Trial Lawyer Resource Center

Yasmin/Yaz is the latest drug receiving scrunity from product liability lawyers.  Yasmin/Yaz have been associated with deep vein thrombosis (blood clots), pulmonary embolism, strokes, heart attacks and, as a result of these health consequences, death. Yasmin/Yaz lawsuits allege product liability, negligence and failure to warn claims against Bayer. There has been in recent months a small flurry of new medical articles have come out in the past week regarding Yasmin and Yaz. Below is a summary of what is out there. Sneak preview: it is not good news for Yaz/Yasmin or its manufacturer Bayer.

Vlieg, et al. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, BMJ 2009;339:b2921.

• Concluded that oral birth control bills increase the risk for venous thrombosis by about five times (this is not new news). But the study also found that drospirenone-based oral contraceptives had an increased risk of 6.3 times that of non-users.
• Many women do not use the safest brands of birth control pills.
• The safest option for women (with regard to venous thrombosis) is a birth control pill that contains levonorgestrel, combined with a low dose of estrogen (again, women have lots of options).

Lidegaard, et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009;339:b2890.

• Drosperinone-containing birth control pills are associated with a higher risk of venous thrombosis than contraceptives containing levonorgestrel.

Yasmin and Yaz both contain the progestin drospirenone—the dangerous one cited in the studies. As a reminder, venous thrombosis is a blood clot that forms in the vein. If the clot breaks off, it can be transported through the circulatory system to the heart or lungs (becoming an embolism). These can be fatal if not treated immediately. Bayer’s comment on the studies: they haven’t seen the data, and can’t comment. But Bayer has to be concerned that this drug should not have been placed on the market. Bayer also does not have the "life saving product" defense that many drug companies - some quite correctly - use. Birth control pills are not saving lives and there a lots of competing drugs that are clearly safe. For more on the Yasmin/Yaz saga, visit:

• Our main Yasmin/Yaz information page
• Information for Yaz lawyers to screen potential Yaz claimsYasmin/Yaz Lawsuits Blog (Yaz lawsuits overview)
• Yasmin/Yaz MDL Motion Filed
• What is an MDL? -or- Yasmin/Yaz MDL Filed, Take 2

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If you are like most Workers’ Compensation Claimant attorneys, your desk and files are crammed with cases that are left open for medical….and the main reason they are left open is the fear on the part of the attorney that something down the road might come back to haunt them. But leaving the medical open forces the attorney into becoming a maintenance firm, continuing to handle medical problems for a client that no longer has any fees attached. With the advent of the dreaded MSP, we now have a way to safely transition the client from Workers’ Compensation Insurance into the Medicare Insurance Program (and closing out the case in total), all the while being mindful not to be “shifting the burden” to Medicare. But in doing so, we all have to be doubly mindful of not “shifting the burden” or creating exposure for our clients.

Whether you are settling an active case, or looking at ways to settle the medical open cases, using a consistent, compliant process will ensure you consider Medicare’s interest, protect your client from future exposure, and limit the potential liability you face as attorneys. First, some basics: 

 

Medicare is interested in both past payments (conditional payments) and future treatment. They have a record of past payments, but use a specialized cost projection to predict the future treatment, in this case called a Medicare Set Aside Allocation (MSA).

 

The MSA is an apportionment tool designed to protect Medicare’s exposure. It is never required, but if not provided then CMS will take the position that the full settlement is for future medical treatment.

 

The MSA covers only those medical treatments and services that are covered by Medicare. There are significant “uncovered” medical services/treatments, including certain medications, which are prescribed by the authorized treating physicians that are not covered at all by Medicare.

 

A Non-Covered Allocation report is a specialized cost projection outlining the scope and future costs of those items typically not covered by Medicare, and not discussed or itemized in the MSA. As you can imagine, the carrier/defense folks are not offering this information. If you are settling the medical portion of your cases based on the MSA alone, you are opening yourself to some very serious, future problems.

 

So what to do? How to handle this safely for you and your client? As soon as you know you have a client that will be eligible for Medicare within 30 months (either by age, SSDI eligibility) or is already a Medicare recipient, start asking the carrier for an MSA. Then determine what future treatment will be necessary---ask the doctor, get a life care planner to prepare a simplified cost projection. When the MSA comes in, get a Non Covered Allocation report. This will take care of the future costs. 

