Actos Update - MDL Panel Consolidates Cases

The Federal Judicial Panel on Multidistrict Litigation has issued its Order consolidating all pending Actos cases in Federal Court. The cases have been consolidated before U.S. District Judge Rebecca Doherty in the U.S. District Court for the Western District of Louisiana. This means that Judge Doherty will preside over all the pretrial proceedings in these cases. Bloomberg has a good article concerning this decision and its impact on Actos litigation against Takeda Pharmaceutical.

I have written previously on the issues surrounding Actos:

  1. Takeda May Face Thousands of Lawsuits over Actos - overview of the potential claims facing Takeda due to its diabetes drug.
  2. Type 2 Diabetes, Actos, and Bladder Cancer - the use of Actos to treat diabetes.

This litigation is only in its early stages. I expect that the court will face a huge number of claims to manage.

The purpose of the multidistrict litigation (MDL) process is to consolidate cases before one court that can handle the various discovery and pretrial proceedings. The idea is that having one court handle the various pretrial issues will conserve resources, save costs, and prevent numerous courts issuing rulings that may be inconsistent. Cases are returned back to the Federal Court where they were originally filed for the trial.

Takeda May Face Thousands of Lawsuits over Actos

I wrote a few days ago about the health issues being associated with the diabetes drug Actos.  Now, the headline yesterday from Bloomberg says it all:

TAKEDA MAY FACE 10,000 U.S. SUITS OVER ACTOS CANCER CLAIMS

Regulators in France and Germany have already pulled the drug from their markets.  In the U.S., the typically slow to act FDA has begun to take steps as a result of the research.

The main issue surrounding Actos involves research into its relationship to bladder cancer.  Unlike many other cancers, there are fewer potential causes of this cancer.  Thus, it will likely be more difficult for Takeda to blame cases of bladder cancer on causes outside the long-term consumption of its drug, Actos.  I believe there will be claims alleging that Actos caused other problems such as strokes and heart attacks as well.  Other prior drugs in the same class as Actos have had similar issues.

A number of suits are already pending around the country over Actos and bladder cancer.  The United States Judicial Panel on Multidistrict Litigation is currently considering where to consolidate the numerous existing and expected cases for pretrial procedures.  Yesterday, the panel held a hearing on the current Actos litigation.

 

Type 2 Diabetes, Actos, and Bladder Cancer

Many adults are impacted by Type 2 diabetes (sometimes referred to as adult-onset diabetes or non insulin-dependent diabetes).  Type 2 diabetes is a chronic condition that affects the way your body metabolizes sugar.  Left untreated it can be life-threatening.  However, the condition can be managed.  Often, it can be managed through diet and exercise.  Unfortunately, sometimes medications are necessary.

The Mayo Clinic website has an excellent chart that lists various medications used to treat Type 2 diabetes.  These medications fall into several different categories of drugs.  Each category works to manage the condition through a different process.

Actos is in the category known as glitazones, that were designed to increase the cell's sensitivity to insulin.  What other medications were in this same category?  One medication in this category was Rezulin which was withdrawn from the market in 2000 due to issues with liver toxicity.  Another was Avandia which has been severely restricted as a result of heart issues.  I have written on prior occasions about the problems with Avandia.  Since my last post on Avandia, there have been new developments concerning the potential harm of that drug.

After these other two drugs were removed or severely restricted in use, the number of Actos prescriptions grew substantially.  How much money did Actos generate for Takeda, the Japanese company producing the drug?  A 2011 article on pharmaceutical sales revealed that Actos recorded $3.58 billion in sales over just the first 9 months of 2010. 

Now, we learn that Actos may also present considerable health risks. In September 2010, the FDA issued a safety announcement about the potential risk of bladder cancer after extended consumption of Actos.  At that time, the FDA said it was reviewing data to determine the association between Actos and bladder cancer.  According to the FDA safety announcement

An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as those exposed to the highest cumulative dose of Actos.

In June 2011, both French and German regulators suspended the sale of Actos in their countries citing studies linking the drug to an increased risk of bladder cancer.  Also, in June 2011, the FDA issued a new safety announcement about Actos.  In this announcement the FDA specifically warned consumers that

use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.

Since Takeda introduced Actos, millions of prescriptions have been issued.  The physicians prescribing the medication were not aware of these risks until the FDA recently issued its safety announcements.  This does not appear to be true for the manufacturer Takeda.  In fact, evidence suggests that Takeda knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical studies, which showed an increase in drug-induced tumors in the bladders of rats.  Yet, Takeda sold Actos without any warning of this increased risk until the FDA's recent actions requiring additional warnings.  And yet, bladder cancer may not be the only problem associated with Actos.  The latest studies indicate that bladder cancer is only one of Actos' potentially life-threatening side effects.

