Alabama Litigation Review : North Alabama Personal Injury Lawyer & Attorney : Jeff Blackwell : Hornsby, Watson, Hornsby, Blackwell & McKown Law Firm : Commercial Litigation, Workers' Compensation : Huntsville, Decatur, Athens

April 27, 2013:

A few days ago, I wrote about the first case to go to trial against Takeda Pharmaceuticals over its diabetes drug Actos. Takeda faces a huge number of cases alleging that its drug Actos is defective.

As I wrote my last post, the jury was about to begin deliberating this first Actos trial. After several days of deliberation, the jury found in favor of the plaintiffs and assessed $6.5 million in damages.

In its initial statements after the verdict, Takeda stated that it would continue to fight the many claims for personal injury and death over its diabetes medication. Initial posturing by Takeda aside, the truth is that the company faces some significant decisions. Many people have suffered tremendously after taking this medication.

The main allegation related to Actos is that it caused bladder cancer in patients and that the company failed to disclose test results which revealed this relationship. However, additional questions related to other conditions, such as liver and heart problems, have also now been raised. Takeda's choices after losing this first trial and the developing research connecting Actos to many serious health issues will be closely watched.

May 3, 2013:

I am continuing to follow the first Actos trial. In the newest development, the trial judge has thrown out the jury's verdict. In his opinion, the judge found that the plaintiff's medical expert was "not reliable." The expert opinion at issue concerns the specific plaintiff in that case and his medical history. The ruling is especially interesting since the judge did not exclude the expert's testimony at trial or issue any ruling prior to the verdict. The injured plaintiff's attorney has vowed to appeal. So, this case is not yet concluded.

Takeda still faces some tough decisions. The jury found that Takeda failed to warn adequately about the risk of bladder cancer. This finding is important, considering the large number of cases presently pending.

Prior Posts Related To Diabetes Drug Actos:

Takeda Faces The First Trial Over Diabetes Drug Actos

Whistleblower Files Suit Against Takeda Over Actos

Actos Update -- MDL Panel Consolidates Cases

Takeda May Face Thousands Of Lawsuits Over Actos

Type 2 Diabetes, Actos, And Bladder Cancer

• Email This
• Print
• Comments
• Trackbacks
• Share Link

A couple weeks ago, the U.S. Judicial Panel on Multidistrict Litigation (JPML) met in Miami to discuss the consolidation of claims against several transvaginal mesh manufacturers. I previously wrote about this issue.

Today, the JPML issued its decision. As requested by many of the plaintiffs, the Court has consolidated the pre-trial proceedings in the Southern District of West Virginia.  The present decision applies to those claims against American Medical Systems, Boston Scientific Corporation, and Ethicon (a Johnson & Johnson related entity).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Last week, news sources reported that Alabama's new Attorney General Luther Strange fired the outside law firms representing Alabama in the BP oil spill litigation.  Now, Attorney General Strange says he will personally assume the role of lead counsel for Alabama.  This is an interesting development.  The big question is -- Did our Attorney General make a good decision or a bad mistake by firing competent outside counsel and assuming the lead role himself?  In all honesty, I see the merits of each side in this debate.

Alabama has a significant history of hiring private law firms to represent our State in litigation seeking to recover damages.  Our last Attorney General Troy King used private firms on several occasions to represent Alabama in complex civil claims.  Some of these claims included:

1. Litigation against certain drug manufacturers as a result of excess charges against Alabama's Medicaid Agency;
2. Litigation against ExxonMobil related to royalty payments owed Alabama;

These claims resulted in the recovery of millions of dollars for the State of Alabama.  So, we have a history of some success with outside private counsel before the BP litigation ever started.  This brings us to the present issues involving Alabama and the results of BP's oil spill.  Without question, Alabama suffered one of the greatest impacts from BP's conduct.  Many of our citizens suffered huge damages, including damages to their property and businesses.  This has resulted in a significant number of personal lawsuits against BP.  Likewise, the State of Alabama has sustained huge losses from the BP oil spill.  According to some estimates, our State lost $148 Million in tax revenue as a result of the catastrophe.  Before he left office, our last Attorney General again engaged private legal counsel to protect Alabama's public interests in the resulting litigation.

