The Actos MDL is a type of mass litigation that was formed on December 30, 2011 by the Judicial Panel on Multidistrict Litigation (JPML). The MDL consolidates all federal lawsuits filed against Takeda regarding its medication, Actos, and the potential link to bladder cancer. The MDL provides for more efficient pretrial proceedings and helps conserve judicial resources and time. Each plaintiff will still have their own trial. There are more than 1,200 complaints pending in the products liability MDL, along with additional cases in individual states.

Allegations raised in Actos side effects litigation

Actos (pioglitazone) is an oral medication for type 2 diabetes that is intended to stabilize blood sugar levels. Joseph DesGranges was given a prescription for Actos in 2001. In December 2011, the plaintiff was diagnosed with bladder cancer. According to the complaint, the plaintiff has suffered severe pain and suffering and has incurred significant medical expenses as a result of the bladder cancer diagnosis, and expects to incur additional medical expenses in the future.

The Actos bladder cancer lawsuit indicates that although the plaintiff is currently in remission, he suffers emotional distress due to the possibility of a recurrence of bladder cancer, which may require the surgical removal of his bladder.

According to the Mayo Clinic, there is a high rate of recurrence of the disease among bladder cancer survivors. Doctors recommend that cancer survivors undergo periodic testing on an ongoing basis. For example, it’s possible that the plaintiff will need to undergo a cystoscopy every three to six months for several years, followed by a cystoscopy once annually thereafter. A cystoscopy is an invasive test that requires the insertion of a hollow tube into the urethra and up into the bladder. This exam has the potential to cause additional complications for the plaintiff, including abdominal pain, painful urination, bloody urine, and infection.

Takeda charged with failure to warn

According to court documents, the plaintiff would never have taken Actos and run the risk of all of the above complications had he been properly informed. The complaint alleges that Takeda Pharmaceuticals knew of the potential risks, including an increased risk of bladder cancer, yet failed to warn patients and healthcare professionals. Furthermore, the complaint alleges that the defendants marketed the product as being beneficial to patients’ cardiovascular health, despite studies that associated the drug with damage to the heart.

Plaintiffs who have joined the Actos side effects litigation point out that the defendants conducted a two-year study prior to marketing the product. That study revealed the development of bladder tumors in rats, which were caused by Actos.

In 2005, the results of a three-year study, known as the PROactive study, became available. The defendants had access to the results, which indicated a significantly increased risk of bladder cancer. Despite these findings, the plaintiffs alleges that the defendants failed to warn patients, and that they “intentionally skewed the study findings.”

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The couple’s Actos lawyer filed the claim on June 4, 2013 in the U.S. District Court, Western District of Louisiana, home of the current products liability litigation involving the controversial drug. Takeda is being charged with failing to warn consumers and the medical community that Actos can cause bladder cancer and heart damage. Louis Woodall was diagnosed with bladder cancer on May 23, 2012 after ingesting Actos for less than two years under the supervision of his physician.

Utah plaintiff seeks Actos cancer compensation

The claimants are requesting damages for Louis’ injuries, blaming Takeda Pharmaceuticals for his bladder cancer diagnosis.

The couple is requesting compensation for:

• Past, present and future medical care
• Ascertainable economic losses
• Pain and suffering
• Attorney fees and court costs
• Loss of spousal consortium
• Punitive damages to punish and deter Takeda from the same or similar conduct 

Louis Woodall began taking Actos in 2010 under the assumption that the medication was safe and effective. However, prior studies had pointed to an increased risk of life-threatening side effects with Actos exposure over prolonged periods of time. Potential side effects of Actos included congestive heart failure, bone fractures, and bladder cancer.

The strong correlation between Actos and bladder cancer prompted both Germany and France to pull the diabetes drug from the market. And despite two FDA safety communications regarding bladder cancer risks and Actos, Takeda continued to promote the medication as safe. By 2008, Actos was the tenth top-selling prescription drug in the United States.

According to court documents, Takeda has yet to adequately warn consumers and the prescribing medical community about the significant risks of bladder cancer associated with Actos use.  And lacking this crucial information about the drug’s adverse side effects, the plaintiff and his physician were not able to accurately assess the true risks of the medicine.

Louis Woodall alleges to be permanently injured and will require ongoing medical care to treat his bladder cancer, which may include surgical removal of the organ if malignancies progress.

Nine counts brought against Takeda

The plaintiffs’ Actos lawyer adopts the following counts in the complaint:

• Products liability: manufacturing defect
• Failure to warn
• Breach of express warranty
• Breach of implied warranty of merchantability and fitness
• Negligence
• Loss of consortium
• Common law fraud
• Constructive fraud
• Negligent misrepresentation

The defendant’s wrongful conduct and negligent misrepresentations about the safety of Actos have caused the plaintiff to incur debilitating bodily injury, mental and physical pain, and economic loss, according to the plaintiffs’ Actos lawyer.  Woodall joins more than 3,000 other plaintiffs who are demanding Actos cancer compensation from Takeda.

