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Appraising Medical Studies for Legal Research: Identifying Valid and Reliable Evidence
Dr.Nancy | Clinical and Medical Research Expert
03 Apr, 2025
Dr.Nancy | Clinical and Medical Research Expert
03 Apr, 2025
Introduction
Simply selecting the relevant medical studies is not sufficient to handle medico-legal cases for legal professionals. It is also essential to cross-check the studies for credibility, accuracy, validity, and strength of evidence. This assures that the data presented to the court collected from medical studies are credible and meet the standards [1].
This article highlights how the legal research ensures the quality of the studies, identifies the biases, and determines whether the evidence is sufficient for use in the medico-legal cases.
Table of Content
- Introduction
- Why does critical appraisal matter in medico-legal research?
- Reasons for evidence rejection:
- Crucial components of a high-quality systematic review or meta-analysis
- Detecting the bias in medical studies
- Scoring and rating medical studies
- How can legal professionals estimate medical studies?
- Conclusion
Why does critical appraisal matter in medico-legal research?
Legal cases involving medical malpractice, pharmaceutical controversies, or healthcare action rely heavily on medical substantiation. Proper appraisal helps to
- Confirm the validity of a study’s findings.
- Identify impulses or methodological limitations that could weaken expert evidence.
- Ensure that medical substantiation meets legal admissibility norms [1].
By using structured appraisal, legal experimenters can challenge unreliable medical evidence and strengthen their legal arguments [2].
Example:
In 2022, Judge Robin Rosenberg rejected the scientific evidence from the plaintiffs and expert testimony in the Zantac litigation case due to lack of reliability and flaws in the methodology and results.
Reasons for evidence rejection:
a) Valisure’s Methodology:
The test methodology used by the Valisure, an independent laboratory in the United States, was dismissed by the judge. Valisure tested the Zantac by heating the substance, which causes Ranitidine to convert into NDMA (N-Nitroso dimethylamine). They have claimed that the presence of NDMA exceeds the FDA’s maximum limit of 96 ng.
The judge rejected the claim, stating that the heating method used Valisure was not representative of real-life scenarios. At normal human temperature, NDMA levels do not reach the daily limit.
b) Stanford University Evidence:
The evidence from Stanford university was retracted by the author due to the contamination of the instrument. But the judge concluded that there was no conclusive evidence provided to directly link ranitidine to cancer [3].
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Key flaws found in evidence:
Some of the key flaws identified for the rejection of the evidence in the court are:
- Flawed methodology and findings.
- Lack of statistical significance.
- Improper study condition.
- Unsupported study results.
- Lack of RCTs or clinical studies claiming the carcinogenic property of Ranitidine.
Hence, use of Daubert standard is essential to ensure that the evidence submitted is scientifically sound, valid, and credible.
Crucial components of a high-quality systematic review or meta-analysis
Systematic reviews and meta- analyses are at the top substantiation, but their trustability depends on how well they’re conducted [2]. A high-quality review must include:
- A clear research question stated using PICO (Population, Intervention, Comparison, Outcome) or PICOS (Population, Intervention, Comparison, Outcome, Setting) frameworks
- Well-defined acceptance/ rejection criteria for opting studies.
- A comprehensive search strategy to detect applicable studies
- Styles for assessing the validity of the included studies.
- A transparent reporting process using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting review and meta-alaysis.
- Structured data collection styles.
- A clean analysis plan outlining how data in interpreted [4].
The Daubert standard provides the criteria to be ensured prior to proceeding scientific evidence on courts. This ensures the expert testimony is valid, suitable for legal cases. If a review lacks originality or excludes crucial data, the findings may be unreliable, making them unsuitable for legal use [5].
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Detecting the bias in medical studies
Bias can occur at multiple stages of a meta- analysis or methodical review, including:
- How the research question is derived.
- Which studies are included or barred.
- How data is uprooted and analysed.
- How study results are interpreted [5].
To minimize bias, experimenters should follow a predefined protocol for conducting reviews. This ensures that:
- The research approach remains harmonious throughout the study.
- No data is widely included or barred to manipulate results.
- Readers can be assured that the study follows scientific practices [2].
- The review provides precious perceptivity by relating gaps in medical research [4].
Example:
In AstraZeneca PLC Securities Litigation, the plaintiffs have identified some bias in the clinical trial data of the COVID vaccine manufactured by AstraZeneca. The plaintiffs filed lawsuit against the company for not disclosing the dosing error data in the clinical trials.
Bias in the study:
- Misleading statement on the safety and efficacy of the COVID vaccine.
- Not disclosing the dosing error.
This bias led the investors to financial loss as the efficacy of the vaccine is not clearly represented. The plaintiffs argued that these actions constituted fraudulent claims under Securities Exchange Act [6].
Scoring and rating medical studies
Some associations, like the National Cancer Institute (NCI), have developed standard systems to estimate the quality of medical studies. The NCI system assigns:
- A numerical score (1 to 4) for study design, where 1 is stylish quality (e.g., double-eyeless randomized controlled trials) and 4 is weakest quality (e.g., case reports and experimental studies).
- A letter grade (A to D) for strength of results, where A is strongest substantiation and D is weakest substantiation [7].
For example, 1A indicates a high- quality randomized controlled trial (RCT) with strong survival issues, making it the most dependable type of substantiation.
Even though there is no universal standing system, the legal experimenters must estimate the study design, bias, and statistical strength [7].
How can legal professionals estimate medical studies?
When assessing medical studies for use in court cases, legal experimenters should ask:
- Was the study design applicable? (e.g., RCTs are stronger than non-experimental studies).
- Was the sample size large enough? (Larger samples = further dependable results).
- Were results statistically significant? (Look for confidence intervals and p- values).
- Were impulses reckoned for? (Check bedazzling, randomization, and study backing sources) [4].
By critically setting medical literature, legal brigades can
- Challenge weak expert evidence in court.
- Support legal arguments with strong medical substantiation.
- Assure that presented medical studies meet admissibility norms [1].
Conclusion
In medico-legal cases, the quality of medical substantiation can make or break a legal argument. Critical appraisal of studies ensures that legal brigades calculate on valid, unprejudiced, and scientifically sound research.
By assessing study design, bias, and statistical trustability, legal professionals can confidently use medical studies in action, assuring that medical evidence is both believable and permissible [2].
At Pubrica, our experts assist you in medico-legal cases with relevant, credible and higher standards of evidence. We use medical evidence that align with the patient’s goal and preferences