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1 Medical Malpractice Law & Strategy Experimental Drugs and the Compassionate Use Doctrine Part One of a Two-Part Article By Janice G. Inman People with chronic illnesses and incurable diseases are often willing to do almost anything to improve their health. That includes seeking alternative treatments and trying unapproved drugs. While gaining access to drugs not yet approved by the Food and Drug Administration (FDA) can be a difficult task, many people will go to nearly any lengths to get them, to include suing a drug manufacturer to force it to provide them the drug. That s what happened in the case of Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL (D.N.J.,2008), a case recently overturned on appeal. In this month s issue, we look at the reasoning of the district court. In next month s issue, we ll see why the appellate court disagreed, and discuss the implications of the compassionate use doctrine for drug research and for individual patient outcomes. A Boy a n d His Fa m i l y Fight for Medication Jacob Gunvalson is a boy in his teens with the terminal disease Duchenne Muscular Dystrophy (DMD). DMD is a genetic disease that causes muscles, including the heart, to continued on page 6 By Kim M. Ruder By definition, spoliation refers to the destruction or failure to preserve evidence that is necessary to contemplated or pending litigation. Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005). Spoliation in the context of a medical malpractice case can raise many issues for lawyers representing doctors and hospitals. These issues can often be overlooked until it is too late to repair the damage done. While most attorneys have heard of the concept of spoliation and have a general or basic understanding of what it means, few appear to have had the opportunity or necessity of litigating the issue before a trial court or on appeal. Due to its less-than-pervasive appearance in litigation and more particularly in medical malpractice actions the subject needs some light thrown upon it. This article shows how medical malpractice attorneys need to think outside the box in their defense of their medical practitioner clients. A Case to Po n d e r Consider the following hypothetical: Dr. Smith is a pathologist in a communitybased hospital. As has become routine in hospital settings, Dr. Smith s professional group maintains a contract with the hospital. The physicians are considered to be independent contractors at the hospital as opposed to being hospital employees. Dr. Smith interprets a pathology sample on a patient as completely benign and signs out his report. A few years later, Dr. Smith is sued for wrongful death/medical malpractice and the plaintiff contends that Dr. Smith misread the pathology on his deceased spouse. As a result, he says, the spouse s cancer went undiagnosed and untreated. Just months before Dr. Smith was served with the lawsuit, the paraffin wax block containing the remaining portions of un-reviewed tissue was discarded by continued on page 2 In This Issue Spoliation in a Med Mal Case... 1 The Compassionate Use Doctrine... 1 Psychiatrist Liability Cases... 3 Med Mal News... 7 Drug & Device News.. 9 Verdicts Movers & Shakers Volume 26, Number 5 February 2009 Spoliation in a Medical Malpractice Case Thoughts to Ponder and Some Words to the Wise

2 Spoliation continued from page 1 employees of the hospital in accordance with a written retention policy. When suit was filed, the plaintiff requested the block from both the pathologist and the hospital (also a named defendant). Clearly neither could produce it. Is Th e r e Sp o l i a t i o n a n d Wh o Is Responsible? How does a court analyze whether spoliation occurred in the first place? As stated above, spoliation occurs when there is a destruction or failure to preserve evidence that is necessary to contemplated or pending litigation. Clearly, the concept of pending litigation is self-explanatory. However, the concept of contemplated litigation necessarily involves a case-by-case analysis of facts. For example, in the case of Wal-Mart Stores, Inc. v. Lee, 290 Ga. App. 541 (2008), Wal-Mart was alleged to have spoliated videotape evidence that depicted surveillance of a Wal- Mart parking lot at the time when the plaintiff was shot. Once a suit was filed, the plaintiff learned that the footage had been destroyed. The plaintiff therefore moved for spoliation sanctions. Wal-Mart argued that it merely re-used the tape in its ordinary course of business and that it did not destroy the tape during litigation. In determining whether the tape had been destroyed in anticipation of litigation, the court seized upon the notion that the plaintiff s former attorney had sent Wal-Mart s CEO a pre-suit demand letter and found this fact sufficient to place Wal-Mart on notice of contemplated litigation. See also Gilmore v. SCI Texas Funeral Services, Inc., 234 S.W.3d 251 (Tex. App. 2007) (duty to avoid spoliation arises only when a party knows or reasonably should know that there is a substantial chance Kim M. Ruder is Of Counsel with the Atlanta office of Carlock, Copeland & Stair, LLP. Her practice focuses on the defense of physicians in medical malpractice actions as well as other matters of general liability. that a claim will be filed and that evidence in its possession or control will be material and relevant to that claim. ); Fuller Family Holdings, LLC v. Northern Trust Co., 371 Ill.App.3d 605 (Ill. App. 2007) ( a defendant owes a duty of due care to preserve evidence if a reasonable person in the defendant s position should have foreseen that the evidence was material to a potential civil action. ); Robertson v. Dept. of Public Safety, 2005 WL (Ohio Ct. Cl. 2005) ( pending or probable litigation ). Simply stated, it is incumbent upon a plaintiff to place a defendant on notice that litigation is being contemplated. Returning to our hypothetical, is there spoliation of the tissue block that was discarded in accordance with the hospital s policies? Absent additional information that would place the doctor and hospital on notice of a potential claim, the answer would seem to be a resounding no. Let s change the hypothetical around to assume that the tissue block was spoliated. Who is responsible for the spoliation? Is it the doctor, the hospital, or both? This much more complicated question poses what could be the single largest puzzle for medical malpractice attorneys in the context of representing a hospital, a physician or a practice operating in a hospital setting. Without truly understanding the intricate division of labor between the hospital and the physician s group, what may seem to be an easy answer does not turn out the way expected. It is virtually impossible to determine where the responsibility lies for the spoliation without delving into the mundane terms and conditions in the agreement governing the relationship between the physician s group and the hospital. Unlike in other med-mal cases, intense scrutiny of the agreement is required in these situations, not just a focus on the medicine. Th e Qu e s t i o n o f Responsibility In answering the question of responsibility for the spoliated tissue continued on page 8 Medical Malpractice Law & Strategy EDITOR-IN-CHIEF... Janice G. Inman EDITORIAL DIRECTOR...Wendy Kaplan Ampolsk MARKETING DIRECTOR...Jeannine Kennedy GRAPHIC DESIGNER... Louis F. Bartella BOARD OF EDITORS DAVID M. AXELRAD...Horvitz & Levy LLP Encino, CA ELISABETH BELMONT....MaineHealth Portland, ME CHRISTOPHER D. BERNARD.... Koskoff, Koskoff & Bieder, P.C. Bridgeport, CT MICHAEL D. BROPHY.... Goldberg Segalla LLP Philadelphia BARRY B. CEPELEWICZ, MD...Meiselman, Denlea, Packman, Carton & Eberz, P.C. White Plains, NY LORI G. COHEN... Greenberg Traurig, LLP Atlanta LINDA S. CRAWFORD... Linda Crawford & Associates New York LAWRIE DEMOREST... Alston & Bird LLP Atlanta ERIC J. FRISCH... Carlock Copeland & Stair LLP Atlanta THOMAS R. HILL.... Dykema Chicago AMY J. KOLCZAK... Owen, Gleaton, Egan, Jones & Sweeney, LLP Atlanta WILLIAM A. KRAIS.... Porzio, Bromberg & Newman P.C. Morristown, NJ KEVIN G. LIEBECK... Hodes Milman, LLP Irvine, CA CARRIE N. LOWE Webb, Zschunke, Neary & Dikeman, L.L.P. Atlanta CONNIE MATTEO... Porzio, Bromberg & Newman, PC Morristown, NJ ERIC PROBST.... Porzio, Bromberg & Newman, PC Morristown, NJ KEVIN QUINLEY... Council on Litigation Management Fairfax, VA JAMES SOKOLOVE....Law Offices of James Sokolove Newton Center, MA JEROME M. STALLER...The Center for Forensic Economic Studies Philadelphia DEBRA SYDNOR... Alston & Bird, LLP Atlanta Medical Malpractice Law & Strategy (ISSN ) is published by Law Journal Newsletters, a division of Incisive Media Incisive US Properties, LLC. All rights reserved. No reproduction of any portion of this issue is allowed without written permission from the publisher. Telephone: (800) Editorial Circulation Reprints POSTMASTER: Send address changes to : Incisive Media 120 Broadway, New York, NY Published Monthly by: Law Journal Newsletters 1617 JFK Boulevard, Suite 1750, Philadelphia, PA Medical Malpractice Law & Strategy February 2009

3 Trial Tactics in Psychiatrist Liability Cases Part Two of a Two-Part Article By Joshua D. Koskoff Joshua D. Koskoff is an attorney with the Connecticut firm of Koskoff, Koskoff and Bieder PC. He concentrates his practice in medical malpractice and air accidents. When handling a case against mental-health professionals such as psychiatrists, psychologists or social workers, there are special considerations that should be kept in mind. The average juror may not be aware of the extent of mental-health professionals duty to protect innocent third parties from their dangerous patients, and they may be reluctant to hold these professionals responsible. Following are some strategies that will help to get the plaintiff s point of view across to the fact finder. Voir Dire You need to make sure that the jury accepts the concept that a professional can be liable where the harm occurs as a result of a deliberate, intentional act of a patient. The jury needs to know during voir dire that the case is only about the civil liability of the professional the question is whether he or she did his or her job, and not whether the psychiatric patient is criminally liable. Make it clear that the criminal part of the case is over. Ask the jurors to state affirmatively that they could hold a therapist liable for not doing his job even where a murder is carried out by one of his patients. If they cannot, they obviously are not good jurors for the plaintiff. If the perpetrator is in jail, it will make some sense to the jury that he won t be testifying. Make sure to point out this circumstance to the jury in advance so they don t see the perpetrator s absence from the witness chair as a weakness in your case. The type of juror you are looking for in a Tarasoff case is different than you might look for in any other plaintiff s cases. (As explained in Part One of this article, in Tarasoff v. Regents of University of California, 17 Cal.3d 425 (1976). a graduate student named Prosenjit Poddar, who was attending the University of California at Berkley, confessed to his counselor a desire to kill another student he was obsessed with: Tatiana Tarasoff. Although his counselor recognized that Poddar was dangerous and even briefly had him committed, neither Tatiana nor her family were warned of the threat. Two months later, Poddar murdered Tatiana Tarasoff.) Conservatives, gun owners, and tough-on-crime types are not going to be sympathetic to a criminal s right to confidentiality over the right to know of a law-abiding citizen. Such jurors are fine for the plaintiff s side, as long as they are not tort-reformers. The right to protect oneself is so fundamental to gun owners that obligating a therapist to warn a potential victim in order that she might exercise that right will make absolute sense to them. Protective fathers, in general, are also good jurors for these cases. If there is any suggestion in the case that the victim should not have been mixed up with the patient/ criminal in the first place, stay away from jurors who are too much like the victim demographically. They are likely to have defense mechanisms in place in order to convince themselves that what happened to the victim in this case would never happen to me because I never would have been involved with him in the first place. This is the socalled identification bias. When you present a case like this for the victim of a psychiatric patient, you are alleging that a mental health professional should have taken some kind of decisive action to commit, to warn, to contain. Therefore you should probably avoid the mealy-mouthed, passive, or overly intellectual juror. You also don t want jurors who have had therapy themselves. Of course, this question has to be delicately raised outside of other jurors hearing, perhaps in a form with a question like, Have you had any experiences with mental health professionals? There is too much risk in accepting a juror who has had periods of therapy. Such a juror is less likely to respond to the idea that a therapist has an obligation, in some cases, to someone other than the patient. Their own fears that their personal, private thoughts could be subject to disclosure to third parties may color their ability to see the value in compelling mental health professionals to speak. The Opening The focus of the trial is, of course, critical. In making an opening statement, the focus needs to be squarely on the professionals; how they are trained to identify risk factors and how they are required to act to prevent harm to their patients and others. Beyond this, you will need a reason or guiding principle. In our opening, in the case in which a young woman (Elaine) was killed by an ex-boyfriend whose therapist did not warn her of the possible danger (see Part One), I talked first about the right to know as stated above. I explained the risk factors known to increase the likelihood of violence. I then told the story, focusing on the therapist s initial evaluation of the boyfriend (Jim) and all that he knew prospectively as set forth in the medical records. Having already listed the risk factors for violence, I was able to line up the medical records and check the risks as we went along Homicidal ideation? Check. Inability to control anger? Check. History of violence? Check. We described the deal between the therapist and Jim, where it was reported that Jim said he would not act on his thoughts but would call if this changes. I suggested to the jury, rhetorically: You might ask yourself whether it made any sense for the therapist to rely on a patient he just met, with serious anger control problems, to pick up the phone and call him if he decided to harm Elaine? continued on page 4 February 2009 Medical Malpractice Law & Strategy 3

