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theReporterTEXAS MEDICAL LIABILITY TRUSTMay-June 2007

by Laura Brockway, ELS

Case studyA patient had a long-standing history of coronary

artery disease, suffering his first myocardial infarction (MI) at age 47. He had recurrent chest pain a year later and underwent a work up to rule out MI. He was treat-ed medically without invasive procedures. Four years after the first MI, he came to a new cardiologist, the defendant in this case.

A cardiac catheterization showed 99% proximal right coronary artery disease with a 90% circumflex le-sion, a 70% diagonal branch and total occlusion of the left anterior descending coronary artery. His ejection fraction was less than 20%, and he had unstable an-gina. The patient underwent right and left heart cath-eterization, coronary arteriography, and percutaneous translumenal coronary angioplasty.

Nine months later, the patient returned to the car-diologist for repeat cardiac catheterization. This cath-eterization showed a totally occluded left anterior descending coronary artery, no advancement in the 40 to 50% narrowing of the circumflex, some evidence of re-stenosis in the proximal one-third of the very large coronary artery which was diffusely diseased, and a

50 to 70% lesion at the site of the previous angioplasty. He was discharged without further procedures under medical therapy.

The patient returned to the cardiologist two years later for a repeat cardiac catheterization. The LAD re-mained totally occluded, the circumflex was a small vessel and it was not possible to do an angioplasty on that vessel.

The patient was again seen by the cardiologist seven years later and the cardiologist reported the pa-tient was doing quite well with occasional shortness of breath upon exertion. He was on medical therapy and was without any significant changes in his clinical status except a reported presence of a Grade I mitral regurgitation murmur.

Approximately two months after his last appoint-ment with the cardiologist, the 61-year-old patient came to a local emergency department (ED) complaining of chest pain, burning in his left chest and epigastric area, and shortness of breath. He was transferred via air ambulance to an urban hospital and to the care of his cardiologist. The EKG showed premature ventricular complexes, left atrial enlargement, septal infarction of

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When patients decline

treatment

informedrefusal

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indeterminate age, marked ST abnormality, and possible inferior subendocardial injury.

The patient was seen in consultation by a gastroenter-ologist who performed an esophagogastroduodenoscopy that revealed focal erythema, edema and small raised dots of reddened mucosa involving the antrum. He diagnosed mild gastritis.

The cardiologist performed an echocardiogram showing severe mitral insufficiency, biatrial enlargement, calculated right ventricular systolic pressure of 43 mm Hg, and left ventricular dysfunction with an ejection fraction of 26%. An EKG performed the following day was interpreted as showing left atrial enlargement, septal infarction and marked ST abnormality, and possible inferior subendocar-dial injury. The patient had a fever of just above 100 degrees every day during his 3-day admission, including the day of discharge.

According to the cardiologist, but not documented in the patient’s medical record, the patient declined cardiac catheterization and wanted to be discharged home. He was to return to the gastroenterologist in five days and the car-diologist in approximately three weeks. The day after his discharge, the patient suffered an MI and died.

A lawsuit was filed against the cardiologist. Allegations included:

• failure to properly care for and treat;• failure to properly evaluate and diagnose; and• failure to properly order other diagnostic studies.The plaintiffs alleged that the patient should have un-

dergone cardiac catheterization and that failure to treat was negligent and resulted in the patient’s death.

Negligence is the failure to use ordinary care, that is, failure to do that which a health care provider of ordinary prudence would or would not have done under the same or similar circumstances.

One of the main issues in this case was documentation. Essentially the case became a debate regarding a conver-sation with the cardiologist and the patient about whether cardiac catheterization was offered and refused. The physi-cian admitted at deposition that he made a mistake in not documenting the patient’s refusal to have a catheterization. However, he was adamant that he did discuss the matter with the patient and the patient refused the procedure.

The plaintiff’s attorney found expert opinion to support the allegations, claiming the patient’s death could have been prevented with appropriate diagnostic tests and revascu-larization. Had the disease been too extensive, bypass sur-gery might have been appropriate.

Defense experts believed the patient was not a surgical candidate. They were supportive of the cardiologist’s deci-sion not to perform a cardiac catheterization in accordance with the patient’s wishes. It was entirely within the standard of care for a physician not to push extreme measures when there was little expectation of success. Further it was rea-sonable for a patient in such poor health to refuse additional intervention.

This case was taken to trial with the plaintiffs requesting an award totaling $2.1 million. The verdict was returned in favor of the plaintiffs, the patient’s four adult children. The jury found the physician negligent and awarded damages of approximately $50,000 for funeral costs, medical expenses, and past mental anguish.

Informed refusalTexas law recognizes that physicians must obtain con-

sent for treatment and that such consent be “informed.” A variant of informed consent is informed refusal, in which a patient refuses treatment after having been informed of the risks and benefits of the intervention.

Many physicians associate the concept of informed re-fusal with the patient who leaves the ED abruptly or dis-charges himself from the hospital. However, as the case study illustrated, a patient’s refusal to consent to a recom-mended intervention can occur under a variety of circum-stances, and can lead to lawsuits involving allegations of failure to treat or failure to inform.

“Implicit in and intrinsic to the concept of consent for treatment is the option of refusal. In Cruzan v Director, Mis-souri Department of Health, the U.S. Supreme Court ruled that all U.S. citizens have a constitutional right to refuse un-wanted therapy, a right residing in the due process clause of the 14th amendment. Authorized surrogates can exercise this right of refusal on behalf of the incapacitated patients they represent. This right of refusal pertains to all therapies, including life-sustaining therapies and artificial hydration and nutrition, without which patients will die.” 1

All patients have the right, after full disclosure, to refuse medical treatment. This can include patients who decline medication, routinely miss office visits, defer diagnostic testing, or refuse hospitalization. Physicians are then pro-hibited from proceeding with the intervention. “Problems arise, however, when the patient or the patient’s family later argue that they were not given enough information to make an informed decision, or that the patient lacked the capacity to make the decision,” says Jane Holeman, vice president of risk management at TMLT.

The process of informed refusalAs is frequently emphasized in the medical risk manage-

ment literature, informed refusal is a process, not a signed document. “Physicians need to show that the patient’s deci-sion to decline treatment was based on a full understanding of all the facts necessary to make that decision,” says Hole-man. “Physicians cannot force a treatment on a patient, all they can do is educate.”

Circumstances in which informed refusal should be obtained vary considerably. Such situations can include “everyday” occurrences such as when a patient refuses to take blood pressure medication or declines a screening colonoscopy. It can also involve the patient who refuses life-saving surgery. “Physicians need to evaluate each situ-ation to determine the consequences of the patient declin-ing the intervention. From there, determine what needs to be discussed with the patient,” says Holeman.

When faced with an ambivalent or resistant patient, it is important for the physician to use clear and unambiguous language to avoid misinterpretation. “Sometimes the only way to get a patient’s attention is for the physician to very bluntly tell the patient ‘if you do not have this surgery, you will likely die,’” says Holeman.

