Schuessler salts for pregnancy is illegal as misleading advertising then legal remedies, if drugs or therapeutic efficacy effects are attributed to, that they have not

Application of cell salts in connection with pregnancy inadmissible: Even if the pregnancy is no indication within the meaning of § 5 HWG is, such advertising is a recommendation of the drug for pregnant women but from a different point of law unfair competition law. It is a case of misleading advertising of medicines, as has also been adopted, the district court. The applicant has a claim under § § 8 Abs. 1, 3, 4 No.. 11 UWG i.V.m. § 3 No.. 1 HWG to. For a misleading legal remedies advertising is not permitted, if drugs or therapeutic efficacy effects are attributed to, that they have not. Also § 3 HWG is a market conduct regulation, aimed at the protection of the health of the individual and the public from the dangers of improper self-medication and the subject of an irrelevant advertising (vgl. Köhler / Bornkamm, UWG, 30. § edition 4 Rdn. 11.137). A misleading advertising of medicines is not permitted by European law principles.

OLG Hamm from 13. December 2012 I-4 U 141/12

Tenor

The appeal by the defendant against the 20. June 2012 announced the verdict 7. Commercial Chamber of the Landgericht Bielefeld is rejected on the basis, that in the judgment of the District Court tenor before the word “as” the passage is inserted: “in the German magazine Midwives”.

The defendant shall pay the costs of appeal.

The judgment is provisionally enforceable.
Reasons

I.

The applicant has to its statute, the task, to protect the commercial interests of its members, and pays particular attention, that the rules of fair competition are respected. The defendant sells the so called.

T2-salts (partially) as homeopathic drugs, The registered as such, but not allowed to use areas are.

The defendant advertised in issue No.. 3 / 2012 the “Midwives magazine” full page (Attachment A 1 Bl.7) with the ad headline

“T2-salts of Pflüger

Gentle companion

in pregnancy.”

In this display, the T2-T6 products

-7 Magnesium phosphoricum D 6

-11 Silicea Lotion und

-2 Calcium phosphoricum D 6

mapped, from which the products with the nos. 7 and 2 registered drug with a degree of dilution D 6 are.

On the package inserts of these drugs, it was the time of the offending advertisement word literally or similar:

“What to consider in pregnancy?

Since no well documented experience with use in pregnancy and lactation, the drug should be used only after consultation with the doctor.” (Appendices A 4 A bus 6 Bl.16 -18).

The applicant has this magazine advertising as a violation of § 5 HWG viewed, as had been advertised with applications. In addition, he has also misleading advertising within the meaning of § 3 HWG held, because am warned explicitly against the advertising message on their packaging prior to use in pregnancy. In addition, funding will not come to the described effect. It lacked any scientific proof of efficacy of the medicinal products. The applicant has on the respondent by letter 20. April 2012 (Attachment A 2 Bl.9 ff.) warned unsuccessful.

By the 4. More 2012 the court received the request of the applicant with reference to § 8 Abs. 3 No.. 2 UWG made an injunction in court. He has again taken the view, in reference to the pregnancy was a Recommendation see, by § 5 HWG was not admissible. In addition, the warning notice standing in the package inserts in an irreconcilable opposition to the advertised application recommendation during pregnancy. Because of these ads were the pregnant women about the causes they care midwives, the harmless drug use, without seeking medical advice before. The defendant expressly recommending the salts with the offending advertisement for use in pregnancy. The salts are then gently bring positive for pregnant women, But what it lacked any evidence. It is not even clear, whether the salts could be taken safely during pregnancy.

The applicant has applied,

the defendant under penalty of law and order means to

prohibit, to advertise in trade:

“T2-salts of Pflüger

Gentle companion during pregnancy.”

The defendant sought,

reject the request.

It has meant, The advertising does not relate to applications in accordance with § 5 HWG, because the pregnancy is not a disease. The advertising claims, at the Expert Group members under § 2 HWG judge, was not misleading. It contains no action statements nor have a specific purpose. The words “Gentle companion” are to be understood as, that for the advertised drug no or only minor risks such as side- and interactions are known. The statement refers therefore only on the risk profile. It will not in the package inserts also warned of specific risks. Such risks can not be known. Even with mild or gentle acting drugs adverse effects could never be completely ruled out, why the risk information as general information about the use of medicines in pregnancy are needed.

