Final Exam - Fall 2013 Torts Prof. George Conk Fordham Law School

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The key takeaways are that this case involves product liability claims regarding surgical mesh used to treat stress urinary incontinence and pelvic organ prolapse. Discovery has concluded and Bard now needs to determine what pre-trial motions to file. Massachusetts, New Jersey, and New York law could potentially apply to different cases.

One issue presented is that the bulk supplier of the polypropylene mesh material included a warning on its safety data sheet stating the material should not be used for permanent implantation in the human body. However, Bard considered this an excess of caution and that the material was sufficiently inert for its intended use in the surgical mesh.

In her deposition, Ms. Rizzo testified that she did not discuss complication rates or risks of the mesh with her doctor prior to surgery. She also stated that she would have consented to the surgery anyway due to trusting her doctor and wanting to improve her quality of life.

Fordham University School of Law Final Examination in Torts (Section 9) Date: Thursday, December 12, 2013 Time 5:30

PM This is a 3 Hour Examination This Exam is 13 pages long including 4 pages of instructions. Prof. George W. Conk ______________________________________________________ Instructions: You have three hours to complete this exam. You must answer all three questions. I will grade each question but the final grade is an overall assessment of your exam paper, as compared to others in the class. I suggest that you first read through the complete exam. (Take a deep breath to shake off the sticker shock, then get back to work.) While you are answering one question thoughts on the others will simmer on the back burner. Before you start writing I suggest you make an outline - or sketch out the issues you want to touch. These are essay questions. Therefore good sentence structure, sensible paragraphs, and readability are important. Each question gives you an opportunity to discuss and apply key concepts in the law of torts and to analyze facts and apply the law to them. You should acknowledge ambiguities in the facts and divergences and uncertainties in the way the law approaches problems. You should try to identify what you think is the best approach to the problem presented. Structure is important. In analyzing a problem you will want to identify: 1) the potential parties 2) the nature of any cause of action or theory of liability that can reasonably be asserted Page 1 of 13 Examination # ____________ Room 205

3) the elements that must be established 4) the available defenses BE SURE TO ANSWER EACH ELEMENT OF THE QUESTION ASKED. The product liability case invites discussion of Massachusetts and New Jersey law, but at least glancing attention should be paid to the New York approach. Except for the product liability question I did not draft them with the jurisdictions law in mind - and no jurisdiction is specified or suggested. You can use any available authority to support the result you think that law and justice demand. Concrete reference to the cases, Restatements, statutes, and other authorities is valuable to clarity of thought and explanation. But a reference to a rule number or a case by itself is not explanatory. The key is to state the principle and explain the logic of the position you urge. The number of the rule or name of the case just shows where you found the idea, or how you know it expresses the law. The essay should be understandable even without the numbers or case names. Limited Open Book The exam is limited open book. You should bring the Franklin, Rabin, Green casebook and the text of any principal case I have assigned on the syllabus page if it is not in the casebook. You may also bring the slides I have posted. If you choose to do that I would print them in outline format. It will enable a quick search for authorities. The casebooks notes following the assigned cases may be of important assistance in preparing for the exam and in forming and structuring your essays. You may bring your own notes or outlines. You may not bring any commercial outlines or other texts or treatises. You may use Exam 4 or may handwrite your answers. If your exam is handwritten it MUST be double-spaced. If it is typed I prefer 1.5 line spacing if that option is available.

