Establishing Negligence in Medical Malpractice and Product Liability
| Medical Malpractice | Product Liability | |
|---|---|---|
| Duty of Care | Was there a physician-patient relationship? Did the physician have a professional obligation to provide care? | Did the manufacturer owe a duty to warn? Was the medication used as intended? |
| Dereliction of Duty | Did the physician’s actions (or inactions) deviate from the standard of care? Were clinical guidelines or best practices followed? Was informed consent obtained and documented? | Did the manufacturer provide sufficient warnings about the medication’s known risks at the time of prescribing to discharge its duty to warn? Was there a defect in design, production, or marketing? |
| Direct Causation | Did the physician’s actions or inactions directly cause harm? Could other factors (e.g., patient comorbidities, external events) have contributed to the harm? | Did the medication’s defect or the company’s failure to warn directly cause harm? Were there intervening factors that might have led to the harm? |
| Damages | What specific physical, emotional, and financial harms resulted from the alleged negligence? Are the damages clearly linked to the negligent actions or omissions? | |
| Defense Strategies | Emphasizing adherence to standard of care Disputing causation Citing shared decision-making with the patient | Invoking the learned intermediary doctrine Disputing causation Asserting compliance with industry standards |
| Standard of Proof | Preponderance of evidence | |