Thus, Attorney General Strange's decision last week alters a course already set in motion by his predecessor.  How did he justify changing course?  When he assumed the lead role for Alabama in the BP litigation, Attorney General Strange argued that his decision would save the taxpayers outside legal fees.  

While I commend any effort to save the taxpayers money, the issue is not quite so simple.  First, the fees are contingent.  That is, the State incurs no fees if the claims are not successful.  Second, complex claims like those involved in the BP litigation require significant skill and experience.  Any attorney can claim that he has the skill to handle complex civil litigation.  However, the reality is far different.  Experience and skill make a significant difference in reaching a successful result.  I see this reality on a daily basis talking to individuals who called an attorney that simply advertised for injury cases or civil litigation without the real expertise to handle the claim.  Typically, the results more than justify the contingent fee paid to skilled litigation counsel.

I don't write this simply to criticize Mr. Strange and argue his decision to fire Alabama's private counsel in this case was short-sighted.  I hope that he has the personal experience (or litigators in his office with the skill and experience) to handle this important litigation.

I also agree with Mr. Strange on one point.  Our last Attorney General was strongly criticized for his conduct in hiring private outside counsel.  This criticism was fueled by the fact that the same outside law firm appeared to get most of this lucrative business.  Maybe the attorney selection process was fair and equitable.  Even if so, the appearance was otherwise.

Our Attorney General has a real opportunity here.  Now that he has assumed the lead for Alabama in the BP litigation, he has a real opportunity to seek full justice for Alabama against BP.  He has the opportunity to make his office a true legal advocate for our citizens.  He also has the opportunity to establish some clear and fair rules for the future use of outside counsel that can assist our State.  Clearly, in a world of complex and varied legal issues, the need for competent outside counsel will always exist.  So, Mr. Strange can take this opportunity to establish fair and equitable rules for the future.  Will Mr. Strange use these opportunities for the public good?  I hope so.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Previously, I wrote about legislation introduced into the U.S. House of Representatives to protect American consumers from dangerous and defective imported products.  The statistics are very troubling.  In 2009, 83% of the recalls announced by The Consumer Product Safety Commission (CPSC) were from foreign manufacturers.  Statistics from recent prior years are similar.

Last week, a Congressional subcommittee held hearings on the proposed bill.  The hearing brief prepared by the subcommittee staff summarizes the current problems with dangerous imported products.  According to the subcommittee brief: 

The import of consumer products into the United States more than doubled in the decade between 1998 and 2007.  This sharp rise in imported consumer products has been accompanied by an overall increase in product recalls and a disproportionate increase in the share of product recalls involving imported products – particularly products from China.

In 2007, the Consumer Product Safety Commission (CPSC) announced 473 recalls.  This was the highest level of recalls in ten years.3 Of those 473 recalls, 389 (82%) involved imported products.  Of the 389 recalls involving imported products, 288 (74%) involved products from China.  Among the defective imported products grabbing national attention in the past several years were: a children’s craft kit containing beads coated with a chemical similar to a date rape drug; toy trains coated with lead paint; a contaminated blood thinning drug; and drywall emitting sulfurous gases.

While the CPSC has been working to bolster its surveillance of imported products and working with foreign governments to improve compliance with U.S. safety standards, holding foreign manufacturers accountable for injuries caused by defective products that make it into the hands of American consumers remains a problem. Victims trying to sue foreign manufacturers for injuries caused by defective products face significant obstacles with respect to providing service of process (notice about the litigation required to be given to the defendant) and establishing jurisdiction over foreign manufacturers in U.S. courts.