 

Don’t forget about the past payments, the conditional payments. CMS can levy very heavy fines for not reporting and repaying these liens.

 

Lest all you Personal Injury attorneys think you are off the hook, start reading about what is going to happen come July, 2009. My next blog post will cover some of the reporting requirements and compliance issues that will help the PI attorney safely guide the client through this maize.

 

ProjectWorks, Inc. is a medical legal support company offering causation and settlement services to attorneys. We specialize in the Non Covered Allocation reports, life care planning, and cost projections.Contact us for a free handout describing the 12 factors Workers’ Compensation coverage provides the injured worker, which 3 are addressed by the MSA, and the 9 addressed by the Non Covered Allocation. Although it will vary from client to client, the NCA has shown to bring anywhere from an additional $80,000 to $2 million+ in some settled cases.

www.projectworksinc.com

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The Wall Street Journal Health blog reports that more than 100 traffic or personal injury incidents have been linked to the smoking cessation drug Chantix, according to the Institute for Safe Medication Practices. Researchers theorize that visual disturbances that may be caused by Chantix are causing these accidents. Patients on Chantix are reporting convulsions, seizures, blackouts, or spasms that could be the cause of injuries with Chantix users.

The report said that 86 cases of convulsions Chantix have been reported since 2006. These numbers are vastly underreported according to Thomas Moore, one the researchers at the Institute for Safe Medication Practices. Moore told The Wall Street Journal he and his fellow researchers were very conservative in the estimates they made in this study.

Pfizer says that there were only three seizures reported with Chantix in the pre-market studies that were conducted before Chantix went on the market. The problem is that Pfizer pressed the FDA to rush Chantix onto the market. When you add "rushing to the market" and "drugs that alter brain chemistry" together, is there any great surprise when the sum equals problems?

Consider this: approximately 4,500 people took Chantix during the development of the drug, with about 450 people getting treatment for at least six months and another 100 for a year. Most of the pre-market study groups were given Chantix for 12 weeks or less. Since then, more than 6 million people have been prescribed Chantix, many of which are long term users.

Again, can we be surprised to learn that we have not flushed out all of the potential problems with Chantix? Lawyers handling Chantix cases were already investigating the suicide risks that have been reported to be associated with Chantix. Now, lawyers are looking at a potential class action involving these Chantix injuries that appear to be caused by these visual disturbances as well as other side effects being discovered such as potentially lethal cardiac rhythm disruptions, acute myocardial infarction, seizures, diabetes, and psychosis. Chantix has also been previously linked in a small number of cases to Stevens Johnson Syndrome, a potentially deadly skin disease.

The FDA has egg on its face again with Chantix. Yet, the Supreme Court is telling us that the FDA should be the sole watchdog for medical devices and perhaps even all pharmaceutical drugs and it will be if the industry has its way in Wyeth v. Levine this Fall. Coming on the heels of debacles with Medtronic leads and Heparin, both cases where the vigilant FDA could have made a difference, you can expect victims' advocates in Congress will have a lot of ammunition to take this ball away from the Supreme Court on the question of preemption.

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Medtronic Sprint Fidelis Defibrillator Lead wires may cause greater risk to Medtronic defibrillator patients than was originally thought when Medtronic first announced that it was, essentially, recalling the Sprint Fidelis leads. Sadly, and this really underscores where we are in this country with medical device safety, this news comes not from Medtronic, but from a report by a Deutsche Bank analyst named Tao Levy. The report indicates that the Medtronic Sprint Fidelis lead wires had poor sensing capability that may compromise communication between the leads and the defibrillator The Deutsche Bank report stated that potential concerns over the Medtronic Sprint defibrillator lead wires’ sensing and transmitting abilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”

So, apparently, Medtronic defibrillator lead wires not only have an unacceptable fracture rate, they also appear to have poor sensing capabilities, even if they do not fracture. The first news Medtronic defibrillator lead patients are hearing of this is not from the FDA or Medtronic, but from an investment bank analyzing the stock. Unbelievable. This should be Exhibit A in attacking the preemption defense.   Exhibit B should be the Baxter heparin recall where contaminated heparin entered the market because the FDA confused which the names of the factories in China and believe it had already inspected the plant that make the active ingredient in heparin that supplied half of this life saving medication that we use in this country. Exhibit C would be the way the FDA rushed Chantix on the market without considering the possiblity that playing with the brain chemistry - however neat the trick might be - might lead to a lot of unwanted side effects.

