New York, NY - - (PR.COM) - - 01/XX/10 - - Nancy E. Fraser, RN, Chief Executive Officer at Med Legal Consulting Source, Inc., has been selected to speak at the 2010 Annual Conference of the Council on Litigation Management (CLM). Ms. Fraser is slated to speak on the topic “Tapping the Talents of Medical Records Review Professionals to Leverage Litigation Defense Dollars.”
The conference will be one of the largest, fully inclusive defense industry conferences in 2010. It will be held March 24-26 in Pointe Vedra, Florida, will feature approximately 150 speakers and is expected to draw attendees from around the world. Registration for the conference is now open at www.litmgmt.org/annual-conference.
Nancy Fraser is Chief Executive Officer of Med Legal Consulting Source, Inc., which she founded in 2000 to provide customized medical record review services to attorneys, insurance companies and corporations.
As a registered nurse for more than 25 years, she co-founded one of the nation’s first outpatient surgery centers in 1987, where she oversaw business operations, managed a medical staff of 350, and coordinated the center’s three operating rooms.
About the Council on Litigation Management
The Council is a nonpartisan alliance of thousands of insurance companies, corporations, general counsel, risk managers, claims adjusters and attorneys. Through education and collaboration, its goals are to create a common interest in the representation by firms of companies, and to promote and further the highest standards of litigation management in pursuit of client defense. To learn more about the Council, please visit www.litmgmt.org or contact Adam Potter.
Thursday, January 14, 2010
Friday, December 4, 2009
Modernize Your Practice to Maximize Damages: The Legal Nurse Consultant’s Role in Litigation
Gone to the barber recently for surgery? Had the blacksmith pound out something special for the horse? Taken a pair of shoes to a cobbler? If this all seems as antiquated as keeping a scrivener outside the office door, why not join savvy plaintiff’s lawyers in the 21st Century by tapping the invaluable, cost-effective capacities of medical records companies to deal with medical records and maximize potential damage awards?
In injury litigation, the value of cases absolutely gets decided by critical information contained in medical and billing records of a patient turned litigant or claimant. But who reviews these medical records, how and at what cost? There’s a powerful argument to be made that current practices are unwise and unsustainable, particularly when compared with the modern, efficient option offered by medical records companies.
These firms, particularly the most advanced of them, can bring together experienced legal nurse consultants, experts in billing and auditing and knowledgeable life care planners in sophisticated, demonstrable and beneficial ways for plaintiff’s counsel. In invaluable, swift fashion, these trained professionals can help attorneys receive the highest damage settlements and awards, protect those awards from legal assault and control costs by:
• Accessing, organizing and analyzing medical records on a client, his current status and his claims and seeing how these all square with preexisting conditions and previous injuries. Legal nurse consultants can provide invaluable professional insight into possible outcomes for unresolved medical issues.
• Providing hard-nosed, objective information so counsel can anticipate how the opposition will counterattack a case, from start to finish, and strategizing how to gain the upper hand from the onset to force resolution at a time that capitalizes damages.
• Tackling difficult medical billings – an invaluable step in light of the current colloquy over so-called Hanif-Nishihama defenses.
• Determining sound, defensible plans for a client’s care and calculating those costs for settlement purposes.
For now, let’s start by tackling medical records and damages, setting this discussion in broad context: The winds of change are gusting through even the most august practices of the law. While litigation often increases in difficult times, most lawyers have seen business plummet as the nation undergoes one of the worst economic crashes in recent memory. The biggest firms are dismissing lawyers and cutting staff; even the billable hour, once sacrosanct for defense attorneys, sits now in clients’ cost-cutting bull’s eye. Entrepreneur-author David Galbenski describes powerfully in his recent book how the legal business is reacting fast: Smart practitioners are scrambling to analyze what they do best and how it gets them the highest return, while unbundling services and shipping out tasks to others who can take them on more efficiently. (David Galbenski, “Unbound: How Entrepreneurship Is Dramatically Transforming Legal Services Today,” 2009) For plaintiff’s attorneys, cost management has become a critical issue. Savvy practitioners are selecting cases carefully, figuring how best to pursue them, strategizing on how to attain the highest damages or knowing when to settle them for a client’s maximum benefit – and doing all this while keeping a careful eye on costs and overhead. This has meant that innovations in the practice of the law no longer are an abstract frill. They’re a must.
But when it comes to medical records, old-fashioned ways still hold. Some lawyers, perhaps out of force of habit, wade through them by themselves. They put associates, paralegals or law clerks to work on them. Or they retain pricey physician experts, many of whom offer opinions only in their specialty area and without a wider perspective about a patient’s care and needs – information critical to building a case. While these professionals carry impressive credentials of their own, what’s unclear to the objective eye is what knowledge, skill and experience they bring to a specialized task – and what’s the return on the investment for their services. As author Malcolm Gladwell has pointed out, it takes a big investment of time – he estimates it to be at least 10,000 hours -- to acquire expertise in a given pursuit. (Malcolm Gladwell, “Outliers: The Story of Success,” 2008, Little, Brown and Co.) After long toil to learn and to practice the law, how many counsel, much less paralegals, associates or law clerks, have sunk enough hours in to really claim mastery of matters medical? Can they accurately scrutinize and assess injury information from medical records, especially if it exceeds what a patient has discussed?