It is very difficult to hear the story of a patient who now suffers cancer after taking Actos for an extended period of time.  Then, on top of that, you consider the evidence that the company may have known of problems and yet sold billions of dollars of pills without a warning.  I think much more information will be revealed in the coming months about the impact of this drug on patients.

 

 

 

Independent Contractor or Employee? Employers Often Misclassify Workers to Avoid the Law

What is a true independent contractor?  How is an independent contractor different from a regular employee?  In some situations, the answer of whether one is independent versus an employee, is obvious.  In other situations, the answer is not always clear.

What is clear is that some employers are misclassifying workers to avoid important laws related to safety, fair wages, taxes and workplace injuries.  A recent article addressed this disturbing trend by some employers.  A separate study in 2010 which surveyed several states, noted that:

Employers increasingly misclassify their employees as independent contractors, denying them the protection of workplace laws, robbing unemployment insurance and workers compensation funds of billions of much-needed dollars, and reducing federal, state and local tax withholding and revenues.

On a state and national level, this issue is a serious one affecting both workers and businesses that are trying to follow the law.  On an individual basis, I frequently receive calls from people who were injured on the job but then denied workers' compensation benefits on the basis of being an "independent contractor."  The key question for these injured people is whether or not Alabama's workers compensation laws provide them needed benefits for a serious injury.

How do Alabama's laws providing workers compensation benefits examine this issue?  This is how our courts have reviewed this issue:

In determining whether an individual is an independent contractor or whether an employer-employee relationship exists, the court looks to the reserved right of control rather than the actual exercise of control.

If the right of control extends no further than directing what is to be ultimately accomplished, an employer-employee relationship is not established; however, if an individual retains the right to direct the manner in which the task is to be done or if that individual does in fact dictate the manner of operation, then an employer-employee relationship is established.

This is a case-by-case issue.  An important point to remember is that - just because the company said you were an "independent contractor" does not make it so.  Regardless of how they titled your work, if the company had the right to control the manner in which you did the job, then you may be considered an employee entitled to workers compensation benefits.  In a case earlier this year, the Alabama Court of Civil Appeals listed several factors to consider in determining the issue of a retained right of control.  They are:

  1. direct evidence demonstrating a right or an exercise of control
  2. the method of payment for services
  3. whether equipment is furnished
  4. whether the other party has the right to terminate the employment

Again, these are just factors to consider.  No single one of them, just by itself, would determine the issue. In today's world where many employers are misclassifying workers to avoid legal requirements, it is important that you don't just accept the company's word for it and fail to get the workers compensation benefits you need for a serious injury or disability.

 

 

Chronic Regional Pain Syndrome - A Devastating Condition Explained

Through the years, I've worked with many clients who suffer what is often termed chronic regional pain syndrome (CRPS) following a personal injury.  This condition is usually devastating to the person suffering.  Not only does the person suffer pain that can leave them disabled, they often cannot get good medical treatment or even straight answers from their physician.  These patients don't just hurt.  They usually become depressed from the pain and frustrated by a medical system that does not help.  Their families also suffer tremendously as well.

The medical issues with chronic pain are complex.  I have deposed many doctors and have found that even the medical professionals often do not understand (or cannot explain) these issues unless they specialize in this area of care.  This evening I came across a blog entry from another attorney that referenced a video explaining the condition.  After watching the video, I decided to post it.  It is a great discussion of chronic pain and its cause. 

 

 

 

Can the Texas-Style Workers Compensation Nightmare Come to Alabama?

If you want to understand the brick wall facing injured workers seeking medical treatment in some states just read the recent article published in the ABA Journal.  The title says it all --

Insult to Injury:  Texas Workers' Comp System Denies, Delays Medical Help

The article begins by telling the story of a Deputy Sheriff who faced a nightmare of denials and delays in his medical care after being shot while in the line of duty.  Those issues included the carrier even claiming the emergency helicopter ride to the hospital for life-saving care was not necessary.

This is not acceptable.  The article paints a picture of Texas where the system may be at its worst.  However, these problems are not unique to Texas.  They occur in Alabama as well.  In the last few years, they have progressively worsened.

The primary purpose of workers' compensation laws is to rehabilitate injured workers so they may return to gainful employment if possible.  More and more, we are losing our focus on this purpose.  I hear it from my clients daily - "I want to work.  I have to get medical treatment."  Yet, they are often frustrated by a system that seems to work against providing medical care.