Under the statement of the defendant, the leaflet has to Silicea lotion (Nr.11) already at the time of magazine advertising had a different wording, namely:

“What to consider in pregnancy?

Ask before using any medicine your doctor for advice”

The district court held the request for injunctive relief, for reasons. It explained, that the defendant under § 3 HWG has failed, So against a provision, a market conduct regulation in accordance with § 4 No.. 11 UWG performing. The advertising claims “Gentle companion during pregnancy” is misleading, because it means the so advertised enclose therapeutic efficacy or otherwise affect, that this would not. This statement containing consider firstly, that the agent is currently suitable for use during pregnancy and for pregnant women no adverse side effects would be:. Secondly, as the name might suggest “Companion”, that the agent is also suitable for regular and permanent use during pregnancy. Imagine then the pregnancy is as a special area of ​​application for these funds, approximately in the sense, that positive, supporting effects would unfold such as the alleviation of pregnancy symptoms. Such an idea is wrong but also on the basis of the arguments of the defendant's own. It has not explained, that the money would just develop specific beneficial effects for the relevant pregnant, which could establish their particular suitability for use in pregnancy. Could be left Given, whether the package insert regarding the T2 salt No. 11 has been changed. What matters namely no longer matters, whether the advertisement conflicting statements resulted in the package inserts a false impression. It also play no role, that advertising may be directed wholly or mainly to midwives and thus to professionals. Even for such advertising, the prohibition of misleading advertising of medicines. It could ultimately remain open, whether it is also an illegal advertising with application areas within the meaning of § 5 HWG had acted.

The defendant attacks the judgment on appeal. She says, the district court was wrong to a violation of § 3 S. 2 No.. 1 HWG accepted, because the advertising complained of the homeopathic medicines have settled effects, that this would not. So be advertising with the statement “Gentle companion during pregnancy” not to infer from the information content, that the pregnancy “special use area” the advertised drug and was therefore expected that the advertising is addressed special pregnancy Indications. Would run counter to the already, that the advertisement on in all their generality 27 various salts refer T2. This might not have any specific indications Pregnancy. Midwives was also the subject of drugs during pregnancy in relation to risks and side effects known and deliberately. Therefore they strove, their patients to make recommendations for the intake of drugs. It would, however, not merely the typical pregnancy symptoms, but the application of drugs in different indications. The midwives had known, that precisely the biochemistry Dr. T2 so far for a variety of everyday ailments offer a wide range with a favorable risk profile. Just the midwives would understand why the advertising so, as it was meant, namely, as an indication of the favorable risk profile of T2-salts. These agents because of their degree of dilution are no particular risks or side effects are known. However, even if the advertising is addressed would refer the complaint to the slogan only three pictured with the drug and advertising, a special area of ​​application will addressed in pregnancy, would not the misleading advertising. The biochemistry of Dr. T2 is based on the knowledge, that diseases are due to a mineral deficiency of cells. The mineral salts acted accordingly directly on the mineral metabolism of the cells and their regulated nutrient, whereby the self-healing would be induced.

Präparat of Calcium Phosphoricum (Nr.2) help the expectant mother, damage to one's body to prevent, because the mineral would especially needed for protein formation in muscle cramps and find application. Therefore had been pointed out in the literature, that prevention of pregnancy with this preparation have special meaning. The defendant points to other recommended books in explanation of applications in pregnancies associated with the expected load on the lime level. The Middle Magnesium phosphate (Nr.7) also help pregnant women, in particular in connection with labor pains and spasm. In the preparation Silicea (Nr.11) will named as Application under the heading of pregnancy the tendency to weak connective tissue and pregnancy stretch marks or cracks, wherein the dosage forms Ointment, Gel or cream will refer. It could also be used in a mastitis.

