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Return to Contents
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How to Navigate the
Administrative Law Waters
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knew very little about administrative law when I first became a lawyer. And, what I mean by very little is that I knew nothing. Frankly, the subject was not on the Texas Bar Exam, so that pretty much meant it was not important, right? How wrong that assumption was! It has been a bumpy ride for me during the past few years as I have learned to navigate my way through the complexities of administrative rules and procedures after being taught solely how to interpret appellate court decisions and follow the Texas Rules of Civil Procedure. No one told me that there was a whole world of law out there being written by technocrats in tiny government offices nor how that body of law has become the real workhorse of the legal system. I hope the information contained in this article saves you time researching administrative law questions, particularly if the attorney for whom you work has not had much experience with this area of law. Additionally, the article will conclude by giving the tools needed to obtain employment in agencies or firms requiring administrative law knowledge. However, before jumping straight into the deep end of the pool, let’s get our feet wet by defining what exactly ‘administrative law’ is.
WHAT IS ADMINISTRATIVE LAW?
We all know that there are three branches of the United States government: the executive, the judicial, and the legislative branches. And, we all have a basic idea about how each branch has different responsibilities that place checks and balances on the other branches. For instance, if the legislative branch passes a statute, the judicial branch, if requested to do so in a lawsuit, has the duty to look at the constitutionality of the statute. Thus, the judiciary checks the power of the legislative branch. But did you know that both at the federal and state level, the legislative branch can delegate some of its powers elsewhere– to an agency? This means someone, someone we never elected to office, someone we have never met nor even seen on television, is writing and adopting laws we have to follow. And, this is all legal. It’s called administrative law.
A. Where is it Practiced?
Administrative law is the law practiced before state and federal agencies, although the decisions and rules made by the agencies can be challenged in district court. This article will focus on Texas state agencies for the sake of familiarity, since we have all had contact with at least one Texas state agency. A state agency (the Texas Department of Public Safety) regulates our drivers’ licenses, after all. Texas agencies are created by statutes passed by the Texas legislature, and those same statutes tell the agency what its purpose
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and mission is. They also tell the agencies what kind of rules they want the agency to make to carry out the mission. The rules agencies make are found in the Texas Administrative Code, which is published on-line and updated frequently (www.sos.tx.gov).
B. What Purpose Does Administrative Law Even Serve?
One way to think about this arrangement is to imagine a company vice-president telling a project manager to make widgets. The vice-president tells the manager what kind of widget to make and gives him facilities and the budget to make the widgets, as well as some general guidelines on the size and color desired. How the manager actually sets forth the details of the widget-making, from hiring staff to the
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manufacturing process, is nothing the vice-president has time to worry about because it takes too much detailed, expert knowledge to get involved in the day-today production of widget production. This is exactly why agencies are created. Legislators, like our widget corporation vice-president, need to give regulatory power to those persons most capable of handling the day-to-day field operations. Agencies are filled with technical and legal staff that possess specialized knowledge in narrow fields of expertise, from areas as diverse as public water supply engineering and horse racing regulations. When you really think about it, if our legislators had to come up with each and every rule on how to measure bacteria levels in water supply or what kind of photography equipment to use to determine which
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pony wins the race, they would never have time to deal with all of the other big issues that need resolving, like property tax relief and health insurance availability for children.
STATE AGENCY POWERS IN ACTION
State agencies are mini-governments unto themselves. They not only, as discussed above, come up with rules, (legislative branch), they also hold hearings on the violation or application of their own rules (judicial branch), and have enforcement powers (executive branch). Agencies are really quite powerful since they create their own rules and then enforce them on the rest of us. To understand how an agency’s parts work together as a whole, it (Continued on page 10)
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The Marker Group, Houston
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T
he Marker Group is a full service litigation support firm located in Houston, Texas. Founded in 1985 by Marlene Marker, The Marker Group is a Certified Women’s Business Enterprise that has developed a national reputation for providing quality services to some of the largest and best-known law firms, corporations and insurers in the United States. The Marker Group (MG) offers five distinct services including record collection and analysis, medical review, court reporting, record collection, and document and e-discovery services. With a staff of more than 100 highly trained and experienced people, MG is positioned to assist its clients with the development of cases of any size. MG has provided services on cases with more than 5,000 individual plaintiffs and on cases with only one plaintiff. Similarly, MG has collected records from all 50 states in the Union and a number of foreign countries. MG has the distinction of being one of a handful of record collection vendors to have provided services to the defendants in the largest mass-tort case in United States history.
