Medical Device Litigation and Dispute Resolution
The medical device industry is growing rapidly, accompanied by an increase in legal disputes. These disputes can relate to defective products causing patient injury (Product Liability) or commercial conflicts between manufacturers, distributors, and clinics. Since medical devices (e.g., implants, pacemakers, diagnostic equipment) are directly linked to human life, lawsuits involving them are complex and high-risk. Disputes often require not only legal argumentation but also complex technical and medical expertise to establish a causal link between device malfunction and the harm caused.
Legal.ge offers access to experienced lawyers specializing in medical device litigation. We protect the business interests of manufacturers and distributors as well as the rights of injured patients. Our approach combines legal strategy with technical knowledge, which is essential for success in court.
What Does Medical Device Litigation Service Cover?
This service covers a wide range of conflicts, from civil liability to administrative disputes:
- Product Liability: Defense or filing lawsuits in cases where a defective device (e.g., a broken implant) caused patient injury or death.
- Commercial Disputes (B2B): Disputes between manufacturers and distributors regarding exclusivity, breach of delivery deadlines, or non-payment.
- Regulatory Disputes: Appealing decisions of the Regulation Agency for Medical Activities (fines, import bans, recalls).
- Public Procurement Disputes: Appealing disqualification in tenders or challenging technical specifications at the Dispute Resolution Board.
- Intellectual Property Disputes: Litigation related to patent infringement between competing companies.
- Warranty Service Disputes: Conflicts between clinics and suppliers regarding equipment service and repair terms.
Common Situations and Scenarios
A typical scenario is a public tender. A clinic announces a tender for a CT scanner with technical parameters tailored to one specific brand. Another distributor considers this discriminatory. A lawyer prepares a complaint to the Procurement Dispute Board, proving the restriction of competition and demanding changes to the tender conditions.
Another scenario is a defective implant. A patient receives a knee prosthesis that fails within a year, requiring re-operation. The patient demands compensation. The manufacturer argues the problem is surgeon error (Malpractice), not a product defect. The lawyer works with experts to distinguish between medical error and product flaw.
Georgian Legislation and Legal Framework
Dispute resolution relies on the Civil Code of Georgia (damages, contract law), the Code on Product Safety and Free Movement (manufacturer liability), and the Law on State Procurement. Administrative disputes proceed according to the General Administrative Code. Judges often rely on forensic expertise conclusions, so the lawyer's role in correctly formulating questions for experts is critical.
Process of Receiving Services
The process begins with case analysis. The lawyer assesses evidence (contracts, medical history, expertise). In commercial disputes, preference is given to negotiation and mediation, as court proceedings can take years. If no agreement is reached, the lawyer prepares a lawsuit and represents the client in court. In regulatory disputes, adhering to deadlines (10-day appeal period) is crucial.
Legal.ge will help you protect your business or health in complex technical and legal disputes.
Why Choose a Specialist on Legal.ge?
Medical device disputes require an understanding of technical details (ISO standards, calibration, wear and tear). On Legal.ge, you will find lawyers with experience specifically in the MedTech sector who can translate complex technical issues into language understandable to a judge.
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