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Puncture Sealing After Cardiac Catheterization Results in Amputation; Evidence Admissible


A man presented to a medical facility with chest pain. He was transferred to a hospital and underwent cardiac catheterization via a left groin entry site. At the end of the procedure an interventional cardiologist who performed the cardiac catheterization used a Duett sealing device to close the puncture site of the left femoral artery. A Duett sealing device is a single-use, disposable, medical device used during surgery that stops bleeding from the femoral artery puncture site following the passage of the catheter (a thin hollow tube) through the blood vessel. The Duett is made up of two main parts: a thick liquid called a procoagulant that rapidly clots blood upon contact, and a flexible balloon catheter used to access and temporarily seal the puncture site. There was also evidence of a totally occluded left superficial femoral artery. The interventional cardiologist noted that a thrombus (blood clot) was identified at what appeared to be the site of the closure device with thrombus extending into the Profunda artery. He attempted to remove the blood clot using an angiojet catheter and a tissue plasminogen activator (tPa), an enzyme that helps dissolve clots. Immediately after the cardiac catheterization procedure the interventional cardiologist told the man’s daughter that he had used the Duett closure device because the team did not think the man could remain still on the table long enough for manual compression.

 

A vascular surgeon performed thrombectomy surgery to remove the blood clot. Following the surgery, the vascular surgeon expressed concern that the man could lose his leg. The man was admitted to the ICU after the thrombectomy surgery. Thirteen days later the man underwent a below-the-knee amputation due to persistent pain and gangrene of his lower left leg.

 

The man sued the hospital for medical negligence. The complaint alleged that the interventional cardiologist used a Duett sealing device at the end of the procedure that was contraindicated by the man’s peripheral vascular disease, causing the man to develop a blood clot that ultimately led to the amputation of his left leg below the knee.

 

During the trial, the hospital sought to use as an exhibit the man’s medical record from a different hospital documenting the use of the Duett sealing device on his right leg without complications two years prior to the cardiac catheterization at issue in this case. The man objected arguing that there was no evidence that the interventional cardiologist relied on the record of its previous use in deciding to use the Duett on his left leg two years later. The hospital presented evidence that the interventional cardiologist had access to and reviewed the record of its previous use prior to the procedure as well as expert opinion that it was common practice to do so. The Circuit Court of the City of St. Louis overruled the man’s objection and admitted the hospital’s exhibit.

 

The hospital sought to use as an exhibit at trial the interventional cardiologist’s addendum to the man’s cardiac catheterization report documenting the use of the Duett sealing device on the man’s left leg at the end of the cardiac catheterization at issue in the case. The addendum indicated that after the catheterization was completed a left femoral angiogram was performed for consideration for vascular closure. The common femoral was felt to be appropriate for some vascular closure. The interventional cardiologist noted that the man was moving around and could compromise a traditional manual closure of the puncture site. The man was noted to have peripheral vascular disease, but the site was deemed reasonable for closure. The man objected to the admission of the addendum arguing that it constituted self-serving hearsay because it was written after the man developed a blood clot to explain why the interventional cardiologist chose to use the Duett closure device even though it was contraindicated because of the man’s peripheral vascular disease. The trial court overruled the man’s objection and admitted the hospital’s exhibit.

 

The trial court entered judgment on a jury verdict in favor of the hospital.

 

The Missouri Court of Appeals, Eastern District, Division Four, affirmed. The court held that the trial court did not abuse its discretion when it admitted into evidence the man’s medical record from a different hospital documenting the use of the Duett sealing device on his right leg two years prior to the cardiac catheterization at issue in this case or the interventional cardiologist’s addendum to the man’s cardiac catheterization report documenting the use of Duett sealing device on his left leg at the end of the cardiac catheterization at issue in the case.

 

The trial court did not abuse its discretion when it admitted into evidence the man’s medical record from a different hospital documenting the use of the Duett sealing device on his right leg two years prior to the cardiac catheterization at issue in this case. The hospital presented credible evidence that the interventional cardiologist had access to and reviewed the record of its previous use prior to the procedure as well as expert opinion that it was common practice to do so. The interventional cardiologist’s notes in the cardiac catheterization report and his resident’s notes indicated consideration of the prior procedure and its comparison to the procedure at issue. Accordingly, although the interventional cardiologist was not available to personally testify he relied in part on the man’s medical record from a different hospital documenting the use of the Duett sealing device on the man’s right leg without complications two years prior in making his decision to use the Duett sealing device, there was sufficient evidence that the cardiologist did. The expert’s opinion that it was common practice to look at a patient’s previous records and especially so in this particular instance of a second cardiac catheterization was supported by competent evidence and had sufficient probative force to be substantial evidence. The court concluded that from this evidence, the jury could have reasonably inferred the interventional cardiologist looked at and considered the man’s medical record from a different hospital documenting the earlier use of the Duett sealing device on his right leg without complications prior to performing the procedure in determining the best method for closure. The court concluded that the trial court did not abuse its discretion in allowing into evidence the man’s medical record from a different hospital documenting the use of the Duett sealing device on his right leg two years earlier.

 

The trial court did not abuse its discretion when it admitted into evidence the interventional cardiologist’s addendum to the man’s cardiac catheterization report documenting the use of the Duett sealing device on his left leg at the end of the cardiac catheterization at issue in the case. Medical records relating to observations, treatment, and diagnoses are generally admissible as business records. The interventional cardiologist’s addendum to the man’s cardiac catheterization report were written by the interventional cardiologist who performed the procedure and detailed the very medical procedure at issue in this case, including follow-up and complications. The addendum was written the day after the procedure. The addendum documented the interventional cardiologist’s medical impressions, course of conduct, reasoning, and conclusions. The court concluded that the interventional cardiologist’s addendum to the man’s cardiac catheterization report was properly admitted under the business records exception to the hearsay rule. The court found the interventional cardiologist’s addendum to the man’s cardiac catheterization report was not self-serving. A self-serving statement is a statement made by a party in his or her own interest regarding liability, and is generally not admissible because the reliability of this type of comment is suspect. The addendum was necessary for subsequent healthcare providers to rely on in treating the man. The man’s expert admitted it is standard practice for a doctor to document any complications in a procedure report, and this allows other doctors to know what happened during the procedure and rely on that information in their own care of the patient. There was independent corroborating evidence in the record supporting the reliability of the interventional cardiologist’s statements about his choice of the Duett closure device. The court reasoned that whether the interventional cardiologist’s statements were to be accepted as credible was ultimately for the jury, not the trial court. The court concluded that the trial court did not abuse its discretion in allowing into evidence the interventional cardiologist’s addendum to the man’s cardiac catheterization report.

 

The Missouri Court of Appeals, Eastern District, Division Four, affirmed the trial court’s entry of judgment on a jury verdict in favor of the hospital.

 

See: Carlson v. Saint Louis University, 2016 WL 2994139 (Mo.App. E.D., May 24, 2016) (not designated for publication).

 

See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death

 

See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease

 

See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues

 

See also Medical Law Perspectives, November 2012 Report: Liability for Electronic and Other Medical Record Information Disclosure

 

See the Medical Law Perspectives July 31, 2015, Blog: Hospital’s Policies, Procedures Not Discoverable in Vicarious Liability Suit

 

See the Medical Law Perspectives May 6, 2015, Blog: Hospital Incident Reports Under Scrutiny Again; In Camera Review Found Necessary To Determine Discoverability 

 

See the Medical Law Perspectives March 2, 2015, Blog: Discovery of Hospital Incident Reports: Prepare for In Camera Review; Discovery Likely

 

 

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