraud on the FDA; or
  • involve off-label promotional activities that are legal under FDA guidelines.
Cornett v. Johnson & Johnson, ___ N.J. ___, ___ A.3d ___, 2012 WL 3210943, at *14 (N.J. Aug. 9, 2012).  The Cornett court sent the plaintiff back with an admonition to come up with the right evidence, otherwise “defendants may move for summary judgment, and the trial court should not hesitate to grant such relief.”  Id.

Not so in Cabana.  That court didn’t care what the state law cause of action was – if the complaint alleged the magic words -- “violation of federal law” – preemption simply disappears.  Ignoring the state-law side of “parallel” was the only way the court distinguished a wealth of cases strongly in favor of preemption.  For instance, as to Riegel v. Medtronic, 552 U.S. 312 (2008), which established express preemption, the court said:
Here . . . plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements.  In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.  Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here. 
Cabana, slip op. at 4-5 (citations omitted).  That’s almost a textbook definition of a purely federal cause of action barred under Buckman and §337(a).  Heck, even Riegel involved off-label use.  552 U.S. at 320 (physician use was contraindicated by the labeling).  Likewise, the court dismissed California appellate law, McGuan v. Endovascular Technologies, Inc., 182 Cal.App.4th 974 (Cal. App. 2010), as inapplicable, because in McGuan the plaintiff’s state law claims focused on “defects in the design, testing, and manufacture of the . . . [d]evice, the failure to warn . . ., and the fraudulent concealment of the dangers and defects of the product.”  Slip op at 5.  Oh really?  That looks no different than plaintiff’s failure to warn and fraud claims in Cabana.   If the point was to distinguish Cabana from McGuan by saying that plaintiff Cabana is bringing a claim for violation of a federal regulation, not a state law tort claim -- well, we direct your attention back to square one:  the United States, not private litigants, enforces the FDCA and FDA regulations.  Hmmm….  What should we use to make the point this time?  How about something recent?
Even if a plaintiff does properly plead facts demonstrating the defendant’s failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA.  Only the federal government may file suits against manufacturers that do not comply with federal regulations.  Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under §360k, §337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations.  As a result, Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.
Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19 (W.D. Pa. March 14, 2012).

The Cabana court was also unpersuaded by defendant’s argument that this was not a parallel violation claim because plaintiff has no evidence that any of the off-label promotion she alleges in her complaint actually violated a federal regulation. A “parallel” claim can’t be “parallel” to nothing.  We discussed this issue last week in our post on Cornett.  While Cabana cites to Cornett, at least Cornett (1) recognized the safe harbor provisions adopted by the FDA regarding off-label promotion, and (2) demanded real evidence of the purported promotion (Cornett was a legitimate pleadings-based case).  Now Cornett didn’t get it exactly either (as we alluded above), because it overlooks the fact that just because off-label promotion may fall outside the safe harbor doesn’t mean it’s tortious off-label promotion.  It’s only potentially “illegal,” and that’s up to the FDA, and the FDA only, to determine.  Cabana misses this point too.

Finally, we are left wondering how plaintiff’s off-label promotion allegations in Cabana support a failure to warn claim.  In the end, if plaintiff is basing her claim solely on allegations that defendant promoted its device for off-label purposes – then we’re in Buckman-land.  Rather, plaintiff must base her cause of action on some other recognized legal claim.  But promotion and warnings are two different things.  By definition, a failure to warn claim requires two things: a warning and causation.

As to the warning, either the risk of an off-label use is the same as that of the labeled use or it isn’t.  If it is, then the label already warns about it, and if it doesn’t, well the plaintiff is asking for something “different from or in addition to” the FDA-approved labeling.  That’s preempted.  If the risk of the off-label use isn’t shared with the labeled use, then … well, it’s the same result, isn’t it − only worse.  This sort of claim creates the potential of a finding that state law would require the defendant to add a warning uniquely related to off-label promotion.  That’s way “different from or in addition to” the approved label. 

Then there’s causation − that whatever the “known” risk (California is a state-of-the-art state) the defendant allegedly failed to warn about  was unknown to the physician using the product, that the physician actually received and relied on the allegedly inadequate information, etc….  There’s none of that in Cabana.  These additional tort requirements (required under Buckman) have nothing to do with if or how the product was supposedly promoted for off-label use.  Promotion allegations, in the end, can’t save a failure to warn claim, negligent or otherwise.  Only the FDA can require a warning about an off-label use.

All in all, we are once again wondering how two courts in the same state, governed by the same law could come to two so disparate conclusions.  While the plaintiff skirted preemption in Cabana, she still hasn’t provided the slightest indication that she actually has facts that could prove her claims – those few that remain.  On that note, we are also very familiar with the adage:  lose the battle, but win the war.   We understand from other reports on this case, there is more discovery to be done and another opportunity to have the judge in Cabana to get it right.  Here’s hoping we can report on a favorable overall outcome in Cabana in the months to come.

1 comment:

Anonymous said...

Recall Medtronic, while not admitting guilt, has settled two whistleblower cases, whereby former Medtronic employees accused the Spinal Unit of using pervasive marketing tactics, including but not limited to kickbacks, royalties, all expense paid trips, entertainment at strip clubs and making available prostitutes to surgeons in an effort to promote the off-label use of Infuse.