Federal Actos lawsuits centralized as MDL

Owing to the large number of claims against Takeda, multidistrict litigation was established on December 29, 2011. The docket is being overseen by Judge Rebecca F. Doherty in the U.S. District Court for the Western District of Louisiana (MDL No. 2299). The Woodall case is one of the latest lawsuits to join the MDL proceedings, which will help expedite the pre-trial process.

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The action was brought on May 28, 2013, and charges the defendant with negligently designing, manufacturing, and distributing a defective prescription medication, known as Actos. The plaintiff took Actos (pioglitazone) under his doctor’s guidance from 2006 to 2009, and was diagnosed with bladder cancer on October 11, 2007. Sellers seeks compensation for his physical injuries and financial losses that were purportedly caused by the defective nature of the drug.

The plaintiff’s Actos bladder cancer lawyer argues that as a direct result of long-term Actos use, Nelin Sellers suffered severe mental and physical pain and suffering, including emotional distress, along with economic loss due to medical expenses.

Key allegations cited in Actos lawsuit

The Oklahoma man’s allegations echo those of hundreds of other plaintiffs who took Actos for the treatment of their Type 2 diabetes and were later diagnosed with bladder cancer.  The medication was approved by the FDA in July of 1999 and quickly became one of the most popular insulin-sensitizing drugs on the market— until reports began trickling in of adverse events associated with pioglitazone.  The now famous three-year PROactive study, which examined cardiovascular outcomes with Actos use, showed a higher rate of bladder cancer cases in patients taking pioglitazone versus competitors. The results of this research were known in 2005, yet Takeda did nothing to alert consumers about potential health risks.

By 2011, Actos had been banned in both France and Germany, after clinical studies and post-market reports showed an increased risk of bladder cancer among Actos users.

In June 2011, the FDA published a safety communication announcing that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

The interim results of a 10-year study showed that patients who were exposed to Actos for 12 months or longer had a 40 percent greater risk of developing bladder cancer. Despite this safety information, the defendant continued to promote Actos as a safe and effective treatment for diabetic patients, enjoying global sales of $4.8 billion each year.

Seller’s attorney says that through Takeda’s misrepresentations and omissions, the company actively concealed the significant risks associated with long-term Actos use from both the plaintiff and his physician.

The Actos lawsuit lists many causes of action, including:

• Manufacturing defect
• Design defect
• Inadequate warning
• Breach of express warranty
• Breach of warranty of fitness for ordinary use
• Breach of implied warranty
• Fraud
• Negligent misrepresentation
• Fraud by non-disclosure
• Negligence

Nulin Sellers is requesting compensatory damages to cover both past and future medical expenses; pain and suffering; emotional distress; loss of enjoyment of life; lost wages and loss of earning capacity; and consequential damages.

Federal Actos cases centralized as multidistrict litigation

The Actos products liability MDL is being presided over by Judge Doherty in the Western District of Louisiana, where complaints alleging similar injuries have been coordinated for more efficient pre-trial proceedings. If mediation is ordered, Takeda may decide to negotiate Actos lawsuit settlements with plaintiffs who were diagnosed with bladder cancer. If settlements are not reached, each case will be sent back to its original court of filing to be tried individually.

At present, Takeda faces more than 1,000 cases, which allege the manufacturer concealed vital information regarding the inherent dangers of Actos and bladder cancer.

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Though new warnings were added to the  Actos label in the U.S. in the summer of 2011, and the product was actually pulled off the market in France at the same time, patients in Australia and New Zealand feel the corresponding warnings on their products were weaker than in other countries. The class action suit seeks to recover damages suffered by patients claiming to have developed bladder cancer after using the medication.

Actos class action lawsuit also filed in Canada

In December 2011, another Actos class action lawsuit was filed in Canada, specifically in the Ontario Superior Court of Justice. The lead plaintiff in that case is the estate of a woman who died in 2011 from bladder cancer believed to be linked to her use of the medication.

According to court documents, manufacturer Takeda Pharmaceuticals failed to provide adequate warnings about the health risks, and should be held liable for damages suffered by patients who took the drug without knowledge of the possible outcomes.

Actos cancer warnings delayed until 2011

The FDA approved Actos in 1999 for the treatment of type 2 diabetes. Warnings about bladder cancer were not added until 2011, however, so for years, patients took the drug without knowing that it could lead to cancer.

Medicare figures show that more than 1.7 million prescriptions for Actos were filled in Australia over the past four years. In 2011, Australia’s drug regulation organization issued a warning, noting that the “use of Actos (pioglitazone) for more than a year may be associated with an increased risk of bladder cancer.” As in the U.S., however, this was the first warning about the potential risk, and resulted in a dramatic reduction in the amount of prescriptions filled—from over 430,000 in 2011 to about 380,000 in 2012.

