Company: DHR
Filing Date: 2025-02-20
Form Type: 10-K
Source: 0000313616-25-000043
Chunk: 146

Company: DANAHER CORP /DE/
Filing Date: 2025-02-20
Form: 10-K
Item: Item 1A
Chunk 146
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 future clinical trials can lead to FDA Form 483 Inspectional Observations, warning letters, notices to customers, declining sales, loss of customers, loss of market share, remediation and increased compliance costs, recalls, seizures of adulterated or misbranded products, fines, expenses, injunctions, civil penalties, criminal penalties, consent decrees, administrative detentions, refusals to permit importations, partial or total shutdown of production facilities or the implementation of operating restrictions, narrowing of permitted uses for a product, refusal of the government to grant 510(k) clearance, suspension or withdrawal of approvals, pre-market notification rescissions and other adverse effects referenced under the risk factor titled “Our businesses are subject to extensive regulation; failure to comply with those regulations could adversely affect our business and financial statements.”  Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources.  Therefore, even if we are successful in defending against any such actions brought against us, our business may be impaired.  Ensuring that our operations and business arrangements with third parties comply with applicable laws and regulations also involves substantial costs.  

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Our products can be subject to human clinical trials, the results of which may be unexpected, or perceived as unfavorable by the market, and could adversely affect our business and financial statements.

As a part of the regulatory process of obtaining marketing clearance for certain new products and new indications for certain existing products, we conduct and participate in clinical trials with a variety of study designs, patient populations and trial endpoints.  Unexpected or inconsistent clinical data from existing or future clinical trials, or a regulator’s or market perception of these clinical data, can adversely impact our ability to obtain product approvals, our position in, and share of, the markets in which we participate and our business and financial statements.  In addition, our products and services may support or be used in connection with customer products that are subject to clinical trials, and adverse results in any such clinical trials may adversely affect future demand for our products and services. 

Off-label marketing of our products could result in substantial penalties.

The FDA and other regulatory agencies around the world strictly regulate the promotional claims that may be made about approved or cleared products.  In particular, any clearances we may receive only permit us to market our products for the intended uses indicated on the labeling cleared by the FDA.  We may request additional label indications for our current products, and the FDA may deny those requests outright, require additional performance or clinical data to support any additional indications or