Reasons for the patient’s refusal should also be discussed. “The patient’s decision may arise from many sources, in-cluding the denial of the potential seriousness of the medical condition; lack of confidence in the physician or institution; disagreement with the plan of management; conflicts be-tween hospitalization and personal obligations; and finan-cial concerns.” 2

2 May-June 2007 May-June 2007 3

Sample informed refusalYour letterhead

In order to diagnose/treat my condition a _____________________________________________ was ordered

for me on ______________________________________. The reasons for ordering this test/procedure have been carefully explained to me. I understand the potential benefits are:

_____________________________________________________________________________________________

_____________________________________________________________________________________________

and the alternatives include ____________________________________________________________________

_____________________________________________________________________________________________.

In addition, Dr. ___________________________________ has informed me of the risks involved in not having a _____________________________________________________ performed. These risks include

_____________________________________________________________________________________________

_____________________________________________________________________________________________.

After careful consideration of the potential benefits and risks concerning the above, I am refusing

______________________________________________________________. My reason(s) for refusing is (are):

_____________________________________________________________________________________________

_____________________________________________________________________________________________.

___________________________________________ ________________________________________ Patient signature Witness signature

___________________________________________ ________________________________________ Date Date

All articles and any forms, checklists, guidelines and materials are for generalized information only, and should not be reviewed or referred to as primary legal sources nor construed as establishing medical standards of care for the purposes of litigation, including expert testimony. They are intended as resources to be selectively used and always adapted – with the advice of the organization’s attorney – to meet state, local, individual organizations and department needs or requirements. They are distributed with the understanding that nei-ther Texas Medical Liability Trust nor Texas Medical Insurance Company is engaged in rendering legal services.


According to Holeman, understanding why a patient refused an intervention is important because the decision could be irrational or based on misinformation. “An extreme example is a patient with an elevated PSA who refuses a prostate biopsy because he is afraid it would make him sterile. It would be important to address this concern in the discussion because you may be able to overcome it and ob-tain consent,” says Holeman.

“In addition, the physician should be sensitive to exter-nal forces or pressures that may be influencing the patient and interfering with his ability to express his true wishes. This may be particularly relevant for elderly patients who are heavily dependent on others and concerned that certain choices will increase the burden on family members.” 3

Assessing decision-making capacity“Although the concept of patient autonomy requires

that patients be permitted to make even idiosyncratic deci-sions, it remains the responsibility of the clinician to assure that no decision is the result of a problem with decision-making capacity or some misunderstanding that needs to be resolved.” 4

With regard to obtaining consent for medical interven-tions, competence and decision-making capacity are often confused. 5 A patient’s competence or incompetence is a legal designation determined by a judge. Decision-making capacity is clinically determined by physician assessment. “All adults are presumed competent legally unless deter-mined incompetent judicially. An adult who possesses le-gal competence, however, may lack the capacity to make specific treatment decisions. Specific decision-making ca-pacity should be determined by a physician’s evaluation rather than by the courts.” 5

Some patients are clearly unable to make medical deci-sions: infants, young children, patients who are comatose, severely mentally handicapped or who suffer from demen-tia. 4, 6 Other patients may be suffering from impaired de-cision-making capacity caused by intoxication, hypoxia, sedation, stress, or fever. “Every effort should be made to reverse potential impairments in capacity, to assure that the patient is making the most rational, autonomous choice.” 7

“Level of needed capacity may also be decision-specific. For example, the physician may have a lower threshold for allowing a patient to refuse suturing a small laceration, than for allowing a patient to refuse admission for a myo-cardial infarction.” 7

Physicians should not conclude that patients lack deci-sion-making capacity because they decline a recommended intervention. “Determining decision-making capacity involves assessing the process the patient uses to arrive at a decision, not whether the decision he or she arrives at is the one pre-ferred or recommended by the healthcare practitioner.” 4

Four elements to assess decision-making capacity are cited in the medical literature. They include:

1. Does the patient understand all the information about the intervention?2. Does the patient appreciate how that information ap-plies to his or her situation?3. Can the patient evaluate the information, comparing risks and benefits?4. Can the patient make a rational and consistent choice and communicate that choice? 4, 6, 8, 9

In the article “Ten myths about decision-making capaci-ty,” the authors address the misconception that only mental

health experts can assess decision-making capacity. “All cli-nicians who are responsible for the care of patients should be able to perform routine capacity assessments. Although psychiatrists and psychologists have specific expertise in diagnosing and treating many of the disorders that cause incapacity, for many routine cases, decision-making capac-ity is best assessed by the clinician who is responsible for the patient’s care.” 4

A number of tools for determining decision-making ca-pacity exist. 4, 5, 6, 9 “Once a patient has been identified as requiring a more careful assessment of capacity, the evalu-ation should proceed in a clear and organized manner.” 9

Additionally, physicians should clearly document the as-sessment and final judgment about capacity in the medical record.

If the physician concludes that the patient lacks deci-sion-making capacity, a determination of surrogacy will be necessary. “In a nonemergent situation, if the patient lacks decision-making capacity, advance directives or a surrogate decision-maker must be consulted, or a court may need to appoint a guardian for the decision-maker if there is no sur-rogate.” 5

Documenting informed refusalPrudent practice involves comprehensive documenta-

tion. As with the informed consent process, informed refus-al should be documented in the medical record. In the case study, the jury found in favor of the plaintiffs when faced with a deceased patient and an undocumented patient de-cision of great importance. A signed refusal for heart cathe-terization — including the risks, benefits and options, with the patient’s signature witnessed — may have prevented this claim.

“All cases of informed refusal should be thoroughly documented in the patient’s medical record. Also, families watching the clinical demise of their loved one due to therapy refusal may demand inappropriate care, and even threaten to sue if such care is not provided, thus the height-ened importance of thorough documentation. Notes of the discussion with the patient (and family, if possible) should be recorded, as well as consultation notes from bioethics, social work and psychiatry specialty services. These notes should also comment on the patient’s mental status and de-cisionmaking capacity.” 10

The documentation of a patient’s informed refusal should include the following:

• describe the intervention offered;• identify the reasons the intervention was offered;• identify the potential benefits and risks of the inter-vention;• note that the patient has been told of the risks — including possible jeopardy to life or health — in not ac-cepting the intervention;• clearly document that the patient has unequivocally and without condition refused the intervention; and • identify why the patient refused, particularly if the patient’s decision was rational and one that could not be overcome. 11,12

Holeman says that many physicians may feel it is not necessary to document the more common instances of informed refusal, such as when a patient refuses to take medication or defers a screening test. “Physicians need to continued on page 15


tmlt CME activity

Course authorNancy Steinmacher is a risk manage-

ment representative at TMLT.

DisclosureNancy Steinmacher has no commercial

affiliations/ interests to disclose related to this activity.

Target audienceThis one-hour activity is intended for

physicians of all specialties who are inter-ested in practical ways to reduce the poten-tial for malpractice liability.

CME credit statementTexas Medical Liability Trust is accred-

ited by the Accreditation Council for Con-tinuing Medical Education (ACCME) to provide continuing medical education for physicians. TMLT designates this educa-tional activity for a maximum of 1 AMA PRA Category 1 Credits.™ Physicians should

only claim credit commensurate with the extent of their participation in the activity.

Ethics statementThis course has been designated by

TMLT for 1 hour of education in medical ethics and/or professional responsibility.

DirectionsPlease read the entire article and answer

the CME test questions. To receive credit, submit the completed test and evaluation form to TMLT. All test questions must be completed. Please print your name and ad-dress clearly. Please allow four to six weeks from receipt of test and evaluation form for delivery of certificate.

Estimated time to complete activityIt should take approximately 1 hour to

read this article and complete the questions.

Objectives

At the conclusion of this educational activity, the physician should be able to:

1. list developments in genetic research;

2. discuss potential risk factors resulting from the use of information gener-ated by genetic testing; and

3. implement practice pro-cedures to increase patient education and reduce liability.

Risks and rewards advancements in genetic testing


Release/review dateThis activity is released on June 1, 2007

and expires on June 1, 2009. Please note this CME activity does not meet TMLT’s dis-count criteria. Physicians completing this CME activity will not receive a premium discount.