Record Collection and Analysis is MG’s flagship offering. RCA, as this service is referred to, is a turn-key service that eliminates the need for law firm staff to identify potential records custodians to the collection vendor. The information MG identifies is communicated to the law firm staff via Marker’s Online (our proprietary web interface) and images of all collected records are also posted for review/downloading.
Medical Review allows for the review of collected medical, employment and insurance records with a critical eye towards the injury and damage issues of the case. The review process is performed by legal nurse consultants (nurse paralegals) and the information extracted can be reported in a variety of formats. MG closely matches LNC’s who have a clinical background similar to the injury issues in each case. This provides a more thorough review and
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commentary on consistency in reporting history, treatment protocol, injury causation and possible pre-existing conditions.
MG uses contract certified court reporters to provide court reporting services across the United States. MG offers real-time, video, e-transcripts, rough ASCII, expedited delivery and other services.
Record collection services are more clerical in nature than RCA and involve no subjective review of the records collected. Potential record custodians are identified by counsel and MG initiates the requests for production of those records. Records can be obtained by letter request with HIPAA-compliant authorizations or by subpoena duces tecum. In Texas, MG can also obtain records by deposition on written questions. MG has compiled a database of more than 500,000 records custodians that includes contact information and any special requirements such as prepayment, location-specific authorizations, and other useful information.
MG also offers document services from
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standard reprographics or copy work to scanning and coding for use in litigation support applications. MG can support all common forms of litigation support applications and also offers options for web-based document repository. MG can provide demonstrative aids (or trial exhibits) in black/white or in color. E-discovery is also an area that MG can assist clients with from consulting on best practices for preservation and collection strategies, through processing of electronic information, up to providing web services for the review and categorization of images and native electronic information.
MG is a technology-driven company with a customer-centric focus. With a continued investment in technology to improve efficiencies in both internal operations and the delivery of client services, MG sets the standard by which other litigation support companies are measured. The Marker Group, Inc. 13105 Northwest Freeway, Suite 300 Houston, Texas 77040 713.460.9070 www.marker-group.com
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petroleum storage tanks. Specifically, 30 Tex. Admin. Code § 334.8(c)(5)(C) requires each tank be permanently labeled, “...on the top of the fill tube or to a nonremovable point in the immediate area of the fill tube....” Bad Egg’s USTs went unlabeled for a number of years, and no one seemed to notice that it was impossible to link the tanks up with the numbers on theregistration form. Apparently, Bad Egg was unaware that the TCEQ Houston Regional Office conducts random compliance reviews of all UST facilities. It was only a matter of time before an investigator visited Bad Egg’s facility and this violation would be discovered. And, eventually, a TCEQ investigator visited the site and immediately noticed that the tanks were not labeled with a number. The violation was written up in an investigation report, and a Notice of Violation was mailed to Bad Egg.
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is best to look at an example. We will take a look at the inner workings of the Texas Commission on Environmental Quality (the “TCEQ”), since it is one of the biggest agencies in Texas.
A. Case Study: The TCEQ
The TCEQ, created under Tex. Water Code § 5.012, is instructed at Tex. Water Code §§ 5.103 and 5.105 to write and implement environmental rules for the conservation of our natural resources and the protection of the environment. Other code sections give the TCEQ authority to regulate specific substances and activities. For instance, Tex. Water Code § 26.343 gives the TCEQ the authority implement rules regarding petroleum substances. And, even more specifically, Tex. Water Code § 26.346(a) directs the agency to make rules regarding underground petroleum storage tanks, “The commission by rule shall establish the procedures and requirements for establishing and maintaining current registration information concerning underground or aboveground storage tanks.” (Emphasis added) The
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TCEQ registration requirements for underground petroleum storage tanks are found at 30 Tex. Admin. Code § 334. The rules were written by technical or legal staff and published in Texas Register for comment. After that process occurred, TCEQ legal staff brought the proposed rule to the Commissioners (who are appointed by the Governor to the post) for their approval. Once the rules are adopted, they must be followed, or violators will suffer the consequences, as we will see the next example.
B. How Does the TCEQ Exercise its
Judicial and Executive Powers?
1. Initiating an Enforcement Action
Let’s say a convenience store named Bad Egg, located in Pasadena, Harris County, Texas, has underground storage tanks (“USTs”) holding gasoline. Bad Egg has some bad management problems, though, and never quite got around to labeling the gasoline tanks with a number for identification purposes. This is in violation of one of the rules found at of 30 Tex. Admin. Code § 334.8 regarding the registration of
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Bad Egg disagreed with the Notice of Violation because while then tanks were not numbered, they were color-coded, which is just about the same as numbering since it organizes the tanks. However, the TCEQ Houston Regional Office disagreed that color-coding is the same as numbering, and the case moved forward to the Office of Legal Services.