Actos cancer lawsuits increasing

Takeda is facing thousands of Actos cancer lawsuits filed in the U.S. over the past few years. Most allege that the company failed to provide adequate warnings, and knew or should have known about the health risks.

The first Actos lawsuit to go to trial took place in California. The plaintiff, Jack Cooper, claimed that his bladder cancer was caused by his use of the medication. The jury returned a verdict awarding Cooper $6.5 million in damages, but the verdict was later reversed by the presiding judge because of post-trial motions involving expert witness testimony.

On December 29, 2011, the U.S. Judicial Panel on Multidistrict Litigation centralized all federal Actos lawsuits in the Western District of Louisiana. The first MDL trial is scheduled for January 2014.

New Zealand patients who have developed cancer allegedly as a result of taking Actos are also invited to join the new Actos class action lawsuit involving Australians.

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Each was diagnosed with bladder cancer within a few years of taking the drug, and each alleges no warning was given by Takeda regarding the risks. According to court documents, Takeda concealed their knowledge of an ‘unreasonable risk’ of cancer associated with taking the drug for more than a year.

The case is one of more than 3,000 Actos bladder cancer lawsuits currently pending. Takeda is facing litigation across the country, with more than 1,200 lawsuits already consolidated in a Louisiana federal court. The first federal case will be heard in January 2014. Complainants allege that their bladder cancer is a direct result of taking the diabetes medication.

Comprehensive study supports allegations

A major study, conducted over 10 years, appears to support Actos bladder cancer allegations. Although the final results will not be known until later this year, the researchers have made some startling predictions regarding the likelihood of contracting bladder cancer within a certain number of months after beginning Actos treatment.

While diabetes patients who take Actos for less than 12 months are at no greater risk of cancer, there is a a 30% increased risk after a year on the medication, according to the study. Patients who take Actos for more than two years have more than a 50% increased risk of a bladder cancer diagnosis.

Actos bladder cancer lawsuit complaints consolidated

Since being launched by Takeda in 1999, Actos has been a major source of income for the drugmaker, pulling in $4.5 billion in 2011 alone. That figure comprised 27% of Takeda’s revenue for the year, according to a Bloomberg report.

Takeda lost patent protection for Actos in 2012, after attorneys working for former Actos patients alleged that the Japanese company’s researchers ignored or downplayed concerns about its carcinogenic properties, and misled regulators about the risks.

In a recent trial – the first Actos bladder cancer lawsuit to reach court – an Actos lawyer told jurors that Takeda had established a link between Actos and cancer as early as 2004, but the company failed to inform regulators for seven years. Internal email messages were presented as evidence that company executives were complicit in failing to update their labeling – even after demands from the FDA to do so.

The $6.5 million jury verdict in favor of the plaintiff was later overturned, after Takeda successfully convinced the court that the claimant – an elderly, diabetic former smoker – was at a high-risk of bladder cancer before taking Actos, and the drug could not be proven to have played a part.

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Important Actos lawsuit news

The recent Actos lawsuit news is significant, because this lawsuit is the first of more than 3,000 filings involving the diabetes drug to go to trial. Decisions made in this trial could have an impact on how future Actos lawsuits are handled. Court filings indicate this particular complaint was expedited by Judge Freeman because he discovered that the plaintiff in the case, Jack Cooper, was “gravely ill.”

Jack Cooper took Actos for four years to treat type II diabetes, before he was diagnosed with bladder cancer in 2011. Cooper and his attorney allege that the cancer diagnosis was a direct result of his Actos use. In addition, the plaintiff claims he was not sufficiently warned about the risk of bladder cancer by Actos manufacturer Takeda.

Original jury verdict resulted in $6.5 million award

The jury for the trial deliberated for five days before deciding in favor of Cooper and awarding him $6.5 million. Takeda quickly filed motions asking Judge Freeman to reverse the ruling, arguing the evidence provided did not show a definitive link between the Actos use and cancer. During the original Actos trial, Takeda had argued that Cooper’s history of smoking, advanced age and diabetes diagnosis were all risk factors for cancer. Cooper was 79 at the time of the trial and had smoked at least 21 years before kicking the habit in 1974.

In a 27-page ruling, Judge Freeman determined that Cooper and his attorney had failed to present sufficient evidence linking Cooper’s Actos use and cancer. Judge Freeman also stated in his decision that testimony presented by Cooper’s physician was “inherently unreliable,” which justified throwing out the jury verdict.

Internal emails suggest Takeda’s knowledge of cancer risks

During the trial, Cooper’s attorney made Actos lawsuit news by producing internal Takeda emails that suggested the company knew of the bladder cancer risk with their drug as early as 2004. In those emails, Takeda executives urged colleagues to persuade the FDA not to require new warning labels for the drug. When the agency did finally ask the company to change product labels in 2005 and 2006, Takeda stalled the process because of the amount of profit Actos was providing the company, according to Cooper’s attorney at the trial.

