Fall 1998
Products Liability Final Exam
Instructor: Michael J. Fitzsimmons. Esq.
1. This is a closed book exam.
2. Total Exam Time: 3 hours
3. This exam consists of three (3) essay questions on 8 pages.
4. I recommend that you spend 1 hour on each essay, however, you are free to allocate your time as you wish.
5. Each question is equal in value. The total value of each essay will be 100 points.
6. Answer each question in the blue books provided. Please write on every other line and only on one side
of the page. Only writings in the blue books will be considered as part of your exam answer.
7. Please be sure to write your exam number on your blue books and on the exam question.
8. Please turn in all questions, scratch pads and blue books after the conclusion of the exam.
9. Please feel free to draw reasonable inferences from the facts provided.
Skip Wrong was a 58-year-old man who for several months had been experiencing episodic burning and abdominal discomfort. Under the terms of his HMO plan, he was directed by his primary care physician to a gastroenterologist and ultimately to a general surgeon, Dr. William Stang. Dr. Stang, after examining the patient and reviewing the available imaging and lab studies, concluded that the patient had gallbladder disease.
After a complete discussion of the options and risks with his physician, Mr. Wrong agreed to undergo an elective laparoscopic procedure to remove his gallbladder. Dr. Stang explained to Mr. Wrong that he might be required to convert the laparoscopic procedure to an open or traditional gallbladder procedure, in the event bleeding occurred. During an open or traditional gallbladder procedure, the abdomen is opened to provide access to the gallbladder. The procedure typically involves a week long hospital stay and 4-6 weeks of painful recuperation. Patients who undergo a laparoscopic procedure, can usually return home within 1-2 days of surgery and can resume normal activities within a week.
Mr. Wrong was admitted to the Community Hospital on October 11,1997 for the surgery. According to Dr. Stang's operative report, he utilized a RAC trocar. RAC is a recognized leader in the field of laparoscopic instrumentation, including trocars. The RAC Trocar has been patented and was and continues to be a product that doctors use. RAC's brochure promoting its product maintains that, because it is a disposable trocar rather than reusable trocar, it lends itself to better sterility, reliable sharpness, ease and greater control of insertion.
In a laparoscopic procedure, the surgeon makes a small incision and insufflates the abdomen with C02 gas, to create a free space away from vital organs. Once the insufflation has been adequately accomplished, the surgeon will make a small incision in the skin utilizing the trocar at a 45-degree angle. The insufflation is necessary and the angle is necessary so that the physician, in puncturing the skin layers, is able to enter the peritoneum cavity and stay clear of internal organs, arteries, mesentery and the small bowel.
A trocar consists of a sharp blade inside a tube which cuts through several layers of skin and muscle into the abdominal cavity. The tubular section of the trocar provides a pathway for viewing the abdomen and for inserting other surgical devises to enable the physician to perform various surgical procedures in a minimally invasive manner.
RAC's trocar is disposable and utilizes a safety shield. This safety shield is disengaged by the surgeon to permit the blade to make the initial incision. The safety shield will then snap back over the blade and lock into place to protect the patient from the sharp blades once the trocar reaches the "free" or open space in the abdomen. The safety shield is made of hard plastic and can be controlled by the surgeon, i.e. the shield can be disengaged by the surgeon by squeezing the device. A clicking sound and a warning window provide the surgeon with information regarding the status of the safety shield.
In this instance, Dr. Stang noted in his operative report, that when he inserted the initial trocar, he did not feel the usual resistance that he expected and that the trocar entered the abdominal cavity "too easily" and it did not "feel right." He immediately withdrew the trocar and noted that muscle tissue had apparently jammed the safety shield so that it not snap back. He then inserted a camera through the trocar port and noted blood in the abdomen and became concerned that an internal injury had been sustained. Due to the bleeding, Dr. Stang promptly converted the procedure to an open traditional one to ascertain the situation. He found a laceration to Mr. Wrong's mesentery and two holes in the small bowel and approximately two liters of blood. He utilized Medtron dissolvable sutures to control the bleeding and close the small bowel tears. Medtron sutures are standard hospital issued sutures utilized in hospitals throughout the country. Medtron sutures are expected to maintain their integrity for approximately 2 months or more, but if frayed or nicked, can dissolve sooner. After controlling the bleeding and making the appropriate sutures, Dr. Stang removed the patient's gallbladder.
Within days Mr. Stang developed signs of sepsis (blood infection.) His abdomen was reopened and it was found that the sutures had not held. The patient's peritoneum was filled with blood and seepage from the small bowel. As a consequence, the patient died of sepsis on October 16, 1997.
Three weeks ago, the plaintiffs filed and immediately served Dr. Stang, Medtron and your client RAC. The plaintiffs in this matter are the wife and two young children of the decedent. The plaintiffs allege that the doctor was negligent in performing the surgery on Mr. Wrong. They allege negligence, negligent and strict liability in the design and manufacturing of the trocar and failure to warn theories against RAC. The plaintiffs also assert a claim of negligence in the design and or manufacturing of the Medtron sutures.
The senior partner has advised you that he is filing an Answer to the Complaint on behalf of RAC. He has asked for your evaluation of the merits and problems and defenses of the plaintiffs' theories against the various parties. In preparation for your memo/evaluation, you have talked to the attorneys for Dr. Stang and Medtron, RAC's in-house experts, as well as the pathologist/coroner.