2. Administrative Litigation
The Litigation Division filed a petition at the TCEQ Central Office, and it informed Bad Egg of the agency’s intention to assess an administrative penalty and require corrective actions for the alleged violation of 30 Tex. Admin. Code § 334.8(c)(5)(C). Bad Egg was adamant that it had committed no violation, and the company demanded a hearing. The TCEQ, like many administrative agencies, sends the hearings to the State Office of Administrative Hearings (“SOAH”) to be heard by an Administrative Law Judge (the “ALJ”), rather than TCEQ personnel. The purpose behind this move is to give the hearings the appearance of impartiality. After the
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parties conducted discovery and had a few pre-trial squabbles, a Contested Case Hearing was scheduled.
Bad Egg’s attorney and corporate representative both appeared, as did TCEQ attorneys and staff. After hearing the evidence, the ALJ wrote a document called the Proposal for Decision. As you probably predicted, Bad Egg was not successful at convincing the ALJ that color-coding wasthe same as numbering the tanks since the color-coding does not match up with tank numbers on the tank registration forms. Bad Egg vehemently disagreed with the Proposal for Decision (“PFD”), so it filed a response. Months passed, and Bad Egg received notice in the mail that the Commissioners were planning to consider the ALJ’s Proposal for Decision at an upcoming Agenda. The Agenda is the public forum in which the TCEQ Commissioners meet for the purpose of adopting rules and regulations, making final adjudications of PFDs, and ordering regulated entities to perform corrective actions or pay administrative penalties.
3. The TCEQ Commissioners, not the ALJ, Have the Final Say
Bad Egg gave it one last shot at Agenda. The corporate representative and his attorney signed in and waited to have the case called. Once called to order, Bad Egg’s attorney stood up in front of the Commissioners and stated that the color-coding of the tanks satisfied the spirit of the identification rules in the Texas Administrative Code, and therefore, his client committed no violation. Next, the Commissioners listened to the ALJ justify his reasoning why the color-coding was found insufficient. The Litigation Division attorney nodded in agreement with the ALJ. The Commissioners then considered Bad Egg’s arguments and argued amongst themselves for a bit, but ultimately, they decided to adopt the Proposal for Decision. Bad Egg was ordered to pay a $3,000 administrative penalty the tanks. Bad Egg was also ordered to number the tanks in accordance with 30 Tex. Admin.
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Code § 334.8(c)(5)(C). The order to number the tanks is called a ‘corrective action’; Tex. Water Code § 7.050 gives the TCEQ authority to order regulated entities to perform corrective actions. In any case, Bad Egg disagreed with the Commissioner’s Decision and Order, and he requested that his attorney file a district court appeal.
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However, Bad Egg’s attorney explained that an appeal of the Commissioner’s Decision and Order would probably fail since the district court could not hear the entire case over again. In other words, the district court review would not be de novo. Instead, the substantial evidence review would be applied. This means that the district court judge could only look to the
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record developed at the administrative hearings to determine if the TCEQ had followed its own rules properly and some evidence supports the finding. In this case, Bad Egg has admitted that the tanks were not numbered on the date of the investigation. And, really, when you look at it, color-coding is not the same as numbering.
Conclusion
The above case study demonstrates how agencies operate as little governments on their own. From the creation and adoption of the underground storage tank rules (legislative), to the SOAH and Agenda hearings (judicial), to the enforcement mechanism of a shut-down order (executive), the TCEQ functions as the environmental law ‘mini-government’ in Texas. This case study also highlights the importance of using technical experts to write the administrative rules, as opposed to having the Texas legislature write them. It would be entirely too time consuming for our legislators to spend the session pondering the utility of color-coding UST labels versus numbering them. This level of detail really belongs in the hands of science professionals.
Where Do I go From Here?
Not all agencies function like the TCEQ, however. If I can stress one single item of importance to the reader, it is to find out everything you can about an agency instead of assuming it works like ‘all the others’ or that it is ‘just administrative law.’ For example, the real-life attorney for Bad Egg never did attend the Agenda session. I suppose he thought the Commissioners would accept the Proposal for Decision without question, but he was wrong. You cannot work under the assumption that if you know your district court ‘stuff,’ that you do not need to have any extra knowledge on administrative procedures and who the players are at the agency. The Commissioners could very well have reduced the penalty in my case. It was not very good advocacy on my
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opposing counsel’s part to remain ignorant of the administrative procedures. And, here’s how to avoid this trap.
