Cal Warriner of the Mass Torts Unit of Searcy Denney will be speaking this week at the Plaintiff Forum on Pharmaceutical Litigation: Transvaginal Mesh, Actos and Orthopedic Devices. The conference will be held on Friday of this week (October 5, 2012) at Le Méridien in Philadelphia, Pennsylvania. Cal will be in good company – he will be speaking to some of the leading medical device and pharmaceutical trial attorneys in the country on the topic of “Case Theories, Challenges, and Case Selection: Consideration for Your Actos Clients.” This conference will be the perfect venue for coordination between the best and brightest of the Mass Torts field, and will surely benefit all parties (and especially, the clients) involved.
Cal’s opportunity to speak at this conference demonstrates his expertise in the field of complex multi-district litigation, as well as his reputation as an able and experienced litigator. We look forward to hearing Cal speak, and will be sure to keep you updated as similar opportunities arise.
The prevalence of these kinds of events and conferences with the purpose of exchanging ideas and information says a lot about this particular field of law – it truly is a community of attorneys absolutely dedicated to making sure that safety is the first topic on the minds of large medical device and pharmaceutical companies who too often place profits over individuals.
A federal judge has scheduled proceedings for the first of two test trials in the Actos litigation. The bellwether trials, as they are known, are set for November 3, 2014, and January 12, 2015 in the multidistrict litigation consolidated in the U.S. District Court for the Western District of Louisiana. These will be essentially test cases to gauge how future litigation will proceed and how jurors will react to the egregious cases of injury from the diabetes drug.
Stay tuned. Actos lawyers from both sides are preparing their cases and theories, but a recently published Canadian study is doing nothing to further fact finding.
The Canadian researchers from the University of Alberta conclude that diabetics have an additional risk of bladder cancer due to their type 2 diabetes. One theory is that type 2 diabetics have higher levels of insulin, a hormone that is produced by the body to convert carbohydrates consumed into sugar to be used for energy or stored. Since insulin is a hormone and cancer cells have insulin receptors, the presence of insulin could theoretically cause cancer to grow, however there is no consensus on what role insulin plays in increasing the risk of bladder complications.
What appears more likely is that in a patient taking Actos, the drug may cause some crystallization to take place inside the bladder irritating it and causing bladder cancer to develop.
The lead researcher Johnson said, “The bladder cancer risk appears to be real, but is pretty small. If you’re not at risk of bladder cancer in the first place, the benefits of pioglitazone [Actos] may outweigh the potential risk,” according to senior author Jeffrey A. Johnson, PhD of the University of Alberta in Edmonton.
However this conclusion runs contrary to a recent British Medical Journal study that supported a 2-fold increase in the risk. And if you are a patient how do you justify taking a 22 percent increased risk of bladder cancer by taking Actos?
The estimated 40 percent enhanced risk of contracting bladder cancer by virtue of being a diabetic has not been firmly established in the literature. As a class of drug, thiazolidinediones diabetes drug (Actos) make the body more sensitive to insulin, thereby reducing the level of insulin the body needs. Because the drug works to reduce the amount of available insulin, the risk of bladder cancer would have to be the result of the direct effect of the medication.
It is reckless and irresponsible to suggest that by virtue of having diabetes you have a 40% increase risk of developing bladder cancer. There is too much science pointing to the direct action of the drug which appears to be causing increases across multiple populations. The FDA even warned last year of an increase in bladder cancer risk with Actos that is now reflected in the drug’s product label.
What more do we need to tell us there is a problem?
According to a study published June 11, the users of Actos (pioglitazone) or Avandia (rosiglitazone) may face an increased risk of developing macular edema. Published in the Archives of Internal Medicine, British researchers collected data on more than 100,000 patients with type 2 diabetes who were enrolled in the British Health Improvement Network database. Actos and Avandia are also called thiazolidinediones that were linked in this study to something called diabetic macular edema, a condition where the macula section of the eye, responsible for sharp vision, swells with a buildup of fluid. It’s unclear whether the condition of diabetes may have contributed to the condition since about 20% of diabetics have macular edema, but participants taking the drugs had a two-to-three fold increased chance of developing macular edema.
Macular Edema Scan
Still the risk is small University of Nottingham researchers found, about 0.2 percent so the absolute risk is less than 1 percent. The conclusion is that routine vision screening accompanies a diabetes checkup among those patients taking Actos or Avandia.
This is just the latest problems for thiazolidinediones medications.
A British Medical Journal (BMJ) article on Actos by Canadian researchers found that Actos was associated with an increased risk of bladder cancer.
Recently released French and U.S. studies also found a link to an increased risk of bladder cancer as the cumulative dosage increased. And for patients taking 28,000 mg or more of Actos for two years or longer, the relative risk of bladder cancer was increased 88 percent to 137 cases per 100,000 patients or 89.4 cases per 100,000 population years.
Consumer Reports says Actos, made by Takeda Pharmaceuticals, is linked to congestive heart failure, bone fractures, and bladder cancer and is a danger to all patients. If you are taking the diabetes medication, the publication suggests you ask your doctor if there are safer drugs that would do the job such as metformin, glipizide or glimepiride, which have all been around longer and have fewer consumer complaints.
Searcy Denney was one of the first Mass Tort Attorneys to file a lawsuit on behalf of a man who took Actos and developed bladder cancer. His case is among the hundreds consolidated in the U.S. District Court in the Western District of Louisiana.
Meanwhile there are more than 2,500 Avandia lawsuits consolidated in the Eastern District of Pennsylvania in federal court. All of the plaintiffs say if they had just been told about the complications they would have saved their lives and taken some of the older, more reliable diabetes medications.