According to a CPSC representative at the hearing, by 2008 almost 80% of the toys purchased in the United States were imported from China or Hong Kong.  The fact that the vast majority of toys we place in the hands of our children are imported certainly makes this an important issue

Currently, injured victims trying to sue a foreign manufacturer face substantial hurdles simply providing the required service of process to the foreign defendant.  The Hague Convention on Service Abroad of Judicial and Extrajudicial Documents in Civil or Commercial Matters, provides a very time consuming method requiring all legal documents to first be translated into the foreign manufacturer's native language and then provided to a governmental authority for actual attempts at service.  Even if the injured victim eventually has the foreign manufacturer served, the manufacturer will often challenge the suit by claiming the U.S. Court does not have personal jurisdiction over it due to its lack of actual contacts in the United States.  The current rules work to greatly increase the time and expense on the innocent victims of the defective product and the judicial system as a whole.  In addition, they often serve as a means for the manufacturer to escape ultimate liability for the damages caused by its defective product.

The current legislation in the House of Representative solves these initial problems by requiring that foreign manufacturers importing products into the United States designate a registered agent in this country who is authorized to accept service of legal papers.  Registering an agent would also constitute a link establishing personal jurisdiction in the United States where the agent was located.  Similar legislation has also been introduced in the U.S. Senate.

The current legislation does not cure the problem of defective products flooding our market.  We certainly need to take steps that will enforce important safety standards for all products, including those imported to the United States.  Enforcing safety standards protects our citizens from needless injury and damage.  However, this legislation will prevent foreign manufacturers from escaping accountability simply based on service of process and jurisdictional issues.  As a result, it is a much needed step.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

A study by The American Association for Justice shows that eighty-three percent (83%) of the recalls announced by The Consumer Product Safety Commission (CPSC) in 2009 were from foreign manufacturers.  The results for 2008 were similar.  What happens when one of these defective foreign-made products injures someone?

The recent litigation concerning defective Chinese drywall highlights the problems with holding foreign manufacturers accountable for the injuries their products inflict upon the public.  Millions of tons of defective Chinese drywall were imported into the United States for use in the construction of homes.  After these homes were built, owners began complaining that the drywall emitted corrosive and irritating fumes.  In November 2009 the CPSC issued a press statement,  after studying the issue, finding "a strong association between homes with the problem drywall and the levels of hydrogen sulfide in those homes and corrosion of metals in those homes."  The defective drywall was emitting hydrogen sulfide gas which not only created an irritating smell, but also, caused parts of the home to corrode.  The CPSC is continuing to study the health issues which may also be associated with the defective drywall.

Last week, a Federal Judge in Louisiana assessed $2.6 million in damages against a Chinese state-owned manufacturer of this defective drywall on behalf of seven Virginia families.  These damages relate only to the costs necessary to remediate the problem and fix the damaged homes of these plaintiffs, not the potential health risks.  Many other damaged homeowners have also filed claims which remain pending.

The problem arises in the enforcement of the Court's judgment.  Will the foreign manufacturer truly be held accountable or is this a judgment that will never be collected?  The Wall Street Journal published a great article discussing the case and its history.  In this litigation, the Chinese manufacturer never even answered the lawsuit.  While the Court's ruling on the initial drywall claim is a positive step, it remains unclear as to whether the foreign drywall manufacturer that caused this harm will ultimately pay for the damages it created.

Foreign manufacturers are often able to avoid their liability because of difficulties obtaining legal service of the claim on the company in its home country, issues related to whether the U.S. Court has jurisdiction over the manufacturer, and then problems collecting any eventual judgment.  It is important to remember that the damages caused by a defective product will be borne by someone.  If the foreign manufacturer avoids its responsibility, then the innocent consumer, our government, or a domestic company that distributed the product, will ultimately (and unfortunately) bear the loss.

In February, several members of the U.S. House of Representatives introduced legislation that would make it easier to hold foreign manufacturers accountable for their defective products.  The American Association for Justice issued a press release detailing some of the problems under current law as well as solutions presented by the proposed legislation.  Among other things, the proposed legislation would require foreign corporations to have an "agent" in the United States to accept service of process for civil and regulatory claims.  It would also require the manufacturer to consent to jurisdiction in our courts.  This is much needed legislation that will hopefully protect consumers in the future. 

• Email This
• Print
• Comments
• Trackbacks
• Share Link