Agency Website: Whether you are preparing for an interview or conducting research, you must visit the agency website as your first stop. A list of the agency websites is found at www2.tsl.state.tx.us/trail/agencies.jsp. Yo u may want to take a look at the agency’s organization chart to see who reports to whom, and, of course, read the Frequently Asked Questions. Most importantly, agencies publish all of their applicable statutes and administrative rules online, so will save yourself research time.
Litigation Pointers: Be prepared to see very wide differences in how each agency handles its hearings. Some agencies, such as the Texas Workforce Commission and Texas Department of Insurance-Workers’ Compensation Division, hold their own hearings rather than outsource them to SOAH. In those two cases, a Hearing Officer, not an Administrative Law Judge, presides over the hearings. In addition, other agencies use Hearing Examiners, which may or may not be attorneys. Attorneys or not, these professionals are still the finder of fact and should be treated with respect by the attorney for who you work. To be on the safe side, refer to all these individuals as “Judge” in any letter, or use their precise title if it pleases you, but try to maintain a certain degree of respect.
SOAH Pointers: If the agency in question uses SOAH to preside over the administrative hearings, visit the website for guidance. The website is found at http://www.soah.state.tx.us. To help guide your research, the website contains a searchable database of Proposals for Decision that could prove key for insight into an individual ALJ’s rationale on similar cases. It will be particu-
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larly helpful if you are preparing for an interview to read a couple Proposals for Decision involving the agency the firm deals with most often. This last piece of advice is even more important for those seeking state employment.
Know your Acronyms: Administrative law is chock-full of acronyms. Each agency refers to itself by its acronym, even if it leads to funny-sounding results, like DADS (Department of Aging and Disability). The State Office of Administrative Hearings has a mouthful of a name, so it is always called “SOAH” (pronounced ‘so-uh’). Most agency websites have a list of common acronyms that you will encounter.
Final Tip: Last, if you are interviewing for a job that requires administrative law knowledge, make it clear in the interview that you know which code contains the statute creating the agency in question and the basic location of their rules in the Texas Administrative Code. Even if you have no experience in the narrow field of law that the agency handles, knowing how to navigate the administrative rules and their relationship to statutes will push you to the head of the pack.
Ann Skowronski is an Enforcement Attorney at the Department of Aging and Disability Services (DADS). The views contained in this article are Ms. Skowronski’s personal opinions; they do not reflect DADS’ views. Ms. Skowronski, a graduate of the University of Texas School of Law, has litigated numerous administrative Contested Case Hearings before both SOAH and the Texas Department of Insurance. She is also a former Texas Workforce Commission Hearing Officer and Assistant Attorney General. Before embarking on a career in administrative law, Ms.Skowronski practiced family law and criminal law in Travis County, Texas.
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Nursine Shuman Jackson, M.S.N, R.N.
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P
aralegals need to ready themselves to participate in the screening of another group of claimants, who now qualify for the Vioxx® litigation, as a result of information acquired when Merck & Company released more data to the FDA in May 2006. Merck is the pharmaceutical company that aggressively marketed Vioxx® to the American public, even though it had little proven efficacy to the average person who would be using it, while it carried significant risks for causing a myocardial infarction or stroke. Paralegals need to have an understanding of the pharmacologic effects of Vioxx and the abnormal clotting that has caused such problems, along with the pathophysiology of cardiovascular disease and risk factors predisposing to thrombotic events. This article aims to provide a foundation for the paralegal involved in client screening and intake.
A BRIEF HISTORY
The story starts in 1996, when in one of Merck’s preclinical studies, patients taking Vioxx® (generic name: rofecoxib) experienced a higher rate of cardiovascular events than patient taking placebo. In spite of these concerning findings, Vioxx went on the market in 1997. In 1998 and 1999 two more internal Merck studies showed much higher risk for cardiovascular events in Vioxx users. Ye t another study, the 1999 Vioxx Gastrointestinal Outcomes Research (VIGOR) showed that Vioxx-users had almost double the risk for suffering thrombotic events, like myocardial infarction and strokei.
Unfortunately, it wasn’t until 5 years later and possibly hundreds of thousands of Vioxx-related injuries and deaths later, that Vioxx was withdrawn from the marketii. It was taken off the market after the release of the results of a study called the APPROVe trial (Adenomatous Polyp Prevention on Vioxx), which initially, in November, 2004, reported a two-fold increase in cardiovascular toxicity, after 18 months of useiii. This drug was deemed “cardiotoxic” and “defective,” but far too late.
Now, nearly two years later, Merck has revealed that the initial data released from the APPROVe study wasn’t complete, and the information that was late in coming, wasn’t exactly good news for Merck, because it would qualify countless additional Vioxx users as claimants in litigation against this pharmaceutical giant. The previously unreleased information showed that short term Vioxx users were also at risk for suffering cardiovascular events; in fact their serious risk for suffering thrombotic events started only days after the initiation of Vioxx use, and the risk continued for a year after discontinuing the drug! Merck now reports that some patients using Vioxx® had their first myocardial infarction (MI) shortly after achieving a therapeutic blood level of Vioxx, i.e., within six to thirteen days (with a median of nine days) after starting the drugiv. The newly released data also demonstrate that the very significant risks from Vioxx persist even one year after the patients stop taking the drug.
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In early May 2006 when National Public Radio (NPR) initially released this information exchanged in a “confidential” report from Merck to the FDA, they reported that “Vioxx patients were 74 percent more likely to develop heart problems in the year after they went off the drug. In the years of taking Vioxx, they were at 90 percent higher risk of heart problems.”v Cardiologists and clinical trial experts who have analyzed this data feel that the persistent risk of cardiovascular problems suggests that Vioxx does long-lasting damage to the arteries.
Merck still contends that the data does not show that the patients remained at an increased risk for hypercoagulability after the drug was discontinued.
MECHANISM OF ACTION
While aspirin acts by inhibiting platelet production, causing vasodilation, and as a result, preventing thrombosis; Vioxx does the opposite. Vioxx (and other drugs in its class called “Cox-2 inhibitors”) causes platelet clumping and vasoconstriction, and as a result, promotes clot formation. Both aspirin and Vioxx work by affecting the complex chemicals called prostaglandins that are released when the body suffers an injury. In order to make prostaglandins, the body releases an enzyme called Cyclooxygenase. There are two forms of Cyclooxygenase that balance each other out. They are Cyclooxygenase-1 (Cox-1) and Cyclooxygenase -2 (Cox-2). Under normal circumstances, if Cox-2 production is stimulated, it results in a series of events that block clotting, (vasodilation, decreased platelet aggregation and decreases vascular smooth muscle proliferation). When Cox-1 is stimulated, it has an opposite effect, i.e., it causes vasoconstriction, increases platelet aggregation, and increases vascular smooth muscle proliferationvi.
When Vioxx inhibits Cox-2, the equation becomes unbalanced, because Cox-1 enzymes continue to act, unopposed. The unopposed enzyme, Cox-1, acts in a manner that promotes clotting. Hence the
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patients who are a high risk for clotting due to pre-existing plaque in their arteries from arteriosclerotic disease are placed at an even higher risk for clotting when they are on Vioxx. Patients who are on hormones or on other drugs or are suffering from disease conditions that place them at risk for clotting (e.g., cancers, clotting disorders), are at even greater risk for a thrombotic event when they take Vioxx. Immobilized patients, patients with heart failure or other conditions causing sluggish blood flow, which places them at risk for developing clots even without Vioxx, are placed in even more danger when they take Vioxx. Even people with no pre-existing or no identifiable risk factors have nearly twice the incidence of thrombotic events when they took Vioxx.
One of the goals of the paralegal performing the intake interview and data collection is to identify and document the Vioxx-user’s risk factors for clotting and co-morbidities that may have contributed to the thrombotic injury, so that the experts can evaluate whether Vioxx caused or contributed to the injury claimed.
LEGAL IMPLICATIONS:
Many more patients than originally estimated may have suffered thrombotic events as a result of their Vioxx use. Both short term users and those who suffered events in the year following discontinuance of Vioxx may now be included as claimants as a result of this new data release. Still, entry criterion for Vioxx claimants is far from standardized.
Barry Hill of West Virginia, who has over 500 Vioxx heart attack and stroke cases filed, or on their way to being filed as lawsuits, cast a wide net in his initial screening, and performed organized data collection. As a result of his advanced planning, as this new data becomes available, he can review his data bases to find additional claimants, rather than going back to re-interview hundreds of Vioxx-users, to determine who may now qualify. He and the other plaintiffs’ lawyers, with whom he is working, believed, even before
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this recent data release, that four days of continuous Vioxx use immediately before a heart attack or stroke was long enough to increase the risk and contribute to causing the event. (They based their client intake criterion on data analysis done by Harvard cardiologist John Markis, MD, soon after Vioxx was removed from the market.)
But not all law firms used the same initial entry criteria, nor did they or do they now, use standardized interviews or intake forms. Many law firms were not set up to do the meticulous screening or data entry needed to keep up with the evolving rules in this litigation. Paralegals working with law firms involved in Vioxx litigation will have to review all past applicants’ data, or re-interview Vioxx users, to determine which of them, may now qualify as claimants. They will also have to revise data collection tools, so that information from new claimants can be properly considered and stored for re-review if and when new iterations of the entry criterion evolve.
CASE INVESTIGATION AND DEVELOPMENT
So how does a paralegal get up to speed to step in on this assembly line already in motion? Unquestionably, the paralegal who presents with a sound knowledge base of the involved pathophysiology and the drug’s mechanism of action will be able to perform intake interviews and data collection more effectively. Working side-by-side with a cardiac nurse to develop a good interview style and data collection tool at the outset would be optimal, however many paralegals are left to their own devices to develop a process. The paralegal, before touching his or her first Vioxx case, at a very minimum, should read nursing textbooks and nursing journal articles to gain a baseline understanding of cardiovascular disease, risk factors, and clotting disorders and on performing a cardiovascular assessment.
Attempting to gain this knowledge base by reading physician’s texts tends to be
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frustrating because they often provides more information than a legal professional needs or wants to know. Likewise, trying to get a foundation via the internet research is not a very efficient means to the end, since the focus of articles available tends not to be specific to the paralegal’s needs. For example, upon entering the search terms “cardiovascular assessment,” the first several hits provide unhelpful information (at least for these purposes). These internet hits give information on interpreting heart sounds, pulses, jugular vein distention and invasive monitoring, but fail to give the step by step overview that would give insights into devising questions for an interview as a nursing text would. A carefully constructed plan for intake questioning implemented from the beginning of client intake will save countless hours later and nursing literature tends to give practical information that is most helpful.
Following is a brief overview of the arduous task of screening and collecting meaningful data for developing Vioxx cases:
Data Collection
Once the plan for data to be collected has been laid out, defining the means for storing the data is in order. The software, whether it is Word tables, Excel spreadsheets, or CaseMap timelines, is not as important as the quality of data collected and consistency of data entry. Most efficiently, data should be entered directly into the data base, as it is obtained during the interview.
Initial Intake
The paralegals for the plaintiff have the benefit and the burden of eliciting medical historical information directly from the patient or his representative, before delving into the medical records. Many firms started by providing potential clients with questionnaires. Others found that skilled interviewers who could alter the intake questioning to meet the needs of the client and his case scenario, so was more effi-
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cient in both screening and in collecting meaningful data.
Each potential claimant’s case must be screened to establish, not only his contemporaneous use of Vioxx at the time of the thrombotic event, but the medical factors that may confound establishing a causal connection between the thrombotic event and the Vioxx use. The paralegal will need to establish the claimant’s medical history, family history, risk factors, Vioxx consumption, his baseline activity and employment status, then his injury and subsequent medical coursevii.
Additionally, the person, either the Vioxx user or his representative, with whom the law office will work and whom the jury will see, needs to be assessed for stamina and personality befitting a credible plaintiff.
At about this point in data collection, the law office often does a review of the potential claimant’s data and makes a decision as to whether additional investigation
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is warranted. Common factors that may exclude a client from further investigation beyond the initial intake include:
• The injury claimed is a hemorrhagic, not thrombotic stroke;
• There is no objective proof of Vioxx use temporally related to the injury;
• The patient has too many comorbidi-ties, or serious illness that would confound establishing a causal connection between the Vioxx use and the injury alleged;
• The patient has no objective evidence of injury;
• The patient has a serious disease process, like cancer that will result in a shortened life expectancy or serious morbidity that will confound or dwarf the Vioxx injury;
• There are personality issues unbefitting a plaintiff;
• There is inadequate or untimely medical documentation to support the case;
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• Medical record are chock full of evidence of noncompliance and/or self destructive behaviors, such as drug or alcohol abuse or self neglect; and
• The client is unable or unwilling to cooperate with the needs of the law office to develop a case.
If the Vioxx user conforms to the inclusion and exclusion criterion as defined by each law firm, then the data collection can proceed to identify the claimant’s providers, past and present. Only then can the daunting task begin, in collecting the medical records, pharmacy print-outs, itemized statements, lien information, and other documents that will illustrate the elements of the Vioxx case.
Each case analysis starts with the tedious process of organizing the records and numbering and tabbing them, a job either performed by or orchestrated by the paralegal. Many “paperless” offices then scan the organized hard copies, and all subsequent reviewers then work off the electronic form of the documents.
Risk Factor Identification
Because many patients who suffer injuries from Vioxx are at risk for suffering a stroke or myocardial infarction even without Vioxx, developing a causal connection between Vioxx use and the event poses a challenge. Merck will argue that patients with multiple risk factors had the throm-botic event due to factors other than Vioxx; plaintiffs will respond that patients with risk factors should not even have been given Vioxx because the drug’s effects doubled their already elevated risk of suffering a thrombotic eventviii. The reality of the case often boils down to a battle of the experts.
To expedite experts’ reviews of the cases to make an assessment of the causal connection, each claimant’s risk factors and confounding disease processes needs to be identified. Baseline demographic information must be compiled for each potential claimant including: age, sex, ethnicity, medical history, in addition to list-
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ing his risk factors. Specific information regarding the claimant’s cardiovascular status should detail his past cardiovascular medical history, co-morbidities and adequacy of his medical management, laboratory data and radiologic data reflecting cardiovascular disease status, family history, his social history, and finally, his medication history in general.
Documenting the History of Vioxx Use
Data that needs to be collected relative to Vioxx use will be used to prove that Vioxx ingestion was temporally associated with the injury. In the best case scenario, appropriate, objective evidence of Vioxx use may consist of a physician’s order stating the prescribed dose and frequency for Vioxx use, plus a pharmacy printout showing that the prescription was filled and refilled surrounding the period in which the user suffered his thrombotic event. A surprising number of patients save empty or partially empty prescription bottles of Vioxx, and these should be collected and marked as exhibits of which the defense is made aware, and then kept within a safe chain of custody until trial.
More often than not, the claimant’s Vioxx history is not so simple to illustrate. The patient may have taken varying doses over time, stopping and starting, using different pharmacies, sharing prescriptions with other family members, etc. The goal in obtaining a Vioxx history is to document:
• Whether the person has taken Vioxx within four days (or whatever number of days the law office has deemed appropriate) immediately preceding the thrombotic event;
• The start and stop dates of each episode of Vioxx usage;
• The dosage prescribed;
• The dose taken;
• The total length of time Vioxx was used;
• Evidence of compliance with the prescribed regimen;
• Concurrent medications used, particu-
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larly drugs that effect clotting, such as nonsteroidal anti-inflammatory drugs, steroids, and other Cox-2 inhibiting drugsix, e.g., Celebrex (generic name: celecoxib) and Bextra (generic name: valdecoxib).
• The recent Canadian study did not provide conclusive evidence of an increased risk of MI for celecoxib, but it may be related to the low doses being consumed by the study sample, since Celebrex is also a Cox-2 drug.x
The supporting documents which commonly illustrate the Vioxx use include the pharmacy printouts, physician’s order sheets, prescription labels, billing statements, insurance documents, and physician and nursing notesxi.
Timelines
The style in which a timeline is developed can be idiosyncratic to the paralegal and/or the law office, however the information collected should document the following:
• Claimant’s baseline status (independence in activities of daily living, health, employment, social status);
• Medication history, particularly evidence of the use of Vioxx in relation to the thrombotic event, allegedly caused by the Vioxx use;
• All medical attention, interventions, and diagnostics;
• The details of his thrombotic event, including objective evidence of the event and resulting injuries, the results of all diagnostics performed, which document the injury;
• His status following the injury (independence in activities of daily living, health, employment, social status);
• Evidence, if documented, of a causal connection to Vioxx use;
• Prognosis related to the Vioxx injury and to other co-morbidities, (e.g., the patient may have suffered a small myocardial infarction that may not change his life expectancy, but has a life
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expectancy of five years due to a concurrent cancer).
Because the timeline is developed to facilitate access to information within the medical records, it should do just that by citing the date, information source, person who documented the fact and specific page number/Bates stamp number, from which the fact was excerpted. The information cited should be accurate reflections of the medical records; therefore direct quotes from the records are more likely, than paraphrased summaries, to depict the content accurately.
