personal injury claim | Lane Brown, LLC

Kudos to the American Association for Justice (AAJ)! Today AAJ filed comments to the Federal Trade Commission (FTC) and the National Highway Traffic Safety Administration (NHTSA) on proposed rulemaking governing the regulation of used cars and the installment of event data recorders in cars, respectively.

The proposed rules by the FTC regarding the sale of used motor vehicles raised consumer protection concerns and AAJ’s comments focused on the liability issues expressed during the Regulatory Review Notice comment period. AAJ specifically opposes the creation of a “safe harbor” for car dealers even if they demonstrate compliance with proposed disclosure requirements.

Comments to NHTSA responded to the agency’s proposal that all light vehicles be equipped with event data recorders (EDRs) or “black boxes” by September 2014. AAJ urged NHTSA to strengthen their regulatory framework by enhancing the availability of EDR data as well as ensuring data accuracy. Also, data recorder equipment malfunctions should not bar litigants from fully investigating their cases through formal discovery requests.

Your parent or other loved one is admitted to a hospital or nursing home because they are ill, or have been injured. They are there because they need assistance or care that they can’t get in their home. Unfortunately, many times patients in hospitals and nursing homes aren’t given the attention they need, and suffer injuries because of malpractice or negligence in their hospital or medical care.

Another common concern for hospitalized patients is posed by the risk of falls. Patients are often disoriented, weak or sedated. Common issues associated with nurses and hospitals are falls due to the lack of the use of rails or supervision during transfers. An elderly confused patient, or a patient narcotized with pain medicine or sedatives, requires full length side rails up so they can’t fall out of bed.

Rails can be important aids in the protection of patients who may be combative, uncooperative or unstable patient. The failure to use rails appropriately may be the basis for a negligence claim. If the nurses’ notes show they did not raise the side rails, or if witnesses establish that the rails were not raised, and the patient falls out of bed and injures himself, those injuries may have been the result of negligence on the part of the hospital and the nurses. Physicians may also be responsible if the doctor was aware that the patient needed the protections afforded by side rails, but failed to order that they be used.

Nurses have an independent duty to ensure the safety of their patients, so you should look to examine the conduct of all three potential causes for the injury: the nurse, the hospital and the doctor. Nurses are trained, and need to be able to determine for themselves whether or not their patients need side rails. If they do, they can and must follow good nursing practice and hospital policy and raise the rails themselves, even without a doctor’s order. In fact, the question of when to use side rails is or should be indicated in the hospital rules of almost every hospital, as set forth by the Joint Commission on Accreditation of Hospitals (JCAH). If the hospital accepts elderly Medicare-insured patients, that hospital must be certified by the JCAH, and the JCAH states that with elderly, confused, or drugged patients, side rails must be used.

Were the Nurses Too Busy?

Sometimes, the nurses are just too busy to give their patients the care they need. Consider whether there was an emergency that required their attention to other patients. Maybe their unit was understaffed. Through the litigation process known as “discovery”, we can find this information, and obtain the “nursing orders” in effect for all the patients on that nursing unit (floor or ward) and their diagnoses. If the nursing unit was understaffed by a hospital looking to make higher profits from lower labor costs, it’s often easy to see why patients fail to receive the nursing and hospital care they need.

The American Hospital Association (AHA) has established new guidelines for managing patients who are suspected of having suffered a stroke. Eligible patients presenting to the hospital with ischemic stroke should receive recombinant tissue plasminogen activator (rTPA) within 60 minutes of arrival, according to the new ischemic stroke guidelines.
Published in Stroke, the guidelines include the following new or revised recommendations:
• Patients with suspected stroke should be quickly taken to the closest certified primary stroke center or comprehensive stroke center. If no such centers exist, they should be taken to the most appropriate institution that provides emergency stroke care.
• In community hospitals without onsite stroke expertise, telestroke consultation with stroke education and training for clinicians could help increase use of rTPA.
• Intravenous fibrinolysis may be considered in patients with mild stroke deficits, rapidly improving stroke symptoms, major surgery in the prior 3 months, and recent myocardial infarction.
• Efforts should be made to reduce the time from symptom onset to reperfusion with intra-arterial therapies.

The FDA has issued a “Warning Letter”, dated January 10, 2013, to St. Jude Medical, a company that manufactures many medical devices used throughout the world, including implantable cardiac devices. In the letter, St, Jude was advised that, during a 2012 inspection of St. Jude’s Sylmar, California facility, FDA investigators determined that St. Jude manufactured implantable cardiac leads which were “adulterated” under federal law, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. While St. Jude has responded to some of the concerns addressed by the investigators,the FDA has concluded that the responses were inadequate.

The FDA has asked St. Jude to provide written notice within fifteen business days from the date they received the warning letter of the specific steps St. Judey has taken to correct the noted violations, as well as an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again. They asked that St. Jude include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that the firm has taken. If St. Jude’s planned corrections and/or corrective actions will occur over time, they are to include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, St. Jude was asked to state the reason for the delay and the time within which these activities will be completed. Finally, the warning letter notes that St. Jude’s “response should be comprehensive and address all violations included in this Warning Letter.” We’ll see…but it looks like the FDA is finally running out of patience with St. Jude.

Cars and trucks that are too quiet? In fact, it appears that some vehicles are so quiet that they may be dangerous! The National Highway Transportation Safety Agency has proposed a new safety standard, as required by the Pedestrian Safety Enhancement Act (PSEA) of 2010, which proposes to establish a Federal motor vehicle safety standard (FMVSS) setting minimum sound requirements for hybrid and electric vehicles. This new standard would require hybrid and electric passenger cars, light trucks and vans (LTVs), medium and heavy duty, trucks, and buses, low speed vehicles (LSVs), and motorcycles to produce sounds meeting the requirements of this standard. This proposed standard applies to electric vehicles (EVs) and to those hybrid vehicles (HVs) which are capable of propulsion in any forward or reverse gear without the vehicle’s internal combustion engine (ICE) operating. This standard would ensure that blind, visually-impaired, and other pedestrians are able to detect and recognize nearby hybrid and electric vehicles, as required by the PSEA, by requiring that hybrid and electric vehicles emit sound that pedestrians would be able to hear in a range of ambient environments and contain acoustic signal content that pedestrians will recognize as being emitted from a vehicle.

Researchers have found that as many as 28% of adult patients in intensive care units die each year with a misdiagnosis,
and up to 8% die with a potentially fatal “major missed diagnosis,” such as pulmonary embolism or myocardial infarction.

These findings come from a meta-analysis of 31 autopsy-based studies (BMJ Qual Saf 2012; doi:10.1136/bmjqs-2012-000803), and might even understate the rate of missed diagnoses, said Bradford Winters, MD, PhD, associate professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, in Baltimore, who led the research.

“Since we did not include non-autopsy-based studies in our analysis, we did not evaluate misdiagnoses that did not result in death, but that are likely associated with increased morbidity health care costs,” Dr. Winters told General Surgery News.

The 31 studies–which were observational, mostly retrospective studies and largely based in the United States–included information from 5,863 autopsied adults who had died in an intensive care unit (ICU). The papers were published between 1966 and 2011. The analysis excluded publications that examined the rate of disease-specific misdiagnoses and studies
that did not include original data. A median of 43% of ICU deaths that occurred during the study period were autopsied.

The investigators turned to the Goldman Classification, widely used for autopsy findings, to group the misdiagnoses they identified. The criteria define class I errors as “missed major misdiagnoses with potential adverse impact on survival and that would have changed management”; class II errors as missed major diagnoses that would not have affected survival or altered the course of care; and class III and class IV errors as misdiagnoses related to the terminal disease but not related to death or unrelated to both disease and death, respectively.

The rate of misdiagnoses detected during autopsy ranged from 5.5% to 100%, with a 28% overall rate (1,632 of 5,863), the researchers found. Class I and class II errors accounted for 8% and 15% of misdiagnoses, respectively; class III and class IV errors accounted for 15% and 21%, respectively. Dr. Winters noted that some studies reported only the total number
of misdiagnoses and class I or class II errors, leaving the specific misdiagnoses of the remaining 41% unclear.

The most common class I and class II misdiagnoses reported in the studies were vascular events and infections.

The 8% rate of major and potentially lethal ICU misdiagnoses is higher than the 5% rate of lethal misdiagnoses documented in the general hospital population in a previous study (JAMA 2003;289:2849-2856). The difference, Dr. Winters explained, can be attributed to ICU-specific factors such as the inability of patients to communicate their medical history during the workup process and limited staff resources leading to “competition for care.” Factors not specific to the ICU, including an overload of information and cognitive errors that lead to a biased interpretation of patient data, also may play a role.

Richard Dutton, MD, executive director of the Anesthesia Quality Institute, in Park Ridge, Ill., who specializes in trauma, said several limitations may undermine the generalizability of the findings. “Most autopsied patients have some level of diagnostic uncertainty to begin with, which makes the population in this meta-analysis not completely representative of the general ICU population,” said Dr. Dutton, who was not involved in the research.

Some of the studies included in the meta-analysis were conducted before the introduction of more accurate and advanced imaging-based diagnostics, Dr. Dutton noted. And he questioned the effect that missed class I or class II diagnoses would have had on patient outcomes had they been identified. “If a patient is dying of septic shock, secondary events like myocardial infarction and pulmonary embolism, which are common during the immediate premortem period, may not have affected their survival.”