The mentioned works, in particular, the standard work of Dr. T2 would give the state of the evidence again in the empirical science of homeopathy as effective and could notice in accordance with § 25 Abs. 2 AMG can be used. Homeopathy is, within the bounds of science pluralism legally recognized as a special branch of therapy. Only such activity prior to the special treatment towards expected preformed specialist group members as midwives at an appropriate advertising. For theirs is the different therapeutic approach of homeopathy generally known. They took into account, that this is going to a cure, that is scientifically accurate evidence deprivation and their cures would predominantly attributed to coincidences and suggestion. It would be added, that a Google search on the topic “T2-salts and pregnancy” at 618.000 Results not only the ubiquity and popularity of the low-risk alternative therapy during pregnancy advices, but also specific recommendations to use T2 salts would be given in this context. The advertised products are also suitable for regular or permanent use during pregnancy. Were for all homeopathic medicines due T2 of the high dilution of at least the fourth Dezimalpotenz (D 4) aware of any risks posed by the drug risks or side effects and to fear. It is also part of the registration of homeopathic medicines under § 38 Abs. 2 S. 3 AMG required for such a degree of dilution absolutely no pharmacological and toxicological testing, because these regularly from the apparent safety of the dilution. The former notes on the product information in the preparations no. 2 and No.. 7, according to which there should be no adequate data for use in pregnancy, had been given as part of their corporate responsibility without specifying the licensing authority. The instructions in the package inserts of all their preparations were now changed with confirmation BfArM then, that will be asked during the pregnancy the doctor for advice before taking any medicine should (Investment BK 4). Such statement was the preparation lotion No.. 11 Silicea bereits zur Zeit der Warning contain.

It would also not an indirect violation of § 5 HWG ago, because the pregnancy is not a concern of applications under this provision. This would include the notion of indication, explain the, what diseases, Suffer, Physical damage or abnormal symptoms the medicine heal, alleviate, to prevent or detect let.

The defendant sought,

amend the judgment under appeal and the application for adoption

the injunction dismissed.

The applicant is applying,

appeal dismissed.

He defends the appealed decision and says further, that the prohibition as a violation of § 5 HWG be justified. The advertising must be understood as, that the recommendation “gentle companion during pregnancy” referring to the two registered drug. If it were accepted, that they all 27 T2-salts is meant to, then imagine the situation is even worse than, namely as absolutely impermissible recommendation for salts. It is not apparent, why all the salts should be for special use during pregnancy recommended. Just raised the midwives were not with the risks and side effects of the salts familiar, likely to arise is, while scientific safeguards missing, which would exclude such risks. Give evidence secured effect of homeopathic medicines, it is still not. These medicines are prepared according to the rules of homeopathy, and should be used according to these rules. It is clear that special, that for small and very small doses dilutions were chosen. Sun contains e.g.. the dilution rate D 4 an active ingredient in a dilution of 1:10.000, of grade D 5 a ratio of 1: 100.000. Homeopathic medicines may therefore under § § 38, 39 AMG to be registered, without the need for an approval for a necessary evidence of effect. Therefore be no indication as information allows the specification of applications. In the present case, however, shall in any event advertised indirectly for an alleged application. That constitutes a violation of § 5 HWG and § 4 No.. 11 UWG. Regardless will also prohibit the misleading ignored. In the field of advertising here are only those relevant health related claims allowed, The one proven scientific knowledge correspond. The T2-salts have also advertised in the evidence submitted by the respondent application areas no scientifically proven effects. It therefore lacked just a scientific background of concept of T2 salts. It is therefore understandable, why this principle of action should then be discussed midwives in training events. The plant BK 16, a misleading advertising contained in any other way, does not preclude the unfairness of the disputed advertising. The further recalling approximately 450 Diseases and applications around pregnancy and birth and T2-salts, that might help, agency also constitutes another violation of the law as the application guidance on the treatment during and after pregnancy. The statement in the Appendix BK 20, that you could use T2-salts in pregnancy, was unoccupied and it justifies itself, that the agent should not have any effect and therefore no side effects. Even that was not at all certain.

II.

The appeal is without merit. The applicant is entitled to the claimed injunction, because the defendant has advertised remedies legally misleading.

1) The application for an injunction and the court following his ban suggest, that only the specific violation complained of form that should be banned. That the applicant has expressly confirmed, even if asked at the hearing before the Senate. There is therefore only a matter of the dispute, even if the applicant as well as injunctive relief from the prohibited indication of applications § 5 HWG as well as misleading advertising of legal remedies § 3 HWG derives.

