Navigating Lanham Act Risk in a Shifting Product Landscape

By Darya Lucas

The medtech sector is operating in an era of rapid innovation, aggressive commercialization, and intense scrutiny. As companies race to differentiate their technologies, the marketing landscape has become far more fraught. Recent Lanham Act (15 U.S.C. §§ 1051 et seq.) cases illustrate that even subtle overstatements about superiority, proprietary features, regulatory status, or comparative performance can trigger costly litigation. Although the Lanham Act is not a regulatory enforcement mechanism, it remains one of the most potent tools that competitors use to police commercial claims, sometimes resulting in injunctions and significant civil damages.

The Expanding Scope of Actionable Claims

A telling example is Crocs, Inc. v. Effervescent, Inc. Although the case arose outside the healthcare field, its implications for medtech are unmistakable. The Federal Circuit held that false or misleading statements about “proprietary,” “exclusive,” or “patented” technology, even when the alleged misrepresentation concerns intangible attributes, can fall within the Lanham Act if those statements create a materially false impression about the product. The court rejected the notion that intangible claims are immune from scrutiny. For medtech companies that frequently tout proprietary algorithms, patented chemistry, or exclusive signal-processing techniques, the message is clear: claims of technological uniqueness must be grounded in fact. Courts are increasingly willing to treat such descriptions as statements about product quality, not mere marketing puffery.

This decision also underscores a growing divergence among federal courts about how broadly the Lanham Act should apply to intangible attributes. While not all circuits have adopted the Federal Circuit’s approach, the trend is moving toward closer scrutiny of claims involving proprietary technology. This point should command attention in an industry where innovation is often intangible.

Regulatory Implications and the Boundaries of Puffery

Regulatory claims under the Lanham Act require careful precision. In Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC, the First Circuit underscored that statements implying compliance with FDA or other regulatory standards are not automatically actionable, but may be misleading if they are inaccurate or unsupported. The decision illustrates that context and substantiation with evidence are critical. Medtech companies must ensure that references to regulatory clearances or approvals, inspections, or validations are precise, verifiable, and not presented in a way that could create a materially false impression. Even slight inaccuracies in how such terms are used can mislead clinicians or consumers and expose companies to Lanham Act liability, particularly where regulatory status is central to the perception of safety or efficacy.

The High Stakes of Comparative Claims

The escalating exposure is best exemplified by Guardant Health, Inc. v. Natera, Inc. The jury found that Natera’s comparative performance claims based on data from non-equivalent studies misled clinicians about the accuracy of competing diagnostic tests. The result was a staggering $292.5 million civil verdict, including damages and disgorgement. Subsequent litigation developments have kept the case in the spotlight. In July 2025, a federal judge imposed nearly $3 million in sanctions related to litigation misconduct, which underscores how seriously courts now treat misleading claims and procedural missteps in this domain.

For medtech companies, the takeaway is direct and has a significant impact. Comparative performance claims require methodological alignment, transparent disclosures, and an understanding that clinical audiences often assume studies presented side-by-side are comparable. When they are not, the risk extends well beyond reputational harm.

Superlatives, “#1” Claims, and Consumer Perception

In Zesty Paws LLC v. Nutramax Laboratories, Inc., the Second Circuit refined the analysis surrounding widely used superlatives such as “#1 Brand.” The court emphasized that these statements are not automatically misleading. Instead, liability depends on how a reasonable consumer would interpret the claim and whether multiple interpretations are plausible. While this might seem favorable to advertisers, its implications for medtech are less permissive. Because statements like “#1 in accuracy,” “leading sensitivity,” or “top-rated platform” often imply data-driven ranking, they are far more likely to be interpreted as factual, particularly by clinicians, purchasing groups, and payers. What is considered puffery in the consumer-product context may not qualify as puffery in a data-driven healthcare market.

The Limits of the Lanham Act

Nevertheless, not all statements are actionable. In Nexus Pharmaceuticals, LLC v. Long Grove Pharmaceuticals, LLC, the federal district court in Massachusetts held that comments about drug shortages concerned market conditions, not product qualities, and thus fell outside the Lanham Act’s scope. The decision affirms that the Act targets misrepresentations about the product itself, its nature, characteristics, and qualities, and not about the surrounding commercial context. Even so, medtech companies should tread carefully; statements that imply superiority, exclusivity, or regulatory favor based on market conditions could still fall within the statute’s reach.

Courts Policing Weak or Overreaching Claims

An illustrative development comes from a sanctions ruling involving Raydiant Oximetry where a federal court awarded more than $1.4 million in attorneys’ fees after finding a false advertising counterclaim to be legally and factually baseless. The ruling serves as a reminder that Lanham Act litigation is not a tool to be used lightly. Companies asserting or defending against Lanham Act claims must ensure their factual and legal foundations are solid. Weak or speculative theories can backfire and result in significant sanctions or fee awards.

“The greatest vulnerability in today’s medtech marketing is not intentional exaggeration but subtle overreach that creates a misleading impression. Courts are showing less tolerance for ambiguity, and companies need evidence that can withstand both regulatory inquiry and competitor challenge.”
– Darya Lucas, Associate Attorney

What This Means for FDA-Regulated Companies

Taken together, these cases demonstrate a legal environment increasingly intolerant of broad or imprecise commercial claims. Medtech companies face particular exposure because so much of their differentiation depends on complex, data-driven, and often intangible attributes. Whether discussing algorithmic performance, diagnostic accuracy, instrument reliability, proprietary data sets, or regulatory status, precision and accuracy matter.

To operate safely in this environment, companies should:

• Ensure that performance claims reflect methodologically comparable data.
• Align regulatory terminology precisely with FDA and CLIA definitions.
• Substantiate proprietary or exclusive technology claims with clear evidence.
• Distinguish genuine puffery from statements that reasonably imply measurable superiority.
• Establish and follow internal review processes that anticipate competitor scrutiny.

As Lanham Act enforcement continues to evolve, the margin of error in medtech marketing is narrowing. In the emerging competitive landscape, companies best positioned for success will be those that combine bold innovation with disciplined marketing and communications to ensure that every superiority claim, regulatory reference, or statement about proprietary technology is substantiated by defensible evidence. In a market where reputations and clinical trust are earned by claims, precision is not merely a compliance obligation, but a strategic differentiator. Medtech leaders who implement these lessons now will be better equipped to innovate boldly, compete confidently, and withstand the scrutiny that defines today’s commercial landscape.

If your organization is evaluating the risk of commercial claims, comparative statements, or proprietary technology descriptions, Gardner Law can provide practical guidance that aligns with FDA, FTC, and Lanham Act considerations. Contact our team to discuss how we can help strengthen your promotional review processes and mitigate competitor-driven litigation risk.