You have learned that Dr. Stang is going to testify that he was aware of the risks of the procedure and that he had read the information booklet which RAC provides with each trocar. He explained these risks to the patient and advised the patient that there was a remote chance of death. The patient signed a hospital consent form. He maintains that the RAC trocar usually works great and without problems. In this case, the safety shield appeared to get some tissue or other material jammed in it and did not "spring back."
RAC's in-house experts are prepared to assert that the RAC trocar is a major advance over reusable stainless steel and non-retracting tip trocars which are the type that doctors have used for decades. The information booklet provided by RAC accompanies the trocar and emphasizes that a bleed injury can occur, 1) if the surgeon fails to establish and maintain the proper amount of insufflation, 2) if there are adhesions or anatomical anomalies or other obstructions within the abdomen or 3) if the physician exerts excessive force or utilizes the wrong angle of insert. The booklet emphasizes that the surgeon's objective should be to maximize the distance between the abdominal wall and the internal vital organs and that the primary way is through insufflation and the angle of insertion.
In a conversation with Medtron's attorney, she advised you that her client is not aware of any other incident of prematurely dissolving sutures. They have not had any reports of problems with this particular suture lot number. (A lot number is a designation of date/time of manufacture.)
On autopsy, the pathologists believe that the sutures had prematurely lost their integrity and would normally be expected to remain viable for approximately 30-days. The pathologist was unable to ascertain whether the sutures failed because they were nicked or whether some other factor caused them to dissolve early.
Please prepare your memorandum and address the following:
I. Merits/Problems/Defenses for:
A. Dr. Stang (15 points)
B. Medtron (30 points)
C. RAC (55 points)
ESSAY NO. 2
Joel is employed by Sansome Printers. He is the utility/maintenance man and his job is to insure that the high-speed circular plate cylinders operate properly and efficiently. The circular plate cylinders were manufactured by Regina Corporation and sold to Sansome Printers in 1980. The cylinders spin at very high speeds during the printing process. The practice of the utility men is to manually apply a piece of plastic to the printing plate while it is spinning to remove imperfections or blemishes that appear on the plate and would result in imperfection on the printed result.
One afternoon, Joel noted an imperfection occurring on the print pages. He attempted to remove the blemishes in the standard manner by applying plastic to the cylinder while the plate was spinning at its operational speed. His hand slipped on to the plate and was momentarily caught. He suffered significant finger and hand injuries.
You have been approached by Joel to pursue a lawsuit. He is particularly angry at Regina Corporation. He had suggested to them in memorandums, on two or three different occasions prior to his injuries, that the industry custom of removing blemishes from the disk should be reevaluated. There had been recent innovations and Regina Corporation now sells brushes which are not as effective, but are safer. His company Sansome Printers, however, elected not to follow his suggestions. Instead, Sansome Printers in 1993, attached a yellow decal to the machine which stated that removing blemishes from the disk should be done by stopping the cylinder and cranking the cylinder manually at slow speeds. The decal had been mailed (by Regina Corporation) to all purchasers of its products in 1990. Despite the decal, Sansome management has emphasized that the cylinder plate should not be stopped except in emergencies and have tacitly endorsed the current practice of removing blemishes.
You have spoken with an expert who is prepared to testify that the safety guard was technologically feasible and utilized in similar machines without any obvious difficulty. On inspection of the machine, a yellow decal had been applied to the machine after time of sale.
I. (35 points)
Please advise Joel of the possible theories that can be brought and why his lawsuit will
likely succeed or fail against:
ESSAY NO. 3
The plaintiff, Tim Rylaarsdam, filed a Complaint for personal injury in Los Angeles
County Superior Court. He contended that for the last 25-years, he has been a vinyl floor
installer by trade. He has been employed with several different companies. Three years ago, he was
diagnosed with pericardial mesothelioma (cancer around the heart.) The plaintiff contends that long term
exposure to asbestos fibers contained in the floor and floor tile products, manufactured by numerous tile
floor manufacturers over the past several years caused this malignant disease.
During discovery, Mr. Rylaarsdam testified that he was regularly exposed to asbestos dust from the sanding of floor tile product. Mr. Rylaarsdam also smoked 2 pack of cigarettes a day during the same time period.
Mr. Rylaarsdam's treating oncologist (cancer doctor) was disclosed by the plaintiff as an expert. In his deposition as both the treating physician and as a disclosed expert, the doctor indicated that he is not aware of any other reports of patients developing this rather unusual type cancer nor is he aware of any studies or reports tying this cancer to floor covering. Nevertheless, the doctor stated that he thinks that plaintiff's exposure to this product "probably contributed" to his cancer.
The plaintiff's theories, as they begin the trial, are 1) that the floor tile was defective when sanded because it failed the consumer expectation test and 2) failure to warn concerning the hazardous properties of the dust generated during the sanding process.
Plaintiff had named three manufacturers of asbestos tile. These three manufacturers are TMG, Fisher and CPS . These manufacturers have accounted for 51% of the market in California during the past 3 years.
None of the tile manufacturer makes asbestos tile at this time.All three of the defendants deny liability and argue that the asbestos fibers were "encapsulated" in the vinyl matrix and therefore were not respirable and not the cause of the cancer. Defendants are able to establish that the incidence of this particular type of cancer is rather rare and that this particular type of cancer is not typically caused by asbestos exposure. Defendants will be calling a cell biologist as an expert on this issue.
Please discuss the following issues based upon the facts presented and any reasonable assumptions that are necessary: