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Mentor H S, Inc. v. Medical Device Alliance, Inc., 244 F.3d 1365, 1380 Fed. Cir. 2001 ; two-step process requiring the fact-finder first determine an accused infringer guilty of conduct, such as willfulness and second exercises discretion to determine if the damages should be increased given the totality of the circumstances ; . 7 Beckman Instruments, Inc., 892 F.2d 1449 at 1551. 8 Knorr-Bremse, 383 F.3d at 1342-43. 9 Andrx Pharmaceuticals, Inc. v. Biovail Corp., 276 F.3d 1368 Fed. Cir. 2002 ; . 10 See 21 U.S.C. 355 j ; 2 ; A ; U.S.C. 355 b ; 1 ; , c ; part of the approval process, an ANDA applicant must make one of four certifications addressing each patent listed in the Orange Book that claims the drug. 12 Each ANDA filed must contain a certification by the filer that in its opinion either I ; there is no patent information filed, II ; that any patents covering the drugs in the ANDA have expired, III ; that they will not market the drug in the ANDA until a time as such patents will exp ire, or IV ; that any patent listed are invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted. 13 These are commonly referred to as paragraph I, II, III, and IV certifications, respectively. When an ANDA contains a paragraph IV certification, the ANDA applicant must give notice to the patentee and the NDA holder and provide a detailed basis for its belief that the patent is not infringed, invalid, or otherwise unenforceable. 14 The patentee then has forty- five days to file suit against the ANDA applicant for patent infringement. If the patentee does not sue, the ANDA will be approved. If the patentee does file suit, the FDA may not approve the ANDA until expiration of the patent, resolution of the suit, or thirty months after the patentee's receipt of notice, whichever is earlier. Being the first to file a paragraph IV certification brings with it some risk of litigation, but also promises great rewards if successful. As a first filer a ge neric drug manufacturer enjoys a 180 day period of exclusivity in which to market its generic drug at a premium before other generic manufactures enter the marketplace. 15 The 180 days begins from the earlier of the first filer's commercial marketing of the drug or a decision of a court holding the patent invalid or not infringed. As a result some generics may rush to challenge a patent in the hopes of being the first to market. 16 A case brought under 21 U.S.C. 355, i.e., the "Hatch-Waxman Act, " like any other infringement action, can warrant the granting of attorney fees if it rises to the level of an exceptional case. 17 Specifically, 35 U.S.C. 271 e ; 4 ; authorizes the awarding of attorney fees under 285 when a patent challenger files a "paragraph IV" certification indicating its intent to commercially manufacture, use, or sell a drug prior to the expiration of the patent. While 35 U.S.C. 271 authorizes the award of attorney's fees under 285 for exceptional cases, the Federal Circuit has explicitly identified the types of conduct that that may give rise to an award of attorney fees for the purposes of 271 e ; 4 ; . Additionally, in Yamanouchi, the Federal Circuit affirmed the granting of attorney's fees under 271 e ; 4 ; based on Danbury's, because aldactone 100 mg.
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ACCoLAte . ACCuPRIL . See quinapril acetaminophen codeine acetazolamide . ACIPHeX . ACtIgALL . ursodiol ACtIVeLLA . ACtoNeL . ACtoS . ACuLAR . acyclovir . AdALAt CC nifedipine eR AddeRALL See amphetamine dextroamphetamine AdVAIR dISKuS . albuterol inhaler . albuterol sulfate tabs, syrup . ALdACtoNe . See spironolactone ALdoMet . See see methyldopa ALLegRA ALLegRA-d . allopurinol . alprostadil . ALReX . ALtACe . amantadine . AMARyL . AMBIeN . AMICAR . See aminocaproic aminocaproic acid . amiodarone . amitriptyline . amoxicillin . amoxicillin clavulanate . amphetamine dextroamphetamine . ampicillin . ANAPRoX . See naproxen sodium ANdRodeRM . ANdRoXy . ANtABuSe . ANtARA anthralin.
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TEST NAME Skin scrapings, hair, nails for Dermatophytes Sodium Sodium - 24 hr urine Sodium - fecal Sodium - random urine Somatomedin-C Insulin Like Growth Factor 1, IGF1 ; Sp. Gravity - fluid Spironolactone Alfactone ; Sputa, endotracheal aspirates, bronchial washings, BALs Sputa, endotracheal aspirates, bronchial washings, BALS Legionella Sputa, endotracheal aspirates, bronchial washings, BALS Mycoplasma pneumoniae Sputa, endotracheal aspirates, bronchial washings, BALS TB AFB Sputum Staclot LA Department Microbiology Clinical Pathology Clinical Pathology Clinical Pathology Clinical Pathology Clinical Pathology Clinical Pathology Clinical Pathology Microbiology Microbiology Microbiology Microbiology Anatomic Pathology Clinical Pathology Biochemistry Biochemistry Biochemistry Biochemistry Biochemistry Biochemistry Biochemistry Public Health Lab. Public Health Lab. Public Health Lab. Nat'l. Micro LabWinnipeg HSC Departmental Section Referred Out by Sunnybrook To: Public Health Lab. Public Health Lab.
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Department of Anesthesiology, University of Connecticut, School of Medicine, Farmington, CT 06015, United States] - ANESTH. ANALG. 2006 103 5 ; - summ in ENGL When conventional intubation methods fail, an accessory rescue airway device must be immediately available and rapidly deployed to assist the clinician in managing the airway. I reviewed an emergency intubation database to determine what airway devices were used as a backup to rescue the primary rescue device failures. The bougie and the laryngeal mask airway each have an intrinsic failure rate. The Combitube, commonly used in the emergency prehospital setting, appeared to be a useful secondary rescue device in the hospital setting when the bougie and laryngeal mask airway failed. 2006 by International Anesthesia Research Society. 387. Incidence and predictors of difficult and impossible mask ventilation - Kheterpal S., Han R., Tremper K.K. et al. [Dr. S. Kheterpal, 1H247 University Hospital, Box 0048, 1500 East Medical Center Drive, Ann Arbor, MI 48103, United States] ANESTHESIOLOGY 2006 105 5 ; - summ in ENGL BACKGROUND: Mask ventilation is an essential element of airway management that has rarely been studied as the primary outcome. The authors sought to determine the incidence and predictors of difficult and impossible mask ventilation. METHODS: A four-point scale to grade difficulty in performing mask ventilation MV ; is used at the authors' institution. They used a prospective, observational study to identify cases of grade 3 MV inadequate, unstable, or requiring two providers ; , grade 4 MV impossible to ventilate ; , and difficult intubation. Univariate and multivariate analyses of a variety of patient history and physical examination characteristics were used to establish risk factors for grade 3 and 4 MV. RESULTS: During a 24-month period, 22, 660 attempts at MV were recorded. 313 cases 1.4% ; of grade 3 MV, 37 cases 0.16% ; of grade 4 MV, and 84 cases 0.37% ; of grade 3 or 4 and difficult intubation were observed. Body mass index of 30 kg greater, a beard, Mallampati classification III or IV, age of 57 yr older, severely limited jaw protrusion, and snoring were identified as independent predictors for grade 3 MV. Snoring and thyromental distance of less than 6 cm were independent predictors for grade 4 MV. Limited or severely limited mandibular protrusion, abnormal neck anatomy, sleep apnea, snoring, and body mass index of 30 kg greater were independent predictors of grade 3 or 4 and difficult intubation. CONCLUSIONS: The authors observed the incidence of grade 3 MV to 1.4%, similar to studies with the same definition of difficult MV. Presence of a beard is the only easily modifiable independent risk factor for difficult MV. The mandibular protrusion test may be an essential element of the airway examination. 2006 American Society of Anesthesiologists, Inc. 388. Performance characteristics of five new anesthesia ventilators and four intensive care ventilators in pressure-support mode: A comparative bench study - Jaber S., Tassaux D., Sebbane M. et al. [Dr. Prof. S. Jaber, Department of Anesthesia and Critical Care B DAR B ; , H pital Saint Eloi, 80 avenue Augustin o Fliche, 34295 Montpellier Cedex 5, France] - ANESTHESIOLOGY 2006 105 5 ; - summ in ENGL BACKGROUND: During the past few years, many manufacturers have introduced new modes of ventilation in anesthesia ventilators, especially partial-pressure modalities. The current bench test study was designed to compare triggering and pressurization of five new anesthesia ventilators with four intensive care unit ventilators. METHODS: Ventilators were connected to a two-compartment lung model. One compartment was driven by an intensive care unit ventilator to mimic "patient" inspiratory effort, whereas the other was connected to the tested ventilator. The settings of ventilators were positive end-expiratory pressures of 0 and 5 cm H2O, and pressure-support ventilation levels of 10, 15, and 20 cm H2O with normal and high "patient" inspiratory effort. For the anesthesia ventilators, all the measurements were obtained for a low 1 l min ; and a high 10 l min ; fresh gas flow. Triggering delay, triggering workload, and pressurization at 300 and 500 ms were analyzed. RESULTS: For the five tested anesthesia ventilators, the pressure-support ventilation modality functioned correctly. For inspiratory triggering, the three most recent anesthesia machines Fabius, Dr gerwerk AG, L beck, Germany; Primus, Dr gerwerk a u a AG; and Avance, GE-Datex-Ohemda, Munchen, Germany ; had a 78.
Walk test on a patient-powered treadmill. J Card Fail 1996; 2: 133139. Bayliss J, Norell M, Canepa-Anson R et al. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J 1987; 57: 1722. Packer M, Bristow MR, Cohn JN et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. US Carvedilol Heart Failure Study Group. N Engl J Med 1996; 334: 13491355. Australia New Zealand Heart Failure Research Collaborative Group. Randomised, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Lancet 1997; 349: 375380. Packer M, Coats AJ, Fowler MB et al. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001; 344: 16511658. CIBIS-II Investigators and Committees. The cardiac insufficiency bisoprolol study II CIBIS-II ; : a randomised trial. Lancet 1999; 353: 913. MERIT-HF Study Group. Effect of metoprolol CR XL in chronic heart failure. Metoprolol CR XL randomised intervention trial in congestive heart failure MERIT-HF ; . Lancet 1999; 353: 20012007. The RESOLVD Investigators. Effects of metoprolol CR in patients with ischemic and dilated cardiomyopathy. Circulation 2000; 101: 378384. Flather MD, Shibata MC, Coats AJ et al. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure SENIORS ; . Eur Heart J 2005; 26: 215225. The Capricorn Investigators. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001; 357: 13851390. The Beta-Blocker Evaluation of Survival Trial Investigators. A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure. N Engl J Med 2001; 344: 16591667. Poole-Wilson PA, Swedberg K, Cleland JG et al. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial COMET ; : randomised controlled trial. Lancet 2003; 362: 713. Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactonr Evaluation Study Investigators. N Engl J Med 1999; 341: 709717. Pitt B, Remme W, Zannad F et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 2003; 348: 13091321. Granger CB, McMurray JJ, Yusuf S et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. Lancet 2003; 362: 772776. Pfeffer MA, Swedberg K, Granger CB et al. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. Lancet 2003; 362: 759766. Maggioni AP, Anand I, Gottlieb SO et al. Effects of valsartan on morbidity and mortality in patients with heart failure not receiving angiotensin-converting enzyme inhibitors. J Coll Cardiol 2002; 40: 14141421. Cohn JN, Tognoni G. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 16671675. Pfeffer MA, McMurray JJ, Velazquez EJ et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003; 349: 18931906. McMurray JJ, Ostergren J, Swedberg K et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet 2003; 362: 767771. Jong P, Demers C, McKelvie RS et al. Angiotensin receptor blockers in heart failure: meta-analysis of randomized controlled trials. J Coll Cardiol 2002; 39: 463470. Coletta AP, Cleland JG, Freemantle N et al. Clinical trials update from the European Society of Cardiology: CHARM, BASEL, EUROPA and ESTEEM. Eur J Heart Fail 2003; 5: 697704 and
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S in the management of almost any medical condition, the best pharmacotherapeutic approach in the management of acute and chronic pain is no drug therapy at all. However, the option of not using drugs in managing many pain syndromes is not realistic. When a clinician has determined that the pain condition is substantial enough to affect the patient's quality of life and that it cannot be treated solely with physical medicine eg, ice packs, massage, physical therapy ; , drug therapy is indicated. When drug therapy is contemplated, there are several important principles to keep in mind. This article reviews important principles in the drug management of pain.
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Fortunately, treatment of heart failure continues to advance. Diuretics remove excess fluid. Digoxin helps the heart pump better. Medications called ACE inhibitors reduce blood pressure, unburden the heart, and improve survival. A drug called aldactoone prevents salt retention by the kidney. Beta blockers reduce stress to the heart, and also improve survival. These interventions, together with a healthy, low-salt diet and close medical follow-up, can lead to very good outcomes in CHF. But even despite optimal medical care, CHF may progress, and often leads to functional limitations. There is interest in finding ways to prevent the functional impairment CHF causes, and at the Prevention Research Center, we're doing our part. We will soon be starting a study using counseling and gentle exercise to try and improve function and quality of life in heart failure. If you or someone you.
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Section IV: Membership and Eligibility Table of Contents Subject . Page Membership and Eligibility .2 Involuntary Disenrollment . 2-5 Policy . 2-3 Procedure. 3-5 Patient Review and Restriction .5 Member Identification . 5-7 Healthy Options . 5-6 Children's Health Insurance Program .6 Basic Health.7 Public Employees Benefits Board.7 Eligibility Verification. 7-8 Community Health Plan of Washington Member Services.8 Community Health Plan of Washington PCP Assignment Procedures.8.
Table 1. Applying Classification of Recommendations and Level of Evidence "Size of Treatment Effect and atarax and aldactone, for example, aldactone interaction.
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2. Request Restrictions You have the right to ask us to restrict how we use or disclose your health information. We will consider your request. But we are not required to agree. If we do agree, we will comply with the request unless the information is needed to provide you with emergency treatment. We cannot agree to restrict disclosures that are required by law. 3. Confidential Communication If you believe that the disclosure of certain information could endanger you, you have the right to ask us to communicate with you at a special address or by a special means. For example, you may ask us to send explanations of benefits that contain your health information to a different address rather than to your home. Or you may ask us to speak to you personally on the telephone rather than sending your health information by mail. We will agree to any reasonable request. 4. Inspect And Receive a Copy of Health Information You have a right to inspect the health information about you that we have in our records, and to receive a copy of it. This right is limited to information about you that is kept in records that are used to make decisions about you. For instance, this includes claim and enrollment records. If you want to review or receive a copy of these records, you must make the request in writing. We may charge a fee for the cost of copying and mailing the records. To ask to inspect your records, or to receive a copy, contact the person listed under "Whom to Contact" at the end of this notice. We will respond to your request within 30 days. We may deny you access to certain information. If we do, we will give you the reason, in writing. We will also explain how you may appeal the decision. 5. Amend Health Information You have the right to ask us to amend health information about you which you believe is not correct, or not complete. You must make this request in writing, and give us the reason you believe the information is not correct or complete. We will respond to your request in writing within 30 days. We may deny your request if we did not create the information, if it is not part of the records we use to make decisions about you, if the information is something you would not be permitted to inspect or copy, or if it is complete and accurate. 6. Accounting of Disclosures You have a right to receive an accounting of certain disclosures of your information to others. This accounting will list the times we have given your health information to others. The list will include dates of the disclosures, the names of the people or organizations to whom theinformation was disclosed, a description of the information, and the reason. - 49.
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J. Each person can stop drawing cards whenever they choose to do so. k. When everyone is finished drawing choice cards, turn the risk cards over. l. Ask each student to add up the value of his or her risk card and choice cards for his or her final total. m. Ask who has a total over their switch value. 6. After everyone has finished, discuss the results. Questions and topics that can be covered: a. How do the students think the game relates to drug addiction? b. What are the differences between drug abuse and addiction? c. How many choice cards did everyone pick? d. How many people went over or equaled their switch value? e. Discuss who went over the switch value. f. Did everyone have the same switch card? Why or why not? g. Did everyone have the same risk card? Why or why not? h. Why couldn't you see your risk card until the end of the game? 7. Have the students repeat the game now that they know that it represents the risk of addiction. 8. After everyone has played a few times, discuss whether people were less risky the second time they played. If so, why? If not, why?.
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