IntroductionWith the evolving technology and public

awareness surrounding genetic testing, it is beneficial for physicians to understand these developments in order to educate patients and to help facilitate informed decision making regarding their patients’ health and treatment options. Whereas advancements in medical science can contribute to the diagnosis and treatment of diseases, such technological change can also complicate treatment planning and decision making and create controversy and adversarial re-sponses. Concern from advocacy groups regarding genetic testing — and how in-formation resulting from it may poten-tially harm individuals — has resulted in proposed legislation to protect the rights of patients. Such legislation restricts how genetic information can be used by inter-ested parties, such as insurance companies and employers, against an individual’s best interests. Additionally, gene patents have generated increasing criticism because of their potential to impede medical research. This article will explore the major compo-nents of genetic testing and address some of the debate surrounding its use.

Applications of genetic testing“The term ‘genetic testing’ covers an

array of techniques including analysis of human DNA, RNA or protein.” 1 Used in both clinical and nonclinical settings, some examples of how genetic tests are used in-clude assisting with confirmation of diag-nosis and prediction of response to therapy, as well as determining predisposition to medical conditions or diseases such as cys-tic fibrosis, hereditary hemochromatosis, BRCA-1 and BRCA-2, celiac disease, and alpha-1 antitrypsin deficiency. Genetic test-ing can also be used to determine paternity and as individual identification in forensic contexts. Currently, more than 1000 tests can determine whether a person carries a par-ticular disease-associated allele, and robust research is ongoing. “It is predicted that within the next few years, the sequencing of a patient’s entire genome will be an af-fordable standard diagnostic tool used in health care.” 1

Direct marketing of genetic tests to con-sumers has already begun, raising concern that these efforts may not fully communicate the limitations of testing or reach at-risk populations. 2 Given the availability of on-line medical information, a common con-cern is that an individual may be persuaded to obtain a genetic test by marketing efforts that promote an unfounded sense of opti-mism or false alleviation of anxiety. While physicians do not have direct control over the independent decisions their patients make, they can become more mindful of opportunities to inform patients and help influence medical decisions that are based upon known facts. Physicians can help pro-vide perspective and alternatives to consid-er during the decision-making process.

Patient educationSome issues physicians might explore

with patients considering genetic testing are: “ • What do you hope to learn? The desire

to satisfy curiosity is one thing, but learning you carry a gene for hereditary breast and ovarian cancer or cystic fibrosis can be life changing. If the results are likely to influ-ence your behavior — such as whether to have your ovaries removed or to have chil-dren — there may be a reason to proceed. But if there is virtually nothing you can do — as in the case of genes linked to Al-zheimer’s disease — you might rather not know.

• Do you understand the potential results? Most people do not. A positive test rarely guarantees that a person will develop can-cer or another disease, but rather that the risk of doing so is increased. Similarly, a negative test is rarely an iron-clad assurance of not getting a particular disease. Most cancers, for example, are believed to result from a complex and still poorly understood interplay between heredity and environ-ment, not genetics alone.

• Can you live for years with uncertainty or anxiety? Everyone has conditions or diseas-es that run in the family. Some can be post-poned or even prevented with good health habits, so why not simply adopt these?

• How solid is the science? Some genetic tests, such as those for hereditary breast and ovarian cancer and cystic fibrosis, are widely accepted in the medical community. Others, such as those that help one select nutritional supplements or that indicate a predisposition to depression, are not.

• Why are you using a home test? If you think a home test will ensure your medical privacy, make sure you understand the test-ing company’s privacy policy. It may offer

no more protection than testing in a hos-pital lab or genetics center. And if you test positive, you will probably tell your doctor, and the results will then become part of your medical record.

• Have you considered family reaction? A positive finding may trigger a cascade of unanticipated consequences, such as angry siblings or upset adult children who feel co-erced into getting tested themselves — or who considered testing but decided they preferred not to know.

• Are you prepared for bad — even devastat-ing — news? Genetic counselors agree that many people underestimate the profound psychological impact test results can have. ‘I really worry about people sitting there alone at home getting results and having no one to talk to,’ said cancer genetics specialist Scott M. Weissman.” 3

Understanding the limitationsThe limitations of genetic testing are

complex. Tests can fail to identify all the mutations that can cause a disease. A posi-tive result does not mean that one will nec-essarily develop a disease. A negative result does not mean that one will not develop a disease. A positive result cannot predict the severity of a disease. Individual genes are only part of the clinical picture. Genetic testing is costly and is often not covered by health insurance plans.

Two cases cited in the Washington Post describe how these limitations can affect patient care. A woman tested for heredi-tary breast cancer may mistakenly think a negative result on a home test means she can forego regular mammograms. In fact, breast cancer genes account for only a frac-tion of cases. Similarly, someone who re-ceives a positive finding on a DNA-based colon cancer screening test may have can-cerous polyps that can be removed, colon cancer that has spread, or neither because the test is a false positive. 4

It is significant to consider the psycholog-ical aspect of genetic testing and its influence on patient expectations of prognosis and treatment outcome. Many argue against ge-netic testing when it has no affect upon the level of care or treatment plan. For some, test results may elicit feelings of anxiety and depression. Likewise, a false sense of security may discourage a patient from fo-cusing on positive lifestyle measures that could help decrease the risk for incurring disease.

There is also concern that some patients may overreact or make important medical decisions that are primarily inspired by an

tmlt cme • Advancements in genetic testing


emotional response to a test result, such as fear or anxiety. Patients may also have unrealistic expectations of treatment out-comes that are based on the perception of predisposed risk, such as inflated optimism that treatment based on test results may al-leviate future concerns. By discussing the occurrence of false negatives and positives involved with testing, physicians may be able to clarify expectations regarding test-ing and the overall diagnostic and treat-ment process.

There is also the concern about patients making important medical decisions based on limited or misinterpreted information, particularly for patients who do not discuss this information with qualified health care professionals. The general consensus is that an individual must be educated about the reliability of genetic testing, the implication of a positive result, and the consequences of elective treatment based on the results of testing. Consequently, physicians can help ensure that patients make decisions with adequate information.

Ethical considerationsEthical issues arise as well. For example,

when should a physician tell a patient that he or she appears to be at risk for develop-ing a medical condition for which there is no current treatment? For example, if an individual appears to be at risk for devel-oping Alzheimer’s disease, is it beneficial for the patient to be told if there are no pre-ventative measures or if it does not affect the standard of care? Physicians must be prepared to educate their patients regard-ing preventative measures they can take to decrease the risk or manage the symptoms of medical conditions for which they may be predisposed.

Another complicated and controversial topic is whether or not a physician should perform genetic testing on an unborn fetus if this might result in the parents electing to terminate the pregnancy. This issue is fur-ther complicated by the evolving trend of couples using testing that was initially de-veloped to screen genetic disorders to deter-mine the sex of their baby. Dr. Jeffrey Stein-berg of Fertility Institutes told ABC News, “We’re coming up on 2,000 couples now that we’ve done Pre-implantation Genetic Diagnosis (PGD) on; eighty-five percent to ninety percent of those couples have done it simply for gender selection. And we’re coming up on close to 940 babies.” 5

“The new use of PGD does not please one of the pioneers of the procedure, Dr. Mark Hughes, director of Genesis Genetics

Institute in Detroit. ‘I went into science and into medicine to diagnose and treat, and hopefully cure disease. And the last time I checked, your gender wasn’t a disease,’ Hughes said.” 5

Some argue that this enables prospective parents to prepare for medical complica-tions or to determine that they may not be equipped practically or emotionally to deal with them; an opposing argument posits that some parents may make this important decision prematurely based on speculation.

Physicians must be able to discuss the implications of genetic testing and medical decisions based upon the outcome of test-ing with their patients. Increased public awareness and use of genetic testing will require that physicians have a heightened awareness regarding issues pertaining to informed consent. This may include hav-ing genetic counselors on staff or knowing where to refer patients for genetic counsel-ing in the community.

