Thaw v North Shore Univ. Hosp.
Supreme Court of New York,
Appellate Division, Second Department
Case No. 2012-10336
June 17, 2015, Decided
親愛的聽眾朋友們，新年好！希望美國(guó)法律講堂在2017年能夠繼續(xù)為大家傳遞有用的普法知識(shí)。
今天我要與大家分享的這個(gè)法案是涉及到醫(yī)療事故糾紛案中有關(guān)“知情同意書”。 這個(gè)法案的裁判告訴我們, 即使患者簽署了同意書，并不一定表明患者“知情”。醫(yī)護(hù)人員有義務(wù)和責(zé)任與患者積極討論擬議治療方法和步驟的風(fēng)險(xiǎn)，益處，可替代的診治方法等，并且確定備錄患者的同意書是在充分“知情” 的情況下簽署的。謝謝您的聽閱，關(guān)注和支持！歡迎留言，點(diǎn)評(píng)，轉(zhuǎn)發(fā)，讓更多的人能在輕松愉快不經(jīng)意間，邊聽案例故事，邊學(xué)法律知識(shí)。
今日講題
本期講解美國(guó)紐約州上訴法院
二零一五年裁判案例
Informed Consent 知情同意
I. 本期語音講解(全文)
II. 本期內(nèi)容提要及 Key Issue (焦點(diǎn))
簽了就等于“知情同意”嗎？(Whether“signed”=“informed consent?)
第九講·知情同意（Informed Consent ）
Thaw v North Shore Univ. Hosp.
Supreme Court of New York,
Appellate Division, Second Department
Case No. 2012-10336
June 17, 2015, Decided
概念定義
“知情同意”(Informed Consent) 是指醫(yī)護(hù)人員有義務(wù)和責(zé)任積極地向患者提供關(guān)于擬議給患者實(shí)施的某種治療方法和步驟的相關(guān)重要信息，并且在確定患者完全知情和理解后，獲得患者對(duì)所要實(shí)施的治療方法和步驟的同意?；颊呔哂蟹ǘ?quán)利被告知與擬議的治療方法和步驟相關(guān)的風(fēng)險(xiǎn)。如果醫(yī)護(hù)人員未能充分正確地讓患者“知情”醫(yī)護(hù)人員會(huì)面臨醫(yī)療事故的起訴。
醫(yī)護(hù)人員通常要求患者簽署同意書。同意書上詳細(xì)列舉和說明擬議治療方法和步驟的風(fēng)險(xiǎn)。但是患者僅僅簽署了同意書并不一定證明患者給予了知情同意。醫(yī)護(hù)人員必須真正地與患者討論擬議治療方法和步驟的風(fēng)險(xiǎn)，以確定患者必須盡可能地對(duì)他或她所面臨的風(fēng)險(xiǎn)有所了解和明白。
案件事實(shí)陳述
原告患者自2004年9月因?yàn)槌暡z查時(shí)發(fā)現(xiàn)骨盆處有腫塊而在LAZAR醫(yī)生處進(jìn)行治療。2005年LAZAR醫(yī)生為原告患者制定了幾項(xiàng)治療方案，其中包括經(jīng)腹部全子宮切除術(shù)。原告患者曾多次告訴LAZAR醫(yī)生她不想接受手術(shù)治療。2007年原告患者在得知她的骨盆腫塊可能是惡性腫瘤后再次去找LAZAR醫(yī)生就診。LAZAR醫(yī)生還是建議原告患者進(jìn)行手術(shù)治療，有可能包括子宮切除術(shù)等。原告患者明確拒絕了LAZAR醫(yī)生的手術(shù)治療建議。之后，原告患者決定接受腹腔鏡手術(shù)。
根據(jù)LAZAR醫(yī)生所說，原告患者“同意有可能做子宮切除手術(shù)”。在手術(shù)之前，原告患者簽署了同意書，該同意書顯示她同意“接受腹腔鏡手術(shù)…可能的探索性剖腹術(shù)、全子宮切除術(shù)、PAP涂片、可能的分期手術(shù) … 去除病變組織“。根據(jù)LAZAR醫(yī)生所說，子宮切除術(shù)的決定是在行腹腔鏡手術(shù)中做出的，因?yàn)槟[塊太大了，十分異常，以及“像是已顯病變”。原告患者在她的證詞中證實(shí)她簽署了同意書，但是宣稱她沒有機(jī)會(huì)閱讀同意書就被強(qiáng)迫簽署了，而且在簽署的時(shí)候她是處于被麻醉的狀態(tài)下。
根據(jù)原告患者的證詞，她當(dāng)時(shí)躺在手術(shù)室內(nèi)，手術(shù)即將開始，在不知道是否已經(jīng)接受麻醉的情況下一個(gè)護(hù)士跑進(jìn)來遞給她同意書。原告患者聲稱LAZAR醫(yī)生當(dāng)時(shí)質(zhì)問手術(shù)室內(nèi)的其他人，為什么知情同意書沒有在之前就讓原告患者簽署。原告患者宣稱自己沒有帶眼鏡，她沒有也無法閱讀同意書。LAZAR醫(yī)生也沒有與她討論同意書的內(nèi)容。相反，據(jù)原告患者所訴，LAZAR醫(yī)生告訴她，她別無選擇，需要簽這份同意書，因?yàn)樗赡芑加邪┌Y。
LAZAR醫(yī)生給出的證詞與原告患者的相反。她表示同意書是在原告患者進(jìn)入手術(shù)室前簽署的，并且所有的內(nèi)容都已經(jīng)解釋給了原告患者。LAZAR醫(yī)生之后進(jìn)行了腹腔鏡手術(shù)，并在手術(shù)操作過程中決定改行開放性手術(shù)以及子宮切除術(shù)。LAZAR醫(yī)生的證詞還表明，盡管原告患者一直堅(jiān)持自己不想進(jìn)行子宮切除術(shù)，但她明白也同意，如果在行腹腔鏡手術(shù)時(shí)，發(fā)現(xiàn)有癌變的可能，是有可能行子宮切除術(shù)的。但是，相反，原告患者在證詞中表明，她在整個(gè)治療過程中堅(jiān)持不做子宮切除術(shù)并且LAZAR醫(yī)生從未告訴過她腹腔鏡手術(shù)可能轉(zhuǎn)換為開放性手術(shù)，包括子宮切除術(shù)。