For lawyers not familiar with the litigation, a lead is a wire that is threaded through the blood vessels and connects to a defibrillator in the patient’s chest. The lead sends messages to the defibrillator that a patient’s heart rhythm is significantly abnormal. The defibrillator then returns a shock to the heart, through the leads, to shock the heart back into rhythm. If a defibrillator lead breaks, it can send a painful, and, of course, terrifying shock to the patient who may think he/she is dying. The fractured lead can also fail to give a needed shock to get the patient’s heart back in rhythm.

Unlike a pacemaker or defibrillator recall, these Medtronic leads cannot generally be recalled, because it can be risky and invasive surgery, particularly in those who have had the leads for some time. The FDA has suggested that it is generally not a good idea to replace a defective defibrillator lead. Common sense tells you that patients with the Medtronic defective defibrillator leads should be talking to their doctors about their options.

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A recent study concluded that powdered infant formula can cause serious illness or death in infants.  The infants are typically diagnosed with Meningitis,Salmonella, Sepsis or Bacteraemia.  These illnesses can often lead to brain damage or death.  Powdered infant formula can be contaminated with harmful bacteria during the manufacturing process or contaminated if not handled properly.  Doctors often diagnose the illness as Meningitis, Salmonella, Sepsis, or Bacteraemia.  These illness can be caused by the bacteria  E. Sakazakii.

Over the past 40 years that have only been 50 reported cases of people effected with E. Sakazakii, but there is evidence to suggest that many cases go unreported. Most of the reported cases have been infants with the death rate being between 33% and 50% in infants. Infants that do survive usually suffer permanent brain damage.

E. Sakazakii can be found in the environment, but scientific studies have linked the infection in infants to powder infant formulas. Powder Infant Formulas are not sterile and can become contaminated with high amounts of E. Sakazakii during the manufacturing process, or by improper preparation, dilution, storage, or hygiene.

Research has concluded that infants most at risk for becoming infected are those with  Low birth weights or less than two months old. This condition also suggest that infected infants may be lacking sufficient colonization of the gastrointestinal tract with normal bacterial flora to compete with the opportunistic pathogen, E. sakazakii. Similarly, in the adult cases, most had underlying diseases that could have increased their chances of being infected with E. sakazakii.

Infants that are infected by E. sakazakii show the following symptoms:  poor feeding response, irritability, jaundice, grunting respirations, and instability of body temperature. As the infection progess infants will being to suffer from severe neurological impairment, Ventriculitis, brain cysts and abscesses, cerebral infarction, and hydrocephalus.



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To effectively convey the scope of your client’s injuries it’s important to actually know anatomy and physiology. If you haven’t taken courses in anatomy in undergrad, there is a cheaper way than going to night school. The Insurance Defense Blog points out  the Teaching Institute’s course Understanding the Human Body: An Introduction to Anatomy Physiology. The course consists of 32 lectures, each 45 minutes long, on DVD or videotape. It is currently on sale for $129.95. Dave Stratton, the author of Insurance Defense Blog bought the course and enjoyed them.

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An Orthopedic Group in Colorado Springs has set up a Spine School on the internet. A lot of great information in simple to read and easy to understand format. Their Spine School includes general information on the anatomy of the back, general problems with the back, tests and procedures to fix the back.

It’s a great resource for clients with back problems, or anyone in your firm that is new to injury work. Thanks to Janabeth Fleming Taylor for the heads up.