2) The application for an injunction is sufficiently definite as defined in § 253 Abs. 2 No.. 2 ZPO, especially after the district court has incorporated the specific act of infringement in the prohibition. The applicant has clarified now additionally by a reference to the advertisement in the magazine Midwives, that it is about an advertisement against professionals. What is meant by experts in connection with the advertising of medicinal products, in § 2 HWG defined and the target audience is so clear cut.

3) Against the available ground here there are no objections. The applicant is the presumption of § 12 Abs. 2 UWG benefit, because he made a claim under antitrust. This presumption is not rebutted. The applicant shall provide available on request 4. More 2012 submitted. There is nothing to suggest, that before the 4. April 2012 Had knowledge of this advertising. She's in the newspaper no midwives. 3 / 2012 erschienen und die Warning stammt erst vom 20. April 2012.

4) The applicant is in regard to the disputed advertisement but not injunctive relief from § 8 Abs.1, Abs. 3 No.. 2, 3, 4 No.. 11 UWG in conjunction with § 5 HWG to. Allowed under this provision for pursuant to § § 38, 39 AMG registered homeopathic medicines are not advertised by the indication of treatment areas.

a) At least with the T2-salts No.. 7 “Magnesium phosphoricum” and No.. 2 “Calcium phosphoricum” is this is the homeopathic medicinal products referred to in § 5 HWG. In any event, even for those at the significant representation of the packaging and its explicit mention in the advert with the offending slogan advertised.

b) For these drugs were not advertised with applications. The display is indeed a point of reference for, context in which the use of these medicines is recommended, explicitly mentioned. These funds are “Gentle companion during pregnancy” be, So be taken during pregnancy. Pregnancy is thus provided applications for this drug; precisely because of the advertising also turns to midwives. But that is not told, that pregnancy also an application area as defined in § 5 HWG is. The provision of § 5 HWG is their meaning and purpose in connection with § 4 Abs. 1 See HWG. After that, in general in the advertising of medicinal products among other factors the particular field are given. For homeopathic registered agent but is the special feature, that is apart from the evidence of these effects objectively verifiable, because due to the high dilution they have one efficacy demonstrated for barely. To protect consumers against erroneous self-medication, therefore allowed the otherwise mandatory to be provided Applications not in the labeling of the drug still in the package insert or in advertising are given (vgl. BGH WRP 2012, 705, 708 -Injectio). § 5 UWG regulates the advertising ban as a derogation, with applications in such special cases. The term “Applications” stands for the indications, for the drug by the competent authority after the registration documents (vgl. the use of the term applications in § 22 Abs. 1 No.. 6 AMG) approved and the ATTACHING THERETO approval decisions is (vgl. Doepner, HWG, 2. Edition (2000) § 4 Rdn: 36; Omsels.info, Online Commentary on UWG, § 4 Abs. 1 HWG, Keyword: Applications). Now, while there are at the present homeopathic medicines such approval not just. In their place, but come the specified direction by the homeopathic treatment applications. As such applications then come diseases, Suffer, Bodily injury or pathological disorders considered, in relation to the drug by its agents here-teaching according to the homeopathic- To be effective. Such diseases and pathological disorders among the normal running not just pregnancy. It is not a disease, but merely a vulnerable natural conservation status. This is an application of § 5 HWG counter.

5) Even if the pregnancy is no indication within the meaning of § 5 HWG is, such advertising is a recommendation of the drug for pregnant women but from a different point of law unfair competition law. It is a case of misleading advertising of medicines, as has also been adopted, the district court. The applicant has a claim under § § 8 Abs. 1, 3, 4 No.. 11 UWG i.V.m. § 3 No.. 1 HWG to. For a misleading legal remedies advertising is not permitted, if drugs or therapeutic efficacy effects are attributed to, that they have not. Also § 3 HWG is a market conduct regulation, aimed at the protection of the health of the individual and the public from the dangers of improper self-medication and the subject of an irrelevant advertising (vgl. Köhler / Bornkamm, UWG, 30. § edition 4 Rdn. 11.137). A misleading advertising of medicines is not permitted by European law principles.

