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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 patientInvoking the learned intermediary doctrine
Disputing causation
Asserting compliance with industry standardsStandard of Proof Preponderance of evidence Key Area for Evaluation Questions to Consider Diagnosis Was the diagnosis reasonable based on available information?
Was the diagnosis supported by thorough assessment?
Were appropriate attempts made to gather information required for diagnostic clarification?Informed Consent Did the patient have the capacity to consent to treatment? If not, were appropriate steps taken to utilize a surrogate decision-maker?
Was the patient adequately informed of treatment risks and benefits?Rationale for Treatment Did the prescriber provide the rationale for the proposed treatment?
Were treatment recommendations justified for the clinical situation?Causation Was the harm directly attributable to the prescriber’s actions or inactions?
Were there other variables or comorbidities that may have contributed to harm?Treatment Decisions Were there errors of omission (i.e., withholding treatment, stopping treatment, or failures to act) that contributed to alleged harm?
Did active decisions (e.g., prescribing teratogenic medications) deviate from standard of care, and if they did, was this justified by the clinical scenario?Adherence to Standards of Care Were treatment decisions consistent with professional guidelines?
Were deviations from standards of care justified by the patient’s unique circumstances?Documentation Was the clinical decision-making process clearly recorded?