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Hidden brain injuries are one of the most difficult medical cases to put together.  The medical findings are subtle, the clues nebulous, but the results are dramatic. If you have a case where the injury or event COULD have produced a head trauma or a brain injury, and a medical history suggesting that your client is experiencing difficulties, look closer at the possibility of a hidden brain injury.  Impact to the case and for the client is significant.  There are a lot of checklists, but here is one that can be helpful:

 

Yes_____    No_____    Reduced attention and concentration
Yes_____    No_____    Memory problems
Yes_____    No_____    Decreased frustration tolerance
Yes_____    No_____    Easily angered
Yes_____    No_____    Anxiety
Yes_____    No_____    Overreaction to events
Yes_____    No_____    Depression
Yes_____    No_____    Decreased emotional responsiveness
Yes_____    No_____    Reduced reasoning and problem solving
Yes_____    No_____    Difficulty following directions
Yes_____    No_____    Misunderstanding what is said by others
Yes_____    No_____    Impulsive or inappropriate social behavior
Yes_____    No_____    Reduced judgement
Yes_____    No_____    Decreased insight into self and others
Yes_____    No_____    Difficulty establishing and maintaining relationships
Yes_____    No_____    Difficulty on the job or at home               
Yes_____    No_____    Headaches
Yes_____    No_____    Nausea
Yes_____    No_____    Dizziness/balance problems
Yes_____    No_____    Muscle weakness
Yes_____    No_____    Numbness and tingling
Yes_____    No_____    Fatigue or difficulty sleeping
Yes_____    No_____    Blurred vision
Yes_____    No_____    Ringing in ears

 

If your client is experiencing a number of these problems, or family members suggest there are problems, a complete evaluation by a team of experts is warranted.  I typically set up IMEs with neuropsychology, neurology, ENT, Occupational Medicine, and Vocational Psychology–and share reports from each with all the others.  ENT typically performs  ENG and  ABR testing to determine if problems are coming from a central (brain injury) cause.  Neuropsychology performs a wide battery of testing to determine cognitive function and loss.  Be sure you ask for a GAF score (see previous blog posts about this).  Neurology helps document status and future treatment.  Occupational Health gives a global overview, provides restrictions based on physical and emotional factors, and discusses ability to perform essential functions of work. Finally, the Vocational Psychologist and/or Evaluator provides opinion on ability to return to work, transfer into new work, or remains unable to be employed.

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Settlement demands and final settlements hinge on medical costs:  past, present, and future.  This is not always easy to figure out.  Medicaid Liens have to be repaid.

 

Other settlement considerations include Annuities, special needs trust funds, rated age, Medicare Conditional payments have to be repaid.  The Client typically has out-of-pocket expenses that need to be reimbursed.  Private health insurance carriers post liens against settlements early in the game. And now the Federal Government says future costs covered by Medicare have to be reasonably considered, and set aside in a special account, as well. Beginning in 2006, prescription medications are also included, which has greatly complicated this process.  Has anyone tried to figure out the “donut hole” yet?

As a Medical Case Developer for Worker’s Compensation cases, I am often involved in the money aspects of a case.   I first determine if the client is eligible for Medicare considerations.  Has he/she applied for Social Security benefits?  Is he/she already receiving SSDI/Medicare benefits due to disability or age?  Is the settlement over $250,000?  Actually these questions should be asked at the beginning, in the middle, and at the end of each and every case you have.  There should be no surprises when settlement day comes.

 

Then I prepare a Disability Cost Projection, which can be described as a mini-life care plan.  This calculation considers only the current treatment, including physician visits, diagnostics typical for injury diagnoses, medications, and probable surgeries coming up.  Yearly costs are multiplied over the normal life expectancy.  The total cost can be quite surprising.  Even if the client is only on a couple of prescription medications, they add up significantly.  For an exercise in this, find www.drugstore.com and type in Celebrex, which is a common medication prescribed for orthopedic injuries.  Taken 4 times a day, the cost quickly adds up to over $500 per month, which is $6000 yearly, and $180,000 over a 30 year life expectancy.

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You order medical records, you talk with doctors, they tell you stuff, but ever wonder what it means?  Recently I had to look up some “signs” to understand exactly what the doctor meant.  This might make a good reference as you read the medical reports:

 

    *    cogwheel phenomenon: jerky motions produced on testing a
         muscle’s strength, the jerks are neither rhythmic nor equal and
         represent malingering or protection from pain
    *    SLR: straight leg raising or Lasegue, for determining nerve root
          irritation, while lying down, the patient elevates his leg straight until there is back pain, or until
          the pain is increased with flexion of the foot
    *    valsalva maneuver: for determining nerve root irritability within the spinal canal, patient takes a           deep breath and then on bearing down (such as a lifting task) notes if pain occurs or is      
          increased
    *    long tact sign: any sign that one would see in affection of either sensory or motor tracts in the               spinal cord
    *    romberg test: for differentiation between peripheral and cerebellar ataxia (useful in
         determining central brain cause)

