It’s not, and while off-label promotion may be illegal, “[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.
We’re pleased to report that, in Healey v. I-Flow, LLC, ___ F. Supp.2d ___, 2012 WL 1185680 (D. Minn. April 10, 2012), the court squashed an FDCA-based illegal promotion claim when masquerading as a claim for punitive damages. Basically, plaintiff argued that, because the defendants allegedly promoted an “inadequately tested” off-label use, they should be liable for punitive damages. Id. at *2. The inadequate testing claim was basically tautological – grounded in the FDA’s refusal to clear the device for the use in question – which is what made it an off-label use in the first place:
Plaintiff . . . seek[s] punitive damages because Defendants . . . market[ed] and promot[ed] the pain pump without researching or testing the safety of its use in intra-articular sites, by disregarding the FDA’s denial of clearance, and by failing to inform doctors and patients of the FDA’s denial.
So the alleged duties in Healey appear to be: (1) not researching uses that aren’t cleared by the FDA and thus can’t appear on the label anyway, (2) off-label promotion of a use the FDA declined to clear, and (3) not telling everybody that the FDA declined to clear that use.
Such claims suffer from a couple of existential problems. First of all, FDA non-clearance doesn’t relate to safety. The Supreme Court emphatically held in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), that the “substantial equivalence” standard for FDA device clearance isn’t safety-related – if it had been, the state-law claim would have been preempted:
The [defendant] exaggerates the importance of the § 510(k) process. . . . [T]he 510(k) process is focused on equivalence, not safety. As a result, “substantial equivalence determinations provide little protection to the public. These determinations simply compare [devices] to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.518 U.S. at 493 (emphasis partially original). Thus, substantially equivalent devices – like the pain pump in Healey – have “never been formally reviewed under the MDA for safety or efficacy.” Id.
So FDA clearance, yes or no, isn't a reflection on the device's safety.
Secondly, these aren’t tort allegations – they’re regulatory. If there wasn’t an FDA, the concept of off-label promotion (truthful or otherwise) wouldn’t exist. Ditto for claims based on the FDA declining to clear the device. These are the sorts of “solely” regulatory claims that Buckman holds do not exist by virtue of exclusive federal FDCA enforcement:
We must also reject [plaintiff’s] attempt to characterize both the claims at issue . . . as “claims arising from violations of FDCA requirements”. . . . [T]he [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. In the present case, however, the . . . claims exist solely by virtue of the FDCA disclosure requirements. Thus, [Lohr] does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.
531 U.S. at 352-53 (emphasis added))
Thus, under Lohr claims grounded in whether the FDA cleared or did not clear a particular use of a particular device are simply beside the point in a product liability suit, since that clearance doesn’t even involve safety. And under Buckman, a private plaintiff has no standing to bring off-label promotion claims in the first place, since such claims have nothing to do with traditional torts and everything to do with alleged FDCA violations.
Thus, in the tort context, while a manufacturer’s promotion of off-label use can violate the FDCA, “off-label marketing of an approved drug is itself not inherently fraudulent.” In re Actimmune Marketing Litigation, 614 F.Supp.2d 1037, 1051 n.6 (N.D. Cal. 2009), aff’d, ___ Fed. Appx. ___, 2011 WL 6887072 (9th Cir. Dec. 30, 2012) (affirmed “for the reasons set forth in the district court's orders”). Thus, off label promotion, without more, is not tortious.
[P]romotion of the off-label uses of a FDA-approved drug concerns lawful activity and is not inherently misleading. . . . Promotion of off-label uses is not inherently misleading simply because the use is off-label. . . . [The defendant’s promotion] was directed at physicians who are familiar with the FDA-approval process and able to independently evaluate the validity of their claims. Given the sophistication of the audience to whom the off-label uses were promoted, this Court cannot conclude, at this stage of the proceedings, that [defendant's] speech was inherently misleading.United States v. Caronia, 576 F. Supp.2d 385, 397 (E.D.N.Y. 2008). Accord Central Regional Employees Benefit Fund v. Cephalon, 2009 WL 3245485, at *4 (D.N.J. Oct. 7, 2009) (“[m]erely alleging that [defendant] marketed the drugs at issue for off-label purposes does not state a claim for fraud”); In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *10 (D.N.J. July 10, 2009) (plaintiff’s “theory of injury requires the Court to assume that off-label promotion is, by its very nature, fraudulent conduct. This is not reality”; theory“is plainly an impermissible attempt by Plaintiffs to turn violations of the FDCA for off-label promotion into a private right of action”).
As the principles of Lohr and Buckman make clear, more than off-label promotion is needed to state a claim under state tort law. Both falsity and causation are necessary:
[I]nsofar as Plaintiffs' claims are based solely on allegations that Defendants promoted [the drug] for off-label purposes, they constitute an impermissible attempt to bring a private suit for violations of the FDCA . . . . The Court grants Plaintiffs leave to amend their complaint to allege . . . that Defendants . . . engag[ed] in deceptive advertising that fraudulently misrepresented the safety of off-label uses of [the drug]. To be clear, the Court emphasizes that Plaintiffs may not rely on allegations that Defendants engaged in off-label promotion of [the drug]; instead, Plaintiffs must point to specific misrepresentations.In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F.Supp.2d 1282, 1292 (C.D. Cal. 2008), accord In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 2009 WL 1703285, at *4 (C.D. Cal. June 17, 2009) (dismissing amended complaint for similar reasons)
Which leads us back to Healey. Forgetting about off-label promotion for a moment, it is of course possible for a plaintiff to base a claim upon a manufacturer’s false statements about its product. Off-label use is neither here nor there – a misrepresentation might, or might not, relate to that particular aspect of the product.