Cooper’s attorney has said they would appeal Judge Freeman’s post-verdict ruling, saying they believe the “court has misinterpreted the law.” The Actos lawyer also stated that he feels confident the ruling will eventually be reversed.

In 2011, the FDA issued a safety communication, which stated that use of Actos for one year or longer was associated with a higher risk of bladder cancer. A Canadian study conducted in 2012 showed that Actos is associated with an approximate 22-percent increase in bladder cancer. More research published that same year showed taking the drug for two years could double the risk of bladder cancer.

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Cooper, who took Actos for over four years, was diagnosed with bladder cancer in November 2011.  The lawsuit alleged that Actos caused the plaintiff’s bladder cancer and that Takeda failed to provide an adequate warning to doctors and patients about the side effects of Actos.

Actos lawyer says Takeda knew of risks

According to the Actos bladder cancer lawsuit, Takeda knew about the risks and potential side effects of Actos, and deliberately withheld this information from the public and from U.S. regulators.  The plaintiff produced evidence showing that Takeda’s internal studies had linked Actos to bladder cancer in 2004, but the company did not alert US regulators until seven years later, in 2011.  Attorneys for the plaintiff also produced emails from company executives urging their colleagues to protect the Actos brand by persuading regulatory authorities not to demand increased warnings about the link between Actos and bladder cancer.

Despite the emails, the FDA did request that Takeda update their product warnings about the health risks of Actos – once in 2005 and once in 2006 – but the company allegedly dragged its heels in an effort to protect its Actos sales, which totaled $1.6 billion per year at the time and peaked at $4.5 billion in the year ending in March 2011.

Jury finds sufficient evidence to link Actos to bladder cancer

At trial, Takeda insisted that Actos was safe and effective and that no direct, causal link had been proven between Actos and bladder cancer.  However, numerous studies do show an association between Actos and an increased risk of bladder cancer, with risk appearing to increase with duration of use and with the total amount of the drug ingested.  One recent study of patients in the United Kingdom showed that use of Actos for five years or more increased the risk of bladder cancer by over 300%, and studies in the US, France, and Thailand have also revealed an association between Actos and bladder cancer.  As a result of these studies, Actos has been pulled off the market in France and is under increased regulatory scrutiny in the U.S. and the European Union.

Case will be a bellwether for thousands of pending Actos suits

Cooper’s case was the first of over 3,000 Actos lawsuits across the country to go to trial.  Two hundred more claims have been consolidated in the California state court system, 1,500 are awaiting trial in the Illinois state court in Cook county, and 1,200 are pending in multidistrict litigation (MDL) in a U.S. District Court in Louisiana.

According to one Actos lawyer, this verdict is good news for the plaintiffs in every other Actos bladder cancer lawsuit.  Since the jury found for the plaintiff, the case will be used as a bellwether – that is, an indication of the trends that future Actos cases may follow – and could have an influence on legal strategies, Actos settlement negotiations, and future calculations of damages.

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The lawsuit alleges that Actos increases the risk of developing bladder cancer when used for a prolonged period of time. Life-threatening Actos side effects have been cited in many of the personal injury/product liability lawsuits filed against Takeda Pharmaceuticals.

Medical studies reveal side effects linked to Actos

Takeda Pharmaceuticals received FDA approval to market Actos as a treatment for type II diabetes in July 1999. Actos is a prescription medication that helps to stabilize blood glucose levels of patients with type II diabetes. In spite of the FDA’s approval of the medication, findings from medical studies have shown that Actos was linked to serious side effects such as an increased risk of bladder cancer, heart failure, and bone fractures.

In 2005, a medical study called PROactive (PROspective PioglitAzone Clinical Trial in MacroVascular Events) concluded that a higher percentage of patients developed bladder cancer when they used Actos compared to other drugs made by competitors. The study’s findings regarding bladder cancer weren’t published by the researchers or the defendants.

In September 2010, the FDA stated that it would start reviewing data from an ongoing 10-year Kaiser Permanente study designed to evaluate the association between Actos and bladder cancer. During the five-year point within the study, the results showed that the risk of bladder cancer increased for patients who took Actos for the longest period of time and patients who used the highest doses of the drug. Robert Spanheimer, the Vice President of Medical and Scientific Affairs for Takeda, disputed the study’s results by claiming that patients who used Actos weren’t at risk of getting bladder cancer.

In June 2011, France and Germany suspended the use of Actos after a three-year French medical study concluded that males who ingested the medication for more than a year were at greater risk of developing bladder cancer. During the same month, the FDA announced that the risk of bladder cancer increases for patients who use Actos for longer than a year. The agency stated the risk of bladder cancer would be updated as a  potential risk factor on Actos warning labels.

Takeda Pharmaceuticals issued a limited recall for Actos in France in July 2011, but continued to distribute the prescription drug in America. Even though Takeda Pharmaceuticals was allegedly aware of Actos side effects based on the results of the 2005 PROactive study and other medical reports, it continued to market the drug as a safe and effective treatment for patients with type II diabetes. The manufacturer also didn’t update the warning labels regarding the risk of bladder cancer until it was ordered to by the FDA in 2011.