Critics say the medical profession has not kept pace with science. Most practicing physicians do not know much about genetic testing, and experts on the subject are hard to find. Rylan Phelan, founder and CEO of DNAdirect, an internet-based gene-testing and counseling service launched in March 2005, told Cnet News.com “Knowledge is power . . . genetics is the next tool out there for consumers.” 6

“One reason Phelan began DNAdirect was the shortage of genetic counselors with the background and expertise to walk peo-ple through a gene test and what it means. Currently, there are about 1500 genetic counselors across the country, largely serv-ing patients in urban areas. By offering vir-tual access to qualified counselors through DNAdirect, Phelan believes it can open doors to many more people.” 6

As some health insurance plans make coverage determinations based on pre-ex-isting conditions, patient advocates express concern about how the results of genetic testing may affect coverage for individuals.

“Insurance is about distributing risk — and about discriminating between people at high risk and low risk. The question is how much discrimination is appropriate in the insurance arena.” 7 If genetic testing were required for the purchase of health or life insurance, this could negatively affect the individual and the individual’s fam-ily. The following is from an abstract in the Medical Journal of Australia:

“• The potential for discrimination when applying for insurance can be of concern for individuals with a family history of cancer or of a genetic disorder and who are consid-

ering genetic counseling or genetic testing. The actual incidence of ‘genetic discrimina-tion’, however, is not known, despite con-siderable media coverage of the issue.

• The clinical details required by insurers have received less attention. We obtained primary application and personal state-ment forms used by 21 different underwrit-ers of voluntary life insurance and found substantial differences in the information requested about family history and genetic testing.

• All insurance applications, however, contained a duty of disclosure that would require revealing the result, if known by the applicant, of a genetic test in a family mem-ber. Therefore, decisions made by family members can affect insurance applications, and people considering genetic testing may also need to consider the implications of the results of other family members.

• Health practitioners should balance the potential benefits of appropriate genetic testing against potential restriction to life and income-protection insurance when ad-vising people about genetic testing.” 8

The following case of discrimination while trying to obtain health care cover-age was described in Faces of Discrimina-tion, a publication of the Coalition for Ge-netic Fairness. “A 28-year-old woman who tested positive for BRCA-1, was denied health insurance coverage because of her genetic status. Although she was not asked for genetic information when she applied for insurance, when the woman reported on her application that she had undergone prophylactic mastectomies and a hyster-ectomy, the insurance company requested her medical records, which included her genetic information. Her application for coverage was rejected, and she was later able to determine that the denial was due to her positive BRCA-1 test result. Only af-ter involving a lawyer, and after much time and effort, was she ultimately able to secure insurance coverage.” 9

Parallel to the concern about insurance discrimination is how employers or pro-spective employers may make employment determinations based on genetic informa-tion that might imply an individual is at risk for a significant medical condition. To date, there have been published reports of this type of discrimination. “Kim was a so-cial worker with a human services agency until she was fired because of her employ-er’s fears about her family history of Hun-tington’s disease. During a staff workshop on caring for people with chronic illnesses, Kim mentioned that she had been the pri-

Advancements in genetic testing • tmlt cme


mary caretaker for her mother, who died of Huntington’s disease. Because of her fam-ily history, Kim had a 50 percent chance of developing the disease herself. One week later, despite outstanding performance re-views, Kim was fired from her job.” 10

Proponents of legislation defining how genetic information can be used advocate for the rights of the individual regarding in-surability and employability. There is a gen-eral concern regarding the lack of specific limitations regulating how this information might be used. A common argument is that genetic testing may not improve quality of health care, but could result in discrimina-tion in anticipation of health issues.

Competition among laboratories has in-troduced yet another issue regarding access to the human genome. The U.S. Patent Office has given rights to various organizations for 20% of the genes found in everyone’s DNA, creating obstacles for researchers focused on developing cures for diseases. 11 It is esti-mated that one out of every five genes in the human body is privately owned. The com-petitive dynamic has actually resulted in limitations in patient care. The proprietary nature of ownership has provided financial barriers that affect interested researchers and end users. For example, fiscal limita-tions prohibit more widespread research of devastating diseases resulting in dimin-ished end results for patients.

According to a recent article by Michael Crichton, “Humans share mostly the same genes. And by now one-fifth of the genes in your body are privately owned. The results have been disastrous. Ordinarily, we imag-ine patents promote innovation, but that’s because most patents are granted for human inventions. Genes aren’t human inventions, they are features of the natural world. As a result, these patents can be used to block in-novation, and hurt patient care.” 12

LegislationCurrently, the most likely source of pro-

tection against genetic discrimination in the workplace comes from Title I of the Ameri-cans with Disabilities Act (ADA). The ADA, which is enforced by the Equal Employ-ment Opportunity Commission (EEOC), does not explicitly address genetic informa-tion, but provides some protections against disability-related genetic discrimination in the workplace. Specifically, the ADA:

“• prohibits discrimination against aperson who is regarded as having a dis-ability;• protects individuals with symptomatic genetic disabilities the same as individu-

als with other disabilities;• does not protect against discrimination based on unexpressed genetic conditions;• does not protect potential workers from requirements or requests to provide genetic information to their employers after a conditional offer of employment has been extended but before they begin work; (a heightened concern because ge-netic samples can be stored); and• does not protect workers from require-ments to provide medical information that is job related and consistent with business necessity.” 13

“In March 1995, the EEOC issued an interpretation of the ADA. The guidance, however, is limited in scope and legal ef-fect. It is policy guidance that does not have the same legal binding effect on a court as a statute or regulation and has not been test-ed in court. According to the interpretation, entities that discriminate on the basis of genetic predisposition are regarding the in-dividuals as having impairments, and such individuals are covered by the ADA. Unaf-fected carriers of recessive and X-linked dis-orders, individuals with late-onset genetic disorders who may be identified through genetic testing or family history as being at high risk of developing the disease are not covered by the ADA.” 13

The Health Insurance Portability and Accountability Act (HIPAA) applies to employer-based and commercially issued group health insurance only. “HIPAA is the only federal law that directly addresses the issue of genetic discrimination. There is no similar law applying to private individuals seeking health insurance in the individual market.” 13 Specifically, HIPAA:

• “prohibits group health plans from using any health status-related factor, including genetic information, as a ba-sis for denying or limiting eligibility for coverage or for charging an individual more for coverage;• limits exclusions for preexisting condi-tions in group health plans to 12 months and prohibits such exclusions if the indi-vidual has been covered previously for that condition for 12 months or more; • states explicitly that genetic informa-tion in the absence of a current diagnosis of illness shall not be considered a preex-isting condition; and• does not prohibit employers from re-fusing to offer health coverage as part of their benefits packages.” 13

In his June 23, 2001 presidential radio address, President George W. Bush stated

“Genetic discrimination is unfair to workers and their families. It is unjustified — among other reasons, because it involves little more than medical speculation. A genetic predisposition toward cancer or heart dis-ease does not mean the condition will de-velop. To deny employment or insurance to a healthy person based only on a predispo-sition violates our country’s belief in equal treatment and individual merit.” 14

No federal legislation has been passed relating to genetic discrimination in indi-vidual insurance coverage or to genetic discrimination in the workplace. Several bills have been introduced during the last decade. Some of these bills attempted to amend existing civil rights and labor laws, while others stood alone. The primary pub-lic concerns are that insurers will use genetic information to deny, limit, or cancel insur-ance policies or employers will use genetic information against existing workers or to screen potential employees. Because DNA samples can be held indefinitely, there is the added threat that samples will be used for purposes other than those for which they were gathered.

In January 2007, the Genetic Nondis-crimination Act of 2007 was introduced. Currently under consideration in the Sen-ate, this legislation:

• Amends the Employee Retirement In-come Security Act of 1974 (ERISA) and the Public Health Service Act to expand the prohibition against discrimination by group health plans and health insurance issuers in the group and individual mar-kets on the basis of genetic information or services to prohibit: (1) enrollment and premium discrimination based on information about a request for or re-ceipt of genetic services; and (2) requir-ing genetic testing. It sets forth penalties for violations.• Amends title XVIII (Medicare) of the Social Security Act to prohibit issuers of Medicare supplemental policies from discriminating on the basis of genetic in-formation.• Extends medical privacy and confi-dentiality rules to the disclosure of ge-netic information.• Makes it an unlawful employment practice for an employer, employment agency, labor organization, or training program to discriminate against an in-dividual or deprive such individual of employment opportunities because of genetic information. Prohibits the collec-tion and disclosure of genetic informa-tion, with certain exceptions.• Establishes a Genetic Nondiscrimina-

tmlt cme • Advancements in genetic testing


tion Study Commission to review the developing science of genetics and ad-vise Congress on the advisability of pro-viding for a disparate impact cause of action under this Act. 15

In Texas, legislation was passed in 1997 that prohibits discrimination in the deter-mination of eligibility for employment, occupational licenses, and coverage under certain health benefit plans based on the use of certain genetic tests. Limitations were also placed on the use of information derived from genetic tests. 16

Current regulatory effortsSeveral agencies are involved in the over-

sight of genetic testing. The Centers for Medicare and Medicaid Services (CMS) reg-ulates clinical laboratory testing to ensure compliance with the Clinical Laboratory Improvement Amendment of 1988, showing accuracy and reliability in conducting as-says. The Federal Trade Commission (FTC) oversees advertising of tests and products. The Food and Drug Administration (FDA) regulates tests sold as “diagnostic devices,” tests manufactured by one company and then sold as a kit to a laboratory for genetic testing. However, the FDA does not regu-late “home brew” tests, those that are both manufactured and performed by the same laboratory. Many common genetic tests (in-cluding the BRCA breast cancer gene tests) fall into this category. Because of this regu-latory exception, genetic testing services using “home brew” tests can be marketed directly to the medical community — and the public — without FDA oversight.

The Secretary’s Advisory Committee on Genetic Testing (SACGT) was formed by the Secretary of the Department of Health and Human Services (HHS) in June 1998. The SACGT is charged with advising HHS about all aspects of the development and use of genetic tests, including the complex medical, ethical, legal, and social issues raised by genetic testing. The SACGT has produced several reports, including “En-hancing the Oversight of Genetic Tests” and continues to develop recommendations for the current Secretary. 17

The Social and Behavioral Research Branch (SBRB) has the broad objective to in-vestigate social and behavioral factors that facilitate the translation of genomic discov-eries for health promotion, disease preven-tion, and health care improvements. “This research encompasses four conceptual do-mains: (1) testing the effectiveness of strate-

gies for communicating information about genetic risks; (2) developing and evaluating behavioral interventions; (3) using genomic discoveries in clinical practice; and (4) un-derstanding the social, ethical, and policy implications of genomic research.” 18

ConclusionBy staying informed about the current

issues in genetic testing, as well as consum-er trends, physicians will be better able to provide guidance and present a clear per-spective regarding genetic testing. As this technology evolves, lending itself increas-ingly to advances in medical practice, it will demand of physicians the ability to educate their patients.

Sources1. National Human Genome Research Insti-tute. Genetic testing. November 2006. Avail-able at http://www.genome.gov/10002335. Accessed November 21, 2006.2. National Human Genome Research Insti-tute. Direct to consumer marketing of ge-netic tests: Direct to Consumer Advertising Workshop Summary. March 23, 2004. Avail-able at http://www.genome.gov/12010659. Accessed November 21, 2006.3. Boodman SG. You’re sure you want to know? Washington Post. June 13, 2006. Available at http://www.washingtonpost. Accessed July 25, 2006.4. Boodman SG. Too much information: Results of home DNA tests can shock, mis-inform. Washington Post. June 13, 2006. Available at http://washingtonpost.com/wp-dyn/content/article/2006/06/12/AR2006061201104. Accessed July 25, 2006.5. ABC News Internet Ventures. Boy or girl? Couple choose unborn children’s sex. March 25, 2006. Available at http://abc-news.go.com/GMA/print?id=1767206. Accessed July 25, 2006.6. Olsen S. Knowledge is power, but can you handle it? Cnet News.com. May 10, 2006. Accessed July 25, 2006.7. Fisher NL. Genetic testing and health in-surance: can they coexist? Clev Clin J Med. January 2004; 71(1).8. Lynch et al. Cancer in the family and ge-netic testing: implications for life insurance. Med J Aust. 2003;179(9):480-483.9. National Partnership for Women and Families, Coalition for Genetic Fairness. Faces of genetic discrimination: how genetic discrimination affects real people. Washington DC. July 2004. Available at http://www.nationalpartnership.org/site/PageServer?

pagename=library_gd_GeneticDiscrimina-tion. Accessed April 30, 2007.10. Council For Responsible Genetics. Ge-netic discrimination: a position paper. Cam-bridge, MA. 2001 Available at http://www.gene-watch.org/programs/privacy/genet-ic-disc-position.html. Accessed November 21, 2006.11. Winik LW. How gene patents are put-ting your health at risk. Parade. November 26, 2006.12. Crichton M. Patents mean we don’t own our genes anymore. Austin American- States-man. February 21, 2007.13. U.S. Department of Energy Office of Sci-ence, Office of Biological and Environmen-tal Research, Human Genome Program. Genetics privacy and legislation. Available at http://www.ornl.gov/sci/techresourc-es/Human_Genome/elsi/legislat.shtml. Accessed November 21, 2006.14. Bush GW. Radio address by the presi-dent to the nation. June 23, 2001. Available at http://www.whitehouse.gov/news/re-leases/2001/06/20010623.html. Accessed on November 21, 2006.15. The Library of Congress. Bills and Resolutions. HR 493. Available at http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR00493:@@@L&summ2=m&. Accessed April 30, 2007.16. Texas Legislature Online. History HB 39. Available at http://www.capitol.state.tx.us/BillLookup/History.aspx?LegSess=75R&Bill=HB39. Accessed April 30, 2007.17. Sternesky L, Association of State and Territorial Health Officials. Oversight of Genetic Testing. January 2002. Available at http://www.astho.org/templates/dis-play_pub.php?u=JnB1Yl9pZD00NDM=.18. National Human Genome Research Insti-tute. Social and Behavioral Research Branch. Available at http://www.genome.gov/ 11508935. Accessed November 21, 2006.

Nancy Steinmacher can be reached at [email protected].

Advancements in genetic testing • tmlt cme


claim studiesclosed

The following closed claim studies are based on actual malpractice claims from Texas Medical Liability Trust. These cases illustrate how ac-tion or inaction on the part of physicians led to allegations of professional liability, and how risk management techniques may have either pre-vented the outcome or increased the physicians’ defensibility. The ultimate goal in presenting these cases is to help physicians practice safe medicine. An attempt has been made to make the material more difficult to identify. If you rec-ognize your own claim, please be assured it is presented solely to emphasize the issues of the case.

PresentationA 17-year-old boy came to the emergen-

cy department (ED) after being involved in a motor vehicle accident. The ED physician ordered a chest x-ray. The radiologist’s im-pression of the chest film was: “right infra-hilar mass-type lesion is noted. Follow-up radiograph and possibly CT scanning sug-gested for further evaluation.” A CT scan of the abdomen and pelvis was read as normal. The patient was referred to his family phy-sician for further evaluation.

Physician actionOn June 23, approximately two months

later, the patient came to his family physi-cian. The patient had a history of cardiac surgery for pulmonary stenosis and surgery to an undescended right testicle when he was three years old. The family physician ordered a CT scan of the chest that revealed a 2.7 x 3.3 cm soft tissue mass in the right lung and a 1 cm mass in the left lung. The family physician referred the patient to a pulmonologist. The family physician also spoke to the radiologist who recommended an upper abdominal CT scan and scrotal ultrasound.