4 Psychiatrist Liability continued from page 3 We have all watched movies where we know what is about to happen to an unknowing victim and wish there was some way to prevent it. Jurors are conditioned through movies and television to know when a person is in danger before the person does. In telling the story of the crime, re-create the scene dispassionately but specifically and slowly. Be sure that the jury knows exactly what is about to happen and how the victim has no clue. You will be tapping into this common thread. Instinctively, the jury will wish that they were in the position to do something and that is the essence of your case. The therapist could have done something! Obviously, you need to avoid anything that could be perceived as appealing to sympathy. I personally don t believe in saying much about damages during opening statement, especially in death cases. The Order of Witnesses If the records aren t bad for your side of the case, and if you have helpful group protocols, call the office manager first. You can go through the records and introduce the policies. This puts the defendant(s) squarely under the gun and the focus is exactly where you want it to be. You want to go methodically through the treatment, and it is best to do this first with an adversarial but disinterested witness (so that you can lead). When it comes to the practice s policies, first make sure they were in effect at the time the patient was being treated. Then, the jury needs to know where the policies came from, and why they were put in place. You are looking to highlight for the jury references to risk assessment, homicidality, suicidality, Tarasoff and exceptions to confidentiality. Your goal is to show that these issues are fundamental to a therapist s doing his job. The policies will help you show that a therapist is expected to take action in certain circumstances to protect others. If you don t have strength in the records or policies, you may have to lead with a teaching expert, followed by the defendant. In any case the defendant should go early in the case. In a homicide case, put the family on at the end of the case. You need to be brief with the family, and don t call every family member. If you have the jury, they will have built up enough concern for the family with their imagination. It is not difficult to identify with the pain a family suffers when their loved one is murdered. Obviously you need to show some pictures of the victim, but you need to be extremely careful about going overboard. You are going to get a big verdict if you win, and you want to avoid the appearance of looking for money. You will need to ask some simple questions about what the family would have done to protect themselves if they had been warned about the dangerous patient. You want to establish that being deprived of that opportunity made a difference in the outcome. Expert Testimony The problem with expert testimony in a psychiatric malpractice case is this: You will have to deal with psychiatrists, who tend to be overly analytical, long-winded, and fungible terrible qualities for court cases. When preparing your psychiatry expert for trial and depositions, you need to discuss the case extensively so that you can help the psychiatrist wade through the psycho-babble to arrive at his or her concrete opinions. I advise having the psychiatrist write all conclusions down on a piece of paper. The list should start with a declarative statement like Dr. Smith should have or Dr. Smith did not : 1) Commit the patient; 2) Warn the police; 3) Do a risk assessment; 4) Bring in the patient s family; etc. If you have one expert, you will have to put the defendant on before the expert. In my experience, the defendants in these cases make lousy witnesses and your goal will be to alienate them from the jury. If you have two experts, you should call one to teach (before the defendant) and one to offer the criticisms (after the defendant). You want the jury to understand that evaluating patients at risk for suicide and homicide is central to what a psychiatrist is trained to do. When reviewing the background of the expert, make sure to elicit the fact that they are educated on how they are supposed to approach patients at risk for homicide and suicide in the first year of their training! They are also taught that, sometimes, they are required to protect the public from their patients. This it is one of the most important parts of their job. The records in these cases are usually deficient and incomplete. To the extent that you can, you want your expert to rely on the records as much as possible because your goal is to build a case around the records. While this is true in any malpractice case, it is especially true in a wrongful death psychiatry case where the additional information is going to come primarily from the mouth of the defendant. At trial, first ask a hypothetical question based solely on the medical records. Preface this so the jury knows what you are doing: Dr Expert, I am going to ask you a question that is based solely on the official records in this case the records made when John Doe was still alive and not on what has been said after the death of John Doe. Then go methodically through the records, asking along the way whether the standard of care was met at various instances. Once you have elicited all the opinions, its time to ask your second hypothetical question: Now, I would like you to assume that Dr Defendant has testified after the fact Fill in the testimony of the defendant and point out contrasts with the records where possible. I like to ask questions like, If you assume what the defendant says is true, isn t that an excuse for not committing the patient? (knowing full well it isn t). continued on page 5 4 Medical Malpractice Law & Strategy February 2009

5 Psychiatrist Liability continued from page 4 Or, If we assume what the defendant says today is true, does that change your opinion? Often, the excuses make the original conduct look worse. Remember not to let the expert roam too much. Also, be honest when you don t understand something the expert has said, or you sense that the jury has become confused. I always interject with something like, You lost me on that one doctor, or, Maybe I m the only one, but I don t understand what you mean by (long medical term). Chances are, if you aren t following the discussion, neither is the jury. Also, please meet the expert the day or night before his testimony. Go to dinner. Put him or her up at a nice hotel. You also do not want your expert driving to court the day of his testimony. The expert needs to be brought into the zone of the case without the stresses caused by fighting traffic and finding the courthouse and a parking space. Cr o s s-examination o f t h e De fe n d a n t As we ve already noted, mentalhealth professionals make bad witnesses. This applies not only to your expert, but also to the psychiatrist your client is suing. Obviously we are trained to control cross-exam, and that is important. However in these types of cases, my experience has been that you need only provide the rope to the defendant, and he will tend to hang himself under a mass of psycho-babble. Remember your case is about the therapist not taking some kind of action not warning the family, not committing the patient, not getting the patients records, etc. If the defendant rambles on, it will likely support the impression that this is a conflicted person, and not a person of action. The defendant is bound to deliver some gems through an answer that you can use surgically on him or her. Prior to crossing the defendant, I put together a list linking any admissions from the deposition or from other sources together with the specific question I will ask. This is my go to list from which I can pull the defendant s words for my questions. I ll say, You would agree that (fill in statement from deposition). If the defendant agrees, that s great. If not, that s even better, because you can nail the witness on the issue of credibility and introduce the prior statement. Always try to pit the medical record against the courtroom testimony. What you are telling us today, doctor, is that John Doe appeared to be better on the day before he killed his victim but that s different from what you recorded in your official medical record prospectively, before John Doe killed her, correct? If there were policies that the defendant didn t follow, let the defendant make excuses as to why those policies were not followed, and write them down. Later, with your expert on the stand, you will need to reiterate all the excuses given by the defendant for the decisions that were made concerning the patient s dangerous propensities. Next, ask your expert about each excuse with questions like: Dr. Smith told us that the reason he didn t call the patient s family was because he didn t want to break confidentiality, doesn t that excuse what he did? Remember when it comes to confidentiality, it is owned by