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Use of Authorities Do Not cite any authorities other than what has been assigned, recommended, cited in class, or posted on TWEN or the Torts Today blog. Brief identifying citations are all that is needed, e.g. Rest. 2d 402A, Greenman v. Yuba Power, Palsgraf, etc. are acceptable forms of citation. But the Rule number and the case name are not a substitute for stating the proposition you are asserting. E.G. `There is a product liability claim under 402A. is opaque. But 402A has been interpreted to encompass manufacturing, design, and inadequate instruction or warning claims. Only a design defect claim appears here. is instructive and is helpful to the reader. Rhetoric - the Art of Persuasion Your object is to reason to a conclusion. State your opinions and defend them. A well organized argument, buttressed by reference to authority, which discusses the issues in an informed, critical way, is your goal. Be careful to draw only reasonable inferences from the facts presented. If answering a question requires assuming or even adding facts to those provided, be sure to state your additional assumptions. I am looking for an essay characterized by persuasive legal argument (with appropriate authorities noted), for accurate statement of the facts, avoidance of rhetorical hyperbole, and for succinct explanations and use of the logic of the law. Please place yourself in the position contemplated by the question and address the intended recipient (e.g. judge, senior partner, insurance claims manager). Think of the reader. That is who you seek to persuade. Sentences must end - preferably sooner rather than later. Paragraphs should be short. Dense blocks of type are unwelcome. Verbs should have objects - mostly.

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Good luck. Ive enjoyed the semester. I hope to see each of you in my classroom again before you graduate from Fordham. - GWC

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Q. 1 JOSEPH SMITH Joseph Smith, a mechanic, is employed by Coughlin & Sons., Inc., which is under contract to provide mechanical maintenance services to Metro Waste Paper Recovery U.S., Inc. (Metro Waste), at a recycling center owned by the County of Clare. Smith has for several years been working as a maintenance mechanic at Metro Waste. Metro operates the facility under contract with Clare County. On August 11, 2012, Smith was walking through the recycling center when a bale of paper weighing nearly one ton fell from a stack of other bales and landed on him. He suffered very serious injuries. Shortly thereafter Metro filed a bankruptcy petition and its contract with the County was terminated because insolvency breached a term of their lease with County Clare. A freedom of information act request has revealed that the County required only $2,000,000 aggregate liability insurance. There are several pending claims that could exhaust that policy of insurance. Coverage therefore may be insufficient to fully compensate Smith if he can prove liability.

Your research reveals that an OSHA federal regulation provides: Storage of material shall not create a hazard. Bags, containers, bundles, etc., stored in tiers shall be stacked, blocked, interlocked and limited in height so that they are stable and secure against sliding or collapse. You have reviewed the contract between the County and Metro Waste which the parties entered in 2002. The agreement says that Metro Waste shall Operate the facility in a safe and efficient manner, shall have complete charge of and responsibility for operation of the facility, its subcontractors, materialmen, materials, equipment and personnel engaged in the performance of its work [and] . . . shall perform its work in accordance with its own methods . . . subject to review by the County Engineer. The contract specified that the County has the right of access to the Facility in order to determine compliance by the Contractor with the terms and conditions of this Agreement, and . . . the right . . . to take visitors and group tours through . . . the Facility. The agreement also gave the County the right to, among other things, determine which persons were authorized to utilize the recycling center, access all books and records maintained and terminate the agreement for cause on 10 days notice. Finally, the agreement required Metro Waste to submit for the Countys approval an annual program manual describing its Plant Operating Procedures, including maintenance, staffing, health and safety.

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Assume your firm represents Smith. You must decide how to proceed. Assess the case. Assume that state law allows an action against a county as if it were a private person, and that the Superior Court has jurisdiction over all personal injury claims arising in the state. What causes of action should you assert? Against whom? How will you establish the elements of the case? What defenses will you encounter? How will you meet them - with what likely result?