Clearly, the workers compensation carriers are cutting their costs at the expense of those with serious injuries.  Yet, I would not call this a cost "saving" measure.  Instead, it is a cost "shifting" measure.  The reality is, workers compensation carriers are shifting the costs from themselves to the rest of us.  Medical costs for work-related injuries should be paid out of the large premiums collected by carriers.  Instead, when legitimate claims are denied or delayed, others shoulder those costs.  As taxpayers, we often pay those costs through programs such are Medicare or Medicaid.  On another level, families sometimes become overburdened by the costs of getting basic care and the loss of income while out of work.

The article quotes a recently retired Texas official who spent his career handling workers compensation issues and best expressed the carrier misconduct that frustrates injured workers and the medical system so greatly.  According to this official:

Sometimes they just create a controversy as to whether they owe on a claim.

What are some of the common actions taken by carriers to create a bad reason for denying care?  What practices are used to wrongfully deny or delay medical treatment to injured workers?  Here are a few:

  1. Claim A Pre-Existing Problem.  I have written about this issue previously.  Don't simply accept such a denial if you were able to do your job before suffering a work-related injury.  It is not necessary that you have been in perfect health before that injury.
  2. Bury The Doctor in Paperwork.  Doctors should spend most of their time treating patients not completing forms.  I have seen far too many cases where the doctor eventually became frustrated and simply gave up because of the level of paperwork required for a claim to get approved.  If your doctor has talked to you about your injury and the need for medical care, then he has most likely put those opinions in your medical records.  That should be sufficient.
  3. Use The "Utilization Review" Process.  Alabama law has an administrative review process that was created to evaluate medical issues that are unclear for a variety of legitimate reasons.  Yet, carriers often use the review process as a means to delay or deny legitimate care.  How is this process abused?  Sometimes, the carrier will use it to place extra paperwork burdens on the treating doctor.  Sometimes, the carrier will pay another medical provider for a negative opinion about the requested medical care.  This is called "peer review."  However, it is really just a negative report purchased from someone who never examined you, may not have seen all your records, and may not even be the right type of specialist for your injury.  You don't have to accept the delays or denials of this process.  Instead, you can seek a remedy in court in Alabama.
  4. Employ A Bad Case Nurse To Work The System.  Let me start by saying that there are plenty of good nurses that try to help injured workers navigate a difficult medical system.  The bad ones gather information to use against you, try to manipulate the doctors, and work to slow the process.  Good or bad, they all approach with a smile and promises of help.  Since you cannot tell the difference, my advice is to act with caution.  Be friendly but do not provide personal information.  Don't discuss your family, job history, finances, or other health issues and injuries.  Keep your discussions to scheduling your next appointment and making sure the treatment requested by the doctor is getting approved quickly.
  5. Require Multiple Opinions.  Alabama law does give the workers compensation carrier some rights to get a second medical opinion.  However, some carriers abuse this limited right by requiring you to get multiple opinions until the carrier gets one it likes.  Another way some carriers abuse this right is by using it as a means to switch your care from a doctor you may like to one more favorable to the carrier.  The carrier cannot legitimately do that and you should not accept it.

Too often employees suffering significant injuries are left without proper medical care because of carrier misconduct.  That is not acceptable.  That is why it is so important to stay alert to these issues that benefit the bad carriers at the expense of everyone else.

 

Our Courts Continue to Allow Foreign Manufacturers to Escape Justice

Yesterday, I read a blog post by Mobile, Alabama attorney Edwin Lamberth.  Edwin's blog is always a great source of commentary.  Edwin's recent post discusses an important issue - foreign companies not being held accountable for the injuries and deaths caused by their defective and dangerous products.

This is a subject I've previously addressed as well.  In my prior posts, I discussed the need for Congress to pass legislation protecting the public from needless injuries by holding these manufacturers accountable.  Last year, such legislation was introduced before Congress.  That proposed legislation would not only protect consumers but would also level the playing field for manufacturers in the U.S. who are going the extra mile to try and produce safe products.

Now, the U.S. Supreme Court has weighed into the issue - but with two bad decisions that deny justice to the victims of defective and dangerous products produced by foreign companies for distribution in the United States.  Edwin's post presents a great analysis and commentary on these new decisions.  Since his post captures my thoughts on the issue as well, I would just urge others to read it.  I am very troubled by these recent Court decisions further closing the doors of justice to families dealing with a severe personal injury or the death of a loved one due to a dangerous and defective product.  I certainly hope this is not the end of this issue.  Perhaps now Congress will finally act in the interests of the public and business by passing legislation to hold those accountable who ship defective products to us.