在這些事實(shí)爭(zhēng)議中，有一個(gè)事實(shí)是無可爭(zhēng)議的，那就是原告患者在她手術(shù)的那天，的確是親自簽署了同意書的。該同意書表示[原告患者]同意腹腔鏡手術(shù)和可能的子宮切除術(shù)。
司法程序及初審法庭裁決
原告患者指控被告LAZAR醫(yī)生在2007年4月27日對(duì)她進(jìn)行了她未經(jīng)授權(quán)的子宮切除術(shù)，構(gòu)成人身侵犯 (Assault & Battery)。同時(shí)原告患者還因缺乏知情同意 (Lack of Informed Consent) 的醫(yī)療責(zé)任事故 (MedicalMalpractice) 指控LAZAR醫(yī)生。
地方初審法庭依據(jù)原告患者簽署的同意書，及原告患者承認(rèn)她的確簽署了同意書，為理由，撤銷了原告患者對(duì)被告LAZAR醫(yī)生的“人身侵犯”(Assault & Battery) 及“缺乏知情同意” (Lack of Informed Consent)的兩個(gè)指控。
原告患者上訴。
上訴法院面臨的裁決/法律焦點(diǎn)
地方初審法庭基于原告患者簽署了同意書而撤銷原告患者對(duì)被告LAZAR醫(yī)生的“人身侵犯” (Assault & Battery) 及“缺乏知情同意” (Lack of Informed Consent) 的指控的裁決是否正確合理？
原告患者簽署的同意書是否就是無可爭(zhēng)議的事實(shí)證明她授權(quán)而且知情同意手術(shù)？
上訴法院的意見分析及裁判
針對(duì) “人身侵犯” (Assault & Battery ) 的指控，上訴法院認(rèn)為這個(gè)指控的成立，原告患者必須依據(jù)事實(shí)證據(jù)證明被告LAZAR醫(yī)生的行為1) 讓原告患者感到急迫的擔(dān)驚受怕會(huì)受傷害, 或 2) 是有意圖的對(duì)原告患者具有攻擊性的身體接觸導(dǎo)致傷害。上訴法院認(rèn)為，盡管原告患者的指控和證詞都聲稱她從未允許做子宮切除術(shù)，她簽署的同意書【是無可爭(zhēng)議的事實(shí)顯示】她明確授權(quán)了這個(gè)手術(shù)，而且她也承認(rèn)她的確是簽了同意書。因此，上訴法院同意地方初審法庭的裁決，即然她明確授權(quán)被告LAZAR醫(yī)生執(zhí)行手術(shù)，對(duì)被告LAZAR醫(yī)生“人身侵犯”的指控就不成立，應(yīng)當(dāng)撤銷。
但是針對(duì)“缺乏知情同意” (Lack of Informed Consent) 的指控，上訴法院認(rèn)為這個(gè)指控的成立，原告患者必須依據(jù)事實(shí)證據(jù)證明：1. 醫(yī)護(hù)人員（如 Dr. LAZAR）沒有披露作為一名合格醫(yī)護(hù)人員應(yīng)當(dāng)披露的手術(shù)風(fēng)險(xiǎn)、益處以及可替代的手術(shù)或治療方法；2. 任何一個(gè)正常人處在原告患者的位置，如果對(duì)【手術(shù)風(fēng)險(xiǎn)、益處以及可替代的手術(shù)或治療方法】充分知情的話，就不會(huì)選擇去做那個(gè)手術(shù)或治療。
這里原告患者的庭外傳訊的證詞顯示她沒有被充分地告知手術(shù)或治療的風(fēng)險(xiǎn)（包括可能的全子宮切除術(shù)或腸穿孔等風(fēng)險(xiǎn)）以及手術(shù)或治療的益處和可替代的方法。地方初審法庭也沒有依據(jù)法律程序來確定裁判，如果原告患者得到了充分的披露，對(duì)手術(shù)或治療的風(fēng)險(xiǎn)充分“知情”，她也許仍然會(huì)同意手術(shù)。被告也沒有針對(duì)原告患者的“未完全告知且知情”的證詞提出反駁證據(jù)。
因此，上訴法院認(rèn)為地方初審法庭僅僅因?yàn)樵婊颊吆炇鹆送鈺蜂N原告患者對(duì)被告LAZAR醫(yī)生“缺乏知情同意” ( Lack of Informed Consent ) 的指控的裁決是不正確的。地方初審法庭應(yīng)當(dāng)要求原被告雙方提供事實(shí)證據(jù)，以此裁判被告是否充分地告知手術(shù)或治療的風(fēng)險(xiǎn)以及原告患者是否在充分知情的情況下簽署了同意書并同意手術(shù)。借此，上訴法院推反了地方初審法庭撤銷對(duì)被告LAZAR醫(yī)生“缺乏知情同意”( Lack of Informed Consent ) 的指控的裁決，要求地方初審法庭針對(duì)“缺乏知情同意”( Lack of Informed Consent ) 的指控依據(jù)事實(shí)證據(jù)進(jìn)行重新審理。
總結(jié)
總之，這個(gè)法案告訴我們，即使患者簽署了同意書，并不一定表明患者“知情”。醫(yī)護(hù)人員應(yīng)當(dāng)充分告之所可能的風(fēng)險(xiǎn)，益處，可替代診治方法等，并且確定備錄患者在完全“知情”“自愿”“清醒”“未受任何藥物影響”的狀態(tài)下簽署的同意書。
III. 本期參考文獻(xiàn) Reference
1. Thaw v North Shore Univ. Hosp., 129 A.D.3d 937
2. https://www.nolo.com/legal-encyclopedia/ medical-malpractice-informed-consent-29872.html;