The patient did not keep his appoint-ment with the pulmonologist on July 11. On July 28, he returned to the family physician. He ordered a sonogram of the scrotum that revealed focal calcification of the left tes-ticle. The patient’s appointment with the pulmonologist was rescheduled for August 2. Again, the patient did not keep this ap-pointment.

The patient returned to the family phy-sician on August 11. He again advised the patient to see the pulmonologist. The fam-ily physician noted in his records “CT scan in three months.”

On August 15, the pulmonologist evalu-ated the patient. His impression was “The differential is broad. The most likely etiology is a prior fungal infection such as Coccidial Mycosis or Histoplasmosis that is now re-solved. Metastatic disease is unlikely. The patient has not had weight loss or progres-sive symptoms over the past four months.” His plan was to obtain the family physi-cian’s records, review blood work, PPD, and scrotal ultrasound.

The pulmonologist ordered a CT scan of the chest that was completed that day. The conclusion was “Lobulated nodular density in right mid lung zone. The fact that it has very low density raises the possibility that this may represent mucoid impaction with-in an area of underlying bronchiectasis. This may be seen in cases of cystic fibrosis or bronchopulmonary aspirate gelosis. Other entities including neoplasm cannot be ex-cluded, but are considered less likely. It is unlikely for this to represent AVM second-ary to the lack of enhancement. Note is made that the nodular density in the left mid lung zone has decreased significantly in size since prior examination, and is almost imperceptible on the current exam.” The patient was scheduled for a follow-up visit

with the pulmonologist on August 18, but he did not keep that appointment.

The patient returned to the family phy-sician on December 12 with complaints of chest pain, cough, rhinorrhea, shortness of breath, and fever for two days. The family physician’s impression was pleuritic chest pain with bronchitits. On February 12, the patient saw the family physician. He re-ported a history of back pain and left nipple swelling for one month. The family physi-cian’s plan was to order an x-ray. The pa-tient returned on February 19 complaining of pain, shortness of breath, cough and spu-tum. The family physician ordered an MRI that was reported as negative. Two more weeks passed. The patient was again seen by the family physician for significant pain, shortness of breath, cough, sputum, and left abdominal pain.

On March 29, the patient saw another family physician. This physician ordered a chest x-ray. The impression was “medi-astinal lymphadenopathy with bilateral pulmonary nodules.” A CT scan completed that day revealed “extensive pulmonary metastases and mediastinal adenopathy consistent with metastatic disease, most likely seminoma or other testicular tumor.” A sonogram of the scrotum revealed a hy-peremic left testicular mass.

The patient was admitted to the hospi-tal by the pulmonologist on March 30. A CT scan of the abdomen revealed extensive retroperitoneal adenopathy consistent with metastatic tumor. A chest x-ray showed me-diastinal and hilar lymphadenopathy and bilateral mass lesions. A urologist was con-sulted, and the patient underwent a left rad-ical orchiectomy on April 1. The pathology report indicated “near malignant germ cell

continued on page 14

Delay in diagnosing testicular cancerby Barbara Rose and Laura Brockway


PresentationA 50-year-old man was receiving treat-

ment for chronic obstructive pulmonary disease from his family physician. The patient’s history included smoking three packs per day for 25 years and extensive alcohol abuse.

On January 28, he came to the emergen-cy department (ED) complaining of nausea, fever, and chills. The patient had a history of hemoptysis seven days before admission and a 40 to 50 pound weight loss over the previous six months. The patient had no history of tuberculosis (TB), chest trauma, syncope, or recent travel. The family physi-cian had taken several sputum cultures to test for TB in the past, and the results were all negative.

Physician actionThe family physician admitted the pa-

tient and contacted a pulmonologist. An-other sputum culture was obtained on Jan-uary 28 and was sent to an outside lab for analysis. A chest x-ray revealed extensive left upper lobe infiltrates with central den-sities surrounded by a small rim of lucency suggesting a cavity with intracavitary as-pergilloma.

The pulmonologist examined the pa-tient, and his initial impression was possible pulmonary TB with upper lobe cavity and intracavitary aspergilloma versus cavitary neoplasm or necrotizing aspiration pneu-monia. The pulmonologist recommended another sputum culture for AFB (acid-fast bacilli), gram stain cultures, cytology, re-spiratory isolation, IV Unasyn, CT scan of the chest, and a bronchoscopy after the AFB smears were obtained. He performed the bronchoscopy and found inflamed, left up-per lobe segments with thin blood-stained secretions. The pulmonologist performed extensive left upper lobe washings, which were sent to pathology for review.

On February 1, the sputum cytology was reported as negative for malignancy or AFB. The bronchial washings were negative for pneumocystis carinii, fungal elements, and AFB. There was a light growth of Candida albicans. The CT scan of the chest showed what looked like a fungal mass or aspergil-loma within the chest. The pulmonologist referred the patient to a general surgeon.

During the investigation of this case, it was discovered that the January 28th spu-tum cultures were reported back to the hospital lab on February 26. One of the spu-tum cultures was reported as positive for AFB. This report was never placed in the

patient’s chart. The general surgeon saw the patient on

March 2. He reviewed the CT scan with the radiologist. The patient had not experienced any additional hemoptysis since the initial episode, and the CT scan was interpreted as showing a cavitary lesion in the left upper lobe compatible with an aspergilloma. The surgeon recommended a left upper lobe lo-bectomy. He obtained consent for a thora-cotomy and left upper lobe lobectomy from the patient.

The surgery was completed on March 17. The surgeon found a large mass in the left upper lobe firmly attached to the apical and posterior aspect of the chest wall with marked adhesions to the pericardium and the hilum. There was massive bleeding from the chest wall attachment, and the patient received three units of packed RBCs. The patient was transferred to the ICU and suf-fered post-surgical coagulopathy and hem-orrhage. The pulmonologist believed the patient was in hemorrhagic shock. He rec-ommended IV transfusion of calcium, sodi-um bicarbonate, vitamin K, platelets, RBCs and surgical re-exploration. The surgical pathology report showed diffuse alveolar damage with anthracotic and iron-contain-ing macrophages. Fungal stains were nega-tive for organisms.

The general surgeon took the patient back to the OR at 6 p.m. that evening. He found a massive postoperative hemothorax, massive bleeding of the left chest wall in the apical portion where previous adhesions and the possible aspergilloma had been lo-cated. The surgeon was able to control the bleeding and the patient was returned to the ICU. The pathology from the surgery re-vealed no granulomas, no malignant cells, and no aspergilloma.

Postoperatively, the patient developed pulmonary edema, and the continued bleeding led to coagulopathy and dissemi-nated intravascular coagulation. He devel-oped an occlusion of the right distal radial artery to the wrist. His condition worsened. A chest x-ray on March 24 revealed acute respiratory distress syndrome and a CT revealed subcutaneous emphysema or old pleural hematoma.

The patient was transferred to another hospital. The infection control nurse at the second hospital called the pathology lab at the first hospital requesting the patient’s sputum culture reports. Among the reports sent was the one positive sputum culture report. TB was allegedly diagnosed and treated at the second hospital. The patient’s

condition stabilized, but he underwent bi-lateral below the knee amputations and amputation of three fingers on the right hand due to coagulopathy.

AllegationsLawsuits were filed against the family

physician, the pulmonologist, the general surgeon, and the first hospital. The plain-tiffs claimed that the patient had TB and was misdiagnosed. Allegations against the pulmonologist included failure to follow up on the sputum cultures and negligence in the referral to the general surgeon. As to the surgeon, they alleged the surgery was not necessary, and that he should have waited on the sputum cultures before pro-ceeding with the lobectomy. The plaintiffs further allege that the surgery was improp-erly performed, leading to a coagulopathy and resulting amputation of the patient’s legs and fingers.