Documenting the Injury
In the early stages of client intake for Vioxx litigation, many different injuries were accepted, because the effects of Vioxx on a large human population were yet to be seen. Our working knowledge about Vioxx injuries is still being developed as clinicians compare notes about what happened to their patients and as researchers re-examine data collected in medical studies. Currently, objectively provable myocardial infarctions and strokes are the only injuries that most law offices accept as being clearly causally related. Other injuries in the grey zone might include pulmonary emboli; arterial clots that lodged in extremities or in the arteries leading to the kidney (renal emboli) or leading to the gut (mesenteric emboli), and deep vein thromboses (DVT’s).
Events that are not usually accepted as injuries for purposes of litigation, include hemorrhagic strokes, edema or fluid retention, hypertension, liver and kidney problems, gastrointestinal problems, and events in which there are no objective signs of injury to explain the patient’s signs and symptoms, e.g., cardiac ischemic events, (new onset angina or changing angina), and/or transient cerebrovascular events [transient ischemic attacks (TIAs) or RINDs (Reversible Ischemic Neurologic Deficits)].
The paralegal will search the medical documents, for objective evidence sup-
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porting the injury claimed. To be able to find the meaningful documents, the paralegal needs to armed with a list of studies and physical findings that are considered appropriate evidence of injury. For example, if the alleged injury is a pulmonary emboli, the paralegal will include in the timeline, results from diagnostic studies: arterial blood gas measurements from the time of the event, CT scan results, D-Dimer results (a blood study that demonstrates that a significant amount of clotting has occurred) and physical findings, on which the clinicians relied to make the diagnosis. In the event the injury is a myocardial infarction, critical evidence may lie in electrocardiogram reports; laboratory results such as cardiac markers (e.g., troponins and CPK MBs); echocardio-grams and other studies reflecting the wall motion of the heart; ejection fractions; vital signs, cardiac outputs, etc. If the injury is a stroke, the paralegal would seek documentation of neurological deficits documented in reports of examinations, as would be detailed in neurological consultations or progress notes; evidence of brain injury on MRIs or CT scans of the head, etc. that are consistent with throm-botic or embolic strokes, not hemorrhagic strokes.
Potential claimants who did not seek treatment at the time of the event, so that their injuries were not diagnosed and documented in a timely manner, will probably be screened and included in the initial client group, but should know that without good evidence of injury and causation, they may be excluded later.
CONCLUSION
Though the expert will ultimately make the determination as to whether the injury is causally connected to Vioxx use, the litigation team must have an adequate knowledge base to sift through the clients’ case presentations and determine which clients warrant the time and expense of additional investigation. Generally, the paralegal is the key team member in data collection, so
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his understanding of the involved patho-physiology is crucial for information gathering to allow the litigation team to make good client selections. With more than 80 million people using Vioxx between 1999 through 2004 suffering countless injuries, Vioxx litigation is certain to continue for years. Paralegals involved in medical cases should take every opportunity to familiarize themselves with these issues, because a Vioxx case is sure to come across your desk one day soon.
Nursine is a Master’s prepared Cardiovascular Nurse Specialist who has provided support to plaintiffs attorneys since the mid 1980’s. She currently has a full-time LNC role supporting the Law Offices of Mark R. Bower, PC, in addition to an independent practice in which she provides support Plaintiff ’s Attorneys across the nation. She teaches in the Graduate and Undergraduate Nursing programs of the University of Pittsburgh, in which she addresses “Liability of the Nurse Practitioner” and provides practical information regarding the LNC role and case development for the Forensic Nursing/LNC course. She has published and lectured extensively on the medical-legal analysis of cases with cardiovascular issues.
iv Levesque, LE, et al. (2006). Time variations in the risk of myocardial infarction among elderly users of COX-2 inhibitors. Canadian Medical Association Journal. 174, (11). v http://www.npr.org/templates/story/story.php? storyId=5400413
vi Pritts, D. (2006). Vioxx® . . . more to the story. Journal of Legal Nurse Consulting. 17, (2). 11-15. vii http://www.htwlaw.us/
viii Donati, M. (2005). Defending a Giant. LiNC. 13, (2). 3, 9-10
ix FitzGerald, G. & Patrono, C. (2001). The coxibs, selective inhibitors of Cyclooxygenase-2. New England Journal of Medicine, 345, 433-442. x Donati, M. (2006). Defending a Giant: Vioxx®. Journal of Legal Nurse Consulting. 17, (2). 16-17. xi Levesque, et al, online pg 6.
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Texas Paralegal Journal © Copyright 2007 by the Paralegal Division, State Bar of Texas.
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