But there has to be a false statement of some sort.
And when punitive damages are involved, as in Healey, there has to be scienter, that is the defendant has to know whatever it said was false. “[P]unitive damage laws . . . punish the same type of conduct – conduct that amounts to a deliberate act with knowledge of facts that make harm very likely.” 2012 WL 1185680, at *5.
Healey then examined the regulatory history – §510k clearance, or else the suit would have been preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) – and concluded, as Lohr makes clear, that the FDA’s refusal to clear pain pumps specifically for “intra-articular” (a fancy word for between the bones of a joint) use, wasn’t any determination that this use was unsafe:
There is nothing . . . to show that the FDA ever concluded that use of the [device] in the intra-articular joint space after orthopedic surgery was not safe and effective. At most, the FDA was simply saying that . . . it would require additional information to determine the safety and effectiveness of the device [and defendant] had not submitted such information. Significantly, the FDA did not require any contraindication labeling to warn surgeons about using the pain pump in the intra-articular space.
2012 WL 1185680, at *8. Thus, the FDA’s not clearing the device did not establish any risk of harm, let alone a “very likely” risk.
Nor, at the time of the defendant’s dealings with the FDA, was there any evidence that the defendant “knew that there was any risk that use of the [device] in the intra-articular space would cause” the harm that the plaintiff alleged. Id. The lack of clearance itself wasn’t a safety determination, and the record showed that actual knowledge of this particular risk of harm lay far in the future. Absence of scienter was to be expected from the FDA’s refusal of “substantial equivalence” clearance:
[N]o infusion pumps of any manufacturer had been cleared with orthopedic indications and . . . a company would be most likely required to submit clinical data [to market for that use].Healey, 2012 WL 1185680, at *8. Well, duh. For “equivalence” to exist, there has to be something for a device to be equivalent to. No predicate use existed, so the device couldn’t be cleared. But the same lack of predicate use necessarily defeated guilty knowledge, since without any use, no adverse events would have occurred either. Non-clearance “does not constitute prima facie evidence that [defendant] had any information from testing or otherwise that [the use] was not safe. Id. at *9 (emphasis added).
If Carl Sagan had been a judge (and were still alive), he would have added that, “absence of evidence [of safety] is not evidence of absence [of safety].”
So all that’s left in Healey was off-label marketing. But off-label use itself is 100% legal, 2012 WL 1185680, at *9 (quoting Buckman), and illegal promotion, without more, is not tortious. To make a tort, the off-label promotion must also be false. And that’s precisely where the plaintiff’s claim foundered in Healey:
Plaintiff provides no authority for the proposition that it was inappropriate for an . . . sales representative to educate an orthopedic surgeon who chose to use the pain pump in this off-label manner . . . . But again, Plaintiff provides no evidence that [defendants] withheld [any] information because they knew, or had any reason to know, that . . . use of the [the device] for post-operative pain management after orthopedic surgery would cause [the alleged harm].2012 WL 1185680, at *10. The plaintiff simply failed to prove any false statement knowingly made – or indeed any false statement at all. Off-label promotion is illegal (putting the First Amendment aside), but by itself it sure ain’t a tort. Accord Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 422, 446 (W.D.N.Y. 2001) (off-label promotion claim dismissed; “no proof of a specific false statement made by defendants upon which [the prescriber] relied”); Samarah v. Danek Medical, Inc., 70 F. Supp.2d 1196, 1208 (D. Kan. 1999) (same; “even if it were the case that defendants' conduct constitutes a violation of the MDA, that fact, standing alone, would be insufficient to establish plaintiff's entitlement to recovery”); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 263-64 (E.D.N.Y. 1999) (same; “no reasonable juror would find that [the prescriber’s] decision . . . was the result of [defendant’s] alleged illegal marketing scheme”); Parks v. Danek Medical, Inc., 1999 WL 1129706, at *8 n.17 (N.D. Ind. June 17, 1999) (same; “there is no legal duty, enforceable in tort, requiring [defendant] to refrain from [acts constituting off-label promotion]); Bradley v. Danek Medical, Inc., 1999 WL 1866401, at *5-6 (W.D. Tenn. March 26, 1999) (same; prescriber “never decided to utilize [the] devices based on FDA approval status”) (sixteen similar decisions authored by same judge); Leigh v. Danek Medical, Inc., 28 F. Supp.2d 401, 406 (N.D. Tex. 1998) (same; “there is no evidence that plaintiff's surgeon . . . was in any way defrauded”); Moses v. Danek Medical, Inc., 1998 WL 1041279, at *6 (D. Nev. Dec. 11, 1998) (same; “[a]ssuming arguendo that Defendants promotion . . . was illegal, there is no indication that Defendants’ actions were the proximate cause”).
Thus the plaintiff’s illegal-promotion-based punitive damages claim crashed and burned in Healey. We’re not surprised in the least. Pain Pump plaintiffs are making the same shopworn arguments about “illegal” off-label use in the context of §510k-cleared medical devices that were tried and found wanting over a decade ago in Bone Screw litigation.
There’s no reason to linger any longer at the accident scene. Move along, nothing to see here.