Answer each question briefly, complete sentences are not necessary. Make sure you put your exam number on each page of the examination. Do not put your name or any other identifying information on the examination. Use no more than the space provided, and not all of the questions require all the space provided. Use specific case and statute references, as necessary. Do not write on the back - I only read what is on the front.
By taking this exam you are on notice that this exam is covered by the honor code. Violating the honor code rule will result in failure in the class and may result in dismissal from law school.
1.) Short takes
a) An M.D. belongs to what school of practice?
b) A D.O. belongs to what school of practice?
c) What doctrine historically prevented physicians from being employees of hospitals?
Corporate practice of medicine
d) Which federal law preempts many medical malpractice claims against HMOs?
e) Which medical specialty drove the development of the modern hospital?
f) What are the state laws called that block product's liability claims against blood banks?
Blood shield laws
g) Which restatement comment discusses "good whiskey"?
h) What is "off label" use of a drug?
Uses not approved by the FDA, which is not always the same as uses not on the label.
i) What federal agency enforces the Controlled Substances Act?
j) The Medical Device Amendments of 1976 divided medical devices into classes. What is the class for the most dangerous devices?
2) Case Info
a) Which case involved the failure to do a PAP smear?
Truman v. Thomas
b) What was the patient's disease in Arato v. Avedon 858 P.2d 598 (Cal 1993)?
c) What standard does Missouri use for determining what to tell patients to get their informed consent?
Physician or community
d) Can patients in Missouri get peer review documents? What statute section controls?
No, 537.035 (or 537.035(4))
e) Which case allowed the exclusion of testimony as a sanction for discovery abuse?
Wilkerson v. Prelutsky
f) Which case involved the failure of the physician to inform the patient of the results of a PAP smear?
Weiss v. Rojanasathit
g) What is the Aralen case?
Sterling Drug v. Yarroe, or the case about not warning about the effects of chloroquine
h) Why wasn't the doctor sued in Feldman v. Lederle Laboratories?
He was the patient's father
i) What case held that the learned intermediary doctrine did not apply when the drug company marketed directly to consumers?
Perez v. Wyeth Labs
j) What case held that a phone call was enough to create a physician patient relationship?
Bienz v. Central Suffolk Hosp.
3) For the following situations, explain why you will be successful or unsuccessful in surviving a motion for summary judgment, based on not being a seller, against a hospital defendant for products liability: Be specific as to how you do or do not meet the requirements of 402a.
I read these
two parts together to make sure I understood your answer.
a) Your client was injured when his hospital gown caught fire.
This is the classic hospital products case as discussed in Cafazzo v. Central Medical Health Services - the gown is not part of the medical services transaction, it does not require medical judgment to select, it is selected by the hospital as an administrative function, it is billed to the patient separately from medical services, and it is the same as items that the patient can purchase outside the hospital from clothing suppliers. It is in the same class as things sold in the gift shop. It is provided as part of the hospital's course of business to all patients, requires no expertise in its use, and is subject to inspection for defects by the hospital. The plaintiff can sue the hospital for a flaming gown.
b) Your client was injured when the artifical hip supplied by the hospital failed.
This is also Cafazzo, as well as Budding, the Missouri case. This is provided ancillary to medical services, it requires medical expertise to select, it is selected and used by the physician, it is a prescription item, it is provided only to patients undergoing the specific surgery where it is specified by the physician, it is not a generic product and cannot be routinely purchased outside the hospital. The hospital has no ability to inspect for defects. The patient cannot sue the hospital for a defective artificial hip. (Some students seemed to be using last years outline and were unaware that Mulligan had been reversed by Budding.)
4) The patient went to the hospital emergency room after a bear took a big bite from his leg. The physician who examined him asked him how he planned on paying for the care. When the patient said he had no money or insurance, the physician stopped the exam, told the patient that he needed care available only at the county hospital, and asked an orderly to drive the patient to the county hospital in the orderly's pickup truck. The physician signed a certification claiming that the patient was stabilized and would be better off with care at the county. The physician threw away the records so HHS would not find out. The patient was injured by the delay in getting proper care.
a) You are the physician's defense attorney. What is your primary defense against a claim brought by the patient under the private cause of action in federal court provided by EMTALA?
Jurisdiction fails - EMTALA does not provide for private actions against the physician.
b) You are the hospital risk manager. How many different ways did they screw-up this case under EMTALA and what are the potential federal penalties? (list)
Talked about money before completing the screening exam
Did not conduct a proper screening exam for discriminatory reasons (not just malpractice)
Did not stabilize the patient before transferring
Transferred for discriminatory reasons (financial)
Did not call county and get permission to transfer
Did not send records with the patient
Falsified the certification
Used improper and unsafe transport
Falsified records to cover up the dump
Penalties - hospital
up to $25,000 fine for a small hospital
up to $50,000 fine for a large hospitals
exclusion from federal benefits
up to $50,000 fine
exclusion from federal benefits
5) Patient has AIDS, but does not want to tell anyone. He is going on a trip to China and wants his travel shots. He makes an appointment with a physician who he has never seen and explains that he needs his travel shots. The physician has him fill out a medical history form and the patient does not indicate that he has any ailments. The physician thinks the patient does not look healthy, but when questioned about how he is feeling, the patient is clear that he just wants his travel shots and nothing else. The physician gives him, among other things, oral polio vaccine. The physician gives the patient the provided patient warning and information sheet which warns against taking the vaccine if you have AIDS and the patient signs the required form, clearly without reading it. The physician himself has not read about polio vaccines since he left medical school, well before the AIDS epidemic, so he does not mention AIDS to the patient. The patient gets polio.
What is the patient's prima facie case of negligence against the physician and what are the physician's defenses? (do not blame the drug company as a defense)
The physician breached the appropriate standard of care by:
Failing to inquire specifically about the nature of the patient's illness
Failing to assure that the patient was aware of the risks of the drug to someone with immunosuppressive illness
Failure to be properly informed about the risks of the drugs that he prescribes and administers
Failure to order medical tests to determine the patient's immunological status or whether he had HIV
Failure to use a less dangerous vaccine when he was unable to assure that the patient did not have immunosuppressive disease
Failure to refuse to administer the vaccine when he was unsure of the patient's condition
Failure of informed consent
The physician breached the appropriate standard of care by failing to inform the patient of the risks of the proposed treatment in a way that effectively conveyed their significance to the patient's own condition
Failure to warn specifically about the risks to persons with HIV
Failure to warn specifically about what it means to contract polio
Provided the patient appropriate information and the patient
assumed the risk of the treatment when he signed the consent form
Patient assumed the risk of the treatment by providing the physician incorrect information on which the physician relied to select the medication
Patient was at fault because he provided false information
Causation failed because the patient lied about his condition and would have lied had the physician asked more specific questions
As a person with AIDS, the patient was on notice of the risks posed by many medications and should have know the potential consequences of lying about his condition
The physician has no duty to determine if the patient is lying
The physician has a duty to respect the patient's choice to not disclose his illness, which in turn means that that patient must assume the risk of failure to disclose the illness.
6) Same facts as 5. Patient also sues the drug manufacturer for products liability, claiming that the drug company knew that the oral vaccine could cause polio in AIDS patients, and that it was well known that AIDS patients often lied to their physicians about their disease. The plaintiff claims that since there is an alternative injectable vaccine that does not use live virus, and thus cannot cause polio, that the drug company should take the oral vaccine off the market. The oral vaccine is still FDA approved and is useful in some limited situations, and this drug company does not make an injectable version with dead vaccine so it would lose all market share if it discontinues the oral vaccine.
What are the drug company's defenses? (Hint, remember to include the relevant Wade factors from Feldman v. Lederle Laboratories.)
1) The core defense is assumption of risk - the plaintiff was provided with adequate information about the risks and signed a waiver (consent form), which is an effective assumption of risk. The patient's further assumed the risk by withholding critical information from his physician, information which would allowed the physician to act as an effective learned intermediary. (comparative fault)
2) The second line defense is the learned intermediary - the physician should have either refused to vaccinate the patient or should have known to use the killed vaccine if he was unsure of the patient's medical status. The company provided adequate information about the risks and benefits of the vaccine. The general risk of using live vaccines on patients with AIDS is well known in the medical community and should be understood by all physicians who provide immunizations.
3) As part of the learned intermediary defense, it is well known that patients are likely to hide their HIV status because of fears of discrimination, thus the physician should have performed an HIV test on the subject before using a live vaccine.
4) Defenses to the removal of the vaccine, based on the Wade factors:
(1) The usefulness and desirability of the product -- its utility to the user and to the public as a whole - The oral vaccine has recognized uses and benefits the public and the user by eliminating the use of needles, which themselves can spread HIV, it also allows mass immunizations to be done quickly and cheaply.
(2) The safety aspects of the product -- the likelihood that it will cause injury, and the probable seriousness of the injury - properly used, the vaccine has a very low risk of causing polio.
(3) The availability of a substitute product which would meet the same need and not be as unsafe - while there is a substitute product, it has its own risks and cannot as effectively be used for quick mass immunizations or in persons with phobias of needles.
(4) The manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility - the product is as safe as it can be made without fundamentally changing its nature, i.e., by killing the virus.
(5) The user's ability to avoid danger by the exercise of care in the use of the product - any user who uses reasonable care by reading the provided literature or by being truthful with their physician can avoid the risk of the product.
(6) The user's anticipated awareness of the dangers inherent in the product and their avoidability, because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions - persons with HIV know generally that they are at significant risk of infection from viruses and bacteria that do not pose a risk to others. The warning information clearly points out that this is a live virus and thus they should appreciate the consequences of taking it. In this case, the physician should also protect the user by not recommending the live virus unless HIV has been ruled out.
(7) The feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance - vaccines lose their usefulness in public health settings if they are too expensive. (There is a comp fund for vaccines that you did not need to talk about, but taxes the cost back to the manufacturer so it also raises the price.)
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