the patient, and not the therapist. Therefore you will want to establish that the defendant never asked the patient if it was acceptable to disclose the information to family members. Final Argument If you get to final argument in a Tarasoff case (I have yet to), remind the jury that People have a right to know when they are in danger. People have a right to protect themselves. This is what will motivate your jury on an instinctive reptilian level. Your jury wants to be protected from lurking predators, and probably doesn t care all that much if getting that protection means confidentiality between a psychiatrist and his patient must be breached. You want to remind the jury that a patient who confides dangerous propensities or ideation to his therapist wants to be stopped, whether they are speaking of suicide or homicide. If they just wanted to kill themselves or someone else, they wouldn t try and get help, they would do it. By their nature, these cases are dramatic and compelling. During closing, I would retell the whole story to the jury, with an emphasis on the opportunity the defendant had to step in. I would also speak from the point of view of the victim who is going about her daily life not knowing of the lurking danger. I would also point out that therapists are not fortunetellers who can see into the future. Therefore, they have to act based on the well recognized risk factors discussed in Tarasoff and its progeny before it is too late. This turns a classic defense argument on its head. At the conclusion of the first portion of the final argument, after damages, I would do what I almost always do in summation: I would ask the defense to answer some questions on behalf of the estate of John Doe. Questions like, Why didn t the psychiatrist obtain the old records on his patient? Why didn t he even try? Why did he choose not to do a thorough risk assessment? Why didn t he bring in one of his colleagues to discuss the patient s care with? Why is he still denying that he has any responsibility? You get the idea. The beauty of ending with questions in your first part is it prevents the defense from standing up and saying see this is all about money. Also the defense in my experience will not answer the questions, which you can point out on rebuttal. If you craft your questions carefully, you ll know there are no satisfactory answers to them. The publisher of this newsletter is not engaged in rendering legal, accounting, financial, investment advisory or other professional services, and this publication is not meant to constitute legal, accounting, financial, investment advisory or other professional advice. If legal, financial, investment advisory or other professional assistance is required, the services of a competent professional person should be sought. February 2009 Medical Malpractice Law & Strategy 5

6 Compassionate Use continued from page 1 degenerate and become paralyzed. Most DMD victims die by the age of 25. Although no drug is currently available to treat DMD in any longterm meaningful way, there are medications that can help relieve symptoms or slow their progression. Jacob was already taking Gentamicin to treat his DMD when his mother, Cherie Gunvalson, inquired about his taking part in a new drug study being performed by PTC Therapeutics Inc. The company was set to conduct a Phase 2 clinical trial of a drug to treat DMD, called PTC 124. The trial would last 28 days, during which time participants would not be permitted to take Gentamicin. In their suit, the Gunvalsons alleged that PTC s Vice President, Claudia Hirawat, advised Mrs. Gunvalson that her son should remain on Gentamicin because it offered him some relief from his symptoms. The plaintiffs said that Hirawat advised them that Jacob should therefore wait to participate in a later PTC 124 trial. Because of this and other conversations with PTC representatives, the Gunvalsons claimed they were induced to forego treatment at the time of that first inquiry. Later, when the first trial was successful, PTC began an expanded trial of the drug, which was to last for two years. When Jacob sought to enter into the group of trial participants for the expanded testing, he and his parents learned that the group was limited to those who had taken part in the first, 28-day trial. Thus, Jacob was now ineligible to participate in a clinical trial of PTC 124. By the time he was rejected for this second clinical trial, Jacob s condition had deteriorated considerably. Because he was barred from the clinical trial, Jacob tried a second method for gaining access to PTC 124; he sought permission to use the drug through the FDA-regulated compassionate use exception to the normal prohibition against drug-manufacturer distribution of unapproved medications. Compassionate Use Drug companies are permitted to give terminally ill people experimental drugs outside of the clinical trial setting in two ways: 1) on a group basis (expanded access program); or 2) on a single-patient basis. When the company is not offering an expanded access program, the singlepatient basis for expanded access is the only route open. To use this option, the potential user of the pharmaceutical product must get his or her doctor to ask the drug company to let the patient use the investigational drug. If the company agrees, the doctor and the manufacturer can ask the FDA to approve the use of the drug for that single patient. The process can be completed in as little as a day, although it generally takes several weeks. In Jacob s case, PTC declined to apply to the FDA on his behalf for an exception. When this last hope fell through, Jacob and his parents brought suit against PTC to compel the company to provide PTC 124 to Jacob. They claimed that PTC induced Jacob to pass up the chance to participate in the first trial group by promising him that he could take part in a second phase of testing, when in fact he could not take part in that second phase if he did not participate in the first. They sued on theories of promissory estoppel, fraudulent misrepresentation and negligent misrepresentation. Significantly to the holding of December 2008, the Gunvalsons also sought a preliminary injunction from the U.S. District Court for the District of New Jersey to immediately compel PTC to give Jacob the drug. The district court had to consider four factors before granting the requested preliminary injunction. They were: 1) The Gunvalsons likelihood of ultimate success on the merits; 2) The irreparable harm to Jacob if the injunction were denied; 3) The hardship the injunction would cause to PTC; and 4) the public interest in the issue. Success on the Merits Concerning the first hurdle, the district court broke the question of whether the Gunvalsons would ultimately prevail on the merits into two parts: 1) Could the plaintiffs show that PTC 124 comports with the requirements of the FDA's compassionate use exception?; and 2) Could they show that PTC had made them an enforceable promise that they would provide Jacob the drug? To show that PTC 124 comports with the requirements of the FDA's compassionate use exception, such that the FDA would allow a drug company to distribute the unapproved drug, four conditions had to be met: 1) The drug must be intended for use in treating a serious or lifethreatening disease; 2) There must be no good alternative; 3) The drug must currently be under investigation in a clinical trial; and 4) The sponsor must be actively pursuing marketing approval. 21 C.F.R The court noted also that, even if PTC 124 met these criteria, the FDA could still deny permission for Jacob to use the drug through the compassionate use exception if there was insufficient evidence of the drug s safety. Looking at all these criteria, however, the district court found no impediment to Jacob s being permitted to use PTC 124 under the compassionate use exception. Thus, the first prong of the test to see if the Gunvalsons might win on the merits was met. The Second Prong Moving on to the second prong, the court had to determine if a promise had been made to Jacob and his family that the company would provide Jacob with PTC 124. And because Jacob had offered nothing in return for the promise that he could take part in a later clinical trial (lack of consideration), he was relying on the doctrine of promissory estoppel to compel PTC to give him their medication. In order to win on a promissory estoppel theory, Jacob and his parents had to show: 1) That a clear and definite promise was made; 2) That the promise was made with the expectation that the plaintiffs would rely on it; 3) That the plaintiffs reasonably relied upon the promise; and 4) That the failure to make good on that promise resulted continued on page 10 6 Medical Malpractice Law & Strategy February 2009