Four Tips To Consider When the Workers' Compensation Carrier Has a Lien on Your Client's Lawsuit

In Alabama, if you are injured on the job then you are entitled to workers' compensation benefits from your employer.  Each state has some form of workers' compensation system.  As a result, the benefits provided to injured workers can vary from state to state.  Although some large employers are self-insured, most purchase insurance coverage to cover the benefits required by a state's workers' compensation system.

An injured employee can obtain workers' compensation benefits regardless of fault.  However, Alabama law also allows the injured worker to pursue a legal claim against another party who may have caused the injury.  Here is an example -- You are a delivery driver.  You are on the job, driving the company truck, when another driver runs a red light and crashes into your vehicle.  You are hurt.  Under Alabama's workers' compensation system, your employer must provide you medical care and may also have to pay you certain disability benefits set out in the law.  Wait, the collision was really caused by the other driver.  If so, then you can pursue a claim against that other driver.  The workers' compensation system does not provide full compensation for all your damages.  However, you can pursue a claim against the other driver for all your damages.  These cases are commonly referred to as third-party claims by attorneys.

One issue in the scenario I just mentioned where you are hurt on the job due to the fault of another is that the workers' compensation carrier has a lien against your recovery from the responsible person.  That is, if your employer or its insurance company paid benefits for medical treatment or disability, they are entitled to get their money back if you successfully recover damages from the responsible party.  This is a complicated issue and it is important that the lawyer handling such a case have a full understanding of this area of the law.  Although complex, here are several quick tips to consider when handling this type of case:

  1. Verify the claimed lien. -- In every case, I ask the insurance carrier for a print-out of all payments.  I often find that the print-out lists administrative and investigation expenses incurred by the carrier.  The carrier's lien only applies to actual expenses for medical or disability payments.  By reviewing the actual payments which comprise the claimed lien you can often eliminate amounts that should not be collected.  Many attorneys simply accept the carrier's statement as to the total lien amount without reviewing all the payments.  You can often save your client considerable money just by performing this simple task.
  2. Bring the workers' compensation adjuster to the trial of your other case. -- When I go to trial in a third party case, I typically present the claims adjuster as a witness.  Since the insurance carrier often has a considerable lien, they should not mind sending a representative to trial.  I have found, however, that the carrier is rarely asked to send its adjuster to trial.  I cannot understand why many lawyers would not do this.  I have spoken with jurors after several of these trials and they have all indicated that having an adjuster testify to the significant amount of money spent to treat your client's injuries as well as the fact that they have a lien, has a great impact.  This witness, if handled correctly, can have a tremendous impact in validating the extent of your client's serious injuries.
  3. Keep the workers' compensation carrier informed as to all difficulties and problems with your other case so that they will be in a position to negotiate with you in an effort to reduce the lien. -- Too many attorneys ignore this issue until there is a settlement in their third-party case.  Then, they call the adjuster handling the claim expecting to negotiate a reduction in the lien.  Whenever I have a third-party case, I periodically call the adjuster to talk about any difficulties with the case.  If you truly have a difficult third-party case where you might need to compromise in order to settle, don't you think the carrier might be in a better position to also compromise its lien if you have informed them of the issues along the way?
  4. Seek discovery of any contracts between your employer and the other party if they had any prior relationship.  -- This is a great issue.  Many third-party cases arise out of construction work or work in an industrial setting.  In order to do this work, your client's employer will often enter into a contract with another business.  If that other business (or one of its employees) caused the injury, make sure you get a copy of the contract.  I have found that these contracts sometimes contain clauses where one party agrees to waive any claims against the other or against any money paid by the other.  Sometimes, these waiver clauses specifically waive liens.  If so, you can argue that there is no lien.  I have successfully argued this on a prior occasion before a trial court in Alabama.  One warning here, however, is that Alabama's Supreme Court has not addressed these clauses, including the issue of whether an employer can waive the lien of its insurance carrier.  This is an interesting issue for appeal.

The issues surrounding liens are often complex.  Too many attorneys either don't understand the issues or don't take the time to deal with them.  However, they are very important issues to consider when handling a claim.  Dealing with these issues correctly can often save your injured client significant money.

 

Jury Size - Does it Matter?

