By Nancy Fraser, RN, CEO
The number and range of occupational respiratory concerns are rapidly increasing, and include the following:
· Asbestos
· Mesothelioma
· Silicosis
· Interstitial Pulmonary Fibrosis
· Popcorn Workers’ Lung
· Wood Dust
· Benzene–Related Diseases
These cases are medical record intensive with many critical details that can be used as ammunition for litigation. Understanding the various medical and diagnostic aspects of each disease etiology is important in knowing what to look for and how to strategize.
All organ systems in the body can be targets of toxic exposure. The respiratory system is both a target organ and a portal of entry for toxicants. As a foundational starting point, let us recall our basic anatomy and physiology. As air is inhaled through the nose and mouth, it collects in the throat and passes through the trachea into the lungs. The windpipe divides into right and left bronchiole tubes. The right lung is divided into 3 lobes, the left into 2. The lungs are surrounded by a membrane, pleura, which separate it from the chest wall. The pleura are mesothelium. The bronchiole tubes are lined with Cilia, hairs that move and combine with mucous, which is the mechanism for carrying unwanted dust, germs and matter up and out of the trachea, which is then coughed up. The smallest subdivisions of the bronchial tubes are called bronchioles, at the end of which, are the air sacs or alveoli. The alveoli are the final destination of the air we breathe and it is here that the exchange of oxygen and carbon dioxide occur in the capillaries.
Picture 1 – Normal bronchioles
As a system of narrowing passageways, any disease or reaction that affects the diameter of the bronchioles impacts breathing, respiration, cardiovascular function, and tissue perfusion. If Cilia and mucus production are impacted, particles are not carried out of the airways. So, any person with pre-existing diseases that restrict airways, such as asthma, COPD (chronic obstructive pulmonary disease), or bronchitis may progress more rapidly with asbestos related disease.
Picture 2 – Asthmatic bronchioles
Most occupational respiratory diseases either manifest as common medical problems or have non-specific symptoms. Etiology distinguishes a disorder as an occupational illness. Unless an exposure history is pursued by the doctor, the etiological diagnosis might be missed, treatment may be inappropriate, and the exposure can continue.
Most people with an illness brought on by exposure to a toxin obtain their medical care from doctors who are not specialists in occupational medicine. Very few providers get information about home, workplace, or community environment as a part of the demographic and social history. There was a recent study of 1000 medical charts in a primary care setting and only 24 percent of charts had any mention of the patients’ occupation, and only 2 percent had exposure history. Although most doctors recognize the importance of taking a work and exposure history to evaluate certain problems, most have little practice in doing so.
Asbestos
Picture 3 – Asbestosis Inflammation
This is a microscopic view of an Asbestos fiber coated by protein surrounded by macrophages. There is conflicting evidence regarding the relative importance of the different physical properties of the asbestos fiber types in causing disease. Certainly, fine fibers are more pathogenic than thick fibers. Larger diameter fibers that are longer tend to become deposited in larger airways, in which they are effectively cleared. In comparison, fibers that are more slender and shorter tend to be deposited in the smaller airways, from which only a portion of them are cleared. Despite differences in their physical properties, all types of asbestos fibers are fibrogenic.
The most recent data from the CDC in 2005 show us that deaths from asbestosis have been on the rise since the late 70’s with a peak in 2000. Asbestosis is reported to develop in 49 percent of adults with industrial asbestos exposure, after a latency period of 20 - 45 years. These patients present clinically with chest pain, pain with breathing, fatigue and clubbing of the fingers.
Asbestosis is diagnosed on the basis of certain clinical, functional, and x-ray findings, as outlined by the American Thoracic Society. These criteria include:
· A Reliable history of non trivial exposure
· Appropriate interval between exposure and detection
· Abnormal chest x-ray
· Abnormal pulmonary function test
· Abnormal diffusing capacity
· Bilateral crackles at the base of the lungs not cleared with coughing
Picture 4 – Diagnostic X-Ray
This x-ray is virtually diagnostic of asbestos exposure with bilateral scattered pleural plaques. Note that there are limitations with x-rays; studies have shown a high rate of both false negative and false positive rates. Extrapleural fat mimics pleural thickening and is a significant cause of false positive readings. 20 percent of asbestos patients have normal chest x-rays. That being said, x-ray is still the preferred modality for initial detection and characterization of pleural disease.
High Resolution Cat Scans are more sensitive and specific than chest x-rays and are playing an increasingly important role in the diagnosis of all asbestos related pleural disease. Other modalities that are being utilized include ultrasound and nuclear medicine, ultrasound to define pleural effusions and guide aspirations, and biopsy. Nuclear medicine is being used to differentiate benign from malignant asbestos-related pleural disease and to give a quantitative index of inflammatory activity.
In looking at the medical records, these studies will all be documented by radiology reports in the diagnostic test section, and will be referenced by physicians in the history and physical, progress notes, consultation notes, and the hospital admission and discharge records.
Mesothelioma
The mesothelium is a membrane that lines the cavities of the body, such as the chest and abdomen, and covers and protects the body’s internal organs. In the chest the mesothelium is known as the pleura, where it covers the lungs and lines the internal chest wall. In the abdomen it is called the peritoneum. Around the heart it is called the pericardium. The mesothelium is only one cell layer thick.
The CDC released figures in 2002 showing the breakdown of types of mesothelioma deaths in 1999. Although most malignant mesothelioma occurs in the lung, there are a substantial number of peritoneal occurrences; it may also arise in the ovaries, scrotum, or pericardium. The lifetime risk of developing mesothelioma among asbestos workers is thought to be as high as 10 percent. The average asbestos worker has a 50 percent chance of dying from a malignancy, compared to around 18 percent for the average American.
Asbestos exposure acts synergistically with cigarette smoking to increase the risk of developing lung cancer. Even with the long latency of approximately 30 to 40 years, cigarette smoking is NOT AT ALL associated with mesothelioma.
The earliest manifestations of asbestos-related disease, including mesothelioma, are pleural effusions, which present as shortness of breath or coughs. These typically occur within 10 years of exposure and they can be self-limiting, chronic, or recurrent. The first symptoms mimic so many other illnesses that unless the primary care physician takes a detailed occupational history, all of these other diseases will be ruled out first, which partially explains why the average survival rate is 10 months once diagnosed.
Because the mesothelial layer is only one cell layer thick, mesothelioma is not reliably detected on CT or MRI. The only way to diagnosis it is through tissue biopsy. There are no screening tests, even for those at high risk. There may, however, be some promise in a new blood test recently approved by the FDA. Mesomark is a biomarker assay test that identifies levels of soluble metholin-related peptide levels in persons who have a history of asbestos exposure. Currently, the test is utilized only as a monitoring and management tool in those already diagnosed with mesothelioma, but has potential to be a useful tool in measuring levels of metholin peptides in workers as a screening process for exposure levels.
John - Didn’t you have a case recently where Mesomark could have been helpful?
Silicosis
Silicosis is relatively rare in the US. It has declined by 90 percent from 1968 to 2002. Silicosis is characterized by nodular lesions and progressive fibrosis.
Picture 5 – Healthy Lung & Picture 6 – Diseased Lung
With a lung like this, the patients would have decreased pulmonary function, decreased chest expansion, and abnormal breath sounds. Again, an exposure history is critical. Although the incidence of Silicosis is significantly decreased, it does not stop the litigation; there are 65 cases in California alone.
Valley Fever is a lung infection caused by an airborne fungus that is contracted in arid dessert environment. It is diagnosed through a positive Cocci skin test. So unless a doctor has reason to suspect Valley Fever through a good history, other causes of pleural effusion would be ruled out first. It is very easy to see how this diagnosis would be confused.
Popcorn Workers’ Lung
Another area of potential concern in the Interstitial Pulmonary Fibrosis arena is what is being collectively referred to as “Popcorn Workers’ Lung.”
Picture 7 – Popcorn Workers’ Lung
Bronchiolitis Obliterans is a rare life threatening form of fixed obstructive lung disease. Symptoms present 2 to 8 weeks after a respiratory illness or toxic exposure. There are 14 different toxic fumes which are known to cause this disease, including diacetyl, the agent in flavoring used in popcorn plants. Patients have a dry cough, shortness of breath, and wheezing, so it is often misdiagnosed as asthma, bronchitis, or pneumonia. It is diagnosed by history, spirometry (the measuring of breath), and CAT scan, with a normal diffusing capacity of the lung. It is irreversible and these patients may need a lung transplant. Prevention relies on early detection of abnormal spirometry.
Wood Dust
Another area of potential concern is Interstitial Pulmonary Fibrosis and cancer from Wood Dust exposure. Wood dust exposure can cause pulmonary fibrosis and upper respiratory cancers of the nose, sinus, and larynx. These are associated with hard wood exposure. There are too few studies of any type to evaluate cancer risks attributable to exposure to softwood alone.
Currently, there are no consistent findings to indicate that occupational exposure to wood dust has a causal role in cancers of the pharynx, lung, lymphatic, and blood systems, or stomach, colon, or rectum.
To effectively manage and litigate these cases, attorneys must understand the primary diagnosis and the scientific causal link to the exposed toxins. The medical records provide critical information.
Start with a detailed review of the records and imaging studies. Understand not only the “Rule In” but the diseases that were “Ruled Out” and what tests were used to make a diagnosis. Does the diagnosis fit within the disease parameters? Understand the occupational exposure history. Identify all of the plaintiff’s symptoms with the numerous alternative causations possibilities to be explored. Understand the co-existing medical factors that potentiate the disease. Include the employment records in the medical record chronology to easily see the exposure symptom relationship. Use the medical records to determine which experts are needed. Get an early IME.
Benzene-Related Diseases
Benzene causes AML (acute myeloid leukemia), but does it cause all diseases in the universe of leukemia? With benzene known to effect bone marrow, there is a rather large leap that is being taken by plaintiff counsels to link exposure to all types of blood dyscrasias. Take non-Hodgkin’s lymphoma, which has gone from being relatively rare to being the fifth most common cause of cancer in the U.S.
Picture 9 – Lymphoma Incidence
This is something to worry about. From a risk management perspective, the numbers are big. As the fifth most common cancer, the incidence of lymphoma has risen 85 percent in less than 30 years. There are over five hundred thousand people with lymphoma today, 70 thousand new cases this year, with 20 thousand deaths annually.
The key to successful litigation in these cases is in getting a good handle on the medical aspects of the case early. It is Med Legal’s responsibility to abstract the critical information from the medical records, and to identify vital occupational respiratory disease indicators, even when a detailed occupational history is not available. This knowledge is critical to our Clients in making these cases winnable.
Wednesday, April 22, 2009
Tuesday, April 14, 2009
Wyeth v. Levin: Supreme Court Rules in Favor of Patients’ Right to Sue Drug Makers
By Nancy Fraser, RN, CEO
In the matter of Wyeth v. Levine, the Supreme Court ruling came down against Wyeth. This is known as the “Preemption” case. A ruling in the other direction would have wiped out the pharmaceutical mass tort industry and taken away all of our protection as consumers relating to drug safety. The following article was published on March 4, 2009, the day of the ruling.
The Supreme Court today upheld the right of patients who are hurt by a prescription or over-the-counter drug to sue the drug maker for damages. The 6-3 decision rejected a strong move by the Bush administration and the pharmaceutical industry to shield drug makers from lawsuits if their products were approved by the Food and Drug Administration. At issue were suits involving the more than 11,000 drugs on the market in the United States. The outgoing Bush administration told the court last fall that federal approval of a drug “preempts,” or bars, juries from deciding whether it is unduly dangerous. But the high court, led by Justice John Paul Stevens, disagreed and said Congress had not taken away the consumer's right to sue. He said the view of the Bush administration "does not merit deference," particularly considering that the FDA prior to the Bush era had favored lawsuits as a means of protecting consumers from dangerous drugs.
Today's ruling upholds a nearly $7 million jury verdict in favor of a Vermont musician whose right arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The injection struck an artery and caused gangrene, a rare but occasional complication from directly administering Phenergan, the anti-nausea drug. Diana Levine, the Vermont woman, settled a suit against the clinic that gave her the injection and then sued Wyeth. She contended that the drug maker had not properly warned her and other consumers of the danger. In its defense, Wyeth said the federally approved warning label told doctors and nurses to use extreme caution when injecting the drug. Levine and her lawyers said that was not sufficient. Who would take an injection to relieve nausea, she asked, if a patient knew she could lose her arm as a result? The jury agreed with her and awarded her $6.7 million in damages. In its appeal in Wyeth v. Levine, the drug company argued that since the FDA had approved its warning label as adequate, a jury should not have the power to second-guess this conclusion. “Congress has repeatedly declined to preempt state law,” Stevens said today. “Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling.” Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer agreed with him. Justice Clarence Thomas concurred in the result. Thomas has been reluctant to go along with decisions that say federal regulations trumps state law. The dissenters were Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. “This case illustrates that tragic facts make bad law,” Alito wrote. He called the result “a frontal assault on the FDA's regulatory regime for drug labeling.”
The defense argued that because the federal government (via the FDA) regulates drugs, patients should not be allowed to sue in state court when drug makers follow the rules established by the FDA. Fortunately, the court rejected this argument. Justice Stevens wrote the majority opinion, “We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations.” He was joined in his opinion by Kennedy, Souter, Ginsburg, and Breyer. Thomas wrote an opinion that was in agreement with this. But Roberts Alito, and Scalia dissented.
Wyeth’s lawyer was quoted saying, “We believed that Federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label.”
Levine’s lawyer commented on the ruling, “The Supreme Court’s opinion reaffirms the important role state law plays in promoting consumer safety and providing compensation for injuries. More importantly, the decision permits Ms. Levine to put this chapter behind her and to move on with her life.”
In a story that received coverage from many news sources, the New York Times (3/5, A1, Liptak) reports on its front page, "In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators." The decision "could have significant implications beyond drug manufacturing" and "many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation."
The Washington Post (3/5, A2, Barnes) reports, “The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.”
The Associated Press (3/5) reports, “The Supreme Court” upheld “a $6.7 million jury award to a musician who lost her arm to gangrene following an injection.” The plaintiff, “Diana Levine of Vermont once played the guitar and piano professionally” and “her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered.” There were many other outlets that covered the Wyeth ruling, including: Business Week (3/5, Johnson), CBS News (3/5, Cohen), the San Francisco Chronicle (3/5, Egelko), the Wall Street Journal (3/5, Bravin), the Legal Times (3/5, Mauro) reports, the AP (3/5, Curran), the Legal Intelligencer (3/4, Passarella), the Los Angeles Times (3/5, Savage), Dow Jones Newswires (3/5, Anderson), USA Today (3/5, Biskupic, Appleby), UPI (3/4) ABC World News (3/4, story 9, 0:30, Gibson), CBS Evening News (3/4, story 4, 2:00, Couric) and NBC Nightly News (3/4, story 5, 2:05, Williams).
Drug industry may face more litigation after ruling. The Financial Times (3/5, Jack) reports, “Pharmaceutical companies face substantial extra litigation after the US Supreme Court ruled yesterday that safety warnings on their drugs approved by federal regulators did not protect them from lawsuits in individual states.” The ruling “marks the failure of efforts by the industry to fight legal settlements by imposing federal pre-emption, an argument that had been supported by George W. Bush's administration.”
Bloomberg News (3/4, Stohr) reported that now drugmakers can be sued “for failing to provide adequate safety warnings.” Justice John Paul Stevens wrote in the opinion, “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” The ruling “might help former users of Wyeth's Prempro and Premarin menopause drugs and consumers of AstraZeneca Plc's antipsychotic drug Seroquel.” However, “the impact isn't clear for allegations that Pfizer Inc. and GlaxoSmithKline Plc should have done more to warn that their anti-depressants might cause suicidal tendencies.”
The Philadelphia Inquirer (3/5, Hill) reports that Sol Weiss, a Philadelphia plaintiffs' lawyer, said, “This doesn't mean you're going to win, but you get your day in court.” He is “not involved in this case” but “he is hoping that the decision will revive his cases involving Pfizer Inc.'s antidepressant Zoloft and GlaxoSmithKline P.L.C.'s antianxiety agent Paxil.” The Wall Street Journal (3/5, Johnson, Mundy, Bravin) also covers the story.
Ruling may make drugmakers more cautious, halt development. The AP (3/5) reports that the ruling “could make drugmakers more cautious about safety issues and may lead them to halt development of some medicines and even pull others off the market.” Erik Gordon, an analyst and professor at University of Michigan's Ross School of Business, said, “They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug.”
Ruling seen as contradictory to medical device case. The New York Times (3/5, B1, Meier, Singer) reports on the front page of its Business Day section that the “result of a decision Wednesday by the Supreme Court” was that “federal law does not protect drug companies from product liability suits in state courts.” However, “in contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.” David C. Vladeck, a professor at Georgetown University Law Center, said, “I think this is going to force Congress to revisit the issue of why medical devices should be insulated from lawsuits.”
Wyeth loss seen as possible victory in disguise. Forbes (3/5, Fisher) reports, “Wyeth's loss dashes the hopes of those who support pre-emption as a tactic for cutting back on excessive jury awards in product-liability cases, which the court affirmed last year in Riegel v. Medtronic.” However, “Wyeth v. Levine may be a victory in disguise. By stepping back from the brink and refusing to give drug companies federal immunity from suits under state laws, the court has likely prevented an even more toxic response from the Democrat-controlled Congress.”
Papers weigh in on Wyeth ruling. The Wall Street Journal (3/5) editorializes, “The decision is a huge victory for plaintiffs lawyers, but it's a much bigger defeat for drug innovation and public health.” The Journal adds, “Yesterday's ruling will expose drug companies to a kind of double innovation jeopardy.” Concluding, the Journal argues that now drug companies “will have to contemplate paying up front -- and paying later, even if the tragic mistake in applying the drug is someone else's. Wyeth is a dream come true for the plaintiffs bar.”
In stark contrast, the New York Times (3/5) editorializes, “The Supreme Court made a wise and surprising decision on Wednesday when it rejected a drug company's claim that it cannot be sued for damages in state courts if a product and its label have been approved by the Food and Drug Administration.” The ruling “demolished the notion that federal regulatory rulings automatically pre-empt the states from enforcing even tougher standards on drugs” and “also exposed as a sham the Bush administration's strenuous efforts to protect its allies in industry with phony pre-emption claims.” The Times concludes, “We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well.”
Wyeth decision seen as not enough to end Michigan's drug law. In an op-ed in the Detroit Free Press (3/5) Henry Greenspan, who teaches about the FDA, ethics and policy at the University of Michigan, writes, “Today was a good one for justice in America – but we in Michigan remain saddled with a law that is based on precisely the argument the high court rejected.” He adds that the court's decision in Wyeth “is not enough to end Michigan's statute.” Greenspan concludes, “The state senators who have blocked repeal will now have to argue that they know better than two-thirds of the Supreme Court” and “they will have to explain why they maintain a view of the FDA that the court called ‘meritless’ and ‘untenable.’”
Ultimately, the Supreme Court’s ruling has put the safety of the patient back in the consumers’ hands, keeping the pharmaceutical mass tort industry alive.
“Supreme Court Rules in Wyeth v. Levine” The Wall Street Journal Health Blog 4 March 2009.
“Supreme Court Backs Patients’ Right to Sue Drug Makers” Baltimoresun.com. 4 March 2009.
“Supreme Court’s Wyeth ruling “a major setback” for drug industry.” 5 March 2009. American Association for Justice.
Medical records management
In the matter of Wyeth v. Levine, the Supreme Court ruling came down against Wyeth. This is known as the “Preemption” case. A ruling in the other direction would have wiped out the pharmaceutical mass tort industry and taken away all of our protection as consumers relating to drug safety. The following article was published on March 4, 2009, the day of the ruling.
The Supreme Court today upheld the right of patients who are hurt by a prescription or over-the-counter drug to sue the drug maker for damages. The 6-3 decision rejected a strong move by the Bush administration and the pharmaceutical industry to shield drug makers from lawsuits if their products were approved by the Food and Drug Administration. At issue were suits involving the more than 11,000 drugs on the market in the United States. The outgoing Bush administration told the court last fall that federal approval of a drug “preempts,” or bars, juries from deciding whether it is unduly dangerous. But the high court, led by Justice John Paul Stevens, disagreed and said Congress had not taken away the consumer's right to sue. He said the view of the Bush administration "does not merit deference," particularly considering that the FDA prior to the Bush era had favored lawsuits as a means of protecting consumers from dangerous drugs.
Today's ruling upholds a nearly $7 million jury verdict in favor of a Vermont musician whose right arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The injection struck an artery and caused gangrene, a rare but occasional complication from directly administering Phenergan, the anti-nausea drug. Diana Levine, the Vermont woman, settled a suit against the clinic that gave her the injection and then sued Wyeth. She contended that the drug maker had not properly warned her and other consumers of the danger. In its defense, Wyeth said the federally approved warning label told doctors and nurses to use extreme caution when injecting the drug. Levine and her lawyers said that was not sufficient. Who would take an injection to relieve nausea, she asked, if a patient knew she could lose her arm as a result? The jury agreed with her and awarded her $6.7 million in damages. In its appeal in Wyeth v. Levine, the drug company argued that since the FDA had approved its warning label as adequate, a jury should not have the power to second-guess this conclusion. “Congress has repeatedly declined to preempt state law,” Stevens said today. “Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling.” Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer agreed with him. Justice Clarence Thomas concurred in the result. Thomas has been reluctant to go along with decisions that say federal regulations trumps state law. The dissenters were Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr. “This case illustrates that tragic facts make bad law,” Alito wrote. He called the result “a frontal assault on the FDA's regulatory regime for drug labeling.”
The defense argued that because the federal government (via the FDA) regulates drugs, patients should not be allowed to sue in state court when drug makers follow the rules established by the FDA. Fortunately, the court rejected this argument. Justice Stevens wrote the majority opinion, “We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations.” He was joined in his opinion by Kennedy, Souter, Ginsburg, and Breyer. Thomas wrote an opinion that was in agreement with this. But Roberts Alito, and Scalia dissented.
Wyeth’s lawyer was quoted saying, “We believed that Federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label.”
Levine’s lawyer commented on the ruling, “The Supreme Court’s opinion reaffirms the important role state law plays in promoting consumer safety and providing compensation for injuries. More importantly, the decision permits Ms. Levine to put this chapter behind her and to move on with her life.”
In a story that received coverage from many news sources, the New York Times (3/5, A1, Liptak) reports on its front page, "In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators." The decision "could have significant implications beyond drug manufacturing" and "many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation."
The Washington Post (3/5, A2, Barnes) reports, “The 6 to 3 vote in the court's most anticipated business decision of the term was a rejection of Bush administration policy and a major setback to pharmaceutical companies, which face thousands of lawsuits in state courts from patients who allege that drugs have harmed them.”
The Associated Press (3/5) reports, “The Supreme Court” upheld “a $6.7 million jury award to a musician who lost her arm to gangrene following an injection.” The plaintiff, “Diana Levine of Vermont once played the guitar and piano professionally” and “her right arm was amputated after she was injected with Phenergan, an anti-nausea medicine made by Wyeth Pharmaceuticals, using a method that brings rapid relief, but with grievous risks if improperly administered.” There were many other outlets that covered the Wyeth ruling, including: Business Week (3/5, Johnson), CBS News (3/5, Cohen), the San Francisco Chronicle (3/5, Egelko), the Wall Street Journal (3/5, Bravin), the Legal Times (3/5, Mauro) reports, the AP (3/5, Curran), the Legal Intelligencer (3/4, Passarella), the Los Angeles Times (3/5, Savage), Dow Jones Newswires (3/5, Anderson), USA Today (3/5, Biskupic, Appleby), UPI (3/4) ABC World News (3/4, story 9, 0:30, Gibson), CBS Evening News (3/4, story 4, 2:00, Couric) and NBC Nightly News (3/4, story 5, 2:05, Williams).
Drug industry may face more litigation after ruling. The Financial Times (3/5, Jack) reports, “Pharmaceutical companies face substantial extra litigation after the US Supreme Court ruled yesterday that safety warnings on their drugs approved by federal regulators did not protect them from lawsuits in individual states.” The ruling “marks the failure of efforts by the industry to fight legal settlements by imposing federal pre-emption, an argument that had been supported by George W. Bush's administration.”
Bloomberg News (3/4, Stohr) reported that now drugmakers can be sued “for failing to provide adequate safety warnings.” Justice John Paul Stevens wrote in the opinion, “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” The ruling “might help former users of Wyeth's Prempro and Premarin menopause drugs and consumers of AstraZeneca Plc's antipsychotic drug Seroquel.” However, “the impact isn't clear for allegations that Pfizer Inc. and GlaxoSmithKline Plc should have done more to warn that their anti-depressants might cause suicidal tendencies.”
The Philadelphia Inquirer (3/5, Hill) reports that Sol Weiss, a Philadelphia plaintiffs' lawyer, said, “This doesn't mean you're going to win, but you get your day in court.” He is “not involved in this case” but “he is hoping that the decision will revive his cases involving Pfizer Inc.'s antidepressant Zoloft and GlaxoSmithKline P.L.C.'s antianxiety agent Paxil.” The Wall Street Journal (3/5, Johnson, Mundy, Bravin) also covers the story.
Ruling may make drugmakers more cautious, halt development. The AP (3/5) reports that the ruling “could make drugmakers more cautious about safety issues and may lead them to halt development of some medicines and even pull others off the market.” Erik Gordon, an analyst and professor at University of Michigan's Ross School of Business, said, “They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug.”
Ruling seen as contradictory to medical device case. The New York Times (3/5, B1, Meier, Singer) reports on the front page of its Business Day section that the “result of a decision Wednesday by the Supreme Court” was that “federal law does not protect drug companies from product liability suits in state courts.” However, “in contrast, the Supreme Court ruled last year that federal law does bar such lawsuits against the makers of heart stents, artificial joints and other critical medical devices.” David C. Vladeck, a professor at Georgetown University Law Center, said, “I think this is going to force Congress to revisit the issue of why medical devices should be insulated from lawsuits.”
Wyeth loss seen as possible victory in disguise. Forbes (3/5, Fisher) reports, “Wyeth's loss dashes the hopes of those who support pre-emption as a tactic for cutting back on excessive jury awards in product-liability cases, which the court affirmed last year in Riegel v. Medtronic.” However, “Wyeth v. Levine may be a victory in disguise. By stepping back from the brink and refusing to give drug companies federal immunity from suits under state laws, the court has likely prevented an even more toxic response from the Democrat-controlled Congress.”
Papers weigh in on Wyeth ruling. The Wall Street Journal (3/5) editorializes, “The decision is a huge victory for plaintiffs lawyers, but it's a much bigger defeat for drug innovation and public health.” The Journal adds, “Yesterday's ruling will expose drug companies to a kind of double innovation jeopardy.” Concluding, the Journal argues that now drug companies “will have to contemplate paying up front -- and paying later, even if the tragic mistake in applying the drug is someone else's. Wyeth is a dream come true for the plaintiffs bar.”
In stark contrast, the New York Times (3/5) editorializes, “The Supreme Court made a wise and surprising decision on Wednesday when it rejected a drug company's claim that it cannot be sued for damages in state courts if a product and its label have been approved by the Food and Drug Administration.” The ruling “demolished the notion that federal regulatory rulings automatically pre-empt the states from enforcing even tougher standards on drugs” and “also exposed as a sham the Bush administration's strenuous efforts to protect its allies in industry with phony pre-emption claims.” The Times concludes, “We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well.”
Wyeth decision seen as not enough to end Michigan's drug law. In an op-ed in the Detroit Free Press (3/5) Henry Greenspan, who teaches about the FDA, ethics and policy at the University of Michigan, writes, “Today was a good one for justice in America – but we in Michigan remain saddled with a law that is based on precisely the argument the high court rejected.” He adds that the court's decision in Wyeth “is not enough to end Michigan's statute.” Greenspan concludes, “The state senators who have blocked repeal will now have to argue that they know better than two-thirds of the Supreme Court” and “they will have to explain why they maintain a view of the FDA that the court called ‘meritless’ and ‘untenable.’”
Ultimately, the Supreme Court’s ruling has put the safety of the patient back in the consumers’ hands, keeping the pharmaceutical mass tort industry alive.
“Supreme Court Rules in Wyeth v. Levine” The Wall Street Journal Health Blog 4 March 2009.
“Supreme Court Backs Patients’ Right to Sue Drug Makers” Baltimoresun.com. 4 March 2009.
“Supreme Court’s Wyeth ruling “a major setback” for drug industry.” 5 March 2009. American Association for Justice.
Medical records management
Tuesday, April 7, 2009
Life Care Planning Department
By Nancy Fraser, RN, CEO, Chief Executive Officer
As you know, Med Legal has been a national leader in medical record review for nearly 10 years. Now, Med Legal is proud to introduce our new and improved Life Care Planning department. We have begun applying our signature system of review and triple-tiered review process to our Life Care Planning services, giving our Clients thorough, defensible Plans for any phase of litigation.
Additionally, we would like to welcome the new members of our Life Care Planning team! We are still recruiting for certified Life Care Planners with experience, and trainable Life Care Planners who are looking to gain experience. All Planners must include cost estimates as a part of their Plans. If you know of a Planner who may be interested, please have them contact us directly (nfraser@medlegal-la.com).
We are excited to be accelerating full-force into this growing field and anticipate a great increase in business in both Medical Record Review and Life Care Planning services due to our ability to offer them together. As always, your questions and comments are welcomed.
As you know, Med Legal has been a national leader in medical record review for nearly 10 years. Now, Med Legal is proud to introduce our new and improved Life Care Planning department. We have begun applying our signature system of review and triple-tiered review process to our Life Care Planning services, giving our Clients thorough, defensible Plans for any phase of litigation.
Additionally, we would like to welcome the new members of our Life Care Planning team! We are still recruiting for certified Life Care Planners with experience, and trainable Life Care Planners who are looking to gain experience. All Planners must include cost estimates as a part of their Plans. If you know of a Planner who may be interested, please have them contact us directly (nfraser@medlegal-la.com).
We are excited to be accelerating full-force into this growing field and anticipate a great increase in business in both Medical Record Review and Life Care Planning services due to our ability to offer them together. As always, your questions and comments are welcomed.
Thursday, April 2, 2009
The Essential Medicine of Elder Abuse
By Nancy Fraser, RN, CEO, Med Legal Consulting Source
The United States currently has a shortage of 200,000 nurses. In 13 years, year 2020, the shortage is projected to be over 800,000. At that time, nursing homes will need 66 percent more nurses than they have today. The most common areas of elder abuse are directly related to nurse staffing issues. The essential medicine of elder abuse revolves around nursing care.
Understanding how normal aging affects the most common areas of elder abuse is important in discerning neglect by an administrator, employee, professional or non-professional staff member providing care and services for elder or dependant adults. Understanding how the nursing care process involves custodial care, attending to basic needs, and the supervision of non-professional staff is important in determining elder abuse.
The elderly and dependent adults are obviously an at-risk population. Dementia puts this group at an even greater risk for abuse and neglect because of a greater degree of dependency and associated behavior problems. As a progressive brain dysfunction, dementia presents with a functional decline in cognitive and physical abilities which worsens over time. Advanced dementia is a common cause for nursing home placement. Studies have shown that aggressive behavior may be seen in over 65 percent of patients with dementia. Because of this, physical restraints are routinely used in this population, making it necessary to pay special attention to these patients to ensure that pressure sores do not result. The natural course of dementia can make it difficult to interpret sudden declines in health. Malnutrition, dehydration, poor personal hygiene, pressure ulcers, and falls may be indicators of abuse and neglect.
Malnutrition
Malnutrition is a common threat not only to dementia patients, but all elderly and dependent adults in health care facilities. The clinical signs of malnutrition include a decrease in body weight of more than 15 percent, low serum albumin levels, and a low total lymphocyte count. There are a number of conditions which can pre-dispose patients to malnutrition ranging from restricted diet and dental issues, to depression, confusion, and cancer. Unintended weight loss occurs during the normal aging process as we lose muscle mass. It also often occurs with patients who require help with eating. Studies have shown that staff members take only 5-10 minutes to feed patients who are unable to feed themselves. Severe malnutrition causes a drop in the albumin level and lymphocyte count. Poor nutritional status impacts tissue healing in bed sores. Also, dehydration can cause a pressure sore to develop.
Dehydration
Patients require a minimum of six eight-ounce glasses of water per day, or, as documented in medical records, 1500 to 2500 milliliters per day. At a minimum, intake must equal the fluid loss through urine, feces, skin, and lungs. When fluid is not replaced to cover the amount lost, then a loss of total body water content occurs. Clinically, this will present as an increased serum osmolality coupled with a rapid weight loss of greater than three percent of body weight. The physical signs and symptoms include concentrated urine, dry skin, dry mucous membranes, thirst, skin tenting, sunken eyes, rapid heart beat, low blood pressure, and mental confusion.
There are many conditions which pre-dispose patients to dehydration, which are taken into account by medical and nursing staff when managing the fluid requirements: Certain chronic conditions, decreased renal functions, neurological impairments, diarrhea, and fever. The nursing staff should implement care to address the problem of a natural blunted thirst mechanism in the elderly, or a patient with dementia who needs to be reminded to drink. Additionally, certain medications will cause fluid loss, such as diuretics, tranquilizers, and sedatives.
The management of adequate fluid intake requires diligent adherence to the nursing process of assessment, planning, implantation, and evaluation to assure that dehydration is avoided. The consequences of which can be wide ranging, from urinary tract infections, pneumonia, pressure ulcers, and even death if undetected.
Poor Personal Hygiene
Poor dentitions can affect a patient’s ability to eat, contributing to malnutrition. 30 percent of people over 65 have no natural teeth. Personal hygiene is the most basic expectation of custodial care to maintain a person’s comfort. Oral care is challenging and time consuming for a caregiver, as it requires daily attention to brush the teeth and dentures. If the patient is compliant and the caregiver does not provide adequate care, neglect is often related to poor staffing. Elderly patients and those with aggressive dementia can be non-compliant regarding personal hygiene by refusing to bathe and/or refusing to allow the caregiver to complete tasks of hygiene. In the extreme, there is a behavior disorder of extreme self neglect called Diogenes syndrome. The non-compliant situation requires good documentation and notification of the doctor and nursing supervisor.
Pressure Ulcers
Pressure ulcers, also called decubitus ulcers or bedsores, are the most common issue involved in elder abuse cases. They are called pressure ulcers because pressure is the single most important factor in ulcer formation. Normal capillary pressure usually ranges between 12 and 32 millimeters of mercury. Pressure sores develop when the outside pressure on the skin exceeds the mean capillary pressure, which reduces the blood flow and tissue oxygenation. When the skin is starved of nutrients and oxygen for too long, the tissue dies and a pressure ulcer forms. The most common sites of ulcers are areas of skin overlying bony prominences because one forms when soft tissue is compressed between a bony prominence and an external surface for a prolonged period of time. 95 percent of all pressure ulcers develop on the lower portion of the body. The National Pressure Advisory Board developed a classification system for staging ulcers. There are four stages:
Stage One: A redden area of the skin that does not turn white when you press it.
Stage Two: Partial thickness skin loss involving the top to layers of the skin: the dermis and epidermis. This looks like a blister or abrasion.
Stage Three: Full thickness skin loss involving the subcutaneous tissue and maybe the
underlying facia. This presents as a deep crater and might involve adjacent tissue.
Stage Four: Full thickness skin loss with extensive destruction, tissue death, muscle, tendon damage, or damage to bone.
A constant pressure of 70 mm of mercury for more than two hours leads to tissue death. If pressure is intermittently relieved, minimal changes occur. Thus, the standard of turning patients is every two hours. This traditional recommendation is a minimal requirement and actually is dependant on the degree of patient mobility and the support surface used. At-risk patients should be monitored closely for stage one pressure sores and have the turning plan revised for more frequent timing. To aid in monitoring the patient, a written re-positioning schedule should be used and posted in the patient’s room. The other factor to be aware of is that the highest interstitial pressure occurs at the bone and muscle interface, with less damage at the epidermal level, so deep tissue trauma can occur with very little superficial damage to alert caregivers to the extent of the injury.
Shearing forces are also a major contributor to pressure ulcers. Clinically, these occur when the head of a supine patient is raised 30 degrees. Friction reduces the amount of pressure needed to produce ulcers. This happens when a bedridden patient is dragged across the bed sheets. A long-term moist environment from urine, perspiration, or fecal material will increase the risk of an ulcer five times. These are all significant on there own, but when combined, ulcer formation becomes almost inevitable.
In addition to these factors, several other conditions pre-dispose a person to pressure ulcers:
Prolonged immobilization, sensory, and circulatory deficits.
Poor nutrition.
Smoking.
Medications.
Upon admission, a complete assessment should be done to identify at-risk patients. A scale, called the Braden Scale, is used to assess the risk factors aforementioned: Sensory perception, moisture, activity, mobility, nutrition, friction, and shear. On the Braden Scale, scores less than 12 indicate a high risk for development of ulcers, whereas a score between 13 and 15 reflects moderate risk, and a score of 16 or 17 indicates mild risk. This assessment forms the basis for medical and nursing care plans.
As is true of most ailments, the key to treatment of pressure ulcers is prevention. The key to prevention of pressure ulcers is pressure reduction. A pressure–reducing surface should be used for all patients at risk; there are many types of mattresses and mattress over-lays that can be used to reduce pressure. Patient positioning is also key to pressure reduction. A right or left 30 degree oblique position is recommended because it avoids direct pressure on 80 percent of the most common sites for ulcers. Maintaining the head of the bed at less than 30 degrees is optimal because greater than 30 degrees increases sheering force, as was previously stated. Patients in chairs for longer than one to two hours should have pressure reducing cushions such as mattress overlays.
If prevention is unsuccessful and an ulcer develops, the treatment proceeds initially with a carefully recorded assessment of all ulcers at the initiation of therapy. This is mandatory as a baseline against which to judge improvement or deterioration. A complete description of each sore should include location, stage, and size; necrotic tissue, odor, and drainage; and serial photos. If surgical treatment is required, it usually includes direct closure, skin graft, and skin flaps.
Pressure ulcers are common in elderly patients with reduced mobility, but they can often be avoided if the appropriate measures are taken. If they are unavoidable, pressure ulcers can be monitored and treated to cease or stunt their progression.
Falls and Fractures
Falls and the injuries sustained occur in three phases. These are important to understand because each phase is evaluated both during a fall risk assessment and a post fall assessment for determining what caused the fall. Phase one is the event that displaces the base of support, phase two is the failure of the motor and sensory system to correct the imbalance, and phase three is the impact itself. Upon facility admission, all patients are assessed for risk of falls. If there is a history of falls, the prior three months are evaluated to obtain a history and identification of causative factors. If dementia is a factor, it is assessed if the patient has an awareness of their limitations. Medical facilities will have fall prevention and restraint avoidance programs already in place. Nursing care plans will focus on preventative measures such as environmental changes, assistive walking devises, and physical therapy.
If a fall and injury does occur, a post fall assessment is done to identify the exact cause of the fall. This requires not only a thorough physical examination but a review of the medical records including current medical problems and medications. Once the cause is isolated, medical and nursing treatment can be initiated specifically for the modifiable factors. All falls require an Incident Report to be completed. There are several questions surrounding facility falls that must be addressed. Did the staff understand the patient’s risk factors and fall history? What measures were implemented to prevent a fall? How did the fall occur? Was a complete post fall assessment done to determine injuries, and was the medical treatment timely and appropriate?
It is important to identify when the abuse occurred, as sometimes patients will arrive at a new facility having already been neglected. Conditions such as malnutrition, dehydration, and pressure ulcers may have already developed at a previous facility or in the care of family, and despite all efforts, the facility in question could do nothing to prevent further decay or to reverse the condition. All elder abuse cases are different, but with a clear understanding of the guidelines for practice and the common indicators of abuse, you will have the foundation for building any case.
The United States currently has a shortage of 200,000 nurses. In 13 years, year 2020, the shortage is projected to be over 800,000. At that time, nursing homes will need 66 percent more nurses than they have today. The most common areas of elder abuse are directly related to nurse staffing issues. The essential medicine of elder abuse revolves around nursing care.
Understanding how normal aging affects the most common areas of elder abuse is important in discerning neglect by an administrator, employee, professional or non-professional staff member providing care and services for elder or dependant adults. Understanding how the nursing care process involves custodial care, attending to basic needs, and the supervision of non-professional staff is important in determining elder abuse.
The elderly and dependent adults are obviously an at-risk population. Dementia puts this group at an even greater risk for abuse and neglect because of a greater degree of dependency and associated behavior problems. As a progressive brain dysfunction, dementia presents with a functional decline in cognitive and physical abilities which worsens over time. Advanced dementia is a common cause for nursing home placement. Studies have shown that aggressive behavior may be seen in over 65 percent of patients with dementia. Because of this, physical restraints are routinely used in this population, making it necessary to pay special attention to these patients to ensure that pressure sores do not result. The natural course of dementia can make it difficult to interpret sudden declines in health. Malnutrition, dehydration, poor personal hygiene, pressure ulcers, and falls may be indicators of abuse and neglect.
Malnutrition
Malnutrition is a common threat not only to dementia patients, but all elderly and dependent adults in health care facilities. The clinical signs of malnutrition include a decrease in body weight of more than 15 percent, low serum albumin levels, and a low total lymphocyte count. There are a number of conditions which can pre-dispose patients to malnutrition ranging from restricted diet and dental issues, to depression, confusion, and cancer. Unintended weight loss occurs during the normal aging process as we lose muscle mass. It also often occurs with patients who require help with eating. Studies have shown that staff members take only 5-10 minutes to feed patients who are unable to feed themselves. Severe malnutrition causes a drop in the albumin level and lymphocyte count. Poor nutritional status impacts tissue healing in bed sores. Also, dehydration can cause a pressure sore to develop.
Dehydration
Patients require a minimum of six eight-ounce glasses of water per day, or, as documented in medical records, 1500 to 2500 milliliters per day. At a minimum, intake must equal the fluid loss through urine, feces, skin, and lungs. When fluid is not replaced to cover the amount lost, then a loss of total body water content occurs. Clinically, this will present as an increased serum osmolality coupled with a rapid weight loss of greater than three percent of body weight. The physical signs and symptoms include concentrated urine, dry skin, dry mucous membranes, thirst, skin tenting, sunken eyes, rapid heart beat, low blood pressure, and mental confusion.
There are many conditions which pre-dispose patients to dehydration, which are taken into account by medical and nursing staff when managing the fluid requirements: Certain chronic conditions, decreased renal functions, neurological impairments, diarrhea, and fever. The nursing staff should implement care to address the problem of a natural blunted thirst mechanism in the elderly, or a patient with dementia who needs to be reminded to drink. Additionally, certain medications will cause fluid loss, such as diuretics, tranquilizers, and sedatives.
The management of adequate fluid intake requires diligent adherence to the nursing process of assessment, planning, implantation, and evaluation to assure that dehydration is avoided. The consequences of which can be wide ranging, from urinary tract infections, pneumonia, pressure ulcers, and even death if undetected.
Poor Personal Hygiene
Poor dentitions can affect a patient’s ability to eat, contributing to malnutrition. 30 percent of people over 65 have no natural teeth. Personal hygiene is the most basic expectation of custodial care to maintain a person’s comfort. Oral care is challenging and time consuming for a caregiver, as it requires daily attention to brush the teeth and dentures. If the patient is compliant and the caregiver does not provide adequate care, neglect is often related to poor staffing. Elderly patients and those with aggressive dementia can be non-compliant regarding personal hygiene by refusing to bathe and/or refusing to allow the caregiver to complete tasks of hygiene. In the extreme, there is a behavior disorder of extreme self neglect called Diogenes syndrome. The non-compliant situation requires good documentation and notification of the doctor and nursing supervisor.
Pressure Ulcers
Pressure ulcers, also called decubitus ulcers or bedsores, are the most common issue involved in elder abuse cases. They are called pressure ulcers because pressure is the single most important factor in ulcer formation. Normal capillary pressure usually ranges between 12 and 32 millimeters of mercury. Pressure sores develop when the outside pressure on the skin exceeds the mean capillary pressure, which reduces the blood flow and tissue oxygenation. When the skin is starved of nutrients and oxygen for too long, the tissue dies and a pressure ulcer forms. The most common sites of ulcers are areas of skin overlying bony prominences because one forms when soft tissue is compressed between a bony prominence and an external surface for a prolonged period of time. 95 percent of all pressure ulcers develop on the lower portion of the body. The National Pressure Advisory Board developed a classification system for staging ulcers. There are four stages:
Stage One: A redden area of the skin that does not turn white when you press it.
Stage Two: Partial thickness skin loss involving the top to layers of the skin: the dermis and epidermis. This looks like a blister or abrasion.
Stage Three: Full thickness skin loss involving the subcutaneous tissue and maybe the
underlying facia. This presents as a deep crater and might involve adjacent tissue.
Stage Four: Full thickness skin loss with extensive destruction, tissue death, muscle, tendon damage, or damage to bone.
A constant pressure of 70 mm of mercury for more than two hours leads to tissue death. If pressure is intermittently relieved, minimal changes occur. Thus, the standard of turning patients is every two hours. This traditional recommendation is a minimal requirement and actually is dependant on the degree of patient mobility and the support surface used. At-risk patients should be monitored closely for stage one pressure sores and have the turning plan revised for more frequent timing. To aid in monitoring the patient, a written re-positioning schedule should be used and posted in the patient’s room. The other factor to be aware of is that the highest interstitial pressure occurs at the bone and muscle interface, with less damage at the epidermal level, so deep tissue trauma can occur with very little superficial damage to alert caregivers to the extent of the injury.
Shearing forces are also a major contributor to pressure ulcers. Clinically, these occur when the head of a supine patient is raised 30 degrees. Friction reduces the amount of pressure needed to produce ulcers. This happens when a bedridden patient is dragged across the bed sheets. A long-term moist environment from urine, perspiration, or fecal material will increase the risk of an ulcer five times. These are all significant on there own, but when combined, ulcer formation becomes almost inevitable.
In addition to these factors, several other conditions pre-dispose a person to pressure ulcers:
Prolonged immobilization, sensory, and circulatory deficits.
Poor nutrition.
Smoking.
Medications.
Upon admission, a complete assessment should be done to identify at-risk patients. A scale, called the Braden Scale, is used to assess the risk factors aforementioned: Sensory perception, moisture, activity, mobility, nutrition, friction, and shear. On the Braden Scale, scores less than 12 indicate a high risk for development of ulcers, whereas a score between 13 and 15 reflects moderate risk, and a score of 16 or 17 indicates mild risk. This assessment forms the basis for medical and nursing care plans.
As is true of most ailments, the key to treatment of pressure ulcers is prevention. The key to prevention of pressure ulcers is pressure reduction. A pressure–reducing surface should be used for all patients at risk; there are many types of mattresses and mattress over-lays that can be used to reduce pressure. Patient positioning is also key to pressure reduction. A right or left 30 degree oblique position is recommended because it avoids direct pressure on 80 percent of the most common sites for ulcers. Maintaining the head of the bed at less than 30 degrees is optimal because greater than 30 degrees increases sheering force, as was previously stated. Patients in chairs for longer than one to two hours should have pressure reducing cushions such as mattress overlays.
If prevention is unsuccessful and an ulcer develops, the treatment proceeds initially with a carefully recorded assessment of all ulcers at the initiation of therapy. This is mandatory as a baseline against which to judge improvement or deterioration. A complete description of each sore should include location, stage, and size; necrotic tissue, odor, and drainage; and serial photos. If surgical treatment is required, it usually includes direct closure, skin graft, and skin flaps.
Pressure ulcers are common in elderly patients with reduced mobility, but they can often be avoided if the appropriate measures are taken. If they are unavoidable, pressure ulcers can be monitored and treated to cease or stunt their progression.
Falls and Fractures
Falls and the injuries sustained occur in three phases. These are important to understand because each phase is evaluated both during a fall risk assessment and a post fall assessment for determining what caused the fall. Phase one is the event that displaces the base of support, phase two is the failure of the motor and sensory system to correct the imbalance, and phase three is the impact itself. Upon facility admission, all patients are assessed for risk of falls. If there is a history of falls, the prior three months are evaluated to obtain a history and identification of causative factors. If dementia is a factor, it is assessed if the patient has an awareness of their limitations. Medical facilities will have fall prevention and restraint avoidance programs already in place. Nursing care plans will focus on preventative measures such as environmental changes, assistive walking devises, and physical therapy.
If a fall and injury does occur, a post fall assessment is done to identify the exact cause of the fall. This requires not only a thorough physical examination but a review of the medical records including current medical problems and medications. Once the cause is isolated, medical and nursing treatment can be initiated specifically for the modifiable factors. All falls require an Incident Report to be completed. There are several questions surrounding facility falls that must be addressed. Did the staff understand the patient’s risk factors and fall history? What measures were implemented to prevent a fall? How did the fall occur? Was a complete post fall assessment done to determine injuries, and was the medical treatment timely and appropriate?
It is important to identify when the abuse occurred, as sometimes patients will arrive at a new facility having already been neglected. Conditions such as malnutrition, dehydration, and pressure ulcers may have already developed at a previous facility or in the care of family, and despite all efforts, the facility in question could do nothing to prevent further decay or to reverse the condition. All elder abuse cases are different, but with a clear understanding of the guidelines for practice and the common indicators of abuse, you will have the foundation for building any case.
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