Plaintiff alleges bladder cancer caused by Actos

According to court documents, the plaintiff received a prescription for Actos from his physician on October 2, 2005. By February 21, 2007, he stopped using the drug. The plaintiff was subsequently diagnosed with bladder cancer on October 13, 2008. The lawsuit alleges that the plaintiff has been permanently injured and will require ongoing medical treatment as a direct result of using Actos. The plaintiff states that he continues to suffer from physical pain and emotional distress and has also incurred substantial financial losses including lost income and medical expenses.

Charges leveled in Actos lawsuit

The counts levied against Takeda Pharmaceuticals and defendants include negligence and strict liability. The claim alleges the defendants knew about the dangerous and life-threatening side effects Actos posed to patients, yet they failed to issue an adequate warning. The defendants allegedly deceived consumers by misrepresenting the safety and effectiveness of the prescription diabetes medication.

According to the complaint, Takeda Pharmaceuticals failed to use reasonable care while designing, manufacturing, and distributing a defective drug. The plaintiff contends that if he had been aware the dangerous side effects, he could have made an informed decision regarding his medical treatment and chosen to use a safer alternative product. The North Carolina man is seeking compensatory and punitive damages.

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At present, the very first Actos bladder cancer trial is underway in the Superior Court of California for Los Angeles County, where claimant Jack Cooper is charging the defendant with failure to warn after being diagnosed with the disease following his use of the diabetes medication. Due to the extent of his bladder cancer and precarious health, Cooper’s case was expedited and commenced on February 19.

Actos litigation update: MDL bellwether trial dates moved up

U.S. District Judge Rebecca Doherty recently announced a novel Pilot Bellwether Program in the federal Actos multidistrict litigation, with a fast-tracked schedule that will include two bellwether trials. The first Actos MDL trial is slated to start on January 27, 2014, and the second trial will begin on April 14, 2014. This decision will impact the pending Actos bladder cancer lawsuits, with a new “hard and fast” schedule. “This court is aware that the schedule established herein will place extraordinary burdens on this court, counsel, and parties,” Judge Doherty commented on the order. “Nonetheless, this abbreviated schedule is imposed so as to serve the very important goal of moving these proceedings toward completion of this court’s responsibilities in a reasonable time frame.”

To get ready for the first Actos MDL trial, both parties have been instructed to nominate five Actos bladder cancer lawsuits each for the Pilot Discovery pool by April 1, 2013. In order to be eligible for the Discovery list, the claims must involve plaintiffs who have been medically diagnosed with bladder cancer after taking Actos. To comply with the new Pilot Bellwether Program, Doherty created the following timetable:

• April 1, 2013: Both parties nominate 5 Pilot Bellwether Discovery Pool cases
• July 15, 2013: Plaintiffs identify their nominee for the first trial, and defendants will name theirs for the second bellwether trial
• October 1, 2013: Discovery deadline
• January 13, 2014: Actos MDL pre-trial conference

In light of the thousands of pending claims – many of which were filed by plaintiffs in poor health due to bladder cancer – Judge Doherty said that the Pilot Program deadlines were considered hard and fast, and confirmed “They will not be extended, continued, or delayed by the court in any way absent extraordinarily good cause shown.”

Similar allegations cited in Actos bladder cancer lawsuits

Considered test cases, the bellwether trials will help measure how juries are likely to react to testimony and evidence presented by both defendant and plaintiffs in the thousands of pending lawsuits. In 2011, the FDA released a safety communication warning that patients who ingested Actos for more than a year may be at an increased risk for developing bladder cancer. Since the FDA Actos warning, a flood of claims by injured patients have been filed against Takeda Pharmaceuticals, with plaintiffs demanding monetary damages based on allegations that the drug maker knew of Actos bladder cancer risks but failed to warn both the public and medical community.

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As noted in court documents, manufacturer Takeda secretly surveyed doctors in 2003 to find out if a bladder cancer warning would deter them from prescribing a type 2 diabetes medication. According to Bloomberg (Feb. 15, 2013), the survey found “a bladder cancer warning would destroy the sales of Takeda’s most important drug.”

FDA warns of Actos and bladder cancer

The FDA approved Actos (pioglitazone) for the treatment of type 2 diabetes in 1999. Post-marketing reports, however, along with later scientific studies, indicated that Actos side effects risk may include bladder cancer.

Takeda didn’t add a bladder cancer warning until June 2011, when the FDA ordered the label change. The agency released a safety communication that same month reporting that data from an ongoing 10-year epidemiological study on Actos and bladder cancer showed that those patients taking the drug for more than a year may be at a 40 percent increased risk for the disease.

As it defends an increasing number of Actos lawsuits around the country, Takeda has maintained that its drug does not cause bladder cancer. Yet documents released as part of this first Actos trial suggest that company executives were concerned about a potential link years before they updated the warning label.