                                   
For more terms like this see www.orthoteer.co.uk/Nrujp .  Now on to malingering tests: You are talking with the doctor, and he says “well, he does have positive Waddel’s signs” so I can’t really support a back injury”.  You nod in agreement, but inside are wondering “what is he saying?”  So here goes:

 

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The title of Medical Case Developer is a new one for me.  I have been a Nurse, a Nurse Case Manager, a Nurse Life Care Planner, and a Nurse Disability Management Specialist for over 30 years but have only recently put together all this experience and skill into helping attorneys truly develop their cases. Being a Case Developer is different than managing a case, or planning for future treatment with costs, or getting the client to MMI.  Developing a case is actually working with the attorney in moving the case from a value of $100,000 to a value of $250,000 or $400,000 (remember SC Worker’s Compensation benefits are extremely limited!) or in the millions for personal injury cases.  And of course, while developing the monetary value of the case, I am also (first and foremost) interested in assuring that the client receives the very best medical care for every condition caused by the injury.

 

When Attorneys ask me to work on a case with them, it is usually because the case is a very involved and challenging file with lots of medical complications and conditions: such as a back injury with a transverse myelitis which led to a paralysis which led to a stroke, etc.  These are usually fairly easy to figure out and link up, takes a lot of work, but medically and scientifically doable.  The ones that pose the most challenge are the ones with hidden causes, or obscure reasons, or those that just don’t make “common sense”.  Like the one we did recently that was a chemical exposure that led to an auto-immune disorder that led to cardiac failure that led to a stroke that ended up a brain injury. Or the back injury (admitted and accepted) that developed into an aggravated Hepatitis C case that resulted in cognitive disorder (not admitted or accepted) which we put together and prevailed for lifelong benefits and medical treatment.

 

Every case has the potential for more value, even a simple orthopedic case. My goal in developing cases is to look for more diagnoses, more restrictions, more impairment, and to move the case through temporary partial disability to temporary total disability to permanent total disability to lifelong benefits for the Worker’s Compensation cases.  In Personal Injury cases the goal is to not only set up for causation but to quantify damages. But how do I develop a case?

 

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As a medical-legal case developer, I often have cases where “emotional overlay” is an issue.  Insurance Carriers love to see this phrase so they have another basis for denial of the claim.  However, when chronic pain is an issue there is bound to be “emotional overlay”; when there is financial difficulties (no work, no money), there is bound to be “emotional overlay”; even when there is pre-existing depression, there is bound to be “emotional overlay” caused by the injury.  Many of my clients are unable to work or resume normal social activities due to this “emotional overlay”. So, how to we get this condition diagnosed, quantified, and linked to the work related injury and/or treatment?

 

Physicians recognize depression in their patients and sometimes will refer to psychology for work-up–they can diagnose for me.  Psychologists and psychiatrists can assign a Global Assessment of Functioning (GAF) score under the DSM-IV, Axis V diagnoses table.  The GAF score describes a person’s ability to function based on behavioral characteristics.  A score of 81-90 describes most of us on a fairly consistent basis: Absent of minimal symptoms, good functioning in all areas, interested and involved in a wide range of activities, socially effective, generally satisfied with life, no more than everyday problems or concerns.  A GAF score of 51-60 describes many of our clients who have suffered loss of job, loss of financial security, loss of self-esteem, has chronic pain, and in serious interpersonal difficulties: Moderate symptoms OR moderate difficulty in social, occupational, or school functioning. Psychologists tell me that a GAF score in this range or below indicates severe inability to maintain a job–so they can quantify for me. Look at www.bsu.edu/csh/ssrc/media/pdf/gafpage.pdf for more information.

 

In order to get this problem linked to the injury, I need a Global Assessment of Functioning evaluation from a qualified Vocational Psychologist who will issue a report containing an opinion, to a reasonable degree of psychological certainty, that the injury and its sequelae have caused, contributed, or aggravated an emotional/behavioral impairment resulting in disability. Using a combination of AMA guides, this disability can be assigned an impairment rating as well.

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