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Q. 2 SHELTON V. CARDINAL HILL REHABILITATION HOSPITAL While tending to her husband during his stay in Cardinal Hill Rehabilitation Hospital, Wilma Jean Shelton became entangled in some monitoring equipment wires strung on the floor by his bed and fell, fracturing her leg. On that day Mrs. Shelton was visiting her husband, Charles, a stroke victim, at Cardinal Hill, where he had been a patient for nearly five weeks. Cardinal Hill is, as its name suggests, an inpatient hospital that provides care for physical rehabilitation needs and medically complex patients. Over the course of her husbands stay, Mrs. Shelton visited him almost daily and performed various acts associated with his care, helping him sit up, talking, encouraging him, etc. This was consistent with the hospitals whole family care and healing philosophy. Wilma has told you that during her visits she was aware of the monitoring equipment wires, cables, and cords that extended out from the right side of her husbands bed to the wall. The bed was placed such that the only path of approach was on the right side, the side where the cords were located. Wilma testified that shetried to avoid andbe careful of the cords. The Sheltons daughter Mary says that she had once complained about the hazard created by the cords: I had made mention when a nurse was in the room I was like well why do all these cords have to be on the floor, they all go to different things which I understand that but it is a rehabilitation center, there are people walking around on walkers, thats the last thing they would need to have there especially since my stepdad, hes paralyzed on the left side, its not the safest environment. Just before she fell, Mrs. Shelton applied a soothing cream to her husbands back, and then she bent over to kiss him goodbye before leaving for the night. As she turned to leave his bedside, her ankle became entangled in the cords. She fell onto her knees and hands. Mr. Shelton and their daughter witnessed the fall and called for help. Mrs. Shelton suffered a severe fracture of her left ankle. She required surgery and is expected to lose several months from her job as a home health aide. She is still walking with a cane. Her husband has returned home but she is not able to do the things for him that she otherwise would. He needs help with bathing and transferring from bed to chair, etc. She cant do those Page 7 of 13

things now. Mrs. Shelton is 59 and says Im worried sick about him, and that I wont be able to return to work. I havent given up hope but I am not up to it yet. And of course at my age, who will hire me, especially if I need to use a cane? Mr. Shelton is on Social Security Disability and receives Medicare. But his wife is still covered by her husbands unions health and welfare fund, which has paid her $25,000 hospital and surgical bills, except for about $3,000 in deductibles and co-pays so far. Assume your firm has been consulted by the Shelton family. Prepare a memo for your boss assessing the possible claims. Should we take the case? What causes of action should be asserted? What duty if any does the defendant owe? Was the duty breached? What expert witnesses should be retained? To prove what facts? What defenses will plaintiffs face? How will they affect the outcome of the case? If the case is allowed to proceed beyond a motion for summary judgment what items of damages can plaintiffs recover? How can they prove them?

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Q. 3 Rizzo, et al. v. C.R. Bard Linda Rizzo, of Marblehead, Massachusetts developed post-partum pelvic organ prolapse. It comes from strain during childbirth. Normally your pelvic organs are kept in place by the muscles and tissues in your lower belly. During pregnancy and childbirth these muscles and tissues can be strained and weakened. If the muscles don't recover, they can't support your pelvic organs. Symptoms include: Pressure on the vaginal wall, feeling a pull or stretch in the groin area or pain in the lower back. Releasing urine without meaning to (incontinence), or needing to urinate a lot. Having pain in the vagina during sex. Having problems with the bowels, such as constipation. Rizzo had all of those symptoms and decided to have corrective surgery. Her surgeon used Bard Avaulta surgical mesh which is intended to support and protect the vaginal wall and prevent the prolapsed, weakened bladder from pressing on it. Unfortunately the surgery created problems. Rizzo suffered a foreign body tissue reaction which clogged up the gaps in the mesh causing recurrent painful abdominal infections which were recalcitrant to antibiotic treatment. She finally opted for surgical removal. That too was problematic. The shape of the mesh included four tabs which became so strongly adherent to her bladder and uterus that the surgeon doing the explantation did not remove those parts for fear of damaging the organs to which they were bonded. The rest was removed, which brought a return of discomfort but was largely successful in reducing the recurrent infections. Her physician feels that some of the persistence of the abdominal infections is due to the remaining wings or tabs. He recommends against removal. In the course of the litigation plaintiffs lawyers have learned of one Dr. Kloster, a prominent Austrian physician, researcher, and designer of surgical mesh. He has written widely about these problems. Like others he argues that larger mesh size is key to avoiding post-implantation infections. He wrote in 2005 that the largest pores Page 9 of 13

in a mesh (mm)