7 M e d Ma l Ne w s Sur rogate Mo t h e r s Suit Against Attorney and Doctor Proceeds A New Jersey court has held that a suit against a lawyer and a doctor who arranged a surrogate pregnancy deal can go forward. The professionals are being sued for civil conspiracy, as well as legal and medical malpractice, for allegedly misleading the surrogate mother about her rights. The ruling came in A.G.R. v. Brisman, Mon-L , a case in which a woman who agreed to be a surrogate mother later decided she wanted to keep the twin babies she bore. In a separate suit, she is seeking custody of the children. The landmark 1988 state Supreme Court case, In the Matter of Baby M, 109 N.J. 396 (1988), held surrogacy contracts unenforceable in New Jersey. Therefore, in New Jersey, custody of children born to surrogate mothers who want to retain custody is decided by the courts, in accordance with the best interests of the children involved. Baby M did not deal, however, with the liability of professionals who set up surrogacy arrangements. The A.G.R. v. Brisman case is a first in that it is seeking money damages for harms related to a surrogacy agreement. Do c t o r Fo u n d No t Guilty in Rushed Transplant Case The California surgeon charged with harming an organ donor in an effort to speed the harvest his kidney and liver was acquitted of the charge of abuse of a dependent adult on Dec. 18, Dr. Hootan Roozrokh is a transplant surgeon who was called to the bedside of the donor, a 25-year-old brain damage victim, in February He was there to remove the donor s organs as soon as death occurred, following the donor s removal from a ventilator. The doctor planned to use a technique called donation after cardiac death, which involves quick harvesting of organs immediately following the donor s cardiac death. The donor, however, did not die until eight hours after the ventilator was removed. In the interim, Dr. Roozrokh administered medications such as morphine to the donor, which the prosecution alleged were excessive and meant to hasten the donor s death. By the time the donor died, his organs were no longer viable and could not be used for transplant. Nearly Simultaneous De a t h s At Nursing Ho m e Pr o m p t Criminal Investigation Three men died on Dec. 18, 2008, in a Long Island, NY, nursing home, prompting a police investigation as to the causes of death. All three deaths occurred on the third floor of the New Carlton Rehab and Nursing Center, beginning with a man who was discovered in his bed not breathing in the early hours of the morning. An hour later, two more men were found unconscious, and they later died. All three patients were gravely ill before their deaths, and there were no immediate signs of foul play. The possibility that the three simply died coincidentally at around the same time was considered highly probable, but autopsies were ordered to determine for certain the causes of death. State Say s Massachusetts To w n s Am b u l a n c e Ser vice Cut Co r n e r s In December 2008, the Massachusetts Department of Public Health (DPH) suspended the town of Hamilton s ambulance license after an investigation unearthed evidence that training and certification requirements for the town s emergency medical technicians (EMTs) were not being met. In Massachusetts, paramedics are required to receive 28 hours of initial training, and must attend annual refresher courses. In addition to the town, 24 individual EMTs were cited by the DPH for falsifying training records. The DPH suspended 13 of these individuals licenses and has proposed that their licenses be revoked for periods up to one year, depending on the severity of each accused s infractions. The other 11 EMTs cited have received reprimands for falsifying their own continuing education training records. In a release, DPH s Director of the Bureau of Health Care Safety and Quality, Paul Dreyer, said, This investigation has revealed serious problems in the way that the emergency medical services were delivered in the town of Hamilton. Training requirements are in place for a reason: to insure the highest quality of care for the residents of the Commonwealth. New Hampshire Jur y Tr ials Put o n Ho l d The economic downturn has affected many sectors of society, including the court systems of the several states, which are being asked to cut their budgets. The State of New Hampshire s court system decided to save money by suspending jury trials for a month this year, putting on hold not only medical malpractice trials but also employment, matrimonial and other types of civil trials. The situation will stick attorneys and their clients not only with the prospect of delayed justice but also with the costs and inconvenience of rescheduling trial dates. Medical Malpractice Law & Strategy is available online. Go to for further information. LAW JOURNAL NEWSLETTERS REPRINT SERVICE Promotional article reprints of this article or any other published by LAW JOURNAL NEWSLETTERS are available. Call Lauren Melesio or for a free quote. Reprints are available in paper and PDF format. February 2009 Medical Malpractice Law & Strategy 7

8 Spoliation continued from page 2 block, it is important to look at the following: Does the agreement state who is the custodian of the tissue block? Do the physicians own anything in the laboratory? Who is responsible for the running or oversight of the pathology laboratory? Who is responsible for authoring and enforcing the rule regarding the discarding of tissue blocks? Do the physicians have the right to direct the activity of hospital employees? Each agreement is different, so this list is not meant to be exhaustive in terms of the questions the attorney must ask. But, ultimately, this factual inquiry will be resolved by a trial judge who will also be interpreting the facts surrounding the division of labor between the hospital and the physician's practice group. The attorneys for both sides must be prepared. After the contractual interpretation of the agreement has been done, there is yet one more thought to consider. There is a line of case law authority that would impose responsibility for spoliation under an agency theory. Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005); see also Boswell v. Overhead Door Corp., 292 Ga. App. 234 (2008) (finding no spoliation sanctions against Overhead Door when City of Atlanta discarded door on its own and not at the request of Overhead Door). In Bouve & Mohr, a defendant was held liable for spoliation sanctions despite the fact that the defendant had no personal involvement in actually destroying evidence. More specifically, in a premises liability case, a plaintiff filed suit against an apartment complex following her alleged rape at the apartment complex. A police officer who acted as security for the apartment was assigned to the criminal rape case. Through a series of factual circumstances, the police officer disposed of the rape kit. The court found there to be circumstantial evidence of agency between the police officer and the apartment complex. In applying the theory of agency to our hypothetical, it is important to be careful to investigate not only the contractual relationship between the hospital and the physician s practice, but also the actual day-to-day operation of the laboratory. If the physician directs or is consulted by laboratory personnel in reference to the storage or discarding of tissue blocks, the physician's group as well as the hospital could find themselves on the hook for spoliation. However, if the hospital employees are alone responsible for carrying out the discarding of the tissue blocks, the hospital is most likely solely responsible for the alleged spoliation. Th e Consequences o f Sp o l i a t i o n In determining the appropriate remedy for spoliation, Georgia s courts, for example, review the following factors: 1) whether the [party seeking sanctions] was prejudiced as a result of the destruction of the evidence; 2) whether the prejudice could be cured; 3) the practical importance of the evidence; 4) whether the [party who destroyed the evidence] acted in good or bad faith; and 5) the potential for abuse. R.A. Siegel Co. v. Bowen, 246 Ga. App. 177, 180 (2000). Other states generally look at the same general factors. See Joyner v. B&P Pest Control, Inc., 852 So. 991 (Ala. Civ. App. 2002); Whirlpool Corp. v. Camacho, 251 S.W.3d 88 (Tex. App. 2008). See also Barnett v. Simmons, 2008 WL (Okla. 2008); Wilson v. Frye, 2008 WL (Wash. App. Div. 2008) State v. Hay, 756 N.W.2d 480 (Iowa App. 2008); Happy Bunch, LLC v. Grandview North, LLC, 142 Wash. App. 81 (2007). What Is the Remedy? Assuming spoliation has occurred, what is the remedy? First and foremost, most attorneys are aware of the dreaded adverse inference charge. The jury can be charged that there is a rebuttable presumption that the lost or destroyed evidence contained information adverse to the spoliator. In the hypothetical identified above, the trial court could instruct the jury that the missing tissue block contained something harmful to the doctor s and the hospital s defense. This could result in the jury forming the impression or presumption that the tissue block contained evidence of malignancy. Simply the giving of an adverse inference charge in the hypothetical could have dire consequences and turn a seemingly defensible case into one that poses serious risks in being tried to verdict. Even more so than the giving of the adverse inference charge, trial courts are vested with discretion to fashion even more damaging remedies for alleged spoliation. For example, a trial court could dismiss the case or could exclude testimony concerning the destroyed or lost evidence. See, e.g., R.A. Siegel Co. v. Bowen, 246 Ga. App. 177, 180 (2000); Covucci v. Keane Consulting Group, Inc., 21 Mass. L. Rptr. 228 (Mass. Super. 2006); Harborview Office Center, LLC v. Camosy Inc., 290 Wis.2d 511 (2006); Farr v. Evenflo Co., Inc., 287 Wis.2d 827 (Wis.App., 2005). Additionally, a trial court could even enter findings of fact pertaining to the lost or destroyed evidence, thus removing certain issues from consideration from the jury s purview. See, e.g., Bouve & Mohr, LLC v. Banks, 274 Ga. App. 758, 762 (2005) (where spoliated evidence was a rape kit performed on the plaintiff after the alleged rape, court entered a finding of fact that the plaintiff was raped in the apartment complex run by the defendant). As you can see, depending on how a trial court perceives an alleged spoliation, the merits of the case could be vastly affected. Importantly, assuming a litigant wishes to appeal the entry of spoliation sanction, that decision is generally reviewed under the deferential abuse of discretion standard. Co n c l u s i o n What is the lesson to be learned by the prudent medical malpractice attorney? First and foremost, it is not just about the medicine and the patient s medical record. When you are representing physicians or their practices in the setting of a community hospital, you must continued on page 10 8 Medical Malpractice Law & Strategy February 2009

9 D r u g & De v i c e Ne w s Class Ac t i o n Off-La bel Drug Lawsuit Dismissed A U.S. District Court judge sitting in Los Angeles dismissed an off-label drug promotion multidistrict litigation on Dec. 17, The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not approved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL (ARG) (C.D. Calif.), that the seven plaintiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has exclusive jurisdiction over enforcement of the rules against promoting off-label drug uses. Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that defendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder, wrote the court. Justice Gutierrez did, however, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done. Following the dismissal, Amgen attorney Mark Cheffo, of Skadden Arps Slate Meagher & Flom in New York, said, The judge is not letting insurers second-guess medical providers across the country. I think he also respected the FDA s role and was not going to allow judges and juries to make decisions around the United States that are inconsistent with the FDA. FTC Sues Phar maceuticals Co m p a n y fo r Antitr ust Vi o l a t i o n s The Federal Trade Commission filed a lawsuit in December 2008 against Ovation Pharmaceuticals Inc., alleging that the company has obtained an illegal monopoly over the only two drugs available to treat premature babies with certain heart defects. The FTC claims in its suit, filed in Federal District Court in Minnesota, that the company in August 2005 purchased the rights to one of the two medications, Indocin. Five months later, it acquired the rights to the second medication, NeoProfen. Soon after this acquisition, the price of a vial of Indocin jumped from $36 per vial to $500 per vial. In a statement issued by the FTC, acting FTC Bureau of Competition Director David P. Wales said, By acquiring its only competitor in the treatment of a serious heart condition affecting premature babies, Ovation has been able to charge dramatically higher prices for its drugs. While Ovation is profiting from its illegal acquisition, hospitals and ultimately consumers and American taxpayers are forced to pay millions of dollars a year more for these life-saving medications. The action taken today is intended to restore the lost competition and require Ovation to give up its unlawful profits. The FTC claims the only alternative to the two medications for babies with the heart defect patent ductus arteriosus is surgery, which is expensive and dangerous. With surgery the only other option, medical caregivers and parents of affected babies are forced to pay the allegedly artificially inflated prices Ovation is charging for its medications. All the participating FTC commissioners voted to approve the complaint. Commissioner Jon Leibowitz issued a separate concurring statement, in which he said, Ovation s profiteering on the backs of critically ill premature babies is not only immoral, it is illegal. Ovation s behavior is a stark reminder of why America desperately needs health care reform and why vigorous antitrust enforcement is as relevant today as it was when the agency was created almost one hundred years ago in CA Na r r o w s Definition o f Primary Caregiver for Medicinal Marijuana Use The California Supreme Court has ruled unanimously that the term primary caregiver, as used in the state s medical-marijuana-dispensing law, the Compassionate Use Act of 1996, refers only to a very limited class of people. The words the statute uses housing, health, safety imply a caretaking relationship directed at the core survival needs of a seriously ill patient, not just one single pharmaceutical need. The statute thus does not shield from state prosecution growers of small amounts of marijuana who want to supply it to their ailing friends. The question arose in a 2005 case against Roger Mentch, who claimed he was growing the 190 plants found in his home because he was providing marijuana to five people with various physical and psychological infirmities. He asserted that he counseled his clients as to proper usage of the drug, taught them how to grow it and occasionally drove them to medical appointments. Mentch lost his battle to prove his innocence by way of the primary caregiver defense after the trial court refused to allow Mentch to present evidence on the issue. The intermediate appellate court found that Mentch should have been allowed to assert the affirmative defense. The State Supreme Court reversed, holding in People v. Mentch, 08 C.D.O.S , that medical marijuana primary caregivers are only those who consistently provided continued on page 12 February 2009 Medical Malpractice Law & Strategy 9

