Salgo v. Leland Stanford Jr. University Board of Trustees

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Salgo v. Leland Stanford Jr., University Board of Trustees
Supremecourtofcaliforniamaincourthouse Supremecourtofcaliforniamaincourthouse.jpg
Supremecourtofcaliforniamaincourthouse
California's first district court of appeals also resides within the California Supreme Court.
CourtCourt of Appeals of California, First District, Division One
Decided1957
Citation(s)154 Cal. App. 2d 560;
317 P.2d 170
Case history
Prior action(s)Scholendorff v. Society of New York Hospital
Subsequent action(s)The rehearing was denied 12 November 1957, and the petition to the Supreme Court was rejected 18 December 1957.
Holding
Martin Salgo was awarded $250,000 for malpractice against Leland Stanford Jr. University Board of Trustees and Dr. Frank Gerbode. This amount was reduced to $213,355 by the trial court.

Salgo v. Leland Stanford Jr. University Board of Trustees was a 1957 court case that helped to establish what the practice of informed consent was supposed to look like in the practice of modern medicine. This was evaluated with respect to the California Court of Appeals case where Martin Salgo sued the trustees of Stanford University and Stanford physician Dr. Frank Gerbode for malpractice as he claimed that they did not inform him nor his family of the details and risks associated with an aortogram which left him permanently paralyzed in his lower extremities. [1] [2]

Contents

The decision in Salgo v. Leland Stanford Jr. University Board of Trustees coined the term "informed consent" in addition to helping to establish what informed consent should look like in modern day practice. [2] [3] At the time, the concept of informed consent was relatively new with the first court cases helping to distinguish it coming to light in the early 20th century. [2] This caused a shift in the idea of what role a physician upheld for their patients from protecting them from harm (physician-advocate) to becoming an advocate for their patient (patient advocate), helping and providing them with the necessary information to make an intelligent, informed decision rather than making a decision in their best interest without consultation. [4] This led to a larger incorporation of the patient in the decision-making process, allowing them to voice their personal values, preferences, fears, and expectations for the procedure.

Although the idea of consent was already established through Walter Reed's "Consent Form," Nuremberg Doctors' Trials, and Schloendroff v. Society of New York Hospital (1914), it had yet to be fully incorporated into practice and the limits of disclosure had yet to be determined at the time of Salgo v. Leland Stanford Jr. University Board of Trustees. [2] [1]

As a result of the decision in the case, Martin Salgo (55 years old) was awarded $250,000 against Stanford University Hospitals and Dr. Frank Gerbode: The trial court later reduced the amount to $213,355. [5]

History

Hippocratic beliefs tended to focus on the physician making decisions for the patient to prevent them from any harm or injustice that could arise. Hippocrates.jpg
Hippocratic beliefs tended to focus on the physician making decisions for the patient to prevent them from any harm or injustice that could arise.

Informed consent is a product of an attempt to include patients in their own treatment planning, allowing them to make decisions for themselves, provided that they are able-minded adults. Previously, it was believed that it was the role of the physician to protect their patient from harm as suggested in the Hippocratic oath: "first, do no harm." Medical historians have stated that in practice, this previously included the idea of mental harm and that this was done by specifically not sharing information that could cause mental harm. [2]

It was not until the Enlightenment movement in the 18th and 19th centuries that it was believed that patients were sufficiently educated to understand their doctors' requirements and prescriptions. However, doctors explained what to do and what was occurring to their patients to help them better follow their prescriptions rather than decide for themselves. It was still not believed that patients could reliably form their own opinions nor make appropriate medical decisions for themselves. [2]

The Doctors' Trial held in Nuremberg, Germany, from December 9, 1946, to August 20, 1947. This case helped to pave the way for the discussion about informed consent. Doctors' trial, Nuremberg, 1946-1947.jpg
The Doctors' Trial held in Nuremberg, Germany, from December 9, 1946, to August 20, 1947. This case helped to pave the way for the discussion about informed consent.
Timeline to Establish Informed Consent [2]
Court CaseYearSignificance
Schloendorff v. Society of New York Hospital 1914This case used the idea of self-determination to articulate the need for consent from patients.
Nuremberg Doctors' Trial 1946This determined that consent must be voluntary, competent, informed, and comprehending for human subjects in studies requiring human test subjects.
Salgo v. Leland Stanford Jr., University Board of Trustees1957This case coined the term "informed consent" by emphasizing the need for recognizable and adequate consent.
Natanson v. Kline 1960This helped establish what was required to be disclosed before a procedure, helping to set the boundaries of informed consent. Negligence could be used in informed consent cases.
Cobbs v. Grant 1972This case caused the courts to define consent as being patient-based: "what would a competent patient need to know to make a rational decision."
Canterbury v. Spence 1972This was another influential informed consent case where the (unsuccessful) plaintiff claimed that they were not sufficiently warned of the potential dangers.