a) The applicant is requesting authority and actively legitimized under § 8 Abs. 3 No.. 2 UWG. It is an association for the promotion of commercial interests within the meaning of this provision and has also and especially in the distribution of drugs to a sufficient and thus significant number of members, the same or similar goods in the same market sell. He's just in this area already established a considerable number supreme court decisions, he likes to quote. It is crucial, that homeopathic medicines are interchangeable with allopathic medicines acting normally.

b) The advertising of the defendant is a business action. It serves the promotion of all and very specific in ads shown and mentioned there T2 salts, by midwives should recommend the appropriate resources are in their treatment of the pregnant women. It is also an advertisement for a medicinal product within the meaning of § 1 Abs. 1 No.. 1 HWG. For any event included in the advertising T2 salts No.. 7 (Magnesium phosphoricum) and No.. 2 (Calcium phosphoricum) are registered as a homeopathic.

c) The ad with the statement “Gentle companion during pregnancy” contains a false promise action within the meaning of § 3 No.. 1 HWG. While the law also mentioned therapeutic efficacy of the application areas within the meaning of the indications referring, other effects can also towards flatter details of applications such as the use of generalized terms, as such does not represent applications, obtain (vgl. for generic terms OLG Stuttgart, Judgment of 19.11.2009 -2 You 40 / 09 S.9). Straight from the interaction of § 3 No.. 1 HWG with § 5 HWG and § 3 a HWG is concluded, that then, if a registered homeopathic medicines to avoid misleading even the only application can not be named, certainly not a comprehensive range may be named, for which the drug has not been registered. Because then the necessary scientific evidence is not effective to teach a fortiori.

aa) It especially is not so, that the statement “Gentle companion during pregnancy” from the perspective of professionals addressed here no serious action statement contains. The Senate may determine the appropriate understanding of the midwives as professionals and self. It is also the understanding of the above statement to a general understanding of language, for the principle in professional circles is nothing more than the general public. Only with the prior knowledge between professionals and the general public will be able to distinguish his. Such differences, the Senate can judge because of his general experience of life itself sufficient, at least in the present case.

bb) The statement “Gentle companion during pregnancy” is considered by the relevant midwives neither as obvious exaggeration advertizing still recognizable as an incomplete statement. Of which the defendant does not project itself. Their understanding of the underlying, that it is from the perspective of midwives IN QUESTION alone an indication of a more favorable risk profile of all T2-salts, or at least of the products shown, falls short. Consider also if, that it is the target market is professionals, For this the advertisement in any case, a recommendation for the use of certain homeopathic medicines, which are shown in the display and addressed, for pregnant women, with which they are confronted by profession. Which then arises not only as a risk Notice, but also as an active message is. This is even more, as the risk profile of an agent as well as the professionals they serve consumers are interested only in conjunction with a corresponding effect of the drug in a given application. Means, about its effect can not be done, interest will not be the only reason, because it is a low risk. Such small risks can be no motivation for, without regard for its effects to recommend an agent and take.

cc) According to the general understanding of language give medicines, the gentle companion can be in the life stage of pregnancy, impression, that they can develop friendly and lasting positive impact especially for pregnant women, the disease or illness from the scope of those drugs have. These two special T2-salts, The drugs are, should also be gentle, So unfold in their effects as few side effects. They should therefore have a gentle. As “Companion” they are during pregnancy and also offer long-lasting protection. Finally, the pregnancy may be particularly emphasized the typical range of this agent. It is also summarized in the eyes of midwives mentioned the recommendation of drugs with certain unnamed applications, which are specifically applied gently in pregnancy and can be taken during this time permanently without much risk.

