Subdural hematoma w/craniotomy results in malpractice claim against Coumadin Clinic. Defense. San Diego County.

Facts and Background

• Facts and Background:

  Plaintiff had a complex medical history requiring use of Coumadin, an anticoagulant, since 1998. Use of Coumadin requires monitoring of INR for assessing the thickness/thinness of blood. Too low of an INR can result in clotting risk, while too high of an INR can result in bleeding risk.

  Standlee's anticoagulation therapy was managed briefly by the Coumadin Clinic at Scripps Clinic in 2000, and was then managed by various outside providers until March of 2009, when she returned to the Scripps Coumadin Clinic for anticoagulation management.

  Standlee initially went to a lab to obtain INR values. However, she had substantial difficulty going to the lab due to child care responsibilities. She missed multiple lab appointments, and the Coumadin Clinic assisted her in arranging for a home INR monitor for ease of testing. During her management by the Coumadin Clinic, Standlee had several instances in which she took unprescribed medications without advising the Coumadin Clinic.

  On one occasion, she ingested excess doses of Coumadin, had a headache, and was told by the Coumadin Clinic of the possibility of intracranial hemorrhage and was urged to seek medical attention at Urgent Care.

  On November 16, 2010, Standlee presented to a physician at Scripps Clinic with symptoms of sinus infection, who prescribed Augmentin, an antibiotic, and instructed Standlee to follow-up with the Coumadin Clinic, as antibiotics may have adverse interactions with Coumadin. Standlee did not do so.

  Standlee returned to Scripps Clinic on November 24, 2010 and was seen by another physician, again with sinus pressure, as well as eye pain. She was prescribed another course of Augmentin and advised to follow-up with the Coumadin Clinic due to potential drug interactions.

  Standlee tested her INR value on November 26, 2010, and obtained an elevated value of 8.0. A Coumadin Clinic pharmacist called her the next day and left a message to inquire as to the cause of the elevated INR, and advised her to go to the emergency room with any severe bleeding or bruising.

  On November 28, 2010, Standlee presented to the emergency room with a severe headache, and was discovered to have a subdural hematoma. She subsequently underwent craniotomy.

• Plaintiff's Contentions:

  Plaintiffs claimed the care and treatment by Scripps Clinic’s Coumadin Clinic fell below the standard of care. Standlee testified she did not recall various physicians discussing the risk of bleeding with use of Coumadin, or the risk of drug interactions between Coumadin and antibiotics. She testified she had absolutely no understanding she was obligated to inform the Coumadin Clinic of newly prescribed medications due to potential drug interactions.

  Plaintiffs’ expert, Dr. Michlin, testified the Coumadin Clinic had a duty to reach the patient on November 26, 2010 when an elevated INR value of 8.0 was obtained. Further, the pharmacist was obligated by the standard of care to review Standlee’s medical record at the time, which would have revealed a complaint of headache from 2 days prior.

  Plaintiffs alleged violation of policies and procedures, and a deficient on-call system for INR values drawn over the weekend, which she claimed resulted in subdural hematoma and related damages.

• Defendant's Contentions:

  The Medical Director of the Coumadin Clinic testified and explained the policies and procedures were both adequate and followed by Coumadin Clinic pharmacists as it pertains to the care of Ms. Standlee.

  The pharmacist testified the message she left for Ms. Standlee the morning of November 27, 2010, was pursuant to and consistent with Coumadin Clinic protocol.The pharmacist further set forth other instances in which Ms. Standlee was advised of the need to report medication changes, and to seek medical attention at the Urgent Care/Emergency Room in the event of a persisting headache with elevated INR values.

  Standlee's treating physicians additionally testified she was instructed on the need for follow-up with the Coumadin Clinic in the event of newly prescribed medications, due to potential drug interactions. They further testified she exhibited acknowledgment and understanding of such instructions.

  Defense expert Dr. Howard Williams testified the standard of care was met in all respects. He testified the on-call system was appropriate and offered more accessibility than most Coumadin Clinics. He testified Standlee was a long-time Coumadin patient, was capable of understanding and following instructions, and was informed of potential drug interactions. He testified that while there is a recognized interaction between Augmentin and Coumadin, Augmentin would not typically elevate the INR to 8.0, and based on Standlee's past history of self-medicating on various occasions, he believed the cause of the elevated INR on November 26 was due to excess ingestion of Coumadin, not due to drug interaction with Augmentin.

  Dr. Williams testified Standlee had a history of somatization and severe pre-existing headaches, and that craniotomy did not cause the headaches currently reported by the patient.