Actos lawsuits and generics take a chunk out of Takeda’s earnings

Court records show that in 2002, Novo Nordisk—another pharmaceutical company—stopped marketing a drug similar to Actos after animal tests indicated it increased risk of cancerous tumors. The FDA inquired into a similar potential connection with Actos.

Acting on concerns that Actos and bladder cancer may be linked, Takeda executives reportedly conducted a secret survey of doctors in 2003, asking them if they would still prescribe a diabetes drug that included a warning about the potentially deadly disease. The survey results were not promising for the sales of such a medication.

Takeda has stated they acted properly in handling Actos warnings, and reiterated that the FDA found the drug to be a safe and effective treatment at its approval in 1999.

Meanwhile, competition from generics, first approved in August 2012, and the pressure from litigation has affected Takeda’s bottom line. They reported a 46.2 percent decrease in sales of Actos over the six-month period ending September 30, 2012. A later report showed the company’s operating profit plunged 53 percent in the nine months that ended December 31, 2012.

Actos lawsuit settlements or jury awards sought

This first trial is considered important Actos litigation news, as lawyers are closely monitoring the proceedings for clues as to how juries may react to evidence in future trials. All federal Actos lawsuits were consolidated in the Western District of Louisiana on December 29, 2011, but the first bellwether trials there aren’t scheduled to begin until November 2014.

Patients suffering from Actos-related bladder cancer seek lawsuit settlements or jury awards to help pay for ongoing medical expenses, prescription medications, therapies, lost wages, and pain and suffering. Most plaintiffs allege that Takeda knew about the risk of Actos and bladder cancer, yet failed to adequately warn physicians and patients.

Actos lawyers in the Cooper case have pointed to evidence that suggests Takeda instructed its sales representatives to gloss over any concerns about bladder cancer when talking to doctors, and focus on increasing sales of the drug.

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Actos lawyer reveals facts of the case

In relating the facts of the case, the Garner’s Actos lawyer states that from approximately 2004 to 2011, Gilbert Garner took Actos for the treatment of type 2 diabetes. He was subsequently diagnosed with bladder cancer in April 2009.

On June 15, 2011, the FDA issued a safety announcement notifying patients and physicians that use of Actos for more than a year may be associated with an increased risk of bladder cancer. They based their warning on the 5-year results of an ongoing 10-year epidemiological study that showed patients taking the drug for more than one year had a 40 percent increased risk of serious Actos side effects, namely bladder cancer.

Actos lawsuit notes studies revealing Actos side effects

In his Actos lawsuit complaint, Garner also notes the several studies prior to the 2011 FDA warning that indicated a connection between Actos and bladder cancer. Because of these studies, he states, manufacturer Takeda should have known about serious Actos side effects and should have done more to warn patients and doctors of the risks.

In 2005, for instance, the PROactive three-year study showed a higher percentage of bladder cancer cases in patients receiving Actos versus those receiving other diabetes drugs. As the study was observing cardiovascular outcomes, however, the results on bladder cancer were not published. Nor did Takeda alert the FDA or physicians about the concerning outcomes.

Prior to issuing its 2011 safety communication, the FDA revealed on September 17, 2010 that it was undertaking a review of the data from an ongoing study conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer.

Takeda fails to warn patients until Actos recall

Meanwhile, Takeda failed to warn consumers about the risk of Actos side effects like bladder cancer. In early 2011, the American Diabetes Association published a study confirming a link between Actos and bladder cancer. “This issue needs constant epidemiologic surveillance and urgent definition by more specific studies,” the authors stated.

On June 9, 2011, the European Medicines Agency announced that the French Medicines Agency had decided to suspend the use of Actos while awaiting study outcomes. A retrospective study in France using the French National Health Insurance Plan demonstrated a statistically significant increase in the risk for bladder cancer in men exposed for more than a year.

On June 10, 2011, Germany joined France in suspending the use of Actos, and advised doctors not to prescribe the medication to any new patients. In July 2011, Takeda implemented an Actos recall in France.

Eligibility for an Actos lawsuit

After the June 15, 2011 FDA warning about bladder cancer related to Actos, Takeda finally updated the product labels in the U.S. to reflect the risk of bladder cancer. An Actos lawyer is likely to claim that up until that date, Takeda needlessly put the lives of many patients at risk by failing to communicate what they knew about the potential health complications.

Many patients like Gilbert Garner were likely unaware of the connection between Actos and their bladder cancer until the 2011 FDA warning. Those who have not yet filed an Actos lawsuit may benefit from a consultation with an Actos lawyer.

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In the most recent order signed January 29, 2013, Judge Doherty made a new appointment to ensure that those plaintiffs who do not have Actos lawyers— and have chosen to represent themselves—will have the information and assistance they need to comply with the orders and deadlines of the court.

