by Kevin G. Burke, Gregory F. Coplan, David J. Rashid

Transcription

1 Time is Brain by Kevin G. Burke, Gregory F. Coplan, David J. Rashid During a stroke, 32,000 brain cells die every minute. 1 Yet every day, patients suffer strokes in the United States without receiving appropriate treatment. Stroke is the fourth leading cause of death in the United States, and the fourth leading cause of permanent disability. 2 It affects 795,000 patients per year. 3 These potential cases warrant careful analysis. I.Tissue Plasminogen Activator ( tpa ) Since 1995, physicians have had the tool of intravenous tpa to limit or eliminate the effects of stroke. 4 A patient must meet specific criteria before physicians can properly administer this medication. 5 Among the greatest barriers to tpa use has been the three hour rule, which provided that intravenous tpa must be administered no more than three hours after the onset of the symptoms, or when the patient was last known to be normal. After that point, many believed the risk of bleeding from intravenous tpa was greater than the potential benefit. In May 2009, the American Heart Association, Stroke Council, expanded the time limit for tpa to 4.5 hours. 6 This event greatly expanded the number of patients that can benefit from this treatment. Despite this expansion, it is estimated that less than five percent of viable candidates for intravenous tpa received this treatment in the emergency department. 7 While there may be many reasons for this phenomenon, failing to give tpa causes untold harm in the form of needless deaths and injury. Additionally, in the last 20 years, the availability of intra-arterial thrombolytic therapy, as well as endovascular mechanical extraction, have become effective interventions for stroke. The time limits for the administration of these intra-arterial methods are greater than the time limits for the intravenous tpa. 8 With intraarterial thrombolytic therapy, the clot busting drug is administered through a catheter, advanced to the site of the occlusion. 9 By comparison, mechanical extraction devices are advanced by catheter to the occlusion, then used to grasp and extract the clot or plaque obstructing the artery. 10 Surprisingly, neither tpa, nor the mechanical extraction or the expanded IV tpa window has been accepted by the Food and Drug Administration. The efficacy of these treatments are enhanced by certain facts: the earlier the treatment the better; young patients do better than older patients; patients with less neurological deficits do better; large vessel occlusions are easier to treat, and occlusions of the posterior circulation provide a greater window for treatment. 11 The presence of these factors increases the likelihood of establishing proximate cause when treatment is negligently withheld or delayed. II. A Brief Medical overview A stroke is a disruption of blood supply to the brain, resulting in death of brain tissue (an infarct ), and often, permanent neurological deficits. The stroke can be either hemorrhagic or non-hemorrhagic (ischemic). An example of a hemorrhagic stroke is a subarachnoid hemorrhage. The patient will have an aneurysm or outpouching of an artery within the brain, which begins to bleed. The bleed prevents the brain downstream from the aneurysm from being supplied with blood, causing a stroke. The more frequent stroke is a non-hemorrhagic event. It involves an occlusion of an artery within the brain, stopping or limiting blood flow distal to the occlusion in the artery. The occlusion is most often a blood clot that has traveled from another location. The primary source of these blood clots is the heart, and the internal carotid and vertebral arteries. Less frequently, an artery may become occluded by the gradual growth of atherosclerotic plaque within the lumen of the artery. In terms of numbers, percent of all strokes are hemorrhagic; 80-85% are non-hemorrhagic. 12 Of the non-hemorrhagic strokes, 80 percent involve the anterior circulation of the brain, which is supplied by the internal carotid arteries. 13 The remaining 20 percent involve the posterior circulation of the brain supplied by the vertebral arteries. 14 The posterior circulation perfuses the cerebellum and brain stem, consisting of the midbrain, pons, and medulla. 15 Frequently, strokes are preceded by transient ischemic attacks (TIA). 16 time is brain continued on page 10 8 Trial Journal Volume 17, Number 2 Summer 2015

