Authors: Avelino Inguane, John Christopher Briones, Laura Braun, Ross Wainwright, Jonathan Ericson, Brian Rodewald
Instructor: Tamara Maddox
Dr. Gregory House is a doctor and teacher practicing in Fairfax County, Virginia. He teaches a course on medicine,
and as part of his teaching, he incorporates technology into his class. This fall, he is required to teach with a
new device, AnatomyVR9000, made by the company MedTechVA. This device is a virtual reality simulator sold to doctors
that purports to show an accurate model of a lung.
The device also lets a student perform simulated experiments on that organ before they do it in actual operations.
MedTechVA claims that the instrument is accurate, and the skills learned through it translate accurately to real medicine.
Dr. Gregory House is a doctor and teacher practicing in Fairfax County, Virginia. He teaches a course on medicine,
and as part of his teaching, he incorporates technology into his class. This fall, he is required to teach with a
new device, AnatomyVR9000, made by the company MedTechVA. This device is a virtual reality simulator sold to doctors
that purports to show an accurate model of a lung.
The device also lets a student perform simulated experiments on that organ before they do it in actual operations.
MedTechVA claims that the instrument is accurate, and the skills learned through it translate accurately to real
medicine.In fact, such skills were put to the test when Brian Miller, a student of Dr. House, performed his first
lung surgery on Mrs. Zita Johnson .
However, Dr. House and a student of his discovered that the device simulates procedures that Brian Miller used during Mrs.
Johnson lung surgery but were not approved by the FDA. He reported this fact to the FDA and the medical board.
The medical board notified MedTechVA that the device would need to be approved by the FDA before selling it.
MedTechVA responded by stating that it is for demonstration use only and that it was designed for students for practice.
According to the PR manager of PZ Medical Center, James Proctor , it has been used by PZ Medical Center for many years,
and they have never had any issues with it. Also, a highly decorated doctor of MedEquipThec, Dr. Anna Stesia makes
the claim that they extensively tested AnatomyVR9000 before its release. Therefore, MedTechVA believes its actions
were within the law.
At the same time that Dr. House learned that Mrs. Johnson's lung problems were worsening, he also read a study in
a peer-reviewed journal that a particular procedure similar to the one used by Brian as depicted by AnatomyVR9000
is likely to fatally damage a patient's lung if done as instructed by the device. Due to a high risk of injury to
the patients, Dr. House alleges that MedTechVA selling the AnatomyVR9000 in this way is harmful and illegal.
Dr. House files a lawsuit against MedTechVA for false advertising and the sale of a device without FDA's approval.
He goes on to tell medical students that this device is unhelpful and that medical schools must stop using it.
Supporting Cases:
ORTHOPEDIC EQUIPMENT CO., Incorporated, Appellant, v. Dennis EUTSLER, Appellee
No. 8002 UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT (LexisNexis)
The legal element affected by this case is the Manufacturer's liability for selling a defective product.
In the case above, like the virtual simulation that can, in turn, be performed in real people, the dispute is
whether the company that sold wrong labeled nails used during leg surgery should be held liable.
The case has been distinguished three times, positively followed two times by the district and circuit courts.
The manufacturer of the device can be held liable for the subsequent injury caused by its use.
DANIEL THRELKELD, Appellant, v. DIRECTOR OF REVENUE, Respondent. WD 55425 COURT OF APPEALS OF MISSOURI,
WESTERN DISTRICT (LexisNexis)
The legal element of whether medical level testing of equipment is affected by this case. The case says that
simulators must be tested thoroughly and to be certified, they must pass certain tests. This affects the overall
trial, as the plaintiff can make the case that since the equipment is marketed as an official device simulator,
it is subject to these rigid testing requirements, and errors such as the ones that are present should not have
slipped through. The shepardization of the case also indicates that it is in good standing.
Opposing Cases:
JANET DIANE TALLEY, Plaintiff-Appellant, v. DANEK MEDICAL, INCORPORATED, Defendant-Appellee.
No. 98-1884 UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT (LexisNexis)
The legal element affected by this case is the fraud for marketing the medical device without statutory approval
in the case above the court requires the plaintiff to show that injury to the plaintiff proximately was caused by
the breach of fraud for marketing the medical device. In other words, the plaintiff must show that the absence of
an license did prohibit the user of sound judgement in administering medical duties.