Some plaintiffs have not retained Actos lawyers

Most plaintiffs in the MDL seek the representation of Actos lawyers. These professionals understand the legal process, and are typically experienced in handling personal injury cases that relate to allegedly defective drugs and medications.

Some plaintiffs, however, choose to represent themselves. These plaintiffs file their Actos lawsuits pro se, which simply means that they are advocating on their own behalf in court, rather than being represented by an attorney.

Because of this choice, these plaintiffs may miss out on some critical information in large litigation like the Actos MDL. A court-appointed individual can make sure that unrepresented plaintiffs who are seeking Actos settlements or jury awards to compensate them for injuries related to the drug have the correct fact sheets and other relevant documentation.

The Pro Se liaison will also be responsible for assisting any incarcerated pro se prisoners with their application to proceed with their lawsuits, and is also tasked with maintaining a current list of all pro se plaintiffs.

Plaintiffs filing Actos lawsuits over bladder cancer injuries

To date, the Actos MDL has over 1,000 lawsuits pending. Most plaintiffs claim that manufacturer Takeda failed to provide adequate warnings as to the risks associated with the type 2 diabetes medication. Actos lawyers claim that Takeda knew their medication could increase bladder cancer risk, yet failed to provide this important information to doctors or patients.

In June 2011, the FDA warned that patients taking Actos for more than a year could experience an increased risk of bladder cancer. They published this warning after reviewing the 5-year results of an ongoing 10-year epidemiological study. The results showed that those taking the drug for longer than 12 months experienced a 40 percent higher risk of the disease.

A study in France about the same time came to similar conclusions. Takeda implemented a voluntary Actos recall in France in July 2011.

Plaintiffs are seeking Actos settlements for their injuries

Judge Doherty has made many appointments along the way since all federal Actos lawsuits were centralized in 2011. In April 2012, for instance, she appointed 19 lawyers to a plaintiff steering committee to manage the litigation. These professionals were in charge of leading the efforts to gather evidence, and for arguing key points pertaining to trial procedure, selection, and scheduling.

In May 2012, Bloomberg estimated that Takeda may face as many as 10,000 claims related to Actos and bladder cancer. Plaintiffs filing cases around the nation are hoping to secure Actos settlements or favorable jury awards to help offset medical expenses, lost wages, pain and suffering.

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The plaintiff claims that as a direct result of his extended pioglitazone treatment, he has suffered severe physical and mental pain, emotional distress, and economic loss due to the ongoing medical treatment for his alleged Actos-related bladder cancer.

No U.S. Actos recall

Although concerns of Actos and bladder cancer risks have prompted many to call for the FDA to issue an Actos recall, the type 2 diabetes drug remains available in the United States. On June 15, 2011, the FDA published a safety communication indicating that patients who use Actos for more than one year may have an increased risk of bladder cancer. The notice was based on conclusive data from an interim analysis of an ongoing, ten-year epidemiological study. Results showed that patients who took Actos for 12 months or longer had a 40 percent increased risk of developing bladder cancer than those who were not exposed the drug.

The FDA website further explains “The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.” Earlier that same year, Actos-related bladder cancer concerns reached new heights when researchers in France reported a high incidence of bladder cancer among users of the insulin-sensitizing medicine. Takeda Pharmaceuticals agreed to recall Actos in France, and several other European countries stopped selling the drug altogether.

Following the 2011 safety communication, Takeda was forced to add language about Actos and bladder cancer risks in its Warnings and Precautions labeling. The FDA urges patients to contact their health care providers if they notice blood in their urine, frequent or painful urination, or discomfort in the lower abdomen – all of which could be early warning signs of bladder cancer from Actos.

Plaintiff requests compensatory damages

In this recent lawsuit, plaintiffs Carl and Joyce Trump level multiple counts against Takeda, including negligent infliction of emotional distress, fraud, misrepresentation, breach of express and implied warranty, strict products liability and gross negligence. Joyce Trump also claims loss of consortium. The claimants allege the defendants failed to warn of Actos and bladder cancer risks and actively concealed the potential dangers of the medication. They join the hundreds of other plaintiffs who’ve take their claims to court in hopes of Actos lawsuit settlements or favorable jury awards.

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The brand-name for pioglitazone, Actos is an oral diabetes medicine that helps control blood sugar levels. First marketed in 1999, it took several years for concerns about the risk of cancer to emerge. Now, increasing numbers of Actos bladder cancer lawsuits have been brought against Takeda, all alleging the company failed to adequately research the side effects or warn about the long-term risk of developing tumors. Plaintiffs are hoping to recover compensation for their injuries in the form of Actos settlements or jury awards.

The FDA launched its own review of the drug in September 2010, after reports of increased incidences of bladder cancer began to appear. A 2011 study conducted by insurance companies led to an Actos recall in France. In the same year, the FDA added a new warning to the label in the U.S., indicating an increased risk of bladder cancer after more than a year’s usage.