Procedure

Evaluation

Martin Salgo (55) visited Dr. Gerbode, a specialist in arterial disease, at the recommendation of his physician with complaints of a limp caused by cramping in his legs, mainly calves, in addition to right side abdominal pain and discomfort in his lower back and hip with exercise. Despite taking medication prescribed by his physician for a year, his condition worsened. Upon evaluation on 31 December 1953, Gerbode observed that Salgo looked much older than 55; his blood pressure was 180/90; the legs blanched when raised, suggesting atrophy; the right leg was blue; there was no distinguishable pulse below the femoral pulse on his right side and only weakly present on the left. This led Gerbode to assume that the blood supply to the legs was impaired, causing him to diagnose Salgo with abdominal aorta occlusion. After talking about the seriousness of the case, Gerbode recommended that he stay in the hospital for further evaluation. [5]

Preliminary diagnosis

Salgo was told that they would study his aorta and x-ray the gastrointestinal tract in an attempt to find the block to perform the correct operation which would help to improve circulation. [5]

An image taken during an aortogram. Dr. Ellis, Dr. Bengle, Dr. Andrews, and technicians performed a diagnostic aortogram on Salgo.

Hospital visit and procedure

After being admitted on 6 January 1954, a series of x-rays of the chest and calcification suggested that Salgo had been afflicted for an extended period of time. A day later (1/7/1954), Dr. Ellis — a surgeon at the university hospital with five years of experience with special diagnostic procedures — informed Salgo that he would be performing an aortogram by injecting contrast material into the aorta which would allow them to take pictures of the circulatory system. Unfortunately, the procedure was postponed due to the presence of residual barium from his previous x-rays, which were taken after his arrival at the hospital. After it was determined that there was not any more barium in his system, they proceeded with the surgery on 8 January 1954 under the supervision of Dr. Ellis (surgeon), Dr. Bengle (anesthesiologist), Dr. Andrews (radiologist), and technicians. Dr. Gerbode stopped in for the first part before leaving. [5]

Before injecting the 70% sodium urokon into the back of the patient while face down, a sensitivity test was performed with radiopaque material. The 70% sodium urokon injection was repeated with 30 c.c.'s and then with 20 c.c.'s in an attempt to get a clear picture of the blockage. [5]

At 5 p.m., Dr. Gerbode was informed by Dr. Ellis that the procedure was a success. Salgo woke up paralyzed in the lower extremities the next day. [1] [6]

Court arguments

Sodium urokon dosage

In court it was argued by the plaintiff (Salgo) that the defendants were negligent, as the manufacturer label states that "'10 to 15 cc of 70% Urokon is adequate' and that the procedure should not be repeated within 24 hours." [5] There was disagreement as to how to classify the second injection and if the second dosage could be classified as a second injection. The plaintiff claimed that inserting two separate amounts of 70% sodium urokon classified as two injections, while the defendants stated that the needle was not actually injected twice as there was not actually a second needle inserted. Additional disagreement from defendants and amicus curiae determined that, in practice, the amount of sodium urokon actually used — contrary to the manufacturer label — varied between 30 and 70 c.c.'s. [5]

Validity of the procedure

It was also debated whether an aortogram with sodium urokon was correct under these conditions. But, it was pointed out that the plaintiff's general practitioner referred him to Dr. Gerbode because of his specialty in vascular surgery. A specialist called on to testify helped determine that an aortography was a normal procedure under the circumstances. [5]

Disclosure of procedural details

The plaintiff and his family also claimed that they were not notified of the potential risks and practices associated with the procedure. Despite contradicting that they did disclose information to the patient, Dr. Gerbode and Dr. Ellis admitted that neither details nor dangers were fully explained. [5] However, during Salgo's case, it had not yet been clarified in court what was needed for a patient to be considered "reasonably informed." Later, this became a balance between giving the patient enough information to make a knowledgeable decision without inundating them with jargon and information and postulating too much into hypotheticals while making sure that they are aware of risks and alternatives. [7]

Decision

Res ipsa loquitur

Salgo v. Leland Stanford Jr. University Board of Trustees went through the California Court of Appeals, first district, division one. California Courts of Appeal district map.svg
Salgo v. Leland Stanford Jr. University Board of Trustees went through the California Court of Appeals, first district, division one.