A recently unsealed complaint filed by whistleblower Helen Ge reveals that over four years, Takeda Pharmaceuticals failed to report to the FDA congestive heart failure cases in patients taking Actos. Takeda manufactures the Type II diabetes drug Actos. Actos is the third in a long line of failed Type II diabetes medicines.
By way of history, Rezulin, launched in the late 1990’s and was almost immediately found to cause liver failure. Within just a short while it was removed from the market. Many Rezulin takers were transitioned to Glaxo Smith Kline’s new wonder drug Avandia. Over time it became apparent that Avandia placed patients at significantly higher risk of developing congestive heart failure. The FDA intervened and required a stern, black box warning to be placed in the label and sales of Avandia slowed to a trickle.
Takeda was quick to pounce on the void left by the Avandia and Rezulin failures. It aggressively marketed Actos as the “safe alternative” to other Type II diabetes drugs. That despite Actos containing the exact same active ingredient as Avandia.
Now we come to find out that Actos only seemed to be the safer alternative. I guess one way to make your drug “appear” safer is to simply lie to the FDA about the number of reported adverse events. It seems no coincidence that Takeda representatives were reluctant to report these events while Avandia was getting pummeled in the press and in scientific circles for causing congestive heart failure.
As Actos filled the void left by Avandia, Takeda was raking in billions. In 2010, the New York Times reported that by 2009 Actos was outselling Avandia seven to one and grossing 3.4 billion dollars. That is 3.4 billion strong reasons to cover up the fact Takeda’s drug was causing the exact same problems that were bringing Avandia to its knees.
The fact Actos too frequently causes congestive heart failure as alleged by Ms. Ge is just the tip of the iceberg. As bad as Avandia was, its potentially life threatening properties were limited to heart failure. Unlike Actos, Avandia was never linked to bladder cancer.
This report causes one to wonder what Takeda knew about its drug causing cancer and when it knew it. If as alleged Takeda is willing to withhold heart failure reports from the FDA, why not keep reports about bladder cancer a secret? It would be interesting to hear what Ms. Ge or other former Takeda employees have to say about that.
One of the first cases involving a plaintiff who developed bladder cancer as a result of taking the diabetes drug, Actos was filed by Mass Tort Attorneys of Searcy Denney in the Southern District of Florida, Miami Division.
This case involves a married executive who lives in the Miami area and took Actos for years before being diagnosed with bladder carcinoma, for which he has undergone numerous procedures and surgeries.
This case is being transferred to the newly-created MDL No. 2299 styled In Re: Actos Products Liability Litigation. Attorney Cal Warriner appeared at the hearing before the Judicial Panel on Multi-District Litigation in late November in Savannah, at which time the panel of federal judges heard argument from plaintiffs as well as Takeda Pharmaceuticals regarding the need for establishment of an MDL as well as the locale. Both sides supported establishment of an MDL to coordinate the litigation, which is expected to ultimately include hundreds if not thousands of cases filed on behalf of diabetics who developed bladder tumors after using the diabetes drugs:
Actoplus met XR
Duetact insulin sensitizing drugs
The litigation may also include claims filed by plaintiffs who contend that Actos and related drugs increased their risks of heart attacks, strokes, and other cardiac ailments. Similar litigation has been pending for years in state and federal courts in Pennsylvania against the manufacturers of Avandia, a diabetes drug similar to Actos, that has been linked to a number of heart injuries.
On December 29, 2011, the JPML issued its order transferring all of the pending Actos lawsuits to the Western District of Louisiana, one of the venues urged by the drug manufacturer and a small group of plaintiffs’ lawyers. The panel rejected the plaintiffs’ suggestions that the cases be sent to federal courts in Alabama, New York, Minnesota, Illinois, Ohio, and New Jersey. Takeda Pharmaceuticals had also suggested that the cases be sent to Chicago, where a number of lawsuits were already pending. Judge Rebecca Doherty, a district court judge in the Western District of Louisiana will oversee the cases.
The first hearing before the judge will take place soon, and private organizational meetings of the plaintiffs’ lawyers who represent Actos claimants have already occurred.
On December 29, 2011 the Judicial Panel on Multidistrict Litigation (JPML) entered an Order consolidating all pending federal Actos bladder cancer lawsuits.
Actos, generically known as pioglitazone, is a prescription medication manufactured by Takeda Pharmaceuticals and used to treat Type 2 diabetes, often referred to as adult onset diabetes. The JPLM’s Order references the existence of over 100 related pending Actos cases in various federal districts. The Order transfers the actions to the Western District of Louisiana before the Honorable Rebecca F Doherty, who was nominated to the court in 1991 by President George H. Bush.
The JPML noted that the litigation did not have strong connections to any particular district and determined that “centralization in the Western District of Louisiana permits the Panel to assign the litigation to an experienced Judge who sits in a district in which no other multidistrict litigation is pending.” Consolidation into multidistrict litigation eliminates duplicative discovery, inconsistent rulings and promotes efficiency and conserves the resources of the parties. The Actos lawsuits allege that individuals taking Actos face an increased risk of bladder cancer and that the Defendants, Takeda Pharmaceuticals and Eli Lilly, concealed their knowledge of this risk and failed to provide adequate warnings.
As early as September 17, 2010, the U.S. Food and Drug Administration (FDA) announced an Actos safety review based upon data from an ongoing ten year study which associated a potential increased risk of bladder cancer based upon the length of exposure to Actos.
On June 15, 2011 the FDA issued a safety announcement informing the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer and mandating that information concerning this risk be added to the Actos label. The FDA cited data that revealed diabetes patients who took Actos longer than 1 year had a 40% increased risk of developing bladder cancer compared to those patients never treated with Actos. The FDA referenced a study from France which also revealed an increased risk of bladder cancer and which led the French government to suspend the use of Actos. The FDA noted that from January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone containing product.