In contrast, good legal nurse consultants possess impressive curriculum vitaes with extensive clinical experience and years of preparing materials for litigation. They’re comfortable with legal process. They’re intimately familiar with medical records; they know how and where to find information, what they contain and how they’re organized. They’ve cared for many, many patients, from injury onward through the medical process. Their expertise can be significant in cases from start to finish.
For plaintiff’s counsel, it’s crucial from the outset and throughout a case to get a full grasp of the extent and legal value of a patient-client’s injury or harm. This key information, first and foremost, resides in medical records, which legal nurse consultants arguably are best positioned to handle. Although experience attorneys might still argue that they are capable of handling the review of medical records or need to do so in order to be properly prepped for their cases, there is a better way. Articulate, high level reviews of records by legal nurse consultants provide lawyers with the pertinent content of the medical records as well as a breath of insight and analysis pertaining to the plaintiff for the plaintiff’s attorney to digest and utilize in what they do best, which is litigate. And from a business perspective, by embracing record review companies as strategic partners in their practice, they appropriately transfer overhead costs to case related charges.
Plaintiff’s attorneys can work with medical records companies to decide the depth and breadth of the scrutiny they want their legal nurse consultants to undertake, from a brief review to a full-blown analysis. A quick scan performed by an expert of the medical records early on can give a plaintiff’s attorney a crucial understanding of the potential value of a case and a way to estimate the effort needed for potential litigation or settlement. In a deeper study, legal nurse consultants can examine in detail what the records tell about a client’s pre-existing injury, harm or conditions and advise, in medical terms, how these fit together. As veteran attorneys know, clients can be forgetful or they can overlook information or incidents that wise counsels need to know, whether in litigation or if the appropriate situation arises for settlement. If there are pending or unresolved issues in a client’s records, legal nurse consultants also can offer insight into their potential medical disposition. For plaintiff’s attorneys, all this information – good, bad and ugly – provided by nurse consultants can be huge in attaining the right experts and specialists, in preparing clients and experts for deposition, knowing what opposing counsel might use to unhinge their witnesses, in planning offensive strategies to undercut defenses impact on minimizing exposure and liability, in arguing motions and or ensuring certain evidence is admissible or excluded, all ultimately leading to obtaining the maximum settlement or damage awards for a client and doing so in the most time- and cost-efficient way for all concerned.
Often, of course, settlement isn’t an option; a case gets beyond billing concerns. Suddenly, plaintiff’s attorneys find themselves in pitched battle with defense counsel with damage awards very much at stake. Absent the easy, frequent access to the plaintiff that his counsel has, the defense – attorneys, insurers and corporations in risk-management roles – absolutely will launch a furious counterattack, often via medical records. And woe be to even the most experienced litigant who fails to anticipate the opposition’s strategies and overestimates an affable client’s credibility. Legal nurse consultants can give a major assist to plaintiff’s attorneys, mapping out via medical records the flaws and strengths in a damage claim and letting them see how their clients look not in flesh-and-blood fashion but via cold ink and electrons.
As they scour the records, legal nurse consultants especially will see and determine the plaintiff’s preexisting conditions or prior injuries and assess whether and how these jibe with current claims. They’ll scrutinize what tests and procedures he has undergone and what kind of care and medications he’s received. The nurse consultant will piece together a picture of the claimant as patient: Was he slow to seek care? How well did he follow doctor’s orders? Did he miss appointments or fail to fill prescriptions or to follow treatment regimens? Did he forget about an old injury or existing condition?
Legal nurse consultants, with their deep experience with records and care, instantly will spot important materials missing in a medical file. This capacity can both buttress a plaintiff’s case (was there negligent handling of him as evidenced by a missing report or diagnoses?) and prevent surprise defense attacks (in raising doubts about “phantom” documentation). And speaking of getting hit head on, how rattled in deposition could your client get when confronted with contradictory, unpleasant or forgotten facts extracted from his own medical records? Plaintiff’s counsel could avert this from occurring with the assist of legal nurse consultants.
It goes without saying that legal nurse consultants, in all their efforts, cut through both medical and legal jargon. They present their findings in clear, organized tables and compelling narratives that can provide counsel the case foundation for a winning storyline. They’re unfazed by reams of documents, and, taking advantage of the latest technologies, they can index and organize materials so an attorney instantly can find whatever’s needed, even in the heat of a courtroom argument.
As with all providers of professional services, counsel, caveat emptor: Look at the qualifications of the individuals who will do the actual work contracted for; consider the company’s capacity and record in delivering what’s needed, especially with the flexibility demanded in difficult, fast-moving and challenging litigation, whether the matters seem large or small. If the point of unbundling this duty is to find someone else to assume this task in a cost-effective, efficient way, is the handling of medical records the central concern of this business? Or is it just one more sidelight? And what kind of customer service will you get and who will you deal with to get it?
Finally, of course, the price for all this expert effort must come into play. It ought to be considerably less than what might be racked up via in-house time and labor expenditures, or, certainly, what might be billed by a consulting physician or combination of medical experts. A quality company that specializes in medical records review will be open to pricing discussions for its services from beginning to end. Legal nurse consultants expect to work closely with clients to provide candor, transparency and controls on costs of their services. This adds to the growing enthusiasm for the medical records companies they’re associated with and their place in legal services, unlike, say, the reception for Bartelby, that Melvillean character, who, when confronted by new work always “would prefer not to.” Of course, this isn’t the 19th Century, scriveners are gone – and sophisticated members of the legal community are tackling 21st Century ways, with help from legal nurse consultants, to do vital work that adds up for the bottom line and contributes to maximizing damages for deserving clients.
In injury litigation, the value of cases absolutely gets decided by critical information contained in medical and billing records of a patient turned litigant or claimant. But who reviews these medical records, how and at what cost? There’s a powerful argument to be made that current practices are unwise and unsustainable, particularly when compared with the modern, efficient option offered by medical records companies.
These firms, particularly the most advanced of them, can bring together experienced legal nurse consultants, experts in billing and auditing and knowledgeable life care planners in sophisticated, demonstrable and beneficial ways for plaintiff’s counsel. In invaluable, swift fashion, these trained professionals can help attorneys receive the highest damage settlements and awards, protect those awards from legal assault and control costs by:
• Accessing, organizing and analyzing medical records on a client, his current status and his claims and seeing how these all square with preexisting conditions and previous injuries. Legal nurse consultants can provide invaluable professional insight into possible outcomes for unresolved medical issues.
• Providing hard-nosed, objective information so counsel can anticipate how the opposition will counterattack a case, from start to finish, and strategizing how to gain the upper hand from the onset to force resolution at a time that capitalizes damages.
• Tackling difficult medical billings – an invaluable step in light of the current colloquy over so-called Hanif-Nishihama defenses.
• Determining sound, defensible plans for a client’s care and calculating those costs for settlement purposes.
For now, let’s start by tackling medical records and damages, setting this discussion in broad context: The winds of change are gusting through even the most august practices of the law. While litigation often increases in difficult times, most lawyers have seen business plummet as the nation undergoes one of the worst economic crashes in recent memory. The biggest firms are dismissing lawyers and cutting staff; even the billable hour, once sacrosanct for defense attorneys, sits now in clients’ cost-cutting bull’s eye. Entrepreneur-author David Galbenski describes powerfully in his recent book how the legal business is reacting fast: Smart practitioners are scrambling to analyze what they do best and how it gets them the highest return, while unbundling services and shipping out tasks to others who can take them on more efficiently. (David Galbenski, “Unbound: How Entrepreneurship Is Dramatically Transforming Legal Services Today,” 2009) For plaintiff’s attorneys, cost management has become a critical issue. Savvy practitioners are selecting cases carefully, figuring how best to pursue them, strategizing on how to attain the highest damages or knowing when to settle them for a client’s maximum benefit – and doing all this while keeping a careful eye on costs and overhead. This has meant that innovations in the practice of the law no longer are an abstract frill. They’re a must.
But when it comes to medical records, old-fashioned ways still hold. Some lawyers, perhaps out of force of habit, wade through them by themselves. They put associates, paralegals or law clerks to work on them. Or they retain pricey physician experts, many of whom offer opinions only in their specialty area and without a wider perspective about a patient’s care and needs – information critical to building a case. While these professionals carry impressive credentials of their own, what’s unclear to the objective eye is what knowledge, skill and experience they bring to a specialized task – and what’s the return on the investment for their services. As author Malcolm Gladwell has pointed out, it takes a big investment of time – he estimates it to be at least 10,000 hours -- to acquire expertise in a given pursuit. (Malcolm Gladwell, “Outliers: The Story of Success,” 2008, Little, Brown and Co.) After long toil to learn and to practice the law, how many counsel, much less paralegals, associates or law clerks, have sunk enough hours in to really claim mastery of matters medical? Can they accurately scrutinize and assess injury information from medical records, especially if it exceeds what a patient has discussed?
In contrast, good legal nurse consultants possess impressive curriculum vitaes with extensive clinical experience and years of preparing materials for litigation. They’re comfortable with legal process. They’re intimately familiar with medical records; they know how and where to find information, what they contain and how they’re organized. They’ve cared for many, many patients, from injury onward through the medical process. Their expertise can be significant in cases from start to finish.
For plaintiff’s counsel, it’s crucial from the outset and throughout a case to get a full grasp of the extent and legal value of a patient-client’s injury or harm. This key information, first and foremost, resides in medical records, which legal nurse consultants arguably are best positioned to handle. Although experience attorneys might still argue that they are capable of handling the review of medical records or need to do so in order to be properly prepped for their cases, there is a better way. Articulate, high level reviews of records by legal nurse consultants provide lawyers with the pertinent content of the medical records as well as a breath of insight and analysis pertaining to the plaintiff for the plaintiff’s attorney to digest and utilize in what they do best, which is litigate. And from a business perspective, by embracing record review companies as strategic partners in their practice, they appropriately transfer overhead costs to case related charges.
Plaintiff’s attorneys can work with medical records companies to decide the depth and breadth of the scrutiny they want their legal nurse consultants to undertake, from a brief review to a full-blown analysis. A quick scan performed by an expert of the medical records early on can give a plaintiff’s attorney a crucial understanding of the potential value of a case and a way to estimate the effort needed for potential litigation or settlement. In a deeper study, legal nurse consultants can examine in detail what the records tell about a client’s pre-existing injury, harm or conditions and advise, in medical terms, how these fit together. As veteran attorneys know, clients can be forgetful or they can overlook information or incidents that wise counsels need to know, whether in litigation or if the appropriate situation arises for settlement. If there are pending or unresolved issues in a client’s records, legal nurse consultants also can offer insight into their potential medical disposition. For plaintiff’s attorneys, all this information – good, bad and ugly – provided by nurse consultants can be huge in attaining the right experts and specialists, in preparing clients and experts for deposition, knowing what opposing counsel might use to unhinge their witnesses, in planning offensive strategies to undercut defenses impact on minimizing exposure and liability, in arguing motions and or ensuring certain evidence is admissible or excluded, all ultimately leading to obtaining the maximum settlement or damage awards for a client and doing so in the most time- and cost-efficient way for all concerned.
Often, of course, settlement isn’t an option; a case gets beyond billing concerns. Suddenly, plaintiff’s attorneys find themselves in pitched battle with defense counsel with damage awards very much at stake. Absent the easy, frequent access to the plaintiff that his counsel has, the defense – attorneys, insurers and corporations in risk-management roles – absolutely will launch a furious counterattack, often via medical records. And woe be to even the most experienced litigant who fails to anticipate the opposition’s strategies and overestimates an affable client’s credibility. Legal nurse consultants can give a major assist to plaintiff’s attorneys, mapping out via medical records the flaws and strengths in a damage claim and letting them see how their clients look not in flesh-and-blood fashion but via cold ink and electrons.
As they scour the records, legal nurse consultants especially will see and determine the plaintiff’s preexisting conditions or prior injuries and assess whether and how these jibe with current claims. They’ll scrutinize what tests and procedures he has undergone and what kind of care and medications he’s received. The nurse consultant will piece together a picture of the claimant as patient: Was he slow to seek care? How well did he follow doctor’s orders? Did he miss appointments or fail to fill prescriptions or to follow treatment regimens? Did he forget about an old injury or existing condition?
Legal nurse consultants, with their deep experience with records and care, instantly will spot important materials missing in a medical file. This capacity can both buttress a plaintiff’s case (was there negligent handling of him as evidenced by a missing report or diagnoses?) and prevent surprise defense attacks (in raising doubts about “phantom” documentation). And speaking of getting hit head on, how rattled in deposition could your client get when confronted with contradictory, unpleasant or forgotten facts extracted from his own medical records? Plaintiff’s counsel could avert this from occurring with the assist of legal nurse consultants.
It goes without saying that legal nurse consultants, in all their efforts, cut through both medical and legal jargon. They present their findings in clear, organized tables and compelling narratives that can provide counsel the case foundation for a winning storyline. They’re unfazed by reams of documents, and, taking advantage of the latest technologies, they can index and organize materials so an attorney instantly can find whatever’s needed, even in the heat of a courtroom argument.
As with all providers of professional services, counsel, caveat emptor: Look at the qualifications of the individuals who will do the actual work contracted for; consider the company’s capacity and record in delivering what’s needed, especially with the flexibility demanded in difficult, fast-moving and challenging litigation, whether the matters seem large or small. If the point of unbundling this duty is to find someone else to assume this task in a cost-effective, efficient way, is the handling of medical records the central concern of this business? Or is it just one more sidelight? And what kind of customer service will you get and who will you deal with to get it?
Finally, of course, the price for all this expert effort must come into play. It ought to be considerably less than what might be racked up via in-house time and labor expenditures, or, certainly, what might be billed by a consulting physician or combination of medical experts. A quality company that specializes in medical records review will be open to pricing discussions for its services from beginning to end. Legal nurse consultants expect to work closely with clients to provide candor, transparency and controls on costs of their services. This adds to the growing enthusiasm for the medical records companies they’re associated with and their place in legal services, unlike, say, the reception for Bartelby, that Melvillean character, who, when confronted by new work always “would prefer not to.” Of course, this isn’t the 19th Century, scriveners are gone – and sophisticated members of the legal community are tackling 21st Century ways, with help from legal nurse consultants, to do vital work that adds up for the bottom line and contributes to maximizing damages for deserving clients.
Thursday, August 20, 2009
Leveraging the Defense Dollar in Medical Malpractice Cases
By Nancy Fraser, RN, CEO
You wouldn’t ask a neurologist to prepare a demurrer. So why do insurance companies ask claims adjusters and attorneys to interpret medical records and opine on the standard of care? Since experts are hired for all other elements of cases, maybe we shouldn't hastily dismiss the value of an expert review of the medical records. After all, medical records are at the heart of all medical malpractice cases.
Legal staff and adjusters lack the expertise to assess the value of key medical data. Medical practitioners aren’t trained in preparing reports for litigation which may result in poor quality work in exchange for exorbitant fees for their time. Not only do these practices ignore the need for expertise, they can compromise the strength of each case. Rectify this by strategically placing a medical record review expert on your case management team to evaluate and you can choose to defend on breach of standard of care or causation. Legal nurse consultants are the perfect experts to steer your cases in the most advantageously effective and cost efficient direction.
Expertise in any area only comes with years of experience. Malcolm Gladwell explores the concept of 10,000 hours in his book Outliers by considering how much time must be invested in order to become an expert in anything. When it comes down to it, lawyers are experts in the law, so we should rely on their expertise when it comes to the law. When expertise is needed regarding medicine or medical records, rely on doctors and nurses. Medical record reviews require the same level of expertise, experience, and training, but also need a bridge between the legal and medical elements involved. Legal nurse consultants can provide both the expertise and the bridge.
