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Volume 29 Number 1 Spring 2018 THE JOURNAL OF egal Nurse Consulting FDA AND PRODUCT LIABILITY



PURPOSE American Association of Legal Nurse Consultants 330 North Wabash Ave. Suite 2000 Chicago, IL 60611 8774022562 3123215177 Fax 3126736655 Email Web site The purpose

ARTICLE SUBMISSION The Journal of Legal Nurse Consulting JLNC, a refereed publication, is the official journal of the American Association of Legal Nurse Consultants AALNC. We invite interested nurses

FROM THE PRESIDENT Presidents update M Debbie Pritts RN LNCC President, AALNC any of you reading this issue have survived some of the coldest weather we have had for a long time. Now spring is comi

FROM THE EDITOR What LNCs need to know about predatory journals Speaking of resources, Ive gotten some interesting emails from an active online community of nurse editors, the International Academy o

FROM THE EDITOR SAMPLE, ERRORS INCLUDED ... ARC always tries to welcome papers in every one of the subjects for distributed in its worldwide Journals in the wake of fitting examination and compelling

SCREENING SKILLS Test Your Case Screening Skills CASE 1 Patient underwent lap gastric bypass in March of 2008. By May, she was having trouble keeping any food or medications down, although she was tr

FEATURE FDA History, Medical Devices, and Searching the Medical Device Database Joanne Walker BSEd, RN The Food and Drug Administration is the oldest comprehensive consumer protecti

Dalkon Shield Dr. Perkins patent tractors mandated the reporting of adverse reactions to medical devices, postmarket monitoring of implants and other devices that pose a serious health risk, recall

FEATURE a patients death, serious illness, or serious injury the Mammography Quality Standards Act MQSA, 1992 requiring all mammography facilities in the United States to be accredited and certified

Although medical device reports MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unv

FEATURE Although this article has focused on the FDA and its regulation of medical devices, there are other registries that LNCs may consider consulting when researching a case. informed treatment d

EARN up to 250 PER HOUR SET YOUR OWN SCHEDULE GET PAID WHAT YOU ARE WORTH Whether you are in businesss for yourself or working for a company, Nurse Life Care Planning offers you the opportunity to e

FEATURE Litigation Involving Contaminated HeaterCooler Devices Used in OpenHeart Surgery Jane E. Barone BS RN LNCC Key Words device, openheart, NTM, nontuberculin M. chimaera, Mycobacterium chimaera,

Schematic of cardiopulmonary bypass circuit. to regulate blood temperature during cardiopulmonary bypass. The CDC learned that Stockert 3T HeaterCoolers, made in Germany, might have been contaminated

FEATURE Mycobacterium chimaera manufactured before September 2014 Perkins 2016. The FDA first issued warnings about the heatercooler infection risk in October 2015 after receiving at least 34 advers

Many hospitals have ordered new machines, but there is a backlog of orders. Some have sent letters to patients who have had open heart surgery at their facility warning them of NTM symptoms others hav

FEATURE The Legal Nurse Consultants Primer on Product Liability Cynthia Mascaranhas, RN, LNCC Keywords product liability, privity of contract, statute of limitations, statute of repose, learned inter

caused by that product. This includes the manufacturer of components, an assembling manufacturer, the wholesaler, and the retail store owner. Legal Information Institute, n.d. Product liability is a s

FEATURE In both product and medical malpractice liability, the plaintiff must prove that a duty was owed, and that duty was breached by a failure to meet the standard of care. In product liability, a

such cases, the manufacturer must ensure that adequate warnings accompany the drug and these side effects cannot become the basis of suit. Manufacturers have a duty to warn of all side effects of a dr

FEATURE When Is a Daubert Expert Not a Daubert Expert James Hanus, RN, BSN, OCN, MHAt hen expert witnesses are retained, be it for Plaintiff or defense, they must be able to pass the Daubert Test 1 a

misread the MRI at HRMC for medical negligence and violation of the Kentucky Consumer Protection Act KCPA and the federal Emergency Treatment and Labor Act EMTALA. Bentley contended the KCPA and EMTAL

FEATURE The Failed Experiment with the New Generation of Metal on Metal Hip Implants Hadley L. Matarazzo J.D. T 24 he first artificial hips with metal on metal articulation were introduced in 195

and the demand for hip replacement surgery in patients aged 45 and over more than doubled from 2000 to 2010.3 Much of the rise in demand can be attributed to a growing percentage of the population ove

FEATURE metal on metal hip implants between 2003 and 2010.14 No hip implant is without risk. A significant risk with metal on metal devices is shedding of metal debris, specifically cobalt and chromiu

Orthopedic surgeons continue to wrestle with questions on whether the risk of revision surgery is outweighed by the damage a metal on metal hip implant is causing a patient, and the risk of a poor out

FEATURE compared the PMA process to the 510k process and also held that under 510k there is no formal FDA review of safety and effectiveness. The Court thus allowed state law claims arising from injur

cost and an attorneys fee assessment on every case filed in the MDL. This is then used to compensate the members of the committees for their time and expenses incurred in pretrial proceedings. METAL

FEATURE Support surface technology An essential component of pressure injury prevention Paula Gruccio, MSN, RN, CWOCN, CPPS, Kathleen C. Ashton, PhD, RN, ACNSBC Keywords Pressure injury, pressure ulc

2014 to 20,900 to 151,700 AHRQ, 2015. Besides the financial burden that pressure ulcers place on the healthcare system, consider the human costs pain, effect on quality of life, infection, and possibl

FEATURE air loss, and some may have additional specialized functions, such as the ability to turn off the alternating feature under specific areas of the body as needed. Nixon, Cranny, and Inglesias 2

also considerations. A wound care professional is called upon to assist with support surface selection, in consultation with other members of the health care team, including physicians, nursing depart

FEATURE 2010. Microclimate in context in Pressure Ulcer Prevention Pressure, shear, friction and microclimate in context, a consensus document. London Wounds International. Finnegan, M. J., Gazzerro,

Medical Malpractice Verdicts, Settlements Experts Published Every Month Since 1984 Since 1989 the Nations Only Journal of Railroad Safety and Liability Published Every Month Since 1987 Ad Page Pr

FEATURE The Pathological Diagnosis of Malignant Mesothelioma Rhonda A. Fritz, BS, RN Keywords Surgical Pathology Malignant Mesothelioma Immunohistochemistry Differential Diagnosis Malignant mesotheli

of the diaphragm, and forms the subpleural membrane. The peritoneum forms a continuous layer over the abdominal structures, except for the ostia of the oviducts. The visceral peritoneum covers the int

Table A. Tumor immunoreactivity in the differential diagnosis of malignant mesothelioma Fritz, 2018 FEATURE TUMOR Adenocarcinoma 1 ANTIBODIES PanCK, CEA, BerEP4, CD15 LeuM1, B72.3, BG8, MOC31, TTF1

are generally, but not always, needed in identification of features of malignancy in desmoplastic mesotheliomas. Husain et al., 2017 A history of asbestos exposure should not be considered by the path

FEATURE A diagnosis of desmoplastic mesothelioma requires the storiform pattern a matted, irregularly whorled pattern, somewhat resembling that of a straw mat and one of stromal invasion bland nec

DIFFERENTIAL DIAGNOSIS The pathologist should document the process used to make the final diagnosis. If you have cytology reports of pleural effusion or ascites, check to determine whether or not the

THE JOURNAL OF egal Nurse Consulting Looking Ahead... XXIV.2, June 2018 EHR revisited XXIV.3, September 2018 Trials XXIV.4, December 2018 PediatricAdolescent Issues AND New Nurse Author Suppleme