3. http://medical-malpractice.lawyers.com/ professional-duty-of-care/lack-of-informed-consent.html
English version
“Informed Consent” is a process where both the doctor and patient should take an activerole, and where the doctor has an obligation and responsibility to provide the patient with essential information about a particular treatment or procedure and get thepatient's agreement to a certain medical procedure or treatment after the patient is fully informed and understood. Patients have a legal right to be advised of keyrisks associated with a proposed medical procedure, and a doctor's failure to adequately inform the patient can form the basis of a medical malpractice case.
Doctors typically require patients to sign a consent form detailing the risks of any given treatment orprocedure. But signing a form alone does not necessarily prove that the patientgave informed consent. The doctor must actually discuss the procedure and risks with the patient. And the patient must understand, to the extent possible, the risks he or she faces.
Factual Background
The plaintiff began seeing Lazar in September 2004, inconnection with a mass detected on a pelvic ultrasound. In 2005, LAZAR offered the plaintiff several treatment options, including a total abdominal hysterectomy (hereinafter ahysterectomy). The plaintiff advised Lazar that she did not want to undergo surgery.The plaintiff returned to Lazar in 2007,after receiving diagnostic [MRI] test results that raised a concern that theplaintiff's pelvic mass might be malignant. Lazar recommended that theplaintiff undergo, among other things, a hysterectomy, and the plaintiff expressly rejected that recommendation. Thereafter, it was decided that the plaintiff would undergo a certain laparoscopic procedure.
However, according to Lazar, the plaintiff 'agreed tothe possibility of a hysterectomy.' Before the operation, the plaintiff signed a consent form, which stated that she was consenting to'[o]perative laparoscopy . Possible exploratory laparotomy. Totalabdominal hysterectomy. PAP smear. Possible staging . . . Removal of diseased tissue.' According to Lazar, the decision to perform the hysterectomy wasmade during the operation, because the pelvic mass was very large, was atypicalin appearance, and 'appear[ed] diseased.' The plaintiff testified ather deposition that she signedthe consent form, but claimed she had no opportunity to read it, was bulliedinto doing so, and was under the influence of anesthesia when she signed it.