10 Compassionate Use continued from page 6 in a definite and substantial detriment to the plaintiffs. See, e.g., Lobiondo v. O Callaghan, 357 N.J.Sup. 488 (N.J.Super.Ct.App.Div. 2003). For evidence of the requisite clear and definite promise, the court noted these and other statements in Cherie Gunvalson s affidavit: That she asked PTC Vice President Claudia Hirawat if Jacob should be enrolled in the initial Phase 2a trials, and Hirawat responded that it was not worth taking Jacob off of Gentamicin for only a 28-day dosage of PTC124. (Aff. of Cherie Gunvalson 17.) That she asked Hirawat if there were any adverse effects on Jacob for not participating in the trial, and she told me there were none. (Cherie Aff. 17.) That Hirawat told Cherie Gunvalson that Jacob had no better or worse chance to be treated in the future based on his non-enrollment in the Phase IIa trial. (Cherie Aff. 25.) That Hirawat assured [Cherie] that Jacob would get access to PTC124. (Cheri Aff. 26.) The court also found that many statements in Hirawat s affidavit confirmed Cheri Gunvalson s contentions, even though other statements in Hirawat s affidavit contradicted them. The court explained its tendency to lean toward Cheri Gunvalson s version of the facts surrounding her interactions with PTC personnel, stating: As an initial matter, all communications between PTC and Plaintiffs must be viewed in light of the unique relationship between Jacob's mother, Cherie, and PTC. Cherie worked at length to lobby funds from Congress for DMD research. In this capacity, she had relationships with PTC employees and officers that transcended the typical relationship that PTC had with parents of children with DMD. Of most relevance to this Court, Cherie appears to have had extensive communications on both a professional and social level with PTC Vice President Claudia Hirawat. Indeed, it is undisputed that Cherie and Jacob have even stayed overnight at Hirawat's home on at least one occasion. Because of these extended connections alone, it seems to the Court that PTC would be more likely to communicate to Plaintiffs more compassionately and less formally than with other parents of DMD children. Because of the corroborating statements of the opposing party and the witnesses relationship with one another, the district court s determined that the promise had been made to the Gunvalsons. The court next concluded that the last three elements required to make a case under the theory of promissory estoppel were present, stating it was reasonably likely that Plaintiffs relied on these and other similar statements made by PTC in declining to enroll Jacob in the Phase 2a clinical trials. This failure to enroll Jacob worked to Plaintiffs' detriment, as Jacob is now not eligible for the extended Phase 2a trials. In summary, the Court finds it reasonably likely that Plaintiffs reasonably relied to their detriment on PTC's promises to provide PTC 124 to Jacob, so the Court prevents PTC from denying Plaintiffs that promise. In the district court s view, this settled the second prong of the question Are the plaintiffs likely to succeed on the merits? Three More Elements The court next moved on to the other requirements the plaintiffs were required to show before a preliminary injunction could be issued. They were: 2) The irreparable harm to Jacob if the injunction were denied; 3) The hardship the injunction would cause to PTC; and 4) the public interest in the issue. Concerning irreparable harm, there was little question here. Jacob is dying of a disease with no currently available cure, and PTC 124 offers some minimal hope. The hardship to PTC of having to provide the drug to Jacob was also easily dismissed as an impediment to injunction by the district court, as all the company could cite to was the difficulty of filing paperwork with and working with the FDA to obtain a compassionate use exception for the boy. According to PTC, this process could take weeks, but that seemed a small price to pay for, perhaps, saving or prolonging a life. Finally, the district court found no harm to the public in issuing a preliminary injunction compelling PTC to provide Jacob with PTC 124, as the public has an interest in providing life-saving experimental drugs to terminally ill persons. This public interest was evidenced, the court said, by the FDA s very enactment of the compassionate use exception. continued on page 12 Spoliation continued from page 8 determine all the parties involvements in the everyday operation of the physician s practice, and establish who is responsible for what. Once you have resolved this one very important fact, you will be in the best possible position to properly represent your client s interest and prevent the blunders that lead to a claim of spoliation. Even absent a claim of spoliation, this inquiry should occur as early as possible in litigation in order to determine which party will be responsible for preserving relevant evidence during suit. Absent such an early investigation, you could find your client on the receiving end of a motion for spoliation sanctions. Finally, if you have a co-defendant, keep the lines of communication open in order to ensure that all relevant documentary evidence is being maintained and preserved, even if it's not your client's documents. This will help in avoiding the issues of who had the responsibility to preserve each item of relevant evidence during discovery. 10 Medical Malpractice Law & Strategy February 2009

11 v e r d i c t s Ju r o r's Dishonesty Did No t Prejudice the Plaintiff When seeking a new trial based on a juror's dishonest answer during voir dire, a party must show that the misconduct prejudiced the outcome of the case, the Ohio Supreme Court ruled on Dec. 11, Grundy v. Dhillon, 2008 WL , Ohio (Ohio, 12/11/08). A jury delivered a defense verdict on claims that hospital and emergency medical staff negligently caused the death of Susanne Sumner. Her estate sought a new trial, asserting that, during jury selection, a juror had failed to disclose that he had a low opinion of the medical facility based on a family member s treatment there. The plaintiff alleged that this failure constituted misconduct warranting a new trial. The trial judge denied the motion. A state intermediate appellate court reversed and the defendants appealed. The Ohio Supreme Court reversed, reinstating the defense verdict. There was no evidence that the juror deliberately lied. Furthermore, if any party had reason to excuse the juror, it would have been the defendants. To obtain a new trial in such cases, the moving party first must demonstrate that a juror answered a material question dishonestly and that prejudice resulted, the court said. To do that, the moving party must show that the juror s accurate response would have provided a valid challenge. In weighing this issue, an appellate court may not substitute its opinion for the trial court's judgment unless it appears that the trial court s attitude was unreasonable, arbitrary, or unconscionable, the court said. The trial court here did not abuse its discretion. Am b u l a n c e Wo r ke r No t Liable Under Georgia Law Georgia s statute immunizing ambulance workers from civil liability, as long as their organization is performing the emergency medical services for no remuneration, applied to the emergency medical technician in this case even though the ambulance company intended to charge plaintiff s decedent a fee to assist with defraying the administrative costs of operating the service. Presley v. City of Blackshear, Slip Copy, 2008 WL (S.D.Ga., 12/31/08). Plaintiff Administratrix of the Estate of the decedent, Antonio Presley, brought suit after the decedent died while in police custody for suspected cocaine possession. Presley had, in fact, consumed a large amount of cocaine at the time of the arrest in an attempt to hide the evidence. The decedent died from an overdose after having been treated and transported to a hospital by emergency medical technician David Farrior. The Administratrix made claims for medical malpractice and negligence against Farrior, a paramedic with Pierce County EMS. Farrier filed a motion for summary judgment, which the court here granted. Farrior claimed in his motion for summary judgment that he was statutorily immune from liability for negligence and medical malpractice under Georgia law. The relevant Code Section provides: (a) Any person, including agents and employees, who is licensed to furnish ambulance service and who in good faith renders emergency care to a person who is a victim of an accident or emergency shall not be liable for any civil damages to such victim as a result of any act or omission by such person in rendering such emergency care to such victim.... (c) The immunity provided in this Code section shall apply only to those persons who perform the aforesaid emergency services for no remuneration. O.C.G.A Plaintiff did not dispute the contention that Farrior was an employee of Pierce County EMS, which was licensed to provide ambulance services by the Georgia Department of Human Resources. In addition, plaintiff presented no evidence suggesting that Farrior did not act in good faith. So, viewing the evidence in light most favorable to plaintiff, the evidence showed, at best, that Farrior s judgment was faulty, which would not support a finding of bad faith. See, e.g. Thomas v. DeKalb County, 489 S.E.2d 58 (Ga.Ct.App. 1997) ( Even if the paramedics exercised bad judgment and acted negligently, such does not amount to a lack of good faith. ). The plaintiff claimed, however, that the statute did not apply because the decedent was supposed to have been charged for the ambulance services in accordance with Pierce County, GA, policy. The county bills those using a Pierce County EMS ambulance for two things: 1) a standard transportation fee; and 2) a mileage fee based upon the length of the transport. The monies collected from transport fees and mileage fees do not cover the budget for the operation of Pierce County EMS, but are used solely to assist with defraying the administrative costs of operating Pierce County EMS. With this in mind, the court looked to Ramsey v. Forest Park, 418 S.E.2d 432 (Ga.Ct.App. 1992), in which the Georgia Court of Appeals held that a fee charged by a governmental organization to assist in defraying the administrative costs of transporting a person to a hospital is not the equivalent of receiving remuneration for providing stated emergency care, within the meaning of O.C.G.A (c). Relying on Ramsey, the court determined that Farrior was protected by the immunity statute, even though the decedent was to have been charged for the ambulance services received. February 2009 Medical Malpractice Law & Strategy 11

12 M o v e r s & Sh a k e r s Looper Reed & McGraw (Houston): Joel C. Thompson joins the firm s general civil litigation, commercial litigation and class action practice groups as partner in the Houston office. Thompson will focus on products liability, wrongful death, insurance litigation, negligent security litigation, premises liability and construction litigation. Previously, Thompson was an attorney in his own private practice. Akerman Senterfitt (Miami): J. Everett Wilson and Michael Gennett join the firm s health care practice as partner and of counsel, respectively, in the Miami office. Wilson will focus on licensing and reimbursement disputes and negotiated managed care. Gennett will focus on representing health-care practitioners and institutional providers. Previously, Wilson Drug & Device News continued from page 9 care to patients prior to deciding that medical marijuana use might be beneficial for them. What is not permitted, wrote the court, is for an individual to establish an afterthe-fact caregiving relationship in an effort to thereby immunize from prosecution previous cultivation or possession for sale. The court went on to note that its decision should not put true primary caregivers in fear of prosecution: The spouse or domestic partner caring for his or her ailing companion, the child caring for his or her ailing parent, the Compassionate Use continued from page 10 Having found that the plaintiffs met all the criteria for obtaining a preliminary injunction, the district court ordered PTC to attempt to get and Gennett were members of the health law practice group at Shutts & Bowen, which was chaired by Wilson. Drinker Biddle & Reath (Philadelphia): George H. Kendall and Audrey A. Hale join the firm s health law practice group as partners in the Florham Park, NJ, office. Kendall and Hale will focus on mergers, acquisitions and joint ventures. Previously, Kendall and Hale were partners at McCarter & English of Newark, NJ. Sedgwick, Detert, Moran & Arnold (San Francisco): Linda A. Willett has been promoted to head of the firm s drug and medical device practice group. Willett joined the firm in July and previously was vice president and deputy general counsel at Bristol-Myers Squibb Co. hospice nurse caring for his or her ailing patient each can point to the many ways in which they, medical marijuana aside, attend to and assume responsibility for the core survival needs of their dependents. an FDA compassionate use exemption for Jacob so that the company could provide him with the drugs he needed. Co n c l u s i o n In next month s issue, we ll see what happened when the district Eckert Seamans Cherin and Mellott (Charleston, WV): The Pittsburghbased firm of Eckert Seamans Cherin and Mellott has merged with the 12-attorney firm of Hendrickson & Long of Charleston, WV. Among the 12 attorneys to join the firm are Hendrickson & Long s named partners, David Hendrickson and R. Scott Long. Hendrickson has more than 25 years of trial experience and focuses his practice on products liability, toxic torts, medical malpractice, insurance defense and general business litigation. Long concentrates his practice on products liability, personal injury, medical malpractice, toxic tort and asbestos defense. The new office of Eckert Seamans will remain at the same location where Hendrickson & Long was based. Manufac turer Up g r a d e s Wa r n i n g o n Cr anial Implant Kits In October 2008, Stryker s Craniomaxillofacial (CMF) business unit voluntarily recalled four lots of its Custom Cranial Implant Kits because there was some danger that they were not sterile. It took the FDA a two months after that recall to determine that the products in question posed an imminent hazard to health, meaning that this is a Class I recall. The company announced the FDA s finding on Dec. 23, 2008, and urged hospitals and physicians with the affected products those with catalogue numbers , , and to return them to the manufacturer. If the kits are used and are not, in fact, sterile, serious problems could ensue, including patient infection and long-term neurological deterioration. The company s notice can be found at: firmrecalls/ stryker12_08.html. court ruling went up on appeal, and we ll look at the policy considerations at stake in rendering help to individual disease sufferers through the compassionate use exception. To order this newsletter, call: On the Web at: 12 Medical Malpractice Law & Strategy February 2009


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