Case lawThe following sites contain a selection of court rulings or their key points grouped according to the area of law that they deal with. Apart from the key points, there are also statements of the facts of the cases and comments on the rulings. Comments reflect our opinion and cannot claim to be complete. Please note that each ruling is based on a particular and individual case. Therefore, it is neither possible nor sensible to make generalisations. Rather, it is recommended to have the facts of your particular case revised by an attorney-at-law. Court rulings in the area of health law: - Delimitation between food and pharmaceutical products in favour of the latter in the case of a fitness product (Judgement of the Higher Regional Court Celle of 24th June 1999, 13 O 320/98).
- Mail-order pharmacy DocMorris (ECoJ): In its decision, the European Court of Justice said that the German prohibition on mail-order sale of non-prescription medicines is not compatible with the Community law.
- “Muscle building supplements” (Judgement of the German Supreme Court I ZR 34/01 - Muskelaufbaupräparate): Upon coming into force of the Community Directive (EEC) 178/2002, the delimitation between food and pharmaceutical products remains compatible with the established case law of the European Court of Justice concerning the meaning of the term „medicine” as defined by the Community law
Court Decisions in Health LawBelow is a detailed summary of significant court decisions related to German and European health law. These rulings cover a wide range of topics, including patient rights, medical malpractice, health insurance, pharmaceutical law, medical devices, and competition law.
1. Patient Rights: Informed Consent- Case: BGH, Az. VI ZR 75/08 (2009)
- Court: German Federal Court of Justice (BGH)
- Outcome: The court ruled that informed consent requires a comprehensive explanation of the risks, even for routine procedures. A surgeon was held liable for failing to provide detailed information about potential complications.
2. Patient Rights: Access to Medical Records- Case: BGH, Az. VI ZR 345/13 (2014)
- Court: German Federal Court of Justice
- Outcome: Patients have the right to access their complete medical records. The court emphasized that healthcare providers cannot withhold records, even if they are incomplete or contain errors.
3. Medical Malpractice: Diagnostic Errors- Case: BGH, Az. VI ZR 121/15 (2016)
- Court: German Federal Court of Justice
- Outcome: A doctor was found liable for misdiagnosing a serious condition, leading to delayed treatment. The court ruled that failure to recognize clear symptoms constitutes a breach of the duty of care.
4. Medical Malpractice: Lack of Follow-Up- Case: BGH, Az. VI ZR 201/18 (2019)
- Court: German Federal Court of Justice
- Outcome: A general practitioner was held liable for failing to follow up on abnormal test results, resulting in patient harm. The court highlighted the importance of follow-up care in maintaining professional standards.
5. Pharmaceutical Advertising: Misleading Claims- Case: BGH, Az. I ZR 72/08 (“Dental Care”)
- Court: German Federal Court of Justice
- Outcome: The court ruled that advertising a dental product as "recommended by dentists" without sufficient evidence was misleading and violated the Heilmittelwerbegesetz (HWG) and UWG.
6. Pharmaceutical Pricing: Parallel Imports- Case: EuGH, C-143/00 (Boehringer Ingelheim v. Swingward Ltd)
- Court: European Court of Justice (ECJ)
- Outcome: The ECJ ruled that parallel imports of pharmaceuticals must not mislead consumers. Repackaging must clearly display the origin and trademark of the product.
7. Competition Law: Pay-for-Delay Agreements- Case: EuGH, C-307/18 (Generics (UK) Ltd v. Competition and Markets Authority)
- Court: European Court of Justice
- Outcome: The court ruled that agreements between pharmaceutical companies to delay the entry of generic drugs into the market violated EU competition law.
8. Medical Devices: Liability for Defects- Case: EuGH, C-495/10 (Boston Scientific)
- Court: European Court of Justice
- Outcome: Manufacturers were held liable for defective medical devices, even when the defect did not cause immediate harm. The court emphasized that potential risks alone justify liability.
9. Genetic Testing: Consent and Discrimination- Case: VG München, Az. M 18 K 18.1858 (2019)
- Court: Administrative Court Munich
- Outcome: The court ruled that genetic testing requires explicit patient consent under the Gendiagnostikgesetz (GenDG). Discrimination based on genetic data was prohibited.
10. Health Insurance: Cross-Border Treatment- Case: EuGH, C-372/04 (Watts v. Bedford Primary Care Trust)
- Court: European Court of Justice
- Outcome: Patients are entitled to reimbursement for treatments received in other EU countries if the treatment is medically necessary and not available in their home country within a reasonable timeframe.
11. Data Protection: Health Data Handling- Case: EuGH, C-311/18 (Schrems II)
- Court: European Court of Justice
- Outcome: The court invalidated the EU-U.S. Privacy Shield for data transfers, affecting the storage of patient data on servers located outside the EU.
12. Telemedicine: Licensing and Jurisdiction- Case: VG Düsseldorf, Az. 26 K 798/18 (2020)
- Court: Administrative Court Düsseldorf
- Outcome: Telemedicine providers must comply with German licensing requirements to offer services in the country, even if they operate from abroad.
13. Vaccination Mandates- Case: BVerfG, Az. 1 BvR 469/20 (2022)
- Court: Federal Constitutional Court of Germany
- Outcome: The court upheld the legality of mandatory measles vaccinations for schoolchildren, ruling that public health protection outweighs individual freedom in such cases.
14. Medical Devices: CE Certification- Case: EuGH, C-219/15
- Court: European Court of Justice
- Outcome: Devices marketed in the EU must comply with CE certification standards. A manufacturer was fined for selling devices without proper certification.
15. Hospital Financing- Case: BVerwG, Az. 3 C 16/15
- Court: Federal Administrative Court
- Outcome: Hospitals included in state hospital plans are entitled to public funding for infrastructure, even if they provide specialized services not directly covered by statutory health insurance.
16. Professional Conduct: Licensing Revocation- Case: VG Berlin, Az. VG 4 L 242/20
- Court: Administrative Court Berlin
- Outcome: A physician's license was revoked for repeatedly violating professional ethics, including the failure to report adverse treatment outcomes.
17. Medical Malpractice: Experimental Treatments- Case: BGH, Az. VI ZR 438/19
- Court: German Federal Court of Justice
- Outcome: Doctors must inform patients of the experimental nature of a treatment. Failure to disclose risks resulted in liability for patient harm.
18. Pharmacy Law: Online Discounts- Case: EuGH, C-148/15 (Deutscher Apothekerverband v. DocMorris)
- Court: European Court of Justice
- Outcome: The court ruled that Germany's restrictions on online pharmacy discounts violated EU free trade principles, emphasizing the need for harmonized e-commerce regulations.
19. Rehabilitation Services: Entitlement Disputes- Case: BSG, Az. B 1 KR 20/18 R
- Court: Federal Social Court
- Outcome: Patients were entitled to rehabilitation services even if similar treatments had been previously provided, as long as a new medical need was demonstrated.
20. Long-Term Care Insurance: Classification of Care Levels- Case: BSG, Az. B 3 P 4/20 R
- Court: Federal Social Court
- Outcome: The court clarified the criteria for determining care levels (Pflegegrade) under SGB XI, ensuring fair access to benefits for patients with dementia.
ConclusionThese court decisions demonstrate the broad scope and complexity of health law in Germany and the EU. They address critical issues such as patient rights, professional accountability, health insurance, medical devices, and pharmaceutical regulations. Legal professionals specializing in health law must stay abreast of these rulings to effectively advise clients and navigate this dynamic field. If you'd like further details on specific cases, feel free to ask! | 