2 time is brain continued from page 8 A TIA is an interruption of blood supply to a portion of the brain causing temporary neurological deficits. 17 These events normally last less than twenty minutes, and usually end before the patient reaches a physician. 18 A TIA cannot be detected on a CT scan or an MRI, because a TIA does not cause an infarct, which can ultimately be seen on these diagnostic tests. Consequently, neither a CT nor an MRI rules in or rules out a TIA. Most importantly, the TIA provides a warning to the physician. Patients who suffer a TIA have a significantly increased risk to have a stroke occurring within the next 48 hours. 19 This window of opportunity is present in percent of all strokes. 20 During this critical time, the physicians have a chance to evaluate and treat the patient. The evaluation consists of a referral to a neurologist who can assess the patient s risk factors, ascertain the probable location of the stroke, determine the appropriateness of anti-platelet medications, and the need for continued observation. 21 If the patient is admitted for observation, the medical team could promptly identify the onset of stroke and begin treatment. A. Scenario One: Thinking Stroke and Thinking Stroke Immediately 1. The Facts A 36-year old male presented to the emergency department with a history of insulin-dependent diabetes mellitus and hypertension. His symptoms included dizziness, imbalance, and slurred speech at home. These symptoms resolved within 25 minutes. He told the emergency department physician that they were not the usual symptoms that occurred when his blood glucose falls. This was the reason he brought himself to the emergency department. The patient also related that once he experienced the symptoms, he ate a sweet dessert with a Coke in an attempt to raise his glucose level. Although the patient did not take his blood glucose level at home, at the hospital, it was measured as normal, or The Standard of Care In this setting, the emergency medicine physician diagnosed hypoglycemia. He fell below the standard of care. The symptoms the patient related may be related to either hypoglycemia or a TIA. As a TIA presents the potential for intervention before a stroke occurs, the physician failed to evaluate that potential. This failure was emphasized by these factors: 1. The patient had significant risk factors for the development of a stroke. The two leading risk factors in the United States are diabetes and hypertension. Combined, they increase the likelihood of stroke. The other leading causes of stroke are smoking and advanced age. 2. The patient reported to the physician that his symptoms resolved quickly. They resolved consistent with the natural history of a TIA, rather than hypoglycemia. OBRA D4C/3RD PARTY POOLED TRUST SERVICES Questions? Interested establishing a trust? Contact Scott Nixon, Executive Director at Or visit our website: Life splan Inc. offers solutions for Trial Lawyers representing clients with a disability settling a Personal Injury, Workman s Comp or Medical Malpractice case. We offer the ex- ception to the rule that a trust is a countable asset. 28 years of providing expertise in managing Special Needs Trusts (Medicaid qualified trusts), offering free consulta- tion to your practice in handling these complicated trusts while offering solutions for the needs of your clients. Pooled Trusts offer people with disabilities the ability to set up their own Special Needs Trust account using pre-drafted trust agreements which qualify for Social Security and Medicaid benefits. The Special Needs trust is excluded as an asset for disabled clients as a non-countable asset. Effective and convenient way to serve the needs of your clients with disabilities. (Small trusts welcome) (<$10K) 10 Trial Journal Volume 17, Number 2 Summer 2015

3 3. The patient s complaint of slurred speech directly points toward a neurological deficit. While it may occur with hypoglycemia, it is not a normal finding. Indeed, it was not a symptom this patient experienced in the past. He specifically told the physician these symptoms were unlike the ones he had in the past. Before the advent of the CT or MRI, strokes were diagnosed by physicians instead of diagnostic studies showing infarcts. Also, by linking the symptoms to certain areas of the brain, the physician can identify the location of the stroke. In this case, the symptoms were of a stroke in the posterior circulation. The primary symptoms of posterior circulation strokes are often referred to as the Five Ds. 1. Dysarthria (slurred speech) 2. Dizziness 3. Dysphagia (difficulty swallowing) 4. Dystaxia (imbalance) 5. Diplopia (double vision) 22 Again, the emergency medicine physician should have recognized the potential that TIA was the explanation for the patient s symptoms, as well as the patient s increased risk for stroke, and placed this as the primary differential diagnosis. Once a TIA is the primary differential diagnosis, the standard of care requires that the patient be admitted for observation, a CT scan performed, an evaluation by a neurologist, search for source of emboli, and the decision of whether to administer Plavix, an anti-platelet 23, 24 agent. Essentially, the TIA has already occurred, so it no longer represents a threat. The threat is that a new clot will form, travel to an artery, and cause a stroke. Anti-platelet medication can and does prevent these strokes from occurring Proximate Cause For the plaintiff s attorney, the issue will then become proximate cause. While the defense will argue that even if the anti-platelet medication had been given to the patient, it would not prevent the stroke, there are numerous studies that identify the reduction in risk from the use of anti-platelet agents. 26 On a second matter, by providing the physicians with an opportunity to evaluate the source of the stroke, the patient will remain in the hospital. If a stroke does occur within the next 24 to 48 hours, near immediate administration of intravenous TPA becomes possible. If the patient returns home, no one can guarantee he can return to the hospital in time. Indeed, no physician could even guarantee that he would not suffer a stroke within the six hours after his discharge from the hospital. B. Scenario Two: The Expanded Timeframe for tpa Administration 1. The Facts Our same patient returns to the emergency department on day three and is experiencing new symptoms. time is brain continued on page 12 When Quality & Experience matter call Lisa Feather, RN BSN PA-C CLNC With 32 years healthcare expeirence: Emergency, Nursing Management, Trauma Educator, Cardiothoracic Surgery, Family Practice, Urgent Care/Occupational Medicine, Lisa Is dedicated to helping bridge the gap between Medicine and Law. Don t let a stack of unintelligible medical records stunt your profits. Let our cost effective CLNC Services be your Lifesaver. FEATHER & ASSOCIATES, will go the extra mile for your Law Firm. Lisa continues to currently practice as a Physician Assistant in Mt. Vernon, Illinois. Recently she became FMCSA Certified Medical Examiner for DOT/CDL physicals. Visit the website for all 30 CLNC services provided: Volume 17, Number 2 Summer 2015 Trial Journal 11

4 time is brain continued from page 11 The symptoms include inability to move the left side of his body, including both his left arm and leg; stiffness of his left arm and leg; headache; slurred speech; and weakness of the left side. The paramedics who brought him to the hospital reached a provisional impression of a suspected stroke. At the hospital, the emergency department physician identified the onset of stroke. Both the patient and EMTs listed the onset of stroke symptoms as being within the past hour. The emergency medicine physician ordered a CT of the brain, which revealed no bleeding, but showed bilateral calcified vertebral arteries. Appropriately, the emergency medicine physician calls for a consult from the neurologist, whom he reaches by phone, and conveys the CT findings as well as the history. Despite the presence of risk factors for stroke, a possible earlier TIA, and recent-onset symptoms consistent with a stroke, the neurologist determines this is a TIA. He has the patient admitted to the hospital, and orders the standard-ofcare treatment for a TIA. 2. The Standard of Care Once again, there is a breach of the standard of care by the neurologist. The primary differential diagnosis must be stroke. In addition to the patient s risk factors, the presentation of one-sided symptoms is consistent with a stroke; and the patient s other symptoms are suggestive of a stroke in the posterior circulation. He has dizziness, dystaxia, dysarthria. Most importantly, the patient s symptoms were continuing. As noted above, the time frame for treating a patient with intravenous tpa has changed over time. From 1995 until September 25, 2008, it was accepted generally that the period for starting tpa was within three hours from the onset of symptoms, or from the time the patient was last asymptomatic. In many cases, neither a patient nor a patient s family could identify when the symptoms began. 