A confusing case regarding a patient with “extremely high” Coumadin (warfarin) levels who received medication in an emergency department to reverse the effects of Coumadin resulted in a $15 million megaverdict against Banner University Medical Center in Tucson, AZ.
Case History
A 42 year old female went to the emergency department for evaluation of severe right sided abdominal pain. During her workup, she was found to have “extremely high Coumadin levels.” She reportedly had experienced Coumadin toxicity on multiple previous occasions and had been given treatments such as Fresh Frozen Plasma, Vitamin K, or was simply advised to stop taking her Coumadin. The reason for the patient’s anticoagulant use was not clear, but the patient reportedly lied about her medical history, telling the physicians that she had a history of DVTs and a prior stroke when she had neither. Due to the potential appendicitis and the potential for an emergency appendectomy, the treating physicians decided to bring the patient’s INR back to therapeutic range as quickly as possible. The emergency medicine resident treating the patient recommended using Profilnine which is a coagulation factor concentrate typically used in Factor IX deficient patients. The hospital had guidelines on Profilnine use including serious or life-threatening bleeding and as preparation for emergency surgery. Although an appendicitis was suspected, it was determined after the medicine had been administered that the patient did not have appendicitis. Therefore in retrospect the patient met neither of the hospital guidelines. After the order to administer Profilnine was entered, shift change occurred and new physicians assumed care for the patient. Two hours after receiving Profilnine, the patient screamed out in pain and became hypotensive. She remained hypoxic for more than an hours and ultimately suffered an MI and brain anoxia resulting in a permanent vegetative state. The patient’s family filed a lawsuit.
Plaintiff’s Position
The patient’s attorneys argued that the doctors were too aggressive in their treatment of the patient’s Coumadin toxicity and should have only given standard treatments. In addition, they argued that the doctors and the hospital violated the hospital’s own policies in administering Profilnine since those policies specifically stated that Profilnine should not be used unless there was a serious bleed or unless in preparation for emergency surgery. With regard to the patient’s untruthful statements about her medical history, they argued that there was no clinical evidence supporting such a history and the patient’s prior medical records had no documentation of such events occurring.
Defendant’s Position
The hospital argued that hospital guidelines permitted physicians to use their own medical judgment when deciding which treatment modality should be used. In this case, because the patient’s Coumadin level was “extremely high” and the patient may have needed emergency surgery, the physicians acted appropriately when administering Profilnine to normalize the patient’s INR as quickly as possible.
According to a summary on the plaintiff law firm’s web site, the defense attorney “repeatedly told the jury that the hospital’s own guideline was simply a ‘suggestion,’ and that the doctors could do what they wanted. The defense attorney also reportedly argued that the patient was at fault for her injuries because she had lied to prior doctors about a lengthy medical history that did not exist. Finally, the defense attorney reportedly argued that because the plaintiff was in a permanent vegetative state and was not aware of her injuries, she did not need any money for those injuries.
Verdict
After 3.5 hours of deliberation, the jury found the defendants 80% negligent, the plaintiff 20% comparatively negligent, and rendered a verdict of $15,000,000. This megaverdict was reportedly the largest medical malpractice award in Arizona for the prior 20 years.
Comments
- The plaintiff’s case focused upon only two factors: A patient with a severe adverse outcome and a hospital policy. Had the patient had a minor adverse outcome (such as an allergic reaction successfully treated with medications), the case would not have been filed. If no hospital policy regarding use of Profilnine existed, the plaintiff attorneys would have had more difficulty proving negligence.
- Hospital policies are a tool with which plaintiff attorneys may bludgeon defendants. Might the outcome of the case been different if the hospital policy contained a disclaimer such as “Hospital policies do not establish a standard of care and may be overridden by a physician’s clinical judgment based on unique patient presentations”? Reciting such a disclaimer to a jury might be more effective than arguing that “doctors can do what they want.”
- None of the case information specifies the patient’s INR (Coumadin level). This study showed significant numbers of bleeding episodes and patient deaths with INR > 9. It also showed that simply withholding warfarin or administering vitamin K was ineffective at reducing the INR within 24 hours, whereas plasma infusion immediately dropped the INR to around 2.4.
- It isn’t clear whether defense attorneys noted that Profilnine is simply a mixture of vitamin K-dependent clotting factors IX, II, X, with lesser levels of VII. Fresh frozen plasma contains fibrinogen, Factor (F)II, FV, FVII, FVIII, F IX, FX, XI, FXII, FXIII, antithrombin III (ATIII), von Willebrand factor antigen (VWF-Ag), protein C (PC), and free protein S (FPS). If the patient had received fresh frozen plasma in the past, the defense could at least seek expert testimony that Profilnine contains the same ingredients as fresh frozen plasma.
- Some may argue that prothrombin complex concentrates like Profilnine are safer than fresh frozen plasma since PCCs don’t have to be thawed like FFP, there is no need to do ABO matching with PCCs, and PCCs have no risk of transfusion related acute lung injury (TRALI) or transfusion-related circulatory overload (TACO). On the other hand, these medications are “concentrates” and the factors contained in them are more concentrated than those contained in FFP.
- Although Profilnine is only indicated for treatment of bleeding in patients with Factor IX deficiency (Hemophilia B), Profilnine is similar to KCentra which is also a clotting factor concentrate. KCentra contains factors II, VII, IX and X, Proteins C and S and DOES have an indication for reversal of Coumadin-related bleeding or need for Coumadin reversal prior to major surgery. Illustrating the similarities between Profilnine and KCentra may help to show that the doctors were reasonable in their judgment.
- It isn’t clear why the patient was taking Coumadin or why she reportedly lied about her medical history. It appears that the jury may have considered the patient’s untruthful statements when rendering its verdict, attributing 20% negligence to the patient.
- Arguing that a vegetative patient does not deserve compensation for injuries allegedly caused by a defendant because the injuries are so severe that the patient isn’t aware of them … defies logic. Statements like this would make anyone angry, presumably including the jury members.
Takeaways
- Be familiar with hospital policies and be able to explain any deviation from hospital policies
- Be familiar with indications and off label uses for medications being prescribed to patients.
- Help educate your attorney when formulating a defense for your case. Providing articles and summaries may assist your attorney in helping a jury understand why your medical treatment was reasonable.
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