RICKY DAN HASHOP, CATHY HINES-TORREGANO, UBALDO GARCIA, and JAMES SPENCER, JR. v. ROCKWELL SPACE OPERATIONS COMPANY
CIVIL ACTION NO. G-94-111 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS, GALVESTON DIVISION (LexisNexis)
The legal element of whether medical level testing of equipment is affected by this case. The case says that simulation
is not adequate in terms of training, as people being trained still need real world experience. In our scenario,
one could make the case that this simulation needs to be accompanied by sufficient supervise real-world training.
This benefits the defendant, as they can claim that this simulator must be used in addition to other teaching tools,
and in that training they should relearn the material that has errors, and therefore not make mistakes. This means
that it is exempt from medical testing rigor that is usually required. The Shepardized report says "caution" with
one case of negative treatment, but it still is in good standing.
To win the case the plaintiff must show both:
1. The existence of an implied warranty. An implied warranty exists if the seller knows the particular purpose of the
buyer, and the buyer is relying on the seller's skill to furnish suitable goods.
(Code of Virginia, § 8.2-315)
2. The defendant did not provide an appropriate warranty exclusion. A warranty exclusion must be written AND
conspicuous.
(Code of Virginia, § 8.2-316)
OR
3. The defendant's actions were negligent.
(Code of Virginia, § 8.2-318)
Code of Virginia, § 8.2-315. Implied warranty: Fitness for particular purpose.
§ Where the seller at the time of contracting has reason to know any particular purpose for which the goods are
required and that the buyer is relying on the seller's skill or judgment to select or furnish suitable goods, there is
unless excluded or modified under the next section [§ 8.2-316] an implied warranty that the goods shall be fit for
such purpose.§
Code of Virginia, § 8.2-316. Exclusion or modification of warranties.
...
(2) Subject to subsection (3), to exclude or modify the implied warranty of merchantability or any part of it the
language must mention merchantability and in case of a writing must be conspicuous, and to exclude or modify any
implied warranty of fitness the exclusion must be by a writing and conspicuous. Language to exclude all implied
warranties of fitness is sufficient if it states, for example, that "There are no warranties which extend beyond the
description on the face hereof."
...
Additional Legal Background:
Under The Virginia Title 8.2 - COMMERCIAL CODE the defendant meets the definition of a seller (§ 8.2-707) and merchant (
§ 8.2-104). Furthermore, the defendant may not dismiss this claim even though no contract exists (§ 8.2-318).
§ 8.2-707. "Person in the position of a seller". (1) A "person in the position of a seller" includes as against a
principal an agent who has paid or become responsible for the price of goods on behalf of his principal or anyone who
otherwise holds a security interest or other right in goods similar to that of a seller.
§ 8.2-104. Definitions: "Merchant"; "financing agency"; "between merchants.". (1) "Merchant" means a person who deals
in goods of the kind or otherwise by his occupation holds himself out as having knowledge or skill peculiar to the
practices or goods involved in the transaction or to whom such knowledge or skill may be attributed by his employment
of an agent or broker or other intermediary who by his occupation holds himself out as having such knowledge or skill.
§ 8.2-318. When lack of privity no defense in action against manufacturer or seller of goods. Lack of privity between
plaintiff and defendant shall be no defense in any action brought against the manufacturer or seller of goods to
recover damages for breach of warranty, express or implied, or for negligence, although the plaintiff did not
purchase the goods from the defendant, if the plaintiff was a person whom the manufacturer or seller might reasonably
have expected to use, consume, or be affected by the goods; however, this section shall not be construed to affect
any litigation pending on June 29, 1962. (Privity, in this case, means that the plaintiff and defendant have a mutual
interest in the product. In effect, this means that a contract cannot bind anyone except the parties that have direct
stake in it. From http://legal-dictionary.thefreedictionary.com/privity and http://en.wikipedia.org/wiki/
Privity_of_contract)
You have been given a list of cases specific to your trial to help you complete Trial Prep assignments, all of which
are accessible directly via Lexis Nexis:
Click to Go to Lexis Nexis
From this bank of cases, at least 3 of the cases are guaranteed to be useful to your side of the trial regardless of
if you are representing the plaintiff or the defendant. Realize that both sides of the trial are sharing the same
bank of cases, so be sure to choose the trials most helpful to your argument when selecting cases. Also, ensure
you use skills learned in your legal research assignment to ensure your cases are both properly shepardized and have
binding precedent in Virginia. THE CASES YOU SELECT ARE NOT BINDING PRECEDENT UNLESS THEY ARE FROM A VIRGINIA
APPELLATE COURT OR A FEDERAL COURT THAT HAS JURISDICTION OVER VIRGINIA.
