distinguishing false establishment claims from lack of substantiation claims

Kurin, Inc. v. ICU Medical, Inc., 2024 WL 5416672, No. 8:24-cv-00564-FWS-ADS (C.D. Cal. Nov. 8, 2024)

The parties compete in the market for medical devices aimed at addressing blood culture contamination (BCC) in hospitals. BCC is both medically and financially costly. Kurin makes the Kurin Lock, while defendants make a series of syringes, collectively VI Syringes. Both allegedly operate similarly, by passively sidelining the initial 0.15mL of blood, which can contain contaminants from the patient’s own skin. However, defendants allegedly overclaimed their advantages in violation of the Lanham Act and coordinate state law.

First, the court found that early summary judgment was not appropriate given the need for some discovery. Defendants cited their own studies in support of their motion, and discovery was appropriate about those studies, as well as other factual claims made by defendants.

The court found that many of the challenged statements were insufficiently pled to be false advertising, though it granted leave to amend.

First, defendants claimed the VI Syringe “[i]mprov[es] sample quality by removing over 99.9% of contaminates.” They allegedly refer to a “Toxikon Clinical Lab Invitro Testing Diversion study” in support. It was not enough to allege, “[o]n information and belief,” that the Toxikon Study does not support the 99.9% Statement, because that was merely a lack of substantiation claim that private parties are not allowed to make. Kurin alleged that defendants’ “in-house study claims diversion of 94%, 97.2% and 98.6% of contaminants,” making the 99.9% claim literally false, but the court found that insufficient. Kurin needed to allege something like its own testing disproving the claim.

FDA Clearance: Kurin alleged that defendants falsely and misleadingly claimed that the FDA cleared their 99.9% Statement when its VI Syringe brochure referred to “Vascular Integrity FDA 510(k) documentation on file.” Kurin alleged that defendants falsely and misleadingly marketed the VI Syringe as if it were another, pre-existing medical device, the Brannon PortSyringe, so as to impute the latter’s Class II device FDA clearance to the former, even though the Brannon PortSyringe was for a two-step approach to collecting blood through a catheter for lab tests, not for blood cultures in hospitals.

The court found that this claim was precluded by the FDCA. It applied the 9^th Circuit’s PhotoMedex rule, which is pre-Pom Wonderful but probably consistent with it. A “central issue” in PhotoMedex was whether the defendant could impute a 510(k) clearance from one device to another and whether the 510K documentation was enough for the defendant to claim the device was “FDA Approved.” “Under the 510(k) process, if the Class II device is deemed “substantially equivalent” to a pre-existing device with prior clearance, ‘it can be marketed without further regulatory analysis.’ ” Thus, whether there was falsity here depended in part on what the FDA thinks, making it inappropriate for a Lanham Act claim.

False claims that the VI Syringe was patented: Ok to be brought under the Lanham Act since 35 U.S.C § 292’s prohibition on false marking isn’t exclusive, but not sufficiently alleged for purposes of Rule 9(b).

Claims about the VI “Microbial Diversion study,” allegedly performed in conditions that are inconsistent with routine blood culture collection which violate industry protocols for conducting performance studies. Thus, Kurin alleged, the study failed to account for four key points of contamination, in violation of industry standards. This was a classic establishment claim challenge, and sufficiently pled. (Note that, because competitors can bring California state law claims and have the Lanham Act standards applied to those claims in pari materia, a competitor-v-competitor case is the one place where you routinely get Lanham Act concepts like explicit/implicit falsity and establishment claims treated as features of state consumer protection law.) Defendants argued that their study was fine, but the court expressed “concern about evaluating the ‘persuasiveness’ of studies at the motion to dismiss stage.” And a Lanham Act plaintiff can plead literal falsity of product testing by “demonstrate[ing] that such tests ‘are not sufficiently reliable to permit one to conclude with reasonable certainty that they established’ the claim made.” Allegations that defendants’ study was not peer reviewed, did not account for the industry-standard four points of contamination, and that the sample size was too small to support their claims, sufficed to plead that the VI Study was scientifically unreliable.

Likewise, advertising that the VI Syringes “Help Reduce Risk of False Positives” by helping to reduce central line-associated bloodstream Infection (CLABSI) via the VI Syringe’s design to “avoid breaks in the aseptic technique required in multi-step line procedures that may contribute to CLABSI rates” was sufficiently pled to be a false establishment claim, for similar reasons. In the context of an establishment claim, falsity can be alleged by alleging that the claim is “unsupported by clinical data, peer-reviewed data or FDA clearance.” The establishment claim—tests prove—is itself falsifiable, distinguishing this from a bare lack of substantiation claim.

Kurin also alleged that “Defendants mislead clinicians payors, and others in the medical community” by claiming “that the VI Syringe includes a field that is free from bacteria or otherwise free from contamination.” The allegations here weren’t precise enough under Rule 9(b).

Finally, Kurin alleged that defendants’ claim that the VI Syringes “Help Reduce Hemolysis” was deceptive. Defendants’ “hemolysis study” concluded that the VI Syringe is “non-Hemolytic” based on ASTM F756 guidelines while using a sample size of three samples. It was not enough to allege that this sample size “is simply insufficient” to reach such a conclusion. “To prove that an advertisement claim based on product testing is literally false, a plaintiff must do more than show that the tests supporting the challenged claim are unpersuasive.” That’s just lack of substantiation. (I think this should be fixable—surely it’s possible to plead that scientists would not consider three samples to constitute a reliable study, and this is exactly the kind of claim that reasonable consumers would expect to be backed up with scientific evidence.) But the court thought that Kurin “has not alleged potentially fundamental flaws in the methodology, as it did for the VI Study.” (Why isn’t a sample size of three a fundamental methodological flaw? Wouldn’t a sample size of one be a fundamental methodological flaw? Now we’re in factual argument territory.)