Plaintiff attorneys are becoming more savvy and sophisticated. They have to choose their med mal cases more carefully. It is becoming more common in their practice to have records reviewed prior to filing law suits. And despite legislative measures devised to reduce frivolous claims, medical malpractice claims are a growing reality. In order to match their methods and handle the growing volume, defense counsel should seriously consider implementing this expert level of review in the management of all medical malpractice claims. Otherwise, you are giving the plaintiffs a head start or an advantage by not having a parallel record review process in place.
In this economic climate, it is vital to use your assets efficiently. Don’t pay a lawyer to go a nurses job. Let attorneys be free to do what they are trained to do and litigate claims. Medical records contain some of the most important, case-informing data of any resource. Their review cannot be limited to a cursory aspect of case management. With proper analysis, medical record reviews can account for massive savings of time and money while adding precious strategic value. Legal nurse consultants have experience and expertise needed to review records and provide insurance companies and law firms with the information to defend claims appropriately. It is essential, now more than ever, to embrace nurse record reviews in your litigation management to control outrageous costs associated with defending claims.
People undervalue the role a good medical record review plays in the foundation of a case. 70% of the
evidence in a medical malpractice claim is the medical records. Lay your foundation from the beginning to support the defense you will build by starting with a proper review of the medical records.
Having an attorney or licensed physician review records to determine if there was a breach in the standard of care is both complicated and expensive. Legal nurse consultants are experienced and capable of making standard of care analysis for nursing and medical deviations. Although not all are the right expert to opine in court, their skill sets can be utilized to leverage your defense dollar early in the claims process to understand where your exposure lies, determine the extent of the injury, choose which experts to engage, and arm you with the medically relevant data to outline your strategy moving forward.
An early evaluation in the claims process ensures adjusters are not bogged down with the review of records. A brief abstraction and analysis provides a clear determination of merit to understand standard of care deviations and areas of exposure prior to forwarding a file to an attorney and providing the opportunity to settle before incurring unnecessary attorneys’ fees. By outsourcing the initial review of medical records to experts for an analysis, it enables claims management to handle more cases, settle sooner, and set reserves appropriately.
Should the claim require an attorney you can reduce associated expenses by providing them with a chronology and expert analysis as tools through the litigation process, allowing them to focus
on building a defense by understanding the case’s strengths and weaknesses from the onset. If no breach in standard of care occurred, this will also be revealed through a thoughtful review of
the medical records, giving you and your team the information necessary to get the claim dismissed.
If a claim is sustainable, mitigation damages can be difficult, but is possible through a thorough analysis by a nurse consultant company that specializes in reviewing medical records. Record review
reports need to include, in addition to a chronology of events and deviations in care, the identification of case strengths, weakness, and potential deponents; these are invaluable in discovery and
the defense of the claim. Then the initial evaluation reports can be used as communication tools and references throughout the life of litigation. All this can be done prior to obtaining expensive
testifying experts.
Should the claim require the retention of experts, a legal nurse review will not only identify which experts to obtain, but what records they need to review. This allows you to save on record review costs by reducing the time it takes for experts to read irrelevant and/or redundant records. In addition, proving experts with a chronology reduces their time in figuring out what occurred and what elements of care to investigate and opine on. The role of a legal nurse consultant and their work product has a cost saving impact throughout litigation.
However, not all legal nurse consultants are the same. Selecting the right team to review your records is as critical as selecting any of your other experts. Assessing clinical experience and specialties, considering education, training and certification, and evaluating consulting exposure and abilities, are all important components in selecting legal nurse consultants. As with most experts, there are varying degrees of competence, ability to execute, and speed at which the produce. In my experience, no matter how well a single reviewer analyzes the records, (even a seasoned nurse consultant), a single review does not compete with a multi-level review. Every record should be reviewed by not one, but two specialized legal nurse consultants. Through this collaborative effort, each nurse expert adds his or her own distinct analysis, building reports that account for every interpretation and strategic consideration extractable from medical record data. A layered quality assurance process should be in place to ensure that no stone goes unturned and that you get all of the advantages up front.
Your claims need nurse consultant reviews and a process that enable you to outsource the review of medical records with comfort and confidence. The result is that you will get stronger data, sooner, and strategic insight that can singlehandedly change your position in a case.
Partnering with a legal nurse consulting firm gives you a competitive edge. With upfront, tailored budgets, this approach to record review and claim management provides the flexibility to work with your schedule and budget while discovering the vital information you need. The work is delivered in timely, thorough, customizable reports that make even the most complicated case comprehensible
for all levels of client staff.
Author:
Nancy E. Fraser, R.N. is CEO of Med Legal
Consulting Source, which she founded in
2000 to provide customized medical record
review services to insurance companies
and attorneys for plaintiff and defense
counsel.
You wouldn’t ask a neurologist to prepare a demurrer. So why do insurance companies ask claims adjusters and attorneys to interpret medical records and opine on the standard of care? Since experts are hired for all other elements of cases, maybe we shouldn't hastily dismiss the value of an expert review of the medical records. After all, medical records are at the heart of all medical malpractice cases.
Legal staff and adjusters lack the expertise to assess the value of key medical data. Medical practitioners aren’t trained in preparing reports for litigation which may result in poor quality work in exchange for exorbitant fees for their time. Not only do these practices ignore the need for expertise, they can compromise the strength of each case. Rectify this by strategically placing a medical record review expert on your case management team to evaluate and you can choose to defend on breach of standard of care or causation. Legal nurse consultants are the perfect experts to steer your cases in the most advantageously effective and cost efficient direction.
Expertise in any area only comes with years of experience. Malcolm Gladwell explores the concept of 10,000 hours in his book Outliers by considering how much time must be invested in order to become an expert in anything. When it comes down to it, lawyers are experts in the law, so we should rely on their expertise when it comes to the law. When expertise is needed regarding medicine or medical records, rely on doctors and nurses. Medical record reviews require the same level of expertise, experience, and training, but also need a bridge between the legal and medical elements involved. Legal nurse consultants can provide both the expertise and the bridge.
Plaintiff attorneys are becoming more savvy and sophisticated. They have to choose their med mal cases more carefully. It is becoming more common in their practice to have records reviewed prior to filing law suits. And despite legislative measures devised to reduce frivolous claims, medical malpractice claims are a growing reality. In order to match their methods and handle the growing volume, defense counsel should seriously consider implementing this expert level of review in the management of all medical malpractice claims. Otherwise, you are giving the plaintiffs a head start or an advantage by not having a parallel record review process in place.
In this economic climate, it is vital to use your assets efficiently. Don’t pay a lawyer to go a nurses job. Let attorneys be free to do what they are trained to do and litigate claims. Medical records contain some of the most important, case-informing data of any resource. Their review cannot be limited to a cursory aspect of case management. With proper analysis, medical record reviews can account for massive savings of time and money while adding precious strategic value. Legal nurse consultants have experience and expertise needed to review records and provide insurance companies and law firms with the information to defend claims appropriately. It is essential, now more than ever, to embrace nurse record reviews in your litigation management to control outrageous costs associated with defending claims.
People undervalue the role a good medical record review plays in the foundation of a case. 70% of the
evidence in a medical malpractice claim is the medical records. Lay your foundation from the beginning to support the defense you will build by starting with a proper review of the medical records.
Having an attorney or licensed physician review records to determine if there was a breach in the standard of care is both complicated and expensive. Legal nurse consultants are experienced and capable of making standard of care analysis for nursing and medical deviations. Although not all are the right expert to opine in court, their skill sets can be utilized to leverage your defense dollar early in the claims process to understand where your exposure lies, determine the extent of the injury, choose which experts to engage, and arm you with the medically relevant data to outline your strategy moving forward.
An early evaluation in the claims process ensures adjusters are not bogged down with the review of records. A brief abstraction and analysis provides a clear determination of merit to understand standard of care deviations and areas of exposure prior to forwarding a file to an attorney and providing the opportunity to settle before incurring unnecessary attorneys’ fees. By outsourcing the initial review of medical records to experts for an analysis, it enables claims management to handle more cases, settle sooner, and set reserves appropriately.
Should the claim require an attorney you can reduce associated expenses by providing them with a chronology and expert analysis as tools through the litigation process, allowing them to focus
on building a defense by understanding the case’s strengths and weaknesses from the onset. If no breach in standard of care occurred, this will also be revealed through a thoughtful review of
the medical records, giving you and your team the information necessary to get the claim dismissed.
If a claim is sustainable, mitigation damages can be difficult, but is possible through a thorough analysis by a nurse consultant company that specializes in reviewing medical records. Record review
reports need to include, in addition to a chronology of events and deviations in care, the identification of case strengths, weakness, and potential deponents; these are invaluable in discovery and
the defense of the claim. Then the initial evaluation reports can be used as communication tools and references throughout the life of litigation. All this can be done prior to obtaining expensive
testifying experts.
Should the claim require the retention of experts, a legal nurse review will not only identify which experts to obtain, but what records they need to review. This allows you to save on record review costs by reducing the time it takes for experts to read irrelevant and/or redundant records. In addition, proving experts with a chronology reduces their time in figuring out what occurred and what elements of care to investigate and opine on. The role of a legal nurse consultant and their work product has a cost saving impact throughout litigation.
However, not all legal nurse consultants are the same. Selecting the right team to review your records is as critical as selecting any of your other experts. Assessing clinical experience and specialties, considering education, training and certification, and evaluating consulting exposure and abilities, are all important components in selecting legal nurse consultants. As with most experts, there are varying degrees of competence, ability to execute, and speed at which the produce. In my experience, no matter how well a single reviewer analyzes the records, (even a seasoned nurse consultant), a single review does not compete with a multi-level review. Every record should be reviewed by not one, but two specialized legal nurse consultants. Through this collaborative effort, each nurse expert adds his or her own distinct analysis, building reports that account for every interpretation and strategic consideration extractable from medical record data. A layered quality assurance process should be in place to ensure that no stone goes unturned and that you get all of the advantages up front.
Your claims need nurse consultant reviews and a process that enable you to outsource the review of medical records with comfort and confidence. The result is that you will get stronger data, sooner, and strategic insight that can singlehandedly change your position in a case.
Partnering with a legal nurse consulting firm gives you a competitive edge. With upfront, tailored budgets, this approach to record review and claim management provides the flexibility to work with your schedule and budget while discovering the vital information you need. The work is delivered in timely, thorough, customizable reports that make even the most complicated case comprehensible
for all levels of client staff.
Author:
Nancy E. Fraser, R.N. is CEO of Med Legal
Consulting Source, which she founded in
2000 to provide customized medical record
review services to insurance companies
and attorneys for plaintiff and defense
counsel.
