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

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

Atrial fibrillation is a huge health issue affecting many individuals.  It is estimated that this condition affects 2.3 million Americans.  At present, the FDA has approved a variety of treatments.

In 2009, the drug company Sanofi-Aventis began to market dronedarone under the brand name Multaq as an additional medication for atrial fibrillation.  Although the FDA approved the marketing of Multaq in July 2009, a petition several years earlier had been denied due to patient safety concerns.  According to medical data, in just over a year on the market, around 147,000 patients filled prescriptions for the medication.  At the time of approval in 2009, the company estimated that sales would eventually reach $1 Billion a year.

However, medical research now indicates that Multaq may not be the blockbuster medication for atrial fibrillation as marketed by its manufacturer.  Researchers at Cedars-Sinai Medical Center are now reporting that the medication is only half as effective as a different generic medication.  However, it is not just the effectiveness of the medication that is now being called into question.  Patient safety is also an issue.

On January 14, 2001, the Food & Drug Administration (FDA) issued a safety announcement warning health care professionals about the possibility of severe liver damage associated with the medication.  Then, on January 28, 2011, the FDA issued a warning letter directly to Sanofi-Aventis.  This warning letter follows an FDA inspection in which it was revealed that the drug maker had failed to timely report possible adverse consequences of its medication Multaq.  At present, it has been reported that several patients on the medication have suffered liver injury, including two who even suffered acute liver failure requiring them to undergo liver transplants.

This is a potential health issue that has already received some coverage from news outlets in Alabama.  In light of the significant number of people suffering from atrial fibrillation and the numerous other treatments available, it is important to continue monitoring developments with Multaq and whether this drug poses a danger of acute liver failure to patients.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

I recently spoke at a seminar where we had a great discussion about ongoing medical device and pharmaceutical litigation.  No, the companies that we discussed did not pay me to mention their products.  No, none of these large corporations agreed to host the seminar at a sunny beach location or at a ski resort.  Then, again, their executives probably would not have paid for the kind of honest discussion we had about the damage caused by some of their products.

However, these same companies have provided millions upon millions of dollars to various physicians and medical groups.  This includes money directly to physicians.  It also includes trips to the fun places I mentioned earlier.  This infusion of cash to the various physicians who are supposed to be unbiased in their assessment and research raises serious questions.  I have written about these issues previously.

According to the Birmingham Business Journal, we now learn that drug companies paid Alabama doctors $4.6 Million in 2009-2010.  A recently released document shows that one local physician, an internist in Decatur, even received over $200,000.00 in payments from GlaxoSmithKline, alone.  If you are taking notes, that is the same company that made billions marketing Avandia before the public became aware of its dangers.  The same company that apparently hid negative test results concerning Avandia.  The same company that may have paid one member of the FDA advisory panel.  I don't mean to single out Glaxo.  The same Decatur physician also received significant money during this short period of time from another pharmaceutical giant as well.

In fairness, I do not know the relationship between the local physician I mentioned and his patients.  I do believe, however, the process of approving and marketing drugs and medical devices to patients is tainted by the flow of money to physicians and those involved with the regulatory process.  If we ever want the process to focus on what should be the most important goals, patient health and safety, then we must insist on a regulatory process that requires full disclosure by both the companies and the decision makers.  We must also insist that patients have full disclosure of the relationships between their medical providers and the companies whose products the are providing.  I would certainly want to know if my doctor had received a significant amount of money from the drug company whose product he was now prescribing to me.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Yesterday, the United States Department of Justice announced that it had recovered $3 Billion in fiscal year 2010 against those companies and individuals who had defrauded our government.  These recoveries involved claims for all types of fraud against our government, including military contracts, non-military contracts, federally-insured mortgages, and mineral leases, among others.  It is a welcome relief to see our government act to pursue those who steal from all of us.  In addition to the record amount recovered, it is also interesting to note that the largest single area of fraud against our government involves the health care industry.  According to the government's announcement and an NPR article involving this issue, $2.5 Billion of the $3 Billion recovered, involves the actions of big pharmaceutical companies.

I have written previously about the long FDA saga with Avandia as well as the manufacturer's apparent concealment of adverse studies involving the health risks of that drug.  I have also written about the deceptive marketing practices involving the use of shoulder pain pumps. 

We are now in the middle of discovering the extent of damage caused by DePuy's defective hip replacements.  DePuy, a Johnson & Johnson subsidiary, sold over 90,000 of these implants, including a large number here in North Alabama.  As the full extent of damage from DePuy's defective implant comes to light, it is important to remember that DePuy has previously been the subject of probes involving the practice of paying kickbacks to physicians in an effort to implant its products into patients.

According to the government's report, this year's false claims actions involved companies such as Pfizer over its promotion of the painkiller Bextra, Astra Zeneca over the anti-psychotic drug Seroquel, and Novartis.  I applaud the efforts of the Department of Justice to pursue issues of fraud against our government, including fraud and abuse concerning drugs and medical devices.  However, the government needs to act during the approval and review process so that the interest of the public is protected, from the beginning.  While recovering taxpayer funds is great, it is too late at that point for the people actually harmed by dangerous and defective products.