Does the number of jurors on a panel matter?  Does it affect the fairness of the panel in deciding cases?  Moreover, does justice require a unanimous verdict?  Or, asked another way, does justice require that one lone dissenter prevent a jury panel from deciding a case?  These questions have long been debated by legal scholars.  Jury practices vary between different jurisdictions and these questions are not just ones for theoretical debate.  Instead, these questions present an opportunity to discuss our court system and how it will continue to operate in the best manner to administer justice fairly in our community.

Yesterday, the New York Times published an opinion piece on the budget crisis facing state courts throughout the United States.  I have written about Alabama's budget problems on several prior occasions.  I certainly would not advocate altering our jury system simply based on cost.  Justice is too important.  However, if the ends of justice could just as equally be obtained with a 6 person panel as opposed to a 12 person panel, then the issue is one that should be considered.  So, it's an interesting debate.

Recently, the Alabama Association for Justice (AAJ) asked me to write a short statement on the issue.  My memo to the AAJ is too lengthy to include here in its entirety.  But, I did find some interesting statistics and research quotes to get a debate started.  To begin, fixing the number of jurors at 12 is largely traditional and dates from medieval times.  In Alabama, that number appears to have been simply accepted as the correct number with little or no thought.  However, in the 1970's, the U.S. Supreme Court addressed the issue and held that 6 member juries were valid under the U.S. Constitution.  Specifically, the Supreme Court held that

we conclude that a jury of six satisfies the Seventh Amendment's guarantee of trial by a jury in civil cases.

While most states have continued to require 12 member juries for felony cases, this is not the case for civil juries.  By 2004, only 25 states continued to require 12 member juries for civil cases in their general jurisdiction courts.

A separate issue involves the requirement that all jurors be unanimous for the jury to reach a verdict.  We have all heard about trials where one lone person disagreed with all the other jurors, resulting in a mistrial.  Should there be a procedure that allows the jury to reach a decision based on less than a unanimous verdict?  I found a 2006 law review article that addressed this issue:

The unanimity standard, however, has significantly eroded for verdicts in civil cases.  Federal juries must be unanimous, but only eighteen states require unanimity and another three accept a non-unanimous verdict after six hours of deliberation.  The remaining states permit super-majorities of between two-thirds and five-sixths in civil cases.

The statistics I pulled on jury size and unanimity are now a few years old.  It is likely that they have changed.  However, the question remains - Would a change in jury size or the unanimity requirement impact the interests of justice?  If the ends of justice are still served by reducing the jury size or allowing for a verdict over a lone holdout, then it is certainly an issue to consider.  The court system would achieve a greater efficiency in moving cases and reducing costs if the standards were relaxed.  When you raise the topic with most attorneys, they immediately have a strong reaction either positively or negatively.  I would love to hear comments from both lawyers and non-lawyers on this important right that makes our justice system so special.

 


 

A Reminder of the Danger Posed by Fire Ants in Nursing Homes

Recently, I was reading a copy of The Safety Report when I found an article written by attorney Billy Cunningham.  Billy is an excellent attorney with the firm Burns, Cunningham & Mackey in Mobile, Alabama.  In past years, I have had several opportunities to discuss cases with the attorneys in this firm.  They approach every case with a great degree of preparation and skill.

The article was entitled The Danger of Fire Ants.  It provides some interesting history on the spread of fire ants throughout the southern United States.

Fire ants pose a danger to anyone working outdoors.  If you have ever seen fire ants swarm, then you know how quickly this danger can become a real injury.  While fire ants are generally found outside, they can come indoors foraging for food.  This is what presents a special danger to elderly patients in nursing homes.

In recent years, there have been several instances of elderly people being attacked by fire ants.  These vicious attacks have led to severe personal injuries and even deaths.  Several years ago, our firm represented an elderly lady who was viciously attacked by fire ants in her nursing home over the course of two nights.  Early in the morning following the second night of attacks, our client's daughter came for a visit.  What she first saw was a horrible scene of thousands of ants swarming her mother's bed.  She then heard screams and found her elderly mother in the bathroom with one of the facility's attendants desperately trying to clean the stinging ants off of her.  Her injuries were devastating.  However, the attacks could have easily been prevented by the nursing home.

Billy gives some great advice in his article.  Hopefully, he won't mind if I copy it here:

Nursing homes, hospitals and day cares – those places where the vulnerable are located- need to recognize this risk and take appropriate actions to assure the safety of their patients and wards. With appropriate interventions fire ants can be controlled. Consumers need to be aware and look for signs in their loved ones’ rooms or areas. Ask the facility if they are looking out for ants and other animals that could cause injury and who the pest control company is. There is no reason such attacks should occur if proper precautions are made in these areas where persons not able to protect themselves.

I would highly recommend reading Billy's article.