According to the plaintiff, she was lying in the operating room, the procedure was about to start, and anesthesia may or may not have beenstarted when a nurse 'came running in' with the consent form. The plaintiff testified that Lazar 'yelled' at other staff in the room,questioning why the consent form had not been signed earlier. The plaintiff asserted that she did not have her glasses, that she did not and could not readthe form, and that Lazar did not discuss it with her. Rather, according to the plaintiff, Lazar told her to sign theform and stated that she had no choice because she might have cancer.
Lazar disputed this version of events, testifying that theconsent form was signed before the plaintiff was taken into the operating room,and that she explained the form to the plaintiff. Lazar thereafter began thelaparoscopic procedure and determined, intraoperatively, to convert the laparoscopic procedure to an open procedure and to perform a hysterectomy.
Lazar testified at a deposition that, although the plaintiff continuously maintained that she didnot want a hysterectomy, the plaintiff understood and agreed that this procedure might be performed if, in the course of performing the laparoscopic procedure,a malignancy was suspected. In contrast, the plaintiff testified at herdeposition that she was adamant throughout her course of treatment with Lazarthat she did not want a hysterectomy and that Lazar never discussed with herthe possibility that the laparoscopic procedure might be converted to an openprocedure, including a hysterectomy.
It is undisputed that, on the day of her surgery, theplaintiff signed a consent form, authorizing the laparoscopic procedure and apossible hysterectomy.
Legal Procedures
The plaintiff sued defendant, alleged that on April 27, 2007,Lazar performed an unauthorized hysterectomy upon her, constituting assault andbattery. The plaintiff also asserts causes of action based on, inter alia, lackof informed consent and medical malpractice.
Thetrial court dismissed the plaintiff’s assault and battery claims because, not with standing the patient's allegations and testimony that she never gave permission for the performance of a hysterectomy,her signed consent
formclearly authorized such a procedure, and she admitted that she signed theconsent form;
For the samereasoning, the trial court also dismissed the plaintiff’s“l(fā)ack of informed consent” claims.
Plaintiff appealed.
Legal Issues Before the Appellate Court
Whetherthe trial court properly dismissed both “assault and battery” and “l(fā)ack ofinformed consent” claims when the plaintiff signed the consent form;
Whetherthe plaintiff’s signed consent provides undisputed facts for her authorizedand/or informed consent for hysterectomy.
Appellate Court Legal Analysis
1) Forthe “assault and battery” claim, the Appellate court needs to decide whether there were no triable issues of facts on a) whether defendants’ act constitutes“intentional physical conductplacing the plaintiff in imminent apprehension of harmful contact” (Assault); or b) “bodily contact made with intent, offensive innature” (Battery);
Not with standing the plaintiff's allegations and testimony that she never gave permission forthe performance of a hysterectomy, the signed consent form clearly authorizedsuch a procedure, and she admitted that she signed the consent form. Therefore, dismissal of the assault and battery cause of action was proper。
2)For “l(fā)ack of informed consent and medical malpractice” claim, the Appellatecourt needs to decide whether there were no triable issues of facts on a) whether Dr.Lazar failed to disclose the risks, benefits, and alternatives to theprocedure or treatment that a reasonable practitioner would have disclosed atthe time the plaintiff signed the consent form; andb) a reasonable person in the plaintiff's position, fully informed, would haveelected not to undergo the procedure or treatment.
Here, theplaintiff's deposition testimony indicates that she was not fully advised ofthe risks, benefits, and alternatives to the procedure or treatment, includingthe fact that one of the risks was a total hysterectomy and/or perforation ofthe bowel, nor was it established as a matter of law that if the plaintiffreceived full disclosure, she still would have consented to the procedure.Since the defendants' submissions included the plaintiff's deposition testimony, they failed to establish, primafacie, that there were no triable issues of fact with respect to the causeof action alleging lack of informed consent.
Appellate Court Ruling
Accordingly, the Supreme Court should have denied that branch of the defendants' motion which was for summary Judgment dismissing the cause of action alleging lack ofinformed consent.
References:
1. Thaw v North Shore Univ. Hosp., 129 A.D.3d 937
2. https://www.nolo.com/legal-encyclopedia/medical-malpractice-informed-consent-29872.html;
3. http://medical-malpractice.lawyers.com/professional-duty-of-care/lack-of-informed-consent.html
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