The court determined that the res ipsa loquitur doctrine (Latin for "the thing speaks for itself") was applicable to this case, meaning that Salgo was able to meet the burden of proof for negligence and that his paralysis was caused by something under the control of the doctors. [8]

Liability

However, Gerbode himself was not held liable as there was not explicit agreement that he would perform the surgery and under the presumption that it is common practice for the attending physician to not be present for the procedure. Furthermore, Gerbode did not perform the procedure, but rather the hospital staff. [5] As a result, Salgo was awarded $250,000 (later reduced to $213,355 in the trial court) from Stanford University Hospital. [5]

Subsequent developments

This helped to set a precedent for the following cases in terms of the patient is adequately informed. If there was a failure to disclose information, danger, and alternatives, there was cause for legal action. However, what adequate information looked like would be established with later cases. The court argued that it was the physicians' responsibility to inform their patients, albeit the court admitted that full disclosure is not advisable under all situations where divulging information to the patient may result in psychological or other harm for the patient. [4]

The court said: "A physician violates his duty to protect his patient and subjects himself to liability if he withholds any factors which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment. Likewise, the physician may not minimize the known dangers of a procedure or operation in order to induce his patient's consent." [4]

Related Research Articles

Res ipsa loquitur is a doctrine in the Anglo-American common law and Roman Dutch law that says in a tort or civil lawsuit a court can infer negligence from the very nature of an accident or injury in the absence of direct evidence on how any defendant behaved. Although modern formulations differ by jurisdiction, Anglo-American common law originally stated that the accident must satisfy the necessary elements of negligence: duty, breach of duty, causation, and injury. In res ipsa loquitur, the elements of duty of care, breach, and causation are inferred from an injury that does not ordinarily occur without negligence.

Informed consent Process for obtaining subject approval prior to treatment or research

Informed consent is a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care. A healthcare provider is often held to have a responsibility to ensure that that the consent that a patient gives is informed, and informed consent can apply to a health care intervention on a person, conducting some form of research on a person, or for disclosing a person's information. A health care provider may ask a patient to consent to receive therapy before providing it, a clinical researcher may ask a research participant before enrolling that person into a clinical trial, and a researcher may ask a research participant before starting some form of controlled experiment. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.

Life support

Life support refers to the treatments and techniques performed in an emergency in order to support life after the failure of one or more vital organs. Healthcare providers and emergency medical technicians are generally certified to perform basic and advanced life support procedures; however, basic life support is sometimes provided at the scene of an emergency by family members or bystanders before emergency services arrive. In the case of cardiac injuries, cardiopulmonary resuscitation is initiated by bystanders or family members 25% of the time. Basic life support techniques, such as performing CPR on a victim of cardiac arrest, can double or even triple that patient's chance of survival. Other types of basic life support include relief from choking, staunching of bleeding by direct compression and elevation above the heart, first aid, and the use of an automated external defibrillator.

Aortic dissection Injury to the innermost layer of the aorta

Aortic dissection (AD) occurs when an injury to the innermost layer of the aorta allows blood to flow between the layers of the aortic wall, forcing the layers apart. In most cases, this is associated with a sudden onset of severe chest or back pain, often described as "tearing" in character. Also, vomiting, sweating, and lightheadedness may occur. Other symptoms may result from decreased blood supply to other organs, such as stroke or mesenteric ischemia. Aortic dissection can quickly lead to death from insufficient blood flow to the heart or complete rupture of the aorta.

Male circumcision is the surgical removal of the foreskin (prepuce) from the human penis. The ethics of circumcision in neonates and children is a source of much controversy.

<i>Bolam v Friern Hospital Management Committee</i>

Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 is an English tort law case that lays down the typical rule for assessing the appropriate standard of reasonable care in negligence cases involving skilled professionals such as doctors. This rule is known as the Bolam test, and states that if a doctor reaches the standard of a responsible body of medical opinion, they are not negligent. Bolam was rejected in the 2015 Supreme Court decision of Montgomery v Lanarkshire Health Board.

<i>Schloendorff v. Society of New York Hospital</i>

Schloendorff v. Society of New York Hospital, 105 N.E. 92, was a decision issued by the New York Court of Appeals in 1914 which established principles of respondeat superior in United States law.

<i>Reibl v Hughes</i> Supreme Court of Canada case

Reibl v Hughes [1980] 2 S.C.R. 880 is a leading decision of the Supreme Court of Canada on negligence, medical malpractice, informed consent, the duty to warn, and causation.

Moore v. Regents of the University of California was a landmark Supreme Court of California decision. Filed on July 9, 1990, it dealt with the issue of property rights to one's own cells taken in samples by doctors or researchers.

Defensive medicine, also called defensive medical decision making, refers to the practice of recommending a diagnostic test or medical treatment that is not necessarily the best option for the patient, but mainly serves to protect the physician against the patient as potential plaintiff. Defensive medicine is a reaction to the rising costs of malpractice insurance premiums and patients’ biases on suing for missed or delayed diagnosis or treatment but not for being overdiagnosed.

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References

  1. 1 2 3 "Some Important Court Cases" (PDF). Stanford. Retrieved 22 January 2020.
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  3. O.P, Grzegorz Mazur (2011-09-22). Informed Consent, Proxy Consent, and Catholic Bioethics: For the Good of the Subject. Springer Science & Business Media. p. 2. ISBN   978-94-007-2196-8.
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  8. "Res Ipsa Loquitur". LII / Legal Information Institute. Retrieved 2020-01-23.