27 In those settings, the inability to identify the onset of the symptoms prevents tpa from being given. In a September 25, 2008, publication in the New England Journal of Medicine, Dr. Werner Hacke provided the results of a study called ECASS III. 28 The study conclusively showed that IV tpa can be given safely up to 4.5 hours after the onset of symptoms, and it can be given effectively. Administering the tpa from 3 to 4.5 hours increased the number of patients who benefitted from the therapy. On May 28, 2009, the Stroke Counsel of the American Heart Association formally accepted Dr. Hacke s work as setting a new time limit of 4.5 hours. Consequently, from May 28, 2009 to the present, tpa can be given within a 4½ hour window Overcoming Proximate Cause Defenses: Having established that the tpa should have been administered by the neurologist, the primary issue now becomes proximate cause. tpa is not a cure all, and does not work for all F.I.R.S.T. TM Program (Work Hardening/Conditioning) Functional Capacity Evaluations New Appointments Offered Within 24 Hours Early Morning, Afternoon & Evening Appointments Most Insurances Accepted Complimentary Injury Screenings Complimentary Patient Transportation Available! 12 Trial Journal Volume 17, Number 2 Summer 2015

5 patients. There have been numerous studies discussing the effectiveness. An apparent consensus from numerous studies shows that approximately 68 percent of the patients will do the same or worse even if tpa is given. 30 The weakness in this analysis is it evaluates all comers. Each of these studies primarily involved patients greater than 65 years of age. 31 It is well accepted within the neurology community that these patients do less well when they suffer a stroke. 32 Consequently, the sub-group of younger patients, such as our example patient, will do better. Next, the severity of the stroke at the time the patient is seen at the emergency department can play an important role. The milder the level of symptoms, the more likely a good outcome will be the result of tpa treatment. Those patients who come into the emergency department with an NIHSS stroke scale greater than 10 are less likely to see any significant improvement. Third, if the stroke is in the posterior circulation, as compared to the anterior circulation, IV tpa results tend to be much better. It seems that that area of the brain has less metabolic demand for oxygen glucose, providing a greater window of opportunity for improvement. Finally, the physician expert for the plaintiff can rely upon their personal experience to demonstrate that in subgroups, greater than 50 percent may survive without any significant disability once the IV tpa is administered. was impaired, but he remained understandable. He also began to complain of difficulty swallowing liquids. This is the symptom of dysphasia. On the morning after his admission, he underwent an MRI. The MRI demonstrated evidence of an infarction. (On a diffusion-weighted image a DWI evidence of infarction will show up as a bright white color, often referred to as light bulb bright.) The DWI images of this patient showed a bilateral medial medullary infarction. Obviously, this infarct was caused by an occlusion in the posterior circulation. By the time the MRI was completed, it had been more than 12 hours since the onset of the stroke. These images must be viewed carefully; the infarction may have been missed by the radiologist, a neuroradiologist, or the neurologist. If seen, the question then becomes what action was taken by the neurologist. 2. The Standard of Care In this setting, the standard of care may be breached if the neurologist does not recognize the stroke, or if the neurologist does diagnose stroke, does not recommend the administration of either intra-arterial tpa or endovascular mechanical extraction of the clot. 33 Intra-arterial tpa involves the advancement of a catheter from the femoral artery, up to the heart, and into the vertebral arteries to the point of the occlusion. 34 At that point, the thrombolytic agent is injected through the catheter into the occlusion itself. A third method is to use the same catheter to advance a mechanical tool referred to as a MERCI retriever or stent to open up the occlusion. 35 Here are examples of these devices: Covidien Solitaire MERCI Retriever C. Scenario Three: The Gift of Intra-Arterial tpa 1. The Facts Our same patient remained in the hospital overnight with a diagnosis of TIA. He did not regain any use of the left arm or left leg. They remained spastic, stiff, and weak. The left arm was actually rotated internally toward the chest. His ability to speak Arterial Stent Efficacy of treatment with IV tpa up to 4.5 hours after the onset of symptoms, or by administration of intra-arterial tpa or mechanical extraction of the clot, may time is brain continued on page 14 Volume 17, Number 2 Summer 2015 Trial Journal 13