Legal implicationsRegarding the actions of the pulmonolo-

gist, the plaintiffs alleged that he should not have referred the patient to the surgeon until the final TB testing results had been re-turned. TMLT defense experts were mixed in their opinions about the care given by the pulmonologist. One expert stated that the defendant had the appropriate differential diagnosis in mind, namely TB and aspergil-loma. He properly requested cultures and performed bronchoscopic examination with washings and samples that were all report-ed as negative for AFB by pathology. This expert stated that he would believe nega-tive washing over a positive sputum culture report, and that the positive sputum culture report was a false positive. He supported the defendant’s decision to refer the patient to the surgeon.

Another pulmonologist stated that the defendant should have waited for the final culture reports from the bronchoscopy be-fore he referred the patient to the surgeon. The only indication for surgical resection of an aspergilloma is persistent or recurrent hemoptysis. Additionally, other diagnostic efforts, such as a percutaneous needle bi-opsy, could have been completed before surgery.

Defense experts reviewing the case against the general surgeon could not sup-port his decision to remove the patient’s lung due to a suspected diagnosis of asper-gilloma. The reviewers stated lobectomy is continued on page 14

Alleged failure to diagnose tuberculosis; unnecessary surgeryby Barbara Rose and Laura Brockway


testicular cancer . . . continued from page 12

neoplasm, equal components of embryonal and yolk sac carcinomas; invasion of medi-astinum testis.” The patient was started on chemotherapy and was discharged from the hospital on April 9. He continued che-motherapy. By December 12, the testicular cancer was in clinical remission. However, the patient was noncompliant in keeping follow up appointments, as documented by the oncologist.

AllegationsLawsuits were filed against the family

physician, pulmonologist, and the urologist. Allegations included:

• failure to order proper testing (family physician and pulmonologist);• failure to follow up on the scrotal ul-trasound and CT scans (family physician and pulmonologist);• failure to refer to a urologist (family physician and pulmonologist); and • failure to inform the patient of the ne-cessity of sperm banking before the or-chiectomy (urologist).This case involved a now 22-year-old

who recovered from metastatic cancer. The medical expenses related to his treatment would have been incurred regardless of the delay in diagnosis. Accordingly, there were no claims for medical expenses or lost wages. The damages involved the patient’s sterility.

Legal implicationsDefense consultants were not support-

ive of the family physician’s actions. On August 11, he indicated he would do a CT scan in three months. When the patient re-turned on December 12, February 12, Febru-ary 19, and March 1, it was not addressed. The family physician did not question the patient about seeing the pulmonologist and did not follow up. The urologist was not directly critical of the family physician, but testified that it would have been reasonable to obtain a urological consult based on the July sonogram. Additionally, the urologist indicated that if the diagnosis had been made earlier, he would have advised the patient of the possibility of sperm banking.

The family physician testified that he thought the pulmonologist was following up on the CT scans. The pulmonologist tes-tified that he never told the family physi-cian he was going to do serial CT scans.

The subsequent treating oncologist tes-tified that it is the standard of care to ob-tain a urological consult when there is an abnormal testicular sonogram. Further, he indicated that the family physician should have ordered a CT scan when the patient returned in December.

Regarding the actions of the defendant pulmonologist, defense experts were criti-

cal of his lack of follow up after the August 18th CT scan. There was no indication in the medical record that the pulmonologist tried to contact the patient when he failed to show for the appointment.

Defense experts were supportive of the urologist’s actions. They indicated that there was no time to consider sperm banking be-cause of the grave condition of the patient (bilateral pulmonary metastasis and lymph-adenopathy). “The fact that the patient was not offered sperm banking is somewhat of a moot point since the object of the treatment was to save his life.”

The plaintiff’s expert agreed that the pa-tient’s outcome would have been the same with earlier diagnosis. He was critical of the delay in diagnosis, and claimed an earlier diagnosis would have allowed more time and opportunity for the patient to consider sperm banking.

DispositionThis case was settled on behalf of the fam-

ily physician. The cases against the urologist and the pulmonologist were dropped.

Risk management considerationsAn issue of note in many lawsuits against

physicians is a failure to diagnose and treat in a timely manner. It is prudent for each physician to develop, implement, and con-sistently use a protocol for follow up to re-ferrals outside the practice (labs, imaging studies, consultants, etc.). One needs to be confident in identifying two facts — the pa-tient did not comply or a report has not been received. It is recommended that a referral follow-up log with date, patient name, and the physician’s order be maintained. As re-ports are received for physician review and action, a patient’s name can be crossed off the list.

Another weakness in this claim involved communication between physicians. Prima-ry care physicians and consultants to whom they refer must clarify who is doing what.

Because this patient did not keep some of his appointments, he contributed to a de-lay in diagnosis and should bear some re-sponsibility. When patients are a “no show,” it is important that this be documented in the medical record. Follow up contacts by phone and by letter, reflect a practice com-mitted to its patients. Documenting these calls and including a copy of letters of con-cern in the record capture the efforts expend-ed for the noncompliant patient. Having these protocols and following them without fail in a practice may help to reduce a phy-sician’s liability and enhance defensibility.

Barbara Rose can be reached at [email protected]. Laura Brockway can be reached at [email protected].

tuberculosis . . . continued from page 13

only necessary if significant hemoptysis is present. (This patient had one documented episode of hemoptysis.) The general sur-geon testified that he would not have op-erated on the patient if the hospital had placed the positive TB results in the pa-tient’s chart before surgery. The surgeon looked at the chart before surgery and it did not contain the positive TB lab result. However, the plaintiffs argued that the chart did indicate that testing had been performed and the surgeon had a duty to wait for the results of the TB test before proceeding.

Regarding causation, the defense ques-tioned the diagnosis of TB. The bronchial washings were negative for TB. The pa-thology report from the March 17th sur-gery makes no mention of TB. During the investigation of this claim, the March 17th specimens were re-reviewed by another pathologist. No AFB was found. The slide containing the positive sputum smear was also re-examined by a pathologist. This pathologist believed the smear was a false positive due to contamination. No other test performed was positive for TB.

This case was complicated by finger pointing among the defendants. The pul-monologist stated that his referral to the general surgeon did not mean that he felt surgery was necessary. Rather, he knew something was in the patient’s lung that needed to be evaluated by a surgeon. The general surgeon stated that the pulmon-ologist sent the patient to him for surgery and not for conservative treatment and testing. However, both defendants stated that if they had known about the positive TB report, the surgery would not have been performed.

DispositionThis case was settled on behalf of all

the defendants.

Risk management considerationsWhen reviewed in hindsight, this com-

plex case still leaves one without clear an-swers and advice regarding the manage-ment of risk. It is known that the hospital lab where the sputum cultures were ex-amined has instituted a policy for prompt dissemination of reports to the ordering physician.

Comments regarding the actions and treatment choices of the defendants and debates regarding standards of care are left to the physicians who read this claim.

Barbara Rose can be reached at [email protected]. Laura Brockway can be reached at [email protected].


informed refusal . . . continued from page 4

protect themselves in these situations. If the patient suffers a bad outcome, he may come back and say he never understood why he needed to take the medication or have a test done,” says Holeman. “At a minimum the physician should have a note in the chart that says ‘patient declined screening mammogram after a discussion of the risks/ben-efits.’” Physicians can further protect themselves by having the patient sign the note.

If the patient’s refusal could lead to severe or permanent impairment or injury or death, an informed refusal form can be used. (Please see sample on page 3) Some physicians streamline this procedure by selecting the interventions most commonly employed in their practices and develop-ing informed consent and informed refusal forms that cov-er these treatments. Taking this step may also help reinforce the seriousness of the situation for the indecisive patient.