Hundreds of Actos bladder cancer lawsuits filed

Thousands ofActos bladder cancer lawsuits have been filed across the country, in state and federal courts. Owing to the sheer number of complaints, some predict there will be ten times that number over the coming months and years. All the cases involve similar allegations, that Takeda failed to provide warnings to physicians or consumers

The first state trial is expected to begin this month in California. Actos lawyers working on behalf of the plaintiff will present evidence against Takeda to a jury for the first time.

Federal Actos lawsuits consolidated in MDL

Federal cases against Takeda have been consolidated in multidistrict litigation (MDL) in the U.S. District Court for the Western District of Louisiana. The  preliminary trials, also known as bellwether trials, are scheduled for Nov. 3, 2014, and Jan. 12, 2015. These cases are generally representative of how juries will respond to evidence, and their outcomes will be closely monitored by both plaintiffs and defendants.

Actos and heart failure

Actos is also linked to cardiomyopathy, a condition in which the heart muscles weaken and blood circulation decreases to dangerous levels, affecting the heart and other organs. It is known that Takeda understood the heart risks associated with the drug before they began marketing it. A clinical trial on 5,238 patients showed a significant number of patients experienced a ‘serious heart failure event’ and there were even incidences of death.

In 2012, the American College of Cardiology and the American Heart Association recommended to doctors that the use of Actos should be closely monitored and patients made fully aware of the risks. The FDA advises patients who have experienced bladder cancer, heart failure, or any other side effects associated with Actos to submit a report to their MedWatch program.

Actos settlements or court awards sought

Thousands of injured patients are now seeking settlements from Takeda after being diagnosed with bladder cancer. With the MDL still nearly two years away, Actos lawyers hope to reach out-of-court settlements for some plaintiffs before their cases reach trial.

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Actos cancer lawsuit alleges failure to warn

Actos, an insulin-sensitizing agent known as thiazolidinedione (TZD), was first approved by the FDA in July 1999 to treat type II diabetes. According to Quintanilla’s lawsuit, the defendants at that time, “concealed their knowledge that Actos can cause bladder cancer.” Furthermore, they allegedly did not adequately inform consumers and the prescribing medical community about the risks of bladder cancer in patients who use the drug in high dosages or for more than 12 months. As a result of the defendants “inactions,” the plaintiff was injured, and continues to this day to suffer various injuries.

Studies linked Actos and bladder cancer before FDA warning

In 2005, results from the PROactive three-year study were published. Researchers had identified a positive link between Actos and bladder cancer, in a higher percentage than for patients taking competing drugs. However, neither the study nor the defendants published those results or made that information available to the public, including the defendant. It was not until September 17, 2010 that the FDA issued a Safety Announcement to warn the public of the risk of bladder cancer. In June 2011, the FDA published an updated Safety Announcement stating that, “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

Plaintiff requests damages for adverse side effects

In his Actos cancer lawsuit, Quintanilla states that he was prescribed and began taking  the medication for long-term maintenance of his type II diabetes. Subsequently, as a direct result of taking the drug, he was diagnosed with bladder cancer. This resulted in alleged permanent and severe injuries with long-term consequences. His case brings counts against the defendants of strict liability and negligence. Quintanilla requests damages for personal and pecuniary injuries, including pain and suffering, medical expenses, lost income and disability.

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George Haddad claims that he began taking Actos in 2002 to treat type II diabetes. In 2004, Haddad was diagnosed with bladder cancer, requiring surgical treatment. Haddad also asserts he suffered physical pain, mental distress and permanent injuries as a result of his diagnosis. To this day, Haddad claims he must endure regular medical care, medications and monitoring to prevent another cancer diagnosis in the future.

Actos bladder cancer lawsuit cites risk

Actos was approved by the FDA in 1999 to treat type II diabetes. In 2005, the result of a three-year study on Actos was published, showing increased bladder cancer risk for Actos users. A second study on Actos and liver safety was also published, showing a possible link between Actos use and increased incidence of bladder cancer. Despite these findings, Haddad’s complaint states Actos manufacturer Takeda withheld the information from product labels and warnings for their drug.

In 2010, the FDA began a review of a 10-year epidemiological study by Kaiser Permanente that examined the link between Actos and bladder cancer. Although the FDA found that Actos use led to a “statistically significant” increase in the risk for bladder cancer, Takeda claimed that the Kaiser study did not show an increased risk of bladder cancer. The complaint states that Takeda “willfully, wantonly and with malice” withheld important information about their drug.

Despite the denials of a risk by Takeda, the FDA issued a warning in 2011 stating that Actos use could lead to a higher risk of bladder cancer, particularly in patients that used the drug for 12 months or more. Bladder cancer is now found under the “warnings” section of the product label. Unfortunately, those warnings came too late for Haddad, who must now live with fear and need for ongoing treatment a cancer diagnosis typically brings.

Actos lawyer seeks multiple damages for plaintiffs

Haddad’s complaint claims Takeda violated numerous federal regulations in marketