September/October 2008

Who can obtain a patient’s consent? Answer elusive


• The Gist: Attorney clients often ask questions that seem so simple, but yet are not. It’s these new frontiers that keep us on our toes.

© 2008 The Medical-Legal News
By Rose Clifford, RN, LNCC

FROM THE EDITOR

I recently was asked by an attorney client to find out if a physician assistant (PA) can be the point person for obtaining informed consent from a patient. The answer has turned out to be trickier than I thought.
The short answer, based on our state statute, is that any “healthcare provider” can obtain informed consent. However, thorny issues arise when the person seeking the consent or explaining the complications is not the person who will be performing the given healthcare service. That is, can or should a nurse or PA obtain informed consent for a procedure that a doctor will be doing? Is it OK if the nurse or PA is an employee of the doctor? What happens when a patient complains or sues because the person most knowledgeable about the procedure (probably the person doing it) is not the one who explained the procedure or obtained the consent?
With regard to PAs for example, the American Academy of Physician Assistants’ Guidelines for Ethical Conduct clearly says that PAs can give informed consent “that is comprehendible to a competent patient….” But does the verbiage also apply in a situation where a PA is serving as the proxy for a doctor? This seems to happen often.
One LNC I asked about this issue noted that some consent forms are pre-signed by doctors or surgeons or that a doctor allows another person to obtain the consent. This seems risky to me.
On the Veterans Affair PA Association website, the PA advisor to the undersecretary for health notes that “PAs may obtain informed consent only for procedures they are responsible for performing.” But the site goes on to ask what happens when PAs share a service with another provider, or only assist. Then what?
The best answer, after some research, seems to be that the individual actually performing a surgery or service is ultimately responsible for the consent and that the consent be understood by the patient. Peter Bergé, a New Jersey attorney and New York State PA notes that obtaining a patient’s signature on a “consent form” is not necessarily a “scope of practice” question for a PA because signing a piece of paper is not the same as obtaining informed consent. His opinion is consistent with case law we have read, where courts have sometimes found that informed consent is beyond the “four corners” of any piece of paper that is called the “informed consent.”
Bergé notes that a provider could perform a procedure and give incomplete or inaccurate information to a patient, or a provider may not do the procedure, yet give excellent and comprehensive information. But ultimately, in his opinion, the person doing the procedure bears the responsibility of making certain the patient gave informed consent after being properly informed.
The medical-legal world keeps treading new ground, right? •

Rose Clifford, RN, LNCC, Editor;
rose@medical-legalnews.com

What to do about those scanned images and medical records

© 2008 The Medical-Legal News
By Paul Martino

ESSAY

With more information arriving in electronic form, an office is challenged to manage these documents.
Suppose you just received a CD full of records and documents along with a helpful note saying they are in PDF format. You open one of the documents and find you cannot copy and paste or add any annotation to the document.
What to do? Grab a pad and pen, jot down the document name and make some notes? How about printing it? That destroys the whole advantage of electronic records in the first place, right?
Take heart! You may already own a tool to help you deal with this. Microsoft Office® 2003 or later has a tool called Microsoft Office Document Imaging. It does not install automatically, so you many need to load it.
What will this tool do? First, it will import any document you can print. Just click “import” and browse to the document. The import process may take a while because it does two things: It creates an image you can view and it also recognizes the text using Optical Character Recognition (OCR). Poor quality of the image will lead to poor OCR. Hand written documents will be a challenge.
Once this is done, select a section of the document and copy the text or image. If you select the text, you then paste it into any Windows® document or program that accepts text. Remember that signature you could not decipher? Copy the image and paste it right into your report!
You annotate the image using the highlighter or pen tool, add a text box for your comments and rotate a page if you need to. The annotations can be viewed or hidden — not a bad little tool that you already have!
Should you decide to use this tool, consider using a dual monitor system. See The Medical-Legal News’ May/June issue for details. •

Paul Martino has a masters in mathematical statistics and is the founder of Legal Nurse Systems, LLC, based in Chardon, Ohio,www.legalnursesystems.com.

Ask Pat Bemis

© 2008 The National Nurses in Business Association, www.nnba.net

Question: In your presentation at the South Carolina American Association of Legal Nurse Consultants (AALNC) chapter, you said you saved considerable time and organized your personal and business life by making better use of technology. Can you tell me more?
Answer: I believe that some of the new technology consumes more time than it saves. Just because technology can do it doesn’t mean it is helpful. Synchronizing a laptop to a desktop and to a mobile device (phone, PDA, etc.) sometimes requires more time than it saves.
Most people have personal and business contacts stored in different locations and in several types of formats such as address books, databases or spreadsheets. They may have an elaborate file folder system for email. Even with the best of systems, phone calls are often not logged at all unless they are billable hours. Need I say more? You know the problems.
In my quest to save time, I have spent a lot of time. The good news is that I have found a solution that works for me and I will share it with you. I truly believe in the concept of KISS (keep it simple stupid).
I use my laptop (IBM PC with large hard drive and a great deal of memory) for both my desktop and my laptop computer. No synchronizing is needed. All my information is with me at home and on the road. At home I add a large monitor, ergonomic keyboard and a tracking ball. On the road I use it as a stand-alone system. When I’m in the car, I plug it in to keep the battery charged. I access the internet with Wi-Fi on the road. In the office I have high speed broadband. I never use webmail. I send and receive directly from my laptop. I can answer email wherever I am and then send and receive when the Internet is available.
For software, I use ACT!®. It is a relationship management system (RMS). Notice that it is not contact management or an address book. It manages the relationship I have with my contacts (personal and business). It integrates with Microsoft Outlook®, QuickBooks® (QB), and other programs as well as phones or other mobile devices.
In ACT! I have records of individuals and companies with whom I interact. I originally imported them from QB, Access® and Outlook®. It was a little scary in the beginning to have all my contacts in one database. Now I love it — one place for everything and everything in its place. When I first started, I entered everything I thought I would ever want to know about each individual or company. Needless to say, it is a living record and must be updated as new information is discovered. ACT! keeps track of every email, phone call, document, meeting and interaction. It can include a photograph and group the records into categories. WOW! When I dial the phone, a little timer, a window to write what we talk about and a one-click button to schedule follow-ups all come up on the screen. If you have ACT! linked to QB and the time is billable, you can write the invoice for the time spent or just open QB and enter the invoice. At the end of the month you will have a complete itemized statement to send. It even keeps track of when to follow up with that individual and has a calendar for meetings. Oh yes, and it has mail merge for both printed material and email, advanced search items, notes and user-defined fields that can be customized for your needs.
Sage Software® pioneered the program for sales people to manage their relationship with customers in Dallas in 1986. Today it is used by many corporations and individuals. There are other programs out there. One is Goldmine®. For me, ACT! is intuitive and not so complex that it takes more time than it saves. You can find more details on the program at www.act.com.
You can reach me by email atbemis@nnba.net or by phone at (321) 633-4610. Keep in touch. • 

Good luck,
Pat

Conscious sedation: Who, what where

© 2008 The Medical-Legal News
By Frances W. Sills, RN, MSN, ARNP

Prior to the 1840s anesthesia was not used when individuals underwent operations. The use of alcohol, opium or other botanicals sometimes helped to alleviate the agony, but most patients remained conscious and endured excruciating pain. The introduction of ether in 1846 allowed surgeons to perform internal procedures that would have been too painful or complicated to perform on a conscious patient.
For many decades after anesthetics became a routine part of surgery, practically nothing was known about how they worked. Virtually all scientists believed that anesthetics blocked nerve cell signaling by disrupting fatty molecules in the membranes that envelop cells. Scientists have now learned that general anesthesia consists of several components, including sedation, unconsciousness, immobility, analgesia (lack of pain) and amnesia (lack of memory). They have developed agents that can provide each of these elements separately, which enables anesthesiologists to tailor the regimen to each procedure and patient.
Each year millions of individuals undergo surgery safely with general anesthesia, although there always remains some risk. Many of these procedures, which have improved the health, longevity and quality of life of the population would not have been possible without modern anesthetic techniques. The discovery that local and regional anesthetics can be used to block specific nerves has provided the patient and physicians with an alternative to general anesthesia for many procedures. The most recent of the discoveries is the use of what has been called “conscious sedation” to facilitate procedures such as:
• Breast biopsy,
• Vasectomy,
• Minor foot surgery,
• Minor bone fracture repair,
• Plastic or reconstructive surgery,
• Endoscopy and other diagnostic procedures.
The debate regarding conscious sedation — now being referred to as moderate sedation — has been going on for years. It has become increasingly popular for both hospitals and outpatient procedures. With its wider use comes a number of new responsibilities for nurses who care for patients undergoing moderate sedation and analgesia. As the use of conscious sedation continues to grow, it is important that nurses have the understanding and knowledge of just what conscious sedation means, where its use is increasing and what responsibilities the professional nurse has when administering the various agents that provide conscious sedation. Four physiological states exist in which the patient receiving anesthesia can be. They are:
A. Conscious sedation or moderate sedation is a state in which the patient can respond purposefully to verbal commands (alone or accompanied by light tactile stimulation), maintain a patent airway and maintain breathing on his own.
B. Minimal sedation (also called anxiolysis) is a lighter state of sedation in which the patient can respond normally to verbal commands.
C. Deep sedation or analgesia is a state in which the patient may need help maintaining a patent airway and may need assisted ventilation. He cannot be easily aroused, but does respond purposefully to repeated or painful stimulation.
D. General anesthesia is a state in which the patient is not arousable, even to painful stimulation, needs assistance in maintaining a patent airway and may require positive-pressure ventilation.
The nurse who is administering moderate sedation must be knowledgeable of the drugs that are used. This knowledge includes, but is not limited to, effects of the medication, potential side effects, contraindications for administration of the medicine and the amount of the medication to be administered. The requisite skills include the ability to: 1) competently and safely administer the medication by the specified route; 2) anticipate and recognize potential complications of the medication and 3) recognize emergency situations and institute emergency procedures. The nurse would also ensure that all safety measures are in force, including back-up personnel skilled and trained in airway management, resuscitation and emergency intubation should complications occur. The nurse managing the care of patients receiving conscious sedation should not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse.
These drugs must be administered in small doses and the patient’s response assessed before giving another dose. Body mass and other factors affect a patient’s reaction. [See chart, next page, bottom, for the most common drugs used.]
In recent years, Propofol, one of the intravenous sedative hypnotics, has been gaining popularity over midazolam and fentanyl as the drug of choice for moderate sedation and analgesia. The use of this drug during endoscopic, radiologic and other procedures is growing in hospitals, ambulatory surgical procedures and physician offices because it offers certain advantages over other drugs used for sedation when used by trained and credential practitioners because it:
• Has a rapid onset and a short duration of action,
• Allows patients to wake up, recover and return to baseline activities and diet sooner that some other sedation agents,
• Reduces the need for opioids, resulting in less nausea and vomiting.
Propofol has also replaced thiopental sodium as a rapid-acting nonbarbiturate induction and maintenance agent for anesthesia or sedation during major surgery. This has added more fuel to the controversy of who should be administering drugs that provide varying levels of sedation.
What are the necessary credentials for administering Propofol? Healthcare facilities, professional organizations and licensing boards across the country are asking this question. A difference of opinion continues among the professional societies about the necessary credentials for individuals administering Propofol for sedation. In brief, the American Society of Anesthesiologists (ASA), the American Association of Nurse Anesthetists and the American Association for Accreditation of Ambulatory Surgery Facilities believe that safe administration of Propofol to non-ventilator-assisted patients is limited to individuals trained in the administration of general anesthesia who are not simultaneously involved in the procedure. The ASA also suggests that, if this is not possible, non-anesthesia staff who administer Propofol must be qualified to rescue patients whose level of sedation becomes deeper than intended and who enter, if briefly, a state of general anesthesia.
In contrast, the American College of Gastroenterology, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society of Gastroenterology Nurses and Associates endorse nurse-administered Propofol under the direction of a physician if state regulations allow it, if the nurse is trained in the use of drugs causing deep sedation and if the nurse is capable of rescuing patients from general anesthesia or severe respiratory depression.
The Joint Commission on Accreditation of Healthcare Facilities (JCAHO) Standard PC.13.20 requires, for the administration of moderate or deep sedation, that a sufficient number of staff, in addition to the person performing the procedure, be present to perform the procedure and monitor and recover the patient. The person administering the sedative agent must be qualified to manage the patient at whatever level of sedation or anesthesia is achieved, whether intentionally or not. While there may be a need for additional monitoring personnel for the procedure, the person administering the sedation must be qualified to monitor the patient.
A review of various states’ Nurse Practice Acts finds that there are more than a dozen states that specifically consider nurse-administered Propofol beyond the scope of nursing practice. Others either do not address it or do in such general terms that it is one of those “gray” areas that need further clarification.
In 1991 a position paper developed by American Nurses Association representatives and several of the major specialty nursing organizations was endorsed by the ANA board of directors. This position paper was titled “Role of the Registered Nurse in the Management of Patients Receiving IV Conscious Sedation.” A statement within it reads: “It is within the scope of practice of the registered nurse to manage the care of patients’ IV conscious sedation during therapeutic, diagnostic or surgical procedures provided the following criteria are met:
1) Administration of IV conscious sedation medications by the non-anesthetist nurse is allowed by state law and institutional policy, and protocol;
2) A qualified anesthesia provider or attending physician orders the medications to achieve the IV conscious state;
3) Guidelines for patient monitoring, dug administration and protocols for dealing with potential complications or emergency situations are available and have been developed in accordance with accepted standards of anesthesia practice;
4) The registered nurse managing the care of the patient receiving IV conscious sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring;
5) The registered nurse managing the care of patients receiving IV conscious sedation is able to:
a. Demonstrate the acquired knowledge of anatomy, physiology, pharmacology, cardiac arrhythmia recognition and complications related to IV conscious sedation and medications;
b. Assess total patient care requirements during IV conscious sedation and recovery. Physiologic measurements should include, but not be limited to, respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm and the patient’s level of consciousness;
c. Understand the principles of oxygen delivery, respiratory physiology, transport and uptake and demonstrate ability to use the oxygen delivery devices;
d. Anticipate and recognize potential complications of IV conscious sedation in relation to the type of medication being administered;
e. Possess the requisite knowledge and skills to assess, diagnosis and intervene in the event of complications with orders (including standing orders) or institutional protocols or guidelines;
f. Demonstrate skill in airway management resuscitation;
g. Demonstrate knowledge of the legal ramifications of administering IV conscious sedation and/or monitoring of patients receiving conscious sedation, including the RN’s responsibility and liability in the event of an untoward reaction or life-threatening complication;
6) The institution or practice setting has in place an educational or competency validation mechanism that includes a process for evaluation and documentation of the individual’s demonstration of the knowledge, skills and abilities related to the management of patients receiving IV conscious sedation. Evaluation and documentation of competence occurs on a periodic basis according to institutional policy.”
The full context of the position paper with additional guidelines can be found on the ANA website at www.nursingworld.org.
It is interesting to note that the ANA and the nursing specialty organizations addressed this issue as early as 1991 and still the debate rages.
Presently there are a multitude of situations where nurses are administering drugs for moderate sedation. This being the reality, it is important for nurses to know that Propofol is considered a high-alert drug. The dosing and titration of this drug is variable, as it is based on the patient’s response and tolerance to the drug. Profound changes in respiratory status can occur rapidly. A patient can go from breathing normally to a full respiratory arrest in seconds, even with low doses, without warning from typical assessment parameters. A pre-op assessment must determine a thorough history of the patient’s allergies (patients who are allergic to eggs or soybeans should not receive Propofol), and any medical problems with special attention to respiratory and cardiac problems, tobacco, alcohol or drug use. Any previous adverse effects with sedation or analgesia cannot be overemphasized.
When the patient arrives in the procedure area, baseline vital signs and oxygen saturation on room air using pulse oximetry should be obtained. The blood pressure, heart rate and rhythm, respiratory rate and oxygen saturation should be recorded every five minutes during moderate sedation. Drugs used in moderate sedation and analgesia are titrated to keep the patient at 2 to 3 on the Ramsay sedation scoring system:
1) Patient is anxious, restless, agitated, or all three.
2) Patient is cooperative, oriented and tranquil.
3) Patient is easily arousable and responds appropriately to stimuli.
4) Patient is asleep but has brisk responses to a glabellar tap or an auditory stimulus.
5) Patient is asleep and has sluggish responses to a glabellar tap or auditory stimulus; responds to painful stimuli.
6) Patient does not respond to stimuli.

During moderate sedation and analgesia, if a patient develops respiratory depression or is difficult to wake, protect his airway. If the patient was sedated with benzodiazepine, give flumazenil as an antidote. If he was sedated with an opioid, give naloxone.
Because flumazenil is a benzodiazepine receptor antagonist, it should be used cautiously in patients who use benzodiazepines chronically or who have a history of epilepsy, as flumazenil can cause seizures in these patients. In opioids-tolerant patients, the opioids-antagonist naloxone can cause tachycardia, hypertension, agitation, nausea, vomiting, diaphoresis, seizures and pulmonary edema if given too quickly or in too large a dose. Monitor the patient closely for opioid-related respiratory depression, which can occur if the opioid’s duration of action is longer than that of naloxone.
With the increasing use of conscious or moderate sedation, and particularly the medication Propofol, it becomes increasingly important that nurses be knowledgeable about just what conscious or moderate sedation is, the nurse’s role in administering it, the state’s Nurse Practice Act’s position as it relates to the scope of practice, and a given institution’s policies. With this knowledge each nurse can make an informed decision as to whether he or she wants to assume this new and fast-growing additional responsibility.
The jury is still out on whether or not this role should be considered advanced practice or not. It is important that when and if a decision is made, everyone involved will have a clear understanding of the ramifications, and that mechanisms will be put in place to ensure optimum safety for the patient. •

Frances W. (Billie) Sills, RN, MSN, ARNP, is an assistant professor at ETSU College of Nursing in Tennessee;dewars3@aol.com.

Liposomal drug delivery: nanotechnology comes of age with targeted medicines

• The Gist: The medical-legal professional should become familiar with this method of drug delivery and its growing usage.

© 2008 The Medical-Legal News
By Margaret Wacker, RN, PhD, CLNC

Application of nanotechnology in drug delivery systems has provided new avenues for the engineering of materials with molecular precision. Liposomal drug delivery is one type of nanotechnology currently in clinical use.
Liposomes are microscopic spheres composed of a phospholipid outer layer and aqueous inner layers capable of encapsulating aqueous drugs. Drugs are gradually released from the inner layer while the body absorbs the nontoxic outer layer.
Drugs that benefit most from a liposomal carrier are those with unfavorable pharmacokinetic (absorption, distribution, metabolism and excretion), biodistribution or toxicity profiles.
Liposomes have a natural ability to target cancer. The liposome delivers the chemotherapeutic agent preferentially to the disease site, thus reducing the side effects of the toxic drug while protecting sensitive tissue from drug exposure.
The ability of liposomes to control drug release rates allows them to function as sustained release systems. This has particular benefit in post-operative pain management. Epidural analgesia involves the use of an indwelling epidural catheter that can interfere with mobility and increases the risk of infection. Extended-release epidural morphine (EREM) is a liposomal formulation for epidural use and provides 48 hours of pain relief without the indwelling catheter.
Now that several liposomal formulations are available and have clinical approval, the pathway is open for other drugs to be considered for this novel system. •

Margaret Wacker, RN, PhD, CLNC is president of Wacker & Associates, based in Florida; chakdoc@aol.com.

A $27 million mistake? Consider this expert witness’s testimony, preparation

• The Gist: In case you were wondering if preparation and attentiveness to civil procedure makes a difference, look no further.

© 2008 The Medical-Legal News
By Dan Clifford, publisher

OPINION

Making the rounds on the internet recently was the fate of a hormone replacement case where a punitive damage award of $27 million against pharmaceutical company Wyeth was overturned after the defense moved for a judgment notwithstand-ing the verdict. What was not apparent at first glance was why the jury verdict was set aside.
If you want to know what can go wrong as an expert witness, or if you don’t know what the case name Daubert means, read on. In short, the court was wholly dissatisfied with the expert witness’s testimony on punitive damages.
In In re Prempro Products Liability Litigation, WL 2688576 (E.D. Ark. 2008), Judge Wilson rejected a dream verdict for plaintiffs based on procedural problems with expert testimony. Some highlights from the court order:
“I cannot accept Plaintiff’s position that [the expert witness] ‘didn’t just read a document,’ but ‘tie[d] pieces of the puzzle together.’ To the contrary, [witness] usually read selected portions of documents in evidence, without further comment. I did not anticipate that documents would be admitted via [witness] so that she could simply engage in recitation of those exhibits; jurors are capable of reading documents. Ironically, on cross-examination, [witness], on at least one occasion, took the position that the document ‘speaks for itself.’”
“If an expert does nothing more than read exhibits, is there really any point in her testifying as an expert? As was seen during the punitive damages stage, the use of the ‘regulatory expert’ to deal with large volumes of documents is subject to abuse. The expert did not explain the documents, provide summaries, or tie them in to her proposed regulatory testimony. [Witness] did not provide analysis, opinion or expertise.”
“Federal Rule of Evidence 702 permits expert testimony to assist a jury in understanding technical or scientific evidence. [Witness] was designated to testify on regulations and the standards and practice in the industry based on her experience. Yet, [witness’s] punitive damages stage testimony was hardly expert in nature. The question and answer sessions merely paid lip service to [witness] testifying from an expert standpoint.”
Ouch!
“[Witness’s] punitive damages stage testimony reveals ‘how vital it is that judges not be deceived by the assertions of experts who offer credentials rather than analysis.’ ‘An expert who supplies nothing but a bottom line supplies nothing of value to the judicial process.’ Expert opinion must be just that — expert opinion drawn from a special expertise. Opinion given through the mouth of an expert does not necessarily make it expert opinion.”
“During the punitive damages stage of the trial, [witness’s] testimony tracked Plaintiff’s legal arguments, and there was very little significant analysis. On numerous occasions, [witness] declared ‘this isn’t fair and balanced,’ but she provided no explanation. [Witness], no doubt has special knowledge and skill regarding FDA operations and regulations, but she did not apply this knowledge and skill to her testimony.”
“When [witness] actually elaborated on documents, her testimony did ‘no more than counsel for plaintiff [did] in argument, i.e., propound a particular interpretation of [defendant]’s conduct.’ Having an expert witness simply summarize a document (which is just as easily summarized by a jury) with a tilt favoring a litigant, without more, does not amount to expert testimony. Because [witness’s] testimony — or reading — invaded areas that required no expert assistance, it was inappropriate ‘expert’ testimony.”
“Since [witness] testified as to the bottom line without any explanation, failed to provide expert analysis, testified beyond limitations established by pretrial orders, testified in areas beyond her expertise, and invaded areas that required no expert testimony, most of [witness’s] punitive damages testimony should have been excluded.”
Double ouch!
The expert witness had been qualified under Daubert as a regulatory expert because of her work at the FDA. On several occasions in the order the judge expanded on the improper witness procedure, and noted her causative testimony and conclusions were lacking for various reasons.
Once Judge Wilson struck the witness’s testimony, the punitive argument was gutted. In addition to being unhappy with the witness’s testimony, the judge also concluded that Wyeth had not shown malice by not doing further tests for a link between cancer and its hormone replacement therapy drugs. Thus, without malice or anything to back it up, punitive damages were unwarranted.
Wilson, in overruling the lower court he had presided over, observed: “Since I have a deep and abiding faith in randomly selected juries, I am always reluctant to set aside a jury finding. This jury was very attentive throughout. I admitted much evidence that should not have been admitted. The fault is mine alone.” •

Hormone replacement /cancer cases draw mixed results in the courts

• The Gist: Preemption issue is a hot one in civil litigation. Proving malicious conduct against a defendant often requires a thorough records review.

© 2008 The Medical-Legal News

A New Jersey superior court judge has tossed out the first two of 168 lawsuits filed against the makers of the hormone replacement therapy (HRT) drugs Premarin, Prempro and Provera, according to the New Jersey Law Journal (2008-07-15). The ruling throws a pall on any optimism for the other cases in the state.
The two cases, Bailey v. Wyeth Inc. and DeBoard v. Wyeth Inc., were based on an inadequate labeling theory. The plaintiffs claim that the HRT drugs caused breast cancers, according to the article.
The judge found that New Jersey’s Products Liability Act (PLA), passed in 1987, subsumed any other method of suing, such as the Consumer Fraud Act and common law claims, and reasoned that the “rebuttable presumption of adequacy” for the labeling under the PLA could not be refuted since the FDA had approved the labeling. The judge said the PLA was intended to “provide the exclusive remedy for harm caused by a product,” according to the article.
Under this reasoning, it seems that once the FDA has approved a label, and the only avenue to liability is via a law that upholds the FDA decision, the door is effectively shut. According to the article, the only way around the law would be to show some intentional misconduct on the part of a drug maker. The judge said: “The ultimate decision of the FDA to provide or not provide certain information in a prescription drug label cannot be criticized unless a plaintiff has provided evidence of the pharmaceutical company’s deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or if the pharmaceutical company was found to have manipulated the post-market regulatory process.” The judge noted that 37 peer-reviewed articles had been published by Wyeth, lending credence to its defense of full disclosure of any potential problems with its HRT medicines, according to the article.
Product liability claims are usually brought under one of three theories: a manufacturing error, a design defect or faulty labeling (failure-to-warn). The article noted that the design defect route might still avail.
In late July, according to Bloomberg news service, Wyeth confidentially settled with two plaintiffs in Nevada concerning Prempro and Premarin. Wyeth is facing upward of 10,000 suits nationwide. •

Plaintiffs in civil suits: Better to settle than fight

© 2008 The Medical-Legal News

A study published in the September issue of the Journal of Empirical Legal Studies found that heading into court, as opposed to settling, is more often a strategic mistake made by plaintiffs than by defendants, according to an article in The New York Times, Aug. 8, 2008.
The report found that bad decisions by plaintiffs to go to trial are most often associated with contingency-fee cases, while on the defense side, bad decisions are more likely found in cases where insurance coverage is missing.
Randall L. Kiser is a co-author of the study and is an analyst at DecisionSet, a firm that advises clients on lawsuit decisions, according to the article.
Defendants lost only 24% of cases when they snubbed settlements and went to court, while plaintiffs lost 61% of cases when they refused a settlement and pressed on. The study looked at 2,054 cases and noted that about 85% of all cases settle.
Litigators often say “good” cases settle, at least from a plaintiff point of view, and this study concurs.
The study also found that wrong decisions to go to trial have become more frequent.
The article noted some possible reasons for the “fight on” miscalculations: 1) plaintiff attorneys may be eager to collect contingency fees; 2) financial incentives to persist may exist for either side; or 3) attorneys may not be informing their clients well — or clients may not be listening. •

Texas AG sues nursing home over standards

• The Gist: Elder care is a growing medical and legal field. By 2050, 82 million of us will be over 65.

© 2008 The Medical-Legal News

The Texas attorney general, Gregg Abbott, filed a lawsuit against Brookhaven Nursing Center near Dallas for its alleged failure to maintain health and safety standards required by state law, according to an online story by Star Community Newspapers, Aug. 11, 2008.
The suit claims that the home failed to implement backup safety and emergency response measures and protocols after a power failure in April, according to the article.
The article said a resident who had been on a breathing machine was found dead at 7 a.m. Electrical power had been off since a 3 a.m. thunderstorm passed through the area.
According to the article, a nurse had seen the decedent flailing around in bed, but that the nurse just assumed the resident was uncomfortable due to a loss of air conditioning. The article said the nurse did not check on the patient.
The AG is seeking $20,000 for each violation, and compliance with state law. •

Big money in healthcare?

© 2008 The Medical-Legal News

An article in the AARP Bulletin of July/August 2008 reported that hospitals are more frequently demanding down payments from patients, before care will be rendered, if the patients are uninsured or underinsured.
The article quoted an American Hospital Association official who said that uncompensated hospital care has grown from $19 billion in 1998 to $31 billion in 2006, and the official also said half of all hospitals lose money on patient care, thus forcing them to seek money from grants and donations.
However, the article noted a Wall Street Journal analysis that found that the 50 largest not-for-profit U.S. hospitals had a net income of $4.27 billion in 2006, an eight-fold increase over 2001. Additionally, the article said the country’s 3,000 community not-for-profit hospitals receive $50 billion per year in subsidies and tax exemptions. •

Depressed clients, counselors, can complicate litigation process

© 2008 Patricia Iyer
By Patricia Iyer, MSN, RN, LNCC

ESSAY

• A physician who is named as a defendant in a medical malpractice suit commits suicide.
• A plaintiff who loses his ability to work after a car accident becomes depressed.
• A woman who is injured by a defective product loses her ability to control her bipolar illness and spirals out of control.
• A child custody battles focuses on the mother’s history of schizophrenia, which has been well controlled with medication.
• An attorney’s erratic behavior exasperates her colleagues, clients, adversaries and the judges.
Every year 40 million Americans experience some form of mental illness, including major depression, schizophrenia, bipolar disorder, obsessive-compulsive disorder and anxiety disorders. [1] Attorneys may be involved in representing, deposing, counseling and suing mentally ill people. Mental illness may complicate the litigation process, affecting the basics of obtaining information and gaining cooperation.
Major depression, a response by many to the stresses associated with litigation, is marked by a loss of interest and pleasure in daily activities. A depressed person may sleep too little or too much, eat too little or too much, and feel slowed down or too agitated to sit still. The individual may be extremely tired — getting out of bed is an effort. Lack of motivation, difficulty performing tasks, withdrawal and isolation from others, and lack of attention to hygiene and appearance may be noted. The individual may blame herself for the way she feels and dwell on guilt feelings and personal failures. There may be difficulty thinking, remembering and concentrating. The person may have a heightened sensitivity to noise, light and stress. The psychotic phase of this disorder, which affects 10-25% of those who are depressed, is marked by grossly disorganized behavior, incoherent speech, hallucinations and delusions.
Even a person who is not psychotically depressed may lack insight into the severity of the problem. Consider how one person well-acquainted with major depression symptoms described her depression: “When you are lost in the woods, it sometimes takes you a while to realize that you are lost. For the longest time, you can convince yourself that you’ve wandered a few feet off the path, that you’ll find your way back to the trailhead any moment now. Then night falls again and again, and you still have no idea where you are, and it’s time to admit that you have bewildered yourself so far off the path that you don’t even know from which direction the sun rises anymore.” [2]
The severely depressed person may have recurrent thoughts of death and impulses, thoughts or plans to commit suicide. Risk factors for suicide include being unemployed, unmarried, having a problem with substance abuse, having a mood disorder and a history of previous suicide attempts. Other risk factors include a change in personality such as being sad, withdrawn, irritable, anxious, tired, indecisive or apathetic. There may be a change in behavior such as an inability to concentrate on school, work or routine tasks, or a change in sleep patterns characterized by oversleeping, insomnia or early waking. Additional symptoms include a change in eating habits, loss of interest in people and activities previously enjoyed. Suicidal patients may be worried about money or illness (real or imagined), feel like they are losing control, going crazy or want to harm themselves or others, or have feelings of overwhelming guilt, shame or self-hatred. They may have no hope for the future or have experienced a recent loss of relationship, marriage, house, job or money. They may have nightmares and express suicidal impulses, or make statements or plans. A classic warning sign is giving away favorite things. The suicidal patient may be agitated, hyperactive or restless.
Healthcare professionals should be alert to the risk factors and signs of suicidal intent. Suicide in a healthcare facility is the second most common sentinel event reported to the Joint Commission, an accrediting body for hospitals.
The attorney or records reviewer should keep in mind a few points when reviewing medical records of a depressed patient. First, detailed notes about the content of psychotherapy sessions are likely to not be supplied by a therapist. General comments about the course of therapy may be turned over, but the intimate notes of sessions may be kept in a separate file. Secondly, it is common for a psychiatrist to define the patient’s problems along five axes, as laid out by the DSM IV-TR. The Diagnostic and Statistical Manual of Mental Disorders (DSM) is an American handbook for mental health professionals that lists different categories of mental disorders and the criteria for diagnosing them, according to the publishing organization the American Psychiatric Association. The DSM is used worldwide by clinicians and researchers as well as insurance companies, pharmaceutical companies and policy makers. The DSM, including DSM-IV TR, is a registered trademark belonging to the American Psychiatric Association. The DSM-V is currently in consultation, planning and preparation, due for publication in approximately 2011. [3]
The five axes are as follows:
• Axis I: Clinical disorders. These consist of all relevant major psychiatric disorders such as schizophrenia, bipolar disorders and major depression.
• Axis II: Personality disorders and mental retardation. Personality disorders as defined in the DSM IV-TR are deeply ingrained maladaptive, lifelong behavior patterns.
•Axis III: General medical conditions that are identified on the basis of a comprehensive history and physical examination, evaluation of symptoms, mental state examination and supplementary assessment instruments. These include any medical condition such as diabetes, hypertension, cystic fibrosis and so on.
• Axis IV: Psychosocial and environmental problems. These can include stressors such as a recent death of a loved one, being a victim of a crime, going through a divorce or losing one’s job, among others.
• Axis V: Global assessment of functioning (GAF), written as numbers (0–100) meaning “current functioning”/“highest level of functioning in past year” with 100 being the highest optimization of functioning and 0 being the lowest. [4]
Thirdly, the attorney can be of value to his or her clients by mentioning resources, such as NAMI, available to help the depressed patient or family. NAMI (National Alliance on Mental Illness at www.nami.org) has chapters in all states and in many counties. NAMI offers an array of peer education and training programs and services for consumers, family members, providers and the general public. NAMI’s education and support programs provide relevant information, valuable insight and the opportunity to engage in support networks. These programs draw on the lived experience of mental health consumers and family members who have learned to live well with their illnesses and have been extensively trained to help others, as well as the expertise of mental health professionals and educators.
There are several effective antidepressants on the market that bring relief of symptoms for those challenged by depression. There is no need to suffer through a major depression. Lives can be saved by confronting depression. •

Patricia Iyer is president of Med League Support Services, a legal nurse consulting firm established in 1989. Pat is a past president of the American Association of Legal Nurse Consultants and was the chief editor of both the Principles and Practices of Legal Nurse Consulting and the online LNC course offered by AALNC;pat@medleague.com.

1. NAMI Family to Family Education Program 2/03e.
2. Gilbert, Elizabeth, Eat, Pray, Love, Penguin Books, 2006.
3. www.wikipedia.com.
4. Mohr, W. “Psychiatric Medical Records,” in Iyer, P., Levin, B. and Shea, M.A., Medical Legal Aspects of Medical Records, Lawyers and Judges Publishing Company, 2006; available through www.medleague.com.


What’s a life worth? $1 million less than before

• The Gist: While the EPA may consider life worth less than it used to be, it cautioned that the number should not be used as a price tag for life.

© 2008 The Medical-Legal News

The value of a human life is falling, at least by the Environmental Protection Agency’s reckoning. The current value, $6.9 million is $1 million less than five years ago, according to The Associated Press.
The EPA does not value life similar to the way a life care planner would (such as earning capacity or value to family members as used in wrongful-death suits or insurance calculations), but rather on a cost-risk analysis that people would impose on themselves, according to the AP.
The story said the EPA claims it is following statistical science, though a former EPA official felt that the change in life value was politically motivated. An economist was quoted as saying that as affluence goes up, the price of a life should, too. He noted that no study has shown Americans are less willing to pay to reduce risks than before.
Why the importance? The story said regulations imposed by government agencies are often decided on a cost-benefit scale that takes into account a life’s value, so the less value, the less need for regulations.
A pithy blogger on thinkprogress.org said, “I thought nothing was more valuable than a human life. Maybe they only meant Teri Schiavo.” •

Formula for “great” work: nurse applies it in insurance business

© 2008 The Medical-Legal News
By Nancy Reisner, RN, CLNC

ESSAY

One thing that has always impressed me about the field of nursing is the unlimited opportunities and roads you can choose to go down. When I was in school, my plan was to work in a hospital at the bedside. I really didn’t stop to think of other options and I certainly had no idea that in 20 years I would need to use a map to find where I am today.
As most nurses can attest, one job leads to another. You take the skills you’ve learned and apply them to your next position, always building on your past experience. It’s sometimes surprising how these skills can cross over into very different applications at times. Much of what we do is to educate. We spend significant time educating our patients, our customers and ourselves. We learn even while we are educating. For those willing to “stretch” those skills, some very interesting jobs or even business opportunities can lie ahead.
My road has been a fairly winding one. I’ve always thought this helped to make me more “well rounded.” I’ve had a nice variety of past nursing positions that have led me to where I am now. Today I am working as a full time legal nurse consultant and have been certified for the past 10 years. I’ve always felt very strongly that education and certification in the specialty area you choose helps equip you to go forward and also assists in marketing yourself more effectively in that area. I have tried being a business owner and found that I like the support and camaraderie of a company and coworkers. I appreciate having the infrastructure that a larger company can provide (e.g., marketing staff and billing assistance). Fortunately, I have been able to team up with a company that shares my passion for this type of work and has supported and encouraged the development of a legal nurse product.
As with general nursing, there are a wide variety of opportunities within the field of legal nurse consulting. The obvious role that we all train for is working directly with plaintiff and defense attorneys. This opens the door to a variety of types of litigation (medical malpractice, personal injury, products liability, managed care cases, toxic torts, criminal abuse, DUI cases, etc.). However, anytime there are medical records, there is an opportunity for a legal nurse to be involved, and the law office is not the only place we can be marketing to.
I have found my legal nurse experience has led me in many directions, one of them being the liability insurance industry. This is not a new area for nurses, as nurses have been providing medical record reviews for insurance companies for years. However, when a legal nurse consultant provides the review, you have someone who is knowledgeable with the litigation process and the theories of liability. The legal nurse is able to apply his or her fine-tuned screening skills and provides professional reports, chronologies, bill reviews and medical research to support an opinion. The legal nurse also understands the importance of looking at the entire “picture” and providing an informed and factual document that the medical records support.
The adjusters I work with are very experienced, but frequently have questions about the injury or the treatment that was sought. They are extremely busy people frequently faced with some very medically complex files. On each case, I work with the adjusters to find out what their concerns are and determine what type of product will best meet their needs. The main question an adjuster generally asks is, “What really happened at the time of the claimed injury and what am I responsible for?”
During the course of the review, essential missing records, pre-existing diagnoses and treatment unrelated to the claimed injury are identified. The report outlines these issues, and notes the supporting documentation. Frequently, this information results in substantial cost savings for the adjuster. The report findings are utilized during the bill paying process and at the time of settlement. The adjuster can use the legal nurse’s report and feel confident that he or she knows the facts of the case and how this impacts the claim.
In my past experience I have found the legal nurse review can be extremely beneficial for those adjusters trying to adjudicate or resolve a liability claim. A legal nurse review should not just be reserved for the most complex cases, although that is where we can have the greatest impact. I enjoy equally the adjuster who calls to ask a question, or who sends me a few pages of bills or records to look at and discuss. This is all a part of the entire process of meeting the needs of your customer and, in the process, developing quality relationships.
If the legal nurse provides a workable product that meets the needs of the adjuster, answers the questions of the case in an understandable manner and notes the supporting documentation, you will have a good work product.
If the legal nurse strives to provide quality service and a superior work product, truly cares about meeting the needs of the adjuster, understands that every dollar counts — including what the adjuster is spending for your services — is passionate about finding the truth based on the available facts, has a keen eye for reviewing the medical records and provides sound nursing opinions based on this, then you will have a great work product.
I base my business on this last paragraph. I care about my customers and I care about the claimant’s files that I review. In the end, whether it’s good news or bad news, it’s important that the adjusters know where they stand. It’s my goal to help them take that stand. •

Nancy Reisner, RN, CLNC, has 23 years of nursing experience with 10 of those years as a Certified Legal Nurse Consultant®. She has been employed with The Alaris Group, Inc. for the last five years.

Policy and standard lapses: simple breaches can hurt — and cost — a lot

• The Gist: Medical-legal professional may not need to look far to find the breach in care, or care below the standard.

© 2008 The Medical-Legal News

The July 2008 and August 2008 issues of the Legal Eagle Eye Newsletter (www.nursinglaw.com) reported several med mal cases of note.
In a case where a 9-year-old boy was suffering from an asthma attack, he was given succinylcholine, which paralyzed his breathing. Delays in intubation then compounded his brain damage from lack of oxygen. Award against the military hospital: $4 million.
A nursing home that was on a campaign to raise revenues admitted a psychiatric patient, who was known to be violent and who had been previously locked up, from a VA hospital. The nursing staff complained that the patient should not be at the home. The patient soon injured his defenseless roommate. Award: $100 million in punitives, which was reduced to $750,000 under Texas caps.
In one case a post-op patient coded. The batteries in the laryngoscope were dead and no spare batteries were on the crash cart, as per hospital policy. Next, the wall-mounted suction in the room did not work. The defendants did a lot of finger pointing, but all settled.
In another case, an aide left a weak and anemic patient alone in the bathroom while he was showering. The patient had asked the aide for assistance. The patient fell, hit his head and suffered a subdural hematoma, from which he later died. The article noted that lapses in patient safety policy are indicative of conduct below the standard of care, so no expert witnesses would be needed.
In another case a lung cancer patient, after a successful surgery, was discharged without compression stockings and without being told stockings were needed. The patient later suffered deep vein thrombosis that led to cardiac arrest and death. Award to widow: $1.3 million.
In another case, nursing staff did not wait for lab results to come back about a patient’s suitability for Coumadin. The patient was hospitalized with severe bleeding problems. Award: $100,000.
Lastly, an ER patient with a known history of suicidal thoughts was left alone in a room by a psychiatric nurse. The patient hanged himself. Settlement: $1 million.

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