need to be at least 3 millimeters implantation, and the

before

i m p l a n t e d mesh needs to maintain a pore size of at least 1 mm because the mechanical load placed on the mesh by movement and the abdominal organs reduces the pore size. It is Dr. Klosters opinion that the pore size and especially the effective pore size after implantation and mechanical load are placed, are the most important features of a biocompatible mesh . Plaintiffs have discovered that in 2008 one Scott, a researcher at Bard, wrote to his superiors: Mesh implants for hernia or vaginal repair achieve satisfactory results. However they are associated with reoccurrence and adverse events. Mesh products designed to date are over engineered with regard to strength. Small pore size results in formation of a scar plate that is rigid and does not integrate well over time with the host tissue. Mesh construction requires optimization so that integration within the host tissue results in a more natural repair where pores do not clog, causing the post-op scar plate to be more elastic to meet biologic requirements.

Statement of Need The materials used to achieve repair have evolved and can be tailored to achieve optimal host integration . Design of a more light weight open pore mesh s needed . Bards bio-engineering chief Bolton rejected Scotts report, saying that strength must be measured against other factors, that no product is perfect, but it is strength that is the most important factor here. Bolton also wrote that that effective pore size is a new theory and is not generally accepted in the scientific community. The company continued to manufacture the (now discontinued) product until some time after Rizzos surgery. Page 10 of 13

Another issue presented is that Phillips Sumika, the bulk supplier of polypropylene the material from which the mesh is made - had long included this statement on its Material Safety Data Sheet: MEDICAL APPLICATION CAUTION: Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues. Bard, like its competitors, considered this to be an excess of caution by Phillips, which is not a medical products company. Bard considers that the substance is sufficiently inert to produce tolerable levels of foreign body tissue reactions. It is both flexible and strong. At deposition Ms. Rizzo testified at some length: Q. So at that point when you go back and youve decided youre going to do the initial surgery, did you at that point talk about complication rates or risks of the use of the mesh or anything like that? A. No. Q. Did you have any sort of questions at that point about any sort of symptoms that can result from mesh surgery, like narrowing of the vagina or pain with intercourse or any of those sorts of things?

A. No, I did not.

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Q. Is it your testimony that you dont believe you were ever told those things prior to the surgery? A. I do not remember. Q. Okay. A. And I would have consented, Im sure, anyway. Q. Okay. Why do you say that? A. Well, a trust factor for the doctor, and I wanted - I wanted to get back to being Linda again, get rid of some of these symptoms; the quality of life, or whatever. Q. So if there had been a discussion previously about pain with intercourse as a possible risk factor, you still would have consented to the surgery? A. I may have. Q. Or about some sort of reoccurrence of your incontinence later, you still would have gone through with the surgery as a try? A. Probably Bard has also taken the deposition of Mrs. Rizzos surgeon, Dr. Kaminski: Q. If you had known of the warning not to use propylene, or of the view of certain researchers at Bard that a larger mesh size should be developed would that have changed your decision about the course of treatment? A. Well, the first thing they tell you in medical school is do no harm. Of course that doesnt mean no harm if it did a surgeon would never pick up a scalpel. It means do what you can to help your patient. Any data would be helpful, including that, yes. In general, again, every bit of information is important for me to make a decision. This would be another one that would be nice to have. Page 12 of 13

You have now concluded discovery in this case which has been selected as a bellwether one of the first to go to trial in a group of several thousand cases consolidated in the mass tort court in new Jersey. You represent Bard. What motions will you make at this time? How do you assess their strength? What is the court likely to decide? Keep in mind that though your headquarters is in New Jersey it is an open question whether New Jersey or Massachusetts product liability law applies. In addition the next trials are expected to include citizens of New York and New Jersey. In those cases the substantive law of those states is likely to apply.

p.s. surgical mesh has been around for fifty years. C.R. Bard certified the device to be substantially equivalent to existing devices. Therefore they avoided full FDA review and federal law does not preempt these actions. State tort law governs. gwc

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