Monday, May 18, 2009
Life Care Planning in Litigation
By Med Legal Consulting Source - Life Care Planning Department
Martha Eggleston, RN, BA, BSN, M.Ed, CLCP
Cecilia Garcia, CDMS, CCM, CLCP, MSCC
Mary Jesko, MS, CCM, CDMS, CRC, CLCP
Nancy Fraser, RN, CEO
What is a Life Care Plan?Martha Eggleston, RN, BA, BSN, M.Ed, CLCP
Cecilia Garcia, CDMS, CCM, CLCP, MSCC
Mary Jesko, MS, CCM, CDMS, CRC, CLCP
Nancy Fraser, RN, CEO
A Life Care Plan is defined as “a dynamic document based upon published standards of practice, comprehensive assessment, data analysis and research, which provides an organized, concise plan for current and future needs, with associated costs, for individuals who have experienced catastrophic injury or have chronic health care needs.”
Life Care Plans are tailored to the patient’s unique current and anticipated needs through life expectancy. They address physical, developmental, cognitive, and psychosocial needs through collaboration with physicians and other professionals, patient and family interviews, resources and standards review, and empirical knowledge from rehabilitation experience. Care needs and frequency are calculated in present day value and are based on industry standards.
History
The history of life care planning is as impressive as its definition. This process arose from the field of Rehabilitation Counseling and was based on its foundational tenets. Initially, the rehabilitation counseling plan focused on assisting individuals who had disabilities and maximizing their potential quality of life and independence. Rehabilitation counselors assist individuals with various physical, mental and emotional disabilities, as defined in the Rehabilitation Act of 1973 and the 1998 Amendments to the Rehab Act, as well as in the Americans with Disabilities Act (ADA). This assistance was provided based on a systematic approach. This process included gathering client information, assessing rehabilitation and medical needs, and developing realistic plans to minimize complications, while maximizing functional independence and mitigating disability. As the field evolved, attorneys, utilizing expert testimony from Rehabilitation Counselors and their “plans”, became increasingly reliant upon this document as a tool to support their claims of damages and future care needs.
Soon, the graduates of these rehabilitation counseling programs entered the workforce. Their “plans” were incorporated into their medical and vocational case management practice. The case management industry quickly recognized the value of these plans. The industry began marketing this plan to attorneys, families, and insurance companies. Registered nurses, physicians, psychologist, social workers and physical therapists began developing what is now known as Life Care Plans. Today, the profession is comprised of a variety of specialized disciplines and multiple perspectives.
Therefore, as a result of this variety, the industry created formal training, certification, and regulation of these practitioners and its practice. Formal training and certification programs address ethics, methodology, trends, and expert testimony through structured classes and continuing educational conferences. Today, there are hundreds of nationally-certified Life Care Planners, along with several formal university certificate programs governing the profession.
Benefits to the Patient
A Life Care Plan details how a patient’s long-term care, financial, physical, and psychological needs will be met. The purpose of a Plan is to maximize quality of life for the rest of the patient’s years, prevent possible complications, and provide assumptions that are needs appropriate, while giving the patient and their family the peace of mind that comes with financial consideration. With each Life Care Plan, the goal is to ease the burden of the injury and restore meaningful life to the injured party as they knew it prior to the injury.
Process and Work Product
In preparation for writing the Plan, Life Care Planners thoroughly review all records with a focus on the medical records, conduct a patient evaluation and medical provider interviews, review depositions and interrogatories of the patient, review expert reports, review depositions of medical providers, research and review supporting literature, and survey vendors. The Life Care Plan is comprised of a narrative report and a table format report detailing the cost projections. The detailed projections include the following:
- Home/Facility Care
- Procedures/Hospitalizations/Surgeries
- Medications
- Routine Medical Care
- Case Management
- Evaluations
- Therapies
- Diagnostic Testing
- Health and Strength Maintenance
- Transportation
- Equipment
- Supplies
- Orthotics/Prosthetics
- Wheelchairs
- Wheelchair Accessories and Maintenance
- Aids for Independent Living
- Home Furnishings and Accessories
- Architectural Renovations
Inclusion of each of these considerations is based on the recommendations found in the medical records, clinical interview and history with the patient and family, treating physician and expert interviews, relevant clinical practice guidelines, relevant research literature, and the empirical knowledge of the Life Care Planner based on rehabilitative experience.
Throughout the process, the Life Care Planner stays in close communication with the patient or patient’s family and their legal representation to ensure a comprehensive and appropriate Plan that meets the needs of the individual.
Life Care Planner’s Role
The role of a Life Care Planner is that of an educator, not an advocate. Planners must maintain objectivity and set forth attainable rehabilitation goals and to assure that all parties involved in the process understand why specific items are included, how/when services should be provided, and how the plan is best implemented. As an educator, the Life Care Planner has a responsibility to educate others regarding the physical and psychosocial sequelae of the injury or illness, what can be expected when the effects of an injury or illness combine with the aging process, and the impact of the injury or illness on the family.
When selecting a Life Care Planner, clinical experience in creating Life Care Plans is critical. This Planner experience and expertise should be the foundation of all Life Care Plans so the resultant Plan is not superficial. A lack of clinical experience in creating Life Care Plans can lead to watered-down Plans, missing critical elements, or even impeachment.
Use in the Legal Arena
A Life Care Plan can be useful to more accurately identify and present the extent of damages arising as a consequence of the condition(s) in question. Benefits of Life Planning services include:
• Providing litigation consultation specific to settlement offers and/or demands
• Providing litigation consultation specific to witness preparation and/or cross examinations
• Presenting damage issues through a single witness in lieu of multiple experts
• Identifying the extent of damages through a standardized process that includes documented foundation
• Documenting “necessary” versus “elective” technologies and services
• Coordinating and/or facilitating “A Day-in-the-Life” video
• Providing documented foundation for Medicare Set-Aside Trusts
A Plan provides valuable information regarding factors that can drastically impact the individual’s case, health care, and affect quality of life. Outside of the judicial arena, it can be used as a preventative Plan for disability management.
Abbreviated or more focused Plans can be useful for evaluating damages or projecting costs and can be effective in preparing for a fair settlement. Additionally, while Life Care Plans are typically designed for catastrophic cases, they can also be used for assessing damages for all levels of injuries to accurately identify and assess costs to any level of future care required.
Needs Based vs. Funding Based
Funding issues are not taken into consideration when developing a Life Care Plan. Instead of fitting a patient’s needs into the amount received as a result of litigation, a Life Care Plan takes the opposite approach. A Plan accurately assesses costs associated with necessary care and/or rehabilitation according to prevailing charges in the patient’s residing community and develops a foundation for the patient to receive appropriate funding that will allow their needs to be met.
Collaboration
Life Care Plans address every aspect of a disability from onset through the end of life expectancy. By the nature of the task, this requires developing information across a broad range of medical and health related professionals. No single Life Care Planner can do so on their own; however, an experienced Life Care Planner is the ideal professional to pull a team together to cover all aspects of the Plan thoroughly. The Life Care Plan is based on case management principles and medical foundations, including clinical practice guidelines, and relevant research literature. Having worked in the rehabilitation environment, experienced Life Care Planners are qualified to ask the appropriate questions, pull in the appropriate people, and cover the clinical aspects of the case. Regardless of their individual experience, Life Care Planners should be a part of a team effort, dependent on the knowledge of other professionals who are working with the patient to collaboratively determine the immediate and future needs of the patient. When choosing a Planner this may well be one of the first questions the referral source may wish to explore.
Methodology
In order to most effectively and accurately analyze the needs of patients, Life Care Planners must employ a consistent methodology and approach to the Plan. Life Care Planners deliberately and methodically organize, evaluate, and interpret patient-specific information. In each of the steps listed below, the goal is to link the recommendations to the supportive documentation.
Life Care Planners take a consistent approach to plan development with a qualified team of professionals on every case:
• Comprehensive review of records and supportive documentation.
• Clinical interview and history with the patient and, whenever possible, a family member or significant contact who knew the patient pre-morbidly as well as post-morbidly.
• Interaction with the medical and health related treatment team to obtain answers to questions not established in the medical records review.
• Research to identify relevant clinical practice guidelines to further establish needs and recommendations as well as support medical and case management foundation.
• Research of relevant literature to further establish needs and recommendations as well as support medical and case management foundation.
• Collaborate with other professionals to determine the patient’s needs.
Rebuttals
The same approach and methodology should be taken for all Life Care Plans, regardless of who is the requesting party, defense or plaintiff. The process and methodology does not change. Consistency in the approach is critical and should not be influenced by the referral source. It is important to note that some variation in Plans of patients with similar disabilities will occur because of unique case variables, but the process and methodology should remain consistent.
Med Legal’s Services
Med Legal Consulting Source’s Life Care Planning Services apply the foundation of our patented record review process by utilizing teams of certified Life Care Planners to review and assess the needs of each case. Our tiered review process assures high quality, reliable, and powerful reports tailored to specific needs. All of Med Legal’s highly qualified Life Care Planners meet our stringent standards for both clinical and legal certification. Every planner is thoroughly vetted and completes extensive training prior to becoming an active member of our team.
Med Legal’s Cost Projections quantify medical damages from a single injury and identify reasonable and necessary medical costs utilizing a consistent and scientific approach. This abbreviated Life Care Planning service can be useful for assessing damages, projecting costs, and reaching a fair settlement.
Med Legal’s Mini Life Care Plan is a projection and estimation of the costs of medical and non-medical needs of the person with a catastrophic injury or chronic health care needs, based on recommendations found in the medical records and through a phone interview with the patient and/or caregiver. The Mini Life Care Plan can be a powerful and effective tool in settlement, or can be used as a preliminary projection of costs before proceeding to a full Life Care Plan.
Med Legal’s full Life Care Plans expand upon the Mini. Evidentiary support for the Life Care Plan is provided in a narrative format with detailed tables for each recommendation, supplemented with summary tables annualizing costs and range of costs through the patient's life expectancy. Prior to generating the Plan, the Planner strategizes with the Client and performs an assessment with the patient and family and/or caregivers. Med Legal's Plans are consistent with standard care practices, recommend care, and produce reports from which all experts have collaborated and approved.
With all of Med Legal’s Life Care Planning services, our team of Life Care Planners performs at the highest level of experience, collaboration, and professionalism. The end result is a substantial, reliable work product that our Clients have come to expect.
Med Legal Consulting Source
1000 Wilshire Blvd., Suite 260
Los Angeles, Ca. 90017
p: 213-347-0203
f: 213-347-0209
www.medlegal-la.com
info@medlegal-la.com
Wednesday, April 22, 2009
Breathless in the Workplace
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.
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.
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.
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