How medical chart review is significant in product liability litigation

How Medical Chart Review Is Significant in Product Liability Litigation A medical device liability lawsuit requires a medical chart review to help identify the nature and extent of injury and its impact on the injured person.

Medical Record Review

Defective medical devices such as pacemakers, faulty surgical instruments, prosthetics, surgical robots, stents and hip implants can be dangerous and generate product liability claims if the patient concerned is injured or dies. In spite of the close monitoring by the U.S. FDA (Food and Drug Administration), products continue to be defective in their manufacturing process, design or marketing strategy. There are numerous state law suits over federally approved medical equipment, which receive considerable attention nationwide. A personal injury/medical malpractice/product liability lawsuit related to a medical device requires a detailed medical chart review to help identify the nature of injury, extent of injury and its impact on the injured person.

Identifying Medical Record Tampering Take the case of Essure permanent contraceptive device for women from Bayer Healthcare Pharmaceuticals Inc. Essure is a small flexible coil that is inserted into the fallopian tube through the cervix and uterus. It causes inflammation that permanently blocks the fallopian tube by around 3 months after insertion. The FDA has opened an investigation on this product after allegations that the manufacturer falsified and altered medical records during clinical trials, did not report adverse events, misled the public and the FDA regarding the device’s efficacy and safety and used defective materials in manufacturing. Hundreds of women who used the device experienced adverse events such as pain, device migration and organ perforation. Bayer has, however denied the charges and stated its conviction regarding the safety and efficacy of Essure.

The allegations leveled against the company are: 

Falsification of the medical records of at least two patients during the clinical trial phase.

The tampering include changing the feedback of a patient in the questionnaire about unusual health problems related to the device, and changing the birth date of a patient in order to conform to FDA premarket approval requirements.

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Failure to report adverse events that resulted from the device.

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Providing false information about the device many times such as saying that no pregnancies occurred during clinical trials whereas actually these did occur. The company had conducted no testing whatsoever to compare Essure with procedures such as vasectomy and tubal ligation but claimed that Essure is the most effective permanent contraceptive available.

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Defective materials were used to manufacture Essure.

Manufacturers as well as physicians may be held liable for personal injury caused by defective medical equipment. The plaintiff has to prove that the equipment had a design or a manufacturing defect, or that the manufacturer gave inadequate warnings about the dangers associated with the product. The surgeon who performed the procedure may also be liable for medical malpractice. This is when he/she fails to provide the level of care expected and the patient is injured consequently. Surgical errors, misdiagnosis and failing to inform the patient about the known risks associated with the particular procedure can result in medical malpractice.

Reviewing the relevant healthcare documents for medical malpractice can be a daunting task.

Different institutes may follow different methods of charting and this adds to the difficulty level. Many healthcare facilities are implementing a computerized charting system whereas others still use paper medical records that are difficult to understand. The standard medical documents reviewed include the following: 

Admission demographic sheet

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Consent for treatment

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Triage assessment

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Nursing assessment

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Nursing notes

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Physician assessment

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Physician orders

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Lab reports

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Imaging records

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Respiratory therapy records

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ECG reports

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Discharge instructions

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Discharge summary

Medical Record Review to Identify Merit and Causation Review of the relevant medical records will help to establish merit and causation. Legal nurse consultants perform the initial chart review. In this they often obtain the services of a medical record review company to organize the medical records and create chronologies and timeline.

This will make the review process easy and help them spot the strengths and weaknesses of a particular case and also identify deviation if any, from the standards of care. These services aim to transform the complicated medical record full of technical jargon into a simple document summarizing the medical events, and preparing a chronology that helps legal professionals understand the case clearly. Medical chart review is labor intensive and time intensive for nonmedical legal staff. It makes sense therefore to partner with experts who can identify and understand relevant information, and spot missing records. Missing records may contain crucial information that may affect the merits of the case.

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