dd) These effects have the advertised drug but not. Especially if the targeted midwives should know about their training, that homeopathic remedies are to develop because of their influence on the mineral balance in certain areas of application effects, this is an intended application areas corresponding effect just scientifically insufficient evidence, why these applications also can not be called. In addition, the pregnancy is just not the typical operating range of advertised here means. These funds will generally affect the mineral balance of the cells and regulate their nutrient. The references to the Internet records to cell salts and pregnancy not say, that it is so far is the typical field. Even if for example, the “Calcium phosphoricum” will unfold in the context of pregnancy precaution for protein formation and presence of impaired lime household and calf cramps on the principles of complementary therapy direction of homeopathy to prevent bone damage effects, Pregnancy is not the specific area of ​​application of the agent; it's just not a typical mid pregnancy. The same is true for the magnesium phosphate, if there are applications also known as labor pains and cramps. A typical pregnancy efficacy claims the defendant did not even nominated by it as part of the registration applications even. The fact, that pregnancy just can not be the special application, is also already working, that with regard to the pregnancy in these kits own risk disclosure is made (s. Appendix A leaflet 4). That means just, that an otherwise lasting working drug should be taken in case of pregnancy with caution. The former interpretation, that there are no well documented experience with use in pregnancy should, was an appropriate action statement even diametrically opposed. Even if it is no longer in use, there is still a commonly held risk considerations there, that pregnant women should consult their physician before use. The change is not based on scientific evidence now available, the safety of use in pregnancy. It is only as, that no special risks are known, which may require a more stringent risk considerations. But this means also, that the agents also are not foolproof in the sense, that they develop absolutely no side effects and may therefore be taken permanently. Also cause there's just no scientific evidence. Was carried out as already, the midwives also addressed the fact, that means from their perspective because of the dilution, Here at D 6 of 1: 1.000.000, can not hurt especially, no decisive importance to, if they do not at the same time it went out, that the pregnant women as part of his normal scope helps. Of such positive effects they go because of the recommendation made, in the context of such drugs is specific, because no applications may be called, But just from. It remains unclear to them, that this is not going to mean, which in pregnancy are of particular importance. Such a statement is unclear advertising but to accept not just in the case of health advertising.

ee) The defendant can not be heard so, that the midwives because of their off- Training could be known, that in the T2-salts due to the high dilution effect no reliable statements

can be made. This does not mean, that such advertising is permitted. There are generally no scientific evidence for the effectiveness of specific homeopathic remedies. They are still registered as a drug and must be used within certain applications, but to protect the patient as may already executed- precisely these applications, So the indications in product advertising are not mentioned, even not at a advertising to professionals. This is in the context of the regulatory drug approval- to see and registration system (vgl. BGH -Injectio, a.a.O. S.707). Therefore, if prescribed by the homeopathic treatment towards applications to protect the patient from harmful self-medication and in advertising may not be specified, we may be at the time of pregnancy to protect the pregnant woman is not advertised so for a particular aptitude in its effect scientifically questionable drugs. The advertiser can § 5 HWG not circumvent by, that he does not name the actual applications of the drug, but acts to a recommendation in a more general range. The diffuse nature of advertising with such statements and the selected focus of pregnancy violates already therefore against the required accuracy, Clarity and precision in the field of health advertising.

ff) By the advertisement is also the danger, that the midwives to pregnant women, relying on the statement of income for the medicinal product advertised rates. If a midwife of pregnant women in reliance on the correctness of the advertisement is the ingestion of certain salts T2 extent recommends gently, this will be such a recommendation may be deterred, to ask their doctor, whether it should take the funds actually. In particular, they can also refrain from taking any other supposedly more burdensome preparations, the her (better) could help. Such a health hazard, an advertisement with the scientifically insufficient evidence about the effects of a drug, as it is inherent in, sufficient in view of EU law, to establish a legal drug advertising mislead professionals. Any further specific health risk to consumers is also necessary for constitutional reasons, to the extent not (vgl. BGH -Injection, a.a.O. S.708 to § 5 HWG).

d) Violation of provisions of the HWG is also a noticeable competitive violation as defined in § 3 Abs. 1 UWG, because the remedy legal standards, the competitive behavior in the market, the drug-as already stated- in the interest of the health of individuals and the health needs of the community rules. These sensitive areas protected by the field of health are affected, when using a banned because of its nature product-related sales advertising a false impression can be awakened at the Midwives, that pursuant to the above may also affect the subject of protection of the health of pregnant women significantly.

The decision on costs is based on § 97 Abs. 1 ZPO.

The decision on the provisional execution results from § § 708 Nr.10,

711, 713 ZPO.

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