Other risk management considerationsIn addition to documenting the informed refusal discus-

sion, the following recommendations may help minimize the risk of lawsuits related to patient refusals.

• As part of routine care, inquire about and encourage patients to complete advance directives before serious ill-ness or capacity questions arise. “If the patient has an Ad-vance Directive or Living Will, this document may also provide helpful information with regard to the patient’s health-care values, especially in light of his/her diagnosis and prognosis with/without the medical intervention in question.” 10

• Under federal and state regulations, a physician is le-gally prohibited from discussing a patient’s medical history with anyone unless the patient permits it. Ask permission to involve the patient’s family — as opposed to assuming the permission would be denied — when dealing with a patient who declines treatment. If the patient refuses to in-volve a family member, ask if any other confidant could be brought into the discussion. 3

• Use any community resources available. “Our advice is to use bioethics, social work and psychiatry services early in the process of therapy refusal, especially when the conse-quences of such refusal are severe, irreversible morbidity or death.” 10 Having the patient obtain a second opinion may be effective, as hearing the same concerns strongly voiced by two physicians may convince the patient to proceed.

• While final responsibility for assessing decision-mak-ing capacity rests with the treating physician, mental health expertise may be necessary in more complex cases. “For example, primary clinicians might need help from mental health consultants in assessing the capacity of patients with major mental disorders such as schizophrenia or severe per-sonality disorders in whom distinguishing poor judgment from lack of decision-making capacity can be difficult.” 4

• “Finally, the physician must be aware that the ethical obligation to do what is in the patient’s best interest is not terminated by the patient’s refusal to follow the physician’s best advice.” 2 If the patient persists in the refusal, it is im-portant for the physician to leave the door open for the patient to return. Instruct the patient about symptoms or signs that would prompt a return. Provide an appropriate referral and detailed discharge or follow-up instructions.

• In addition to documenting the patient’s refusal at the time it is given, document the refusal again if the patient returns. “This may apply more to primary care physicians

who see the patient routinely. It may be necessary to ad-dress the intervention that the patient refused at each sub-sequent visit,” says Holeman. Document this discussion in the medical record, “again discussed with patient the need for cholesterol-lowering drugs . . . patient declined.”

• “The best way for physicians to avoid problems with informed consent and informed refusal is to fully communi-cate to patients the diagnosis or potential diagnosis, its nat-ural course if untreated, the recommended treatment along with its potential benefits and risks, and the alternative treatments including their potential benefits and risks.” 13

Sources1. Bernat J, Peterson L. Patient-centered informed consent in surgical practice. Arch Surg. 2006 Jan;141(1):86-92.2. Solomon R. Ethical issues in medical malpractice. Emerg Med Clin N Am. 2006 Aug;24(3): 733-747.3. Engel KG, Cranston R. When the physician’s medical judgment is rejected. Clinical case 2. American Medical Asso-ciation Virtual Mentor Archives. February 2004. Available at www.ama-assn.org/pub/category/11846.html. Accessed April 12, 2007.4. Ganzini L, Volicer L, Nelson W, Fox E, Derse A. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005 May-June;6(3 Suppl):S100-104.5. Jones R, Holden T. A guide to assessing decision-making capacity. Clev Clin J Med. 2004 Dec; 71(12):971-975.6. Derse AR. What part of “no” don’t you understand? Pa-tient refusal of recommended treatment in the emergency department. Mt Sinai J Med. 2005 July;72(4):221-227.7. Marco CA. Does patient autonomy outweigh duty to treat? Clinical case 1. American Medical Association Virtual Mentor Archives. February 2003. Available at www.ama-assn.org/ama/pub/category9575.html. Assessed April 12, 2007.8. Bramstedt KA, Arroliga AC. On the dilemma of enigmat-ic refusal of life-saving therapy. Chest. 2004;126(2):630-633.9. Tunzi M. Can the patient decide? Evaluating patient ca-pacity in practice. Am Fam Physician. 2001 Jul;64(2):299-306.10. Bramstedt K, Nash P. When death is the outcome of informed refusal: dilemma of rejecting ventricular assist device therapy. J Heart Lung Transplant. 2005 Feb;24(2): 229-230.11. Evans GF, Meyer MA, Texas Medical Liability Trust. In-formed consent: the third generation. February 2004.12. American College of Obstetricians and Gynecologists Committee on Professional Liability. ACOG Committee Opinion No. 306. Informed refusal. Obstet Gynecol. 2004 Dec; 104(6):1465-1466.13. Wagner RF, Torres A, Proper S. Informed consent and informed refusal. Dematol Surg. 1995 Jun;21(6):555-559.

Laura Brockway can be reached at [email protected].


Pre-sorted StandardU.S. Postage

PAIDPermit No. 90 Austin, Texas

TEXAS MEDICAL LIABILITY TRUST

P.O. Box 160140 Austin, TX 78716-0140 800-580-8658 or 512-425-5800 E-mail: [email protected] www.tmlt.org

Editorial committeeBob Fields, Acting President and CEOJill McLain, Vice President, Claim OperationsDon Chow, Senior Vice President, MarketingJane Holeman, Vice President, Risk ManagementDana Leidig, Vice President, Communications & Advertising

Editor Laura Brockway, ELS

Contributing EditorBarbara Rose

Staff Nancy Steinmacher, William Malamon

the Reporter is published by Texas Medical Liability Trust as an information and educational service to TMLT policy-holders. The information and opinions in this publication should not be used or referred to as primary legal sources or construed as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalizations can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. It is distributed with the understanding that neither Texas Medical Liability Trust nor Texas Medical Insurance Company are engaged in rendering legal services. © 2007 TMLT.

theReporter

In case you missed it . . . recent FDA Medwatch alertsThe U.S. Food and Drug Administration

communicates safety information on drugs and other medical products through Med-Watch. Physicians can sign up to receive MedWatch notices via email or RSS feed. Visit http://www.fda.gov/medwatch/ for complete instructions. The following Med-Watch notices were sent in April 2007.

New safety information for Avastin (bevaci-zumab)

Genentech and the FDA notified health care professionals of new safety informa-tion regarding tracheoesophageal (TE) fis-tula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). Formation of TE fistula exceeds the background rate in a study of patients receiving chemotherapy and radia-tion plus Avastin for the treatment of lim-ited-stage SCLC. Avastin is not approved for the treatment of SCLC. Genentech is revising the package insert to include more detailed information about the incidence of

all cases of fistula in patients treated with Avastin.

Shelhigh devices seizedThe FDA and U.S. marshals seized all

implantable medical devices from Shelhigh, Inc. after finding significant deficiencies in the company’s manufacturing processes. The FDA has also issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the market-place, including hospital inventories

The products include heart valves and valve conduits, annuloplasty rings, grafts, meshes and other implants.

FDA’s inspections of Shelhigh, Inc. re-vealed significant manufacturing problems that included improper sterilization and extension of expiration dates for the firm’s medical devices. Critically ill patients, pe-diatric patients and immuno-compromised patients may be at greatest risk from the use of these devices. Physicians and patients concerned about Shelhigh devices can visit

www.fda.gov/cdrh/safety/041907-shel-high.html and www.fda.gov/cdrh/medi-caldevicesafety/atp/041907-shelhigh.html for more information, including a list of the company’s products.

Defibrillators recalledBoston Scientific/Guidant and the FDA

announced that a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families was recalled. The implantable cardiac defibrillators and car-diac resynchronization therapy defibrilla-tors were recalled because of faulty capaci-tors. The capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months. Al-though the current recall is similar to the re-call of May 2006, the failure modes and pa-tient outcomes differ from those described in the May 2006 recall.

16 May-June 2007

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May-June 2007 Reporter - TMLTresources.tmlt.org/PDFs/Reporter/MayJune2007.pdf · meet state, local, individual organizations and department needs or requirements. They are distributed