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

It's been an eventful summer for GlaxoSmithKline (GSK) and its diabetes drug, Avandia.  First, the New York Times dropped its bombshell that secret company testing in 1999 indicated the increased risk of heart attacks associated with Avandia.  Yet, the company may have hidden its own test results, while reaping billions of dollars in revenue continuing to market the drug.

Then, this month, an FDA Advisory Panel met to discuss the future of the drug.  When the panel voted, 29 of the 32 members voted either to remove Avandia from the market or change its warning label in light of the medical issues.  Only 3 members voted to do nothing and 1 member abstained.  Now, we hear that one of the 3 members who defended Avandia and voted to do nothing may have a significant conflict of interest.  In fact, the FDA has even referred this serious issue to the Inspector General of the Department of Health and Human Services for further investigation. 

The investigation into this potential conflict of interest is still ongoing and the facts are not yet clear.  However, it now appears that the panel member under investigation may have received more than $14,000 as a paid speaker for another GSK drug.  It is unclear as to whether the panel member disclosed his advocacy of a different GSK drug to the FDA before serving on the panel.  If he did, then the FDA may not consider that issue to present a conflict since it did not involve Avandia.  While the FDA may not consider such advocacy of a different drug by the same manufacturer to be a conflict if disclosed, it still does not sit well with me.

However, the issue goes beyond the panel member advocating one of GSK's other drugs and whether he properly disclosed his relationship to the pharmaceutical giant.  More troubling, GlaxoSmithKline has now revealed that the same panelist may have actually received money for sitting on an Avandia advisory board.  Did this person have a prior relationship with the company concerning the very drug that he was considering as an FDA panel member?  If true, this undisclosed conflict would certainly present a troubling picture.

The government agencies that protect consumers and the public at large have important roles.  It is essential that the difficult investigations and decisions of these agencies be free from conflict.  In the recent few months we have clearly seen the results of a system where the same people responsible for our safety are tainted by money and relationships to the very companies they are regulating.

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

Three days ago, I wrote about the diabetes drug Avandia and the allegations in The New York Times that its manufacturer GlaxoSmithKline (GSK) hid test results indicating the increased risk of heart attacks from using the drug.  At the time of that post, a Food and Drug Administration (FDA) advisory panel was scheduled to meet and discuss Avandia.

Well, the advisory panel has met.  The results of that meeting can be "spun" by both sides of the debate.  What is clear is that a significant majority of the panel voted that Avandia does increase heart risks.  Yet, the panel did not vote to remove the product from the market.  How can the results be interpreted concerning Avandia's future? 

Harlan Krumholz is a physician who is also a Professor of Medicine and Epidemiology at Yale.  Yesterday, he wrote a column in Forbes providing his interpretation of the panel's vote.  In his column, he aptly stated:  "This is a drug with a cloud hanging over it."  Although the panel did not vote to remove the product from the market, a clear majority voted either to remove the product or restrict its marketing.  His article provides some excellent opinion concerning how to interpret the panel's vote.  Interestingly, on the same day as the panel meeting, GSK apparently agreed to settle a large majority of the lawsuits currently pending against it as a result of Avandia, for the sum of $460 million.

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

Explosive!  That's the bombshell dropped by The New York Times yesterday.  The article involves the drug Avandia, manufactured by GlaxoSmithKline (introduced to the market by its predecessor SmithKline Beecham).  Avandia entered the market in 1999 as a drug to treat diabetes.  Since then, GlaxoSmithKline has reaped enormous revenue from the sale of this drug.  To put these sales in perspective, it appears that in 2006, the company received $2.2 Billion in revenue from marketing Avandia.

In 2007 (after approximately 8 years of selling this drug), a Food and Drug Administration (FDA) panel issued a black box warning saying that this diabetes treatment was linked to potential increased risks of heart attack.  GlaxoSmithKline continued to market Avandia after this additional warning.

Now, we learn additional information.  Apparently, the company did its own secret internal testing, back in 1999.  What did it reveal?  According to the New York Times, the secret 1999 study results indicated the increased risk of heart attacks associated with Avandia.  Did the company stop marketing Avandia?  No.  Did the company publish the results?  Apparently not.  In fact, the Times article indicates that internal corporate emails specifically stated that the results should be hidden.

Is this the first time that this drug maker has been caught concealing important health and safety information?  Again, the answer is no.  Several years ago, the company was found to have hidden data linking its anti-depressant Paxil to suicidal thoughts in children and teenagers.

The drug maker is not alone in receiving blame in this situation.  In past years, the FDA has failed in its duty to protect us and allowed many unsafe products to be marketed.  Hopefully, the FDA will now "step up to the plate" and do its job.  This week an FDA advisory committee is meeting to discuss the developments concerning Avandia.  Hopefully, the complete nature of this drug will be revealed so that an honest decision can be made concerning its continued use.

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