6 time is brain continued from page 13 be challenged by defense experts. One of their arguments may be to refer to the lack of approval of these methods by the United States Food and Drug Administration. The admissibility of this testimony will vary from state to state. 36 In cases where it is admissible, most courts will consider it as evidence of the standard of care, rather than the standard of care. 37 From the plaintiff s perspective, the standard of care must be set by physicians, and not by a regulatory body of the federal government. If we assume that the FDA s lack of approval is admitted into evidence, plaintiff s attorney must be prepared to respond. The first response can be the wide acceptance of these treatment modalities by the medical community. This evidence will have to come from the plaintiff s expert. However, during the course of discovery, all the witnesses need to be questioned on the use of these methods. The more they recognize them as being accepted, the more unlikely that this defense will prevail with a jury and perhaps, the more likely such evidence could be excluded by a Motion in Limine. Next, the plaintiff must obtain and be prepared to use the literature to support the use of these treatment modalities despite the lack of FDA approval. This evidence can come from the plaintiff s expert, but it can also come through the defense expert. Third, the plaintiff must be prepared to introduce evidence that the FDA, by its own announcements, does not set the standard of care. The FDA determines whether a particular drug or treatment modality is safe and effective for use under a certain set of circumstances. Whether that drug or treatment modality would be used under different circumstances or a different group of patients depends on the individual discretion of the physician. This was explicitly recognized by the FDA in the context of off-label uses for medications. 38 Finally, plaintiff s counsel may also avail themselves of the numerous errors that have occurred due to the FDA pronouncements over the years. Many drugs and medical devices have been approved by the FDA, only to go on to cause serious harm Proximate Cause: The Doctrine of Lost Chance The final legal argument plaintiff will face is proximate cause. In 24 different jurisdictions, the doctrine of lost chance is recognized. Consequently, even if the plaintiff cannot provide expert testimony that the administration of the intravenous tpa, intra-arterial tpa, or other interventions reduce the risk of longterm disability by greater than 50 percent, the lost chance doctrine will provide an avenue to compensate the client for their harms and losses. In many states, this recovery will be for the full measure of damages. Plaintiff s counsel must be aware whether in their jurisdiction, recovery of damages is full or proportional. We get people back to work Rehabilitation Counselors have been serving clients throughout the State of Illinois for over 20 years. Counselors have extensive testimony experience before the Illinois Worker s Compensation other legal venues. our comprehensive assessment and evaluation protocol provide the clearest understanding of the disabled worker's potential 14 Trial Journal Volume 17, Number 2 Summer 2015

7 III. Conclusion Strokes are often deadly, and those who survive are commonly left with severe, debilitating injuries. Advances in medicine have provided physicians with ever-improving tools to increase a stroke victim s chances of making a full recovery. By continuing to advocate for change, and require accountability when these chances are missed by health care providers, we can play our part in advancing early intervention and positive outcomes. Endnotes 1 Time is Brain Quantified. Stroke 37, Stroke Declines from Third to Fourth Leading Cause of Death in the United States: Historical Perspective and Challenges Ahead. Stroke. 2011;42: American Heart Association. Heart Disease and Stroke Statistics 2011 Update. Dallas, Texas: American Heart Association; 2010; Stroke Awareness. Information for Patients. Stanford Hospital and Clinics. 4 The National Institute of Neurological Disorders and Stroke rt-pa Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333: TPA Stroke Study Group Guidelines. The Brain Attack Coalition. guidelines/tpa_guidelines.html. First Accessed 11/02/ Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American Heart Association/ American Stroke Association. Stroke Aug;40(8): The ECASS III results and the tpa paradox. Int J Stroke Feb;4(1): Intravenous or Intra-Arterial Thombolysis? Stroke. 2007;38: The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke Aug;40(8): Safety and efficacy of mechanical embolectomy in acute ischemic stroke: results of the MERCI trial. Stroke Jul;36(7): ; Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis. N Engl. J. Med 365(11): National Institutes of Neurological Disorders and Stroke (NINDS) (2011). Arteriovenous Malformations and Other Vascular Lesions of the Central Nervous System. Fact Sheet. 12 Acute Stroke Diagnosis. Am Fam Physician. Jul 1, 2009; 80(1): Guidelines for the Prevention of Stroke in Patients with Stroke or Transient Ischemic Attack: A Guideline for Healthcare Professionals from the American Heart Association/ American Stroke Association. Stroke. 2011, 42: Posterior Circulation Stroke. Foundation for Education and Research in Neurological Emergencies. Available at Lectures/ipcs%20intro% htm time is brain continued on page 16 For more than 40 years, we have helped clients develop comprehensive, cost-effective insurance programs, and offer a full range of services including: Property and Casualty Employee Benefits Life and Disability Insurance Private Client Insurance Structured Settlements Investment Management Global Markets Insurance Services Consulting mesirowfinancial.com Securities offered through Mesirow Financial, Inc. Member FINRA, NYSE, SIPC. Insurance services offered through Mesirow Insurance Services, Inc. Mesirow Financial refers to Mesirow Financial Holdings, Inc. and its divisions, subsidiaries and affiliates. The Mesirow Financial name and logo are registered service marks of Mesirow Financial Holdings, Inc. 2015, Mesirow Financial Holdings, Inc. All rights reserved. Volume 17, Number 2 Summer 2015 Trial Journal 15

8 time is brain continued from page Ibid. 16 Definition and Evaluation of Transient Ischemic Attack. Stroke 2009,40: Ibid. 18 Transient Ischemic Attack (TIA) Symptoms, Treatment and Medications. Accessed 12/8/ National Stroke Association guidelines for the management of transient ischemic attacks. Ann Neurol Sep;60(3): Guidelines for the Prevention of Stroke in Patients with Stroke or Transient Ischemic Attack: A guideline for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke. 2011, 42: See supra n See Guidelines for the Prevention of Stroke, supra n See Posterior Circulation Stroke, supra n See Guidelines for the Prevention of Stroke, supra n Royal College of Physicians Intercollegiate Stroke Working Party. National clinical guidelines for stroke, second edition. London, England: Royals College of Physicians, 2004: Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack. N Engl J Med. 369;1:11; Amplified Benefit of Clopidogrel HOW CAN YOU GET INVOLVED IN ITLA? Take advantage of the many membership benefi ts included with your ITLA membership. - EDUCATION - Educational CLE Programs - As an accredited MCLE provider, ITLA offers the most comprehensive civil educational programs in the state. Members receive reduced rates for 9 seminars annually. Educational Materials - Our course handbooks and CDs offer you legal education advancement at your home or offi ce, AND you have the opportunity to receive MCLE credit when you purchase and listen to seminar CD s. Notebooks for Trial - The Workers Compensation Notebook and the Medical Malpractice Trial Notebook are updated annually with the latest information. They are indexed, easy to read and save you hours of research time. Bonus: Now you can order the notebooks on CD. Load this on your laptop or ipad to take with you to the courthouse. versus Aspirin in Patients with Diabetes Mellitus. Am J Cardiol Sep 15; 90(6) Aspirin and clopidogrel compared with clopidogrel alone after recent ischemic stroke or transient ischemic attack in high-risk patients (MATCH): randomized, double-blind, placebocontrolled trial. Lancet 2004; 364:331-37; CHANCE Trial. Stroke. 2013;44: This can occur when the patient was by himself and is no longer able to relay the history or when the patient wakes up from a nap or a long sleep and now has symptoms. 28 Thrombolysis with Alteplase 3 to 4.5 Hours after Acute Ischemic Stroke. N Engl J Med. 2008;359: See TPA Stroke Study Group Guidelines, supra n % of the patients will have a better outcome if tpa is given within the 4.5 hour limit, 3% will have a catastrophic bleed due to the IV tpa, and the remaining 65% will have no change in their outcome despite the administration of IV tpa. 31 Thrombolysis in Young Adults with Ischemic Stroke. Stroke. 2009, 40: Ibid. 33 Long-term Outcome After Intravenous Thrombolysis of Basilar Artery Occlusion. JAMA. 2004;292(15): Clinical and Radiological Predictors of Recanalisation and Outcome of 40 Patients with Acute Basilar Artery Occlusion Treated with Intra-arterial Thrombolysis. J Neurol Neurosurg Psychiatry 2004;75: Intra-arterial Thrombolysis in Acute Basilar Artery Thromboembolism: The Initial Mayo Clinci Experience. Mayo Clin Proc 1997;72: See Stenting versus Aggressive Medical Therapy, supra n See, Thompson v. Carter, 518 So.2d 609, (Mississippi Supreme Court); Retkwa v. Orentreich, 584 N.Y.S.2d 710 (Sup. Ct. 1992) (This is, of course, a medical malpractice action, 16 Trial Journal Volume 17, Number 2 Summer 2015

9 not a products liability case, and as such non-fda approval of silicone would be generally inadmissible.). 37 Morlino v. Medical Ctr., 706 A.2d 721, 729 (N.J. Supreme Court) (holding that the FDA approval, does not outline a medical standard of care, in part because allowing FDA as relevant evidence of standard of care would not be consistent with the FDA s position that physicians are not bound by PDR recommendations). 38 See Physician s Desk Reference: The FDA has always recognized that the [Food, Drug, and Cosmetics] Act does not, however, limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may choose to prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. The FDA also observes that accepted medical practice often included [sic] drug use that is not reflected in approved drug labeling. 39 Market withdrawal of new molecular entities approved in the United States from 1980 to Pharmacoepidemiology and Drug Safety. 2011; 20: (drugs include Alatrofloxacin; Aprotinin; DePuy ASR Hip; Rofecoxib; Aprotinin). Kevin G. Burke represents plaintiffs in complex negligence cases. His main areas of practice include medical negligence and product liability. Mr. Burke is active in bar association work and lectures extensively on legal and liability topics. He has given lectures for the Chicago Bar Association, the Illinois Bar Association, the American Bar Association, the Illinois Trial Lawyers Association, several state trial lawyer associations and most often for the American Association of Justice. He has been named one of the Top Ten Lawyers in the State of Illinois by Illinois Super Lawyers for the years 2005 and 2006 as well as by Leading Lawyers Network for the years 2006, 2007, 2008, 2009, 2010, 2011, and Mr. Burke is a partner in the fi rm Burke Wise Morrissey & Kaveny in Chicago, Illinois. Greg Coplan is a founding partner of Coplan & Crane, Ltd., a practice of committed and energetic trial lawyers representing injury victims and their families in cases involving auto and trucking collisions, defective products, and medical negligence. A Super Lawyer since 2009, Greg also serves ILTA in many capacities, as lecturer at seminars, as co-chair of multiple committees, and since 1999, has authored chapters included in ILTA s Medical Malpractice Trial Notebook. David J. Rashid represents plaintiffs in personal injury and medical negligence cases. He is a member of the American Association for Justice, the Illinois Trial Lawyers Association, the Illinois State Bar Association and the Chicago Bar Association. Mr. Rashid graduated from George Mason School of Law in December Immediately after graduation, he joined the firm of Burke Wise Morrissey Kaveny as an associate and continues in that position today. LLC Theresa Ellingsen, RN BSN CLNC 335 East Geneva Road #260 Carol Stream, IL ellingsenandassoc.com ellingsenandassoc@att.net SAVE MONEY ON YOUR EXPERT WITNESSES! A Certified Legal Nurse Consultant Gets you through the pathophysiology Identifies the standard of care point for point Maps the issues Targets questions for your expert witness SPEND LESS TIME WITH PREMIUM EXPERT WITNESSES AT PREMIUM PRICES. Call today to get your free initial review and verbal report. Volume 17, Number 2 Summer 2015 Trial Journal 17