Plaintiff Client Witness: Mrs. Zita Johnson, Patient
Plaintiff Friendly Witness: Brian Miller, Medical Student
Defendant Client Witness: James Proctor, PR manager of PZ Medical Center
Defendant Friendly Witness: Dr. Anna Stesia, Dr. of MedEquipThec
After undergoing an operation on her lungs that followed a simulation from the AnatomyVR9000,
she noticed that her condition worsened, with symptoms including long coughing fits and chest pains.
Once Miller shared with her that her operation may have been potentially harmful because of the VR9000,
she immediately concluded that that must have been the cause of her worsening condition. One fact that
she keeps to herself (though is not a secret) is that she does not live a very healthy lifestyle.
She rarely exercises and has smoked in the past (though has since quit), despite this,
she blames MedTechVA completely for her situation. Mrs. Johnson describes the injury caused
by procedures MedTechVA's software required the doctor to use, and the further medical expenses
that she had to settle with her insurance company for following the injury, which took many long weeks.
Because of her medical and financial injuries, she believes that MedTechVA must lose this case.
Information the witness is reluctant to disclose: Secretive blah blah...
After some research, Brian Miller discovered that a procedure similar to the one perform on Mrs.
Johnson could potentially cause permanent damage to the patient's lungs. He is aware that there
are some minor differences between the researched operation and the actual operation simulated by
the machine, but Mrs. Johnson's worsening condition suggests to him that they may have resulted
in similar side-effects or may even be worse.
He is able to demonstrate that the software on the device at the time violates FDA guidelines.
For example, one of the parts of the lung is much smaller than it is supposed to be. Also, he
demonstrates an error in an algorithm that the software is supposed to use. He discusses that
competing companies have resolved similar errors that he and other doctors encountered, and how
that has saved patients whose doctors used competitors' equipment. That MedTechVA did not follow
the competition's procedures, which led to injury to Mrs. Johnson, is a very important factor
in Miller's strong belief that his side will win.
Information the witness is reluctant to disclose: Secretive blah blah...
Claims that, despite not being approved by the FDA, his doctors have not reported issues with the device in the past.
Proctor also has experience with how the software simulates the lung. For example, Proctor sees that most doctors have
successfully followed the software's simulations on the lung on real patients, long before the device has been announced.
Because of the well-known use of that procedure, Proctor speculates that the erratic behavior of the software is
a bug that the company had been in the process of fixing, has been fixed mostly by the time the surgery was planned,
and has been fixed completely between the time of the surgery and the suit being filed.
He demonstrates a use case showing the known bug. Moreover, Proctor believes the doctor should have reported the bug to
the company, and demonstrates the procedure a similar bug that has been reported goes through to be addressed.
Because Proctor believes that the device manufacturer followed the proper steps in addressing the bug, MedTechVA is innocent.
Information the witness is reluctant to disclose: Secretive blah blah...
Claims that the AnatomyVR9000 was thoroughly tested before being released to the public.
She was aware that the device had yet to be approved by the FDA, but felt that the potential
risks with a product such as this were too insignificant to be a problem. As of before the trial,
she demonstrates that the device, indeed, is on the way to FDA approval. Even though the machine
was peer-reviewed extensively by professionals, meeting all of the FDA's standards was not by then a priority.
Also, Stesia claims that the plaintiff actually used a version of the software with a bug known for a very long time.
The software installed on the device that was used with plaintiff witness Johnson's surgery was out of date
by several months before. A patch released by the company before the surgery could have seriously lessened the
chance the lung problem might occur. Had the doctor upgraded the software on the device before, the lung problem
might not have occurred. All of this should demonstrate that a version of the software that has the correct
procedure for the lung had been available to doctors by the time the surgery was performed. Therefore, MedTechVA is innocent.
Information the witness is reluctant to disclose: Secretive blah blah...