SKW Schwarz (litigation counsel: Dr. Oliver Stöckel) obtained an important landmark decision from the Higher Regional Court of Hamburg for the listed pharmaceutical and medical device manufacturer Sedana Medical on the advertising of the interaction between medical devices and pharmaceutical products. The judgment, which was already handed down on 6 November 2025 (docket no. 3 U 74/23), is final.
What was the case about?
The action was brought against two companies, a medical device manufacturer and its exclusive distributor. It concerned a medical device for the administration of volatile anaesthetics (anaesthetic gases) for so‑called “inhaled sedation”. In inhaled sedation, the patient is calmed or immobilised by mixing the gaseous pharmaceutical product into the air inhaled by the patient, for example during mechanical ventilation in an intensive care unit (ICU).
Volatile anaesthetics are prescription‑only pharmaceutical products. With the exception of one preparation of the claimant, which is also approved for the sedation of patients in combination with its special application medical device, the anaesthetic gases available on the market are approved exclusively for anaesthesia (e.g. in the operating theatre) and not for inhaled sedation.
The proceedings concerned numerous advertising claims which primarily emphasised the medical advantages of inhaled sedation with volatile anaesthetics and the defendants’ medical device. Using the defendants’ medical device, the volatile anaesthetics are administered in a manner that deviates from the marketing authorisation, so that the patient does not fall into full anaesthesia but is merely sedated. In anaesthesia, contrary to sedation, the organism is numbed with central suppression of pain and consciousness; the primary purpose is the complete elimination of sensory perception, e.g. to enable the performance of surgery.
Because the mode of administration of the anaesthetic gases for sedation purposes with the defendants’ medical device, which was highlighted as particularly advantageous in the advertising, is not covered by their marketing authorisation, this use constitutes a so‑called off‑label use. The use of pharmaceutical products outside their approved indications is not generally prohibited in Germany. However, it may not be advertised (Sec. 3a of the German Healthcare Advertising Act). In addition, the off‑label use of pharmaceutical products is generally associated with increased risks, because there is no marketing authorisation study for the off‑label use. Therefore, special liability risks as well as duties of care and information apply to physicians and hospitals when using pharmaceutical products outside their approved indications. It is therefore important for physicians and hospitals to know when a particular pharmaceutical product use constitutes an off‑label use.
Which fundamental legal questions were in dispute?
At its core, the dispute concerned two fundamental legal questions which have so far remained largely unresolved in case law:
- Does advertising the medical advantages of a pharmaceutical product which arise precisely due to the specific mode of administration of an application medical device (here: administration of volatile anaesthetics for sedation rather than for anaesthesia) in the advertising for this application medical device constitute co‑advertising of the pharmaceutical products used? If so, this constitutes advertising of an off‑label use of the administered pharmaceutical products prohibited under Sec. 3a of the Healthcare Advertising Act, provided that these are at least identifiable in the advertising (product‑related advertising).
- Does it violate the prohibition on misleading advertising under Sec. 3 of the German Act against Unfair Competition in conjunction with Art. 7(c) MDR and Sec. 3 of the Healthcare Advertising Act if advertising for the intended use of a medical device (here: administration of volatile anaesthetics for sedation purposes) does not disclose that such intended use of the medical device results in an off‑label use of the administered pharmaceutical products?
How did the court decide?
The Higher Regional Court of Hamburg answered both fundamental questions in the affirmative in favour of the claimant represented by SKW Schwarz and awarded the action against the distributor in full. The court prohibited the distributor, inter alia, from advertising its medical device at all for inhaled sedation with volatile anaesthetics. In addition, numerous advertising claims aimed at promoting sales of the medical device by emphasising the medical advantages of inhaled sedation with volatile anaesthetics were prohibited.
With regard to the manufacturer, however, the court took the view that the distributor’s advertising statements could, for the most part, not be attributed to the manufacturer, because it could not be proven that the manufacturer had initiated them. The manufacturer therefore only bears liability for its own advertising statements, not for those of the distributor.
What did the court say specifically about the fundamental questions raised?
I. Advertising the medical device for inhaled sedation also constitutes prohibited advertising for an off‑label use of the administered pharmaceutical products
The court agreed with the claimant that the advertising for the application medical device also constitutes advertising for the pharmaceutical products used. The contested advertising directly and purposefully addressed the substance groups to be administered, isoflurane, desflurane and sevoflurane, by highlighting their medical advantages specifically in inhaled sedation. Because the pharmaceutical products advertised are at least identifiable for the targeted professional audience, this constitutes product‑related pharmaceutical product advertising within the meaning of Sec. 1(1) No. 1 of the Healthcare Advertising Act. In this context, the court primarily relied on the case law of the Court of Justice of the European Union (CJEU) on Art. 86(1) of Directive 2001/83, including CJEU, d.d. 8 November 2027 – C-143/06 paras. 20-39 – Gintec; CJEU, d.d. 27 February 2025 – C-517/23 paras. 32, 33 – Apothekerkammer Nordrhein/Doc Morris NV; CJEU, d.d. 22 December 2022 – C-530/20 – EUROAPOTIEKA; and CJEU, d.d. 5 May 2011 – C-316/09 – MSD/Merckle. The decisive factor is the objective suitability to promote sales.
In the present case, the court assumed this sales promotion intention with respect to the pharmaceutical products even though the defendants do not themselves market them. The court followed the argument put forward by SKW Schwarz that the objective of the advertising message – to induce the targeted professional audience to purchase the defendants’ medical device – necessarily presupposed that the audience first decided to procure the volatile anaesthetics to be administered, primarily in place of intravenously administered pharmaceutical products. Without such a primary decision to procure volatile anaesthetics for inhaled (instead of intravenous) sedation, the medical device would not be needed at all, so that the decision to procure the pharmaceutical products is a prerequisite for the sales success of the medical device.
Therefore, the advertising message that inhaled sedation is preferable to intravenous sedation is a core argument of the contested advertising materials. The medical arguments placed at the centre of the advertising, however, all relate to the advantages of the pharmaceutical products and not to the mode of operation of the medical device. The advertising by the defendants therefore also pursues the aim of promoting the prescription, dispensing, sale or consumption of these pharmaceutical products.
The court held that, for the assumption of product‑related pharmaceutical product advertising, it is irrelevant whether individual preparations are recognisable (which, in the view of the court, was in any case the situation in some of the contested advertising videos). The concept of “advertising for pharmaceutical products” within the meaning of Art. 86(1) of Directive 2001/83 relating to pharmaceutical products for human use is not to be understood as covering only advertising for a specific pharmaceutical product (CJEU, loc. cit., para. 38 – EUROAPTIEKA). Advertising for a group of pharmaceutical products or even for the entire range of products may also be product‑related (Federal Court of Justice, PharmR 2025, 681 para. 21 – PAYBACK). In the present case, the advertising concerned three specific, by name stated substance groups (isoflurane, sevoflurane, desflurane) which represent readily identifiable pharmaceutical products for the targeted professional audience.
According to the Higher Regional Court of Hamburg, determining for which specific indications a pharmaceutical product is authorised constitutes a question of law and not of fact. The issue is the interpretation of an administrative act, namely the marketing authorisation, by corresponding application of Sec. 133, 157 of the German Civil Code. Such interpretation leads in the present case, as the claimant explained in detail, to the conclusion that the volatile anaesthetics advertised are only authorised for anaesthesia and not for sedation.
Because the advertised use of the pharmaceutical products – inhaled sedation – is not covered by their marketing authorisation, the contested advertising therefore constitutes a violation of Sec. 3a of the Healthcare Advertising Act.
II. Misleading advertising due to failure to disclose the off‑label use
The court further considered it misleading to advertise the use of the medical device for inhaled sedation without disclosing that such treatment involves the particular risks associated with the off‑label use of the relevant pharmaceutical products. In this regard, the advertising gave rise to the misconceptions asserted by the claimant concerning the scope of the examination of the treatment’s efficacy and safety by the authorities in the context of the marketing authorisation procedure. In fact, the advertised treatment, as it is not covered by the marketing authorisation, is not sufficiently safeguarded by the authorities in this sense.
III. Infringement of Art. 7(c) MDR
Finally, according to the court, the advertising also infringes Art. 7(c) MDR. The intended use of the medical device for inhaled sedation gives rise to risks associated with the off‑label use of the administered pharmaceutical products. This constitutes a risk requiring disclosure, which falls under Art. 7(c) MDR both according to the rationale of the provision and its wording. The advertising creates the false impression among the targeted audience that they can use the medical device as intended for inhaled sedation without thereby incurring the particular risks of off‑label use of the pharmaceutical products to be administered.
What does the judgment mean in practice for advertising medical devices and pharmaceutical products?
The decision clarifies several fundamental issues in healthcare advertising where a treatment involves the interaction between medical devices and pharmaceutical products.
If the interaction between medical devices and pharmaceutical products is advertised, it must be assessed as a whole and, in case of doubt, constitutes advertising both for the medical device and for the pharmaceutical product. In particular, where the promotion of a medical device is conducted by emphasising the advantages of the pharmaceutical products intended to form part of the treatment, the advertising of the medical device will as a rule also encompass co‑advertising of the pharmaceutical products. The court did not follow the defendants’ attempt to separate the two elements, even though they were combined in the advertising.
Where pharmaceutical products also play a role in the intended use of medical devices in the envisaged treatment – for example in the case of application medical devices such as in this case – it must always be examined whether the advertising of the medical device also involves promoting the sales of the pharmaceutical products. If this is the case, the pharmaceutical product advertising contained in the combined advertising must comply with the statutory requirements for pharmaceutical product advertising. This is particularly important where prescription‑only pharmaceutical products are involved, because in such cases, among other things, the prohibition on advertising to the general public under Sec. 10(1) of the Healthcare Advertising Act applies – with the consequence that “combined” advertising for a medical device and pharmaceutical product must then be restricted to those HCPs listed in Sec. 10(1) of the Healthcare Advertising Act. If the intended use of the medical device, as here, results in an off‑label use of the pharmaceutical product, no advertising for such use may be undertaken at all due to Sec. 3a of the Healthcare Advertising Act.
Furthermore, failure to disclose what the intended use of the medical device means at the level of the pharmaceutical products can render the advertising for the medical device impermissible as misleading, if circumstances requiring disclosure – such as, for example, an off‑label use of the pharmaceutical products applied when the medical device is used as intended – are not disclosed (Sec. 3 of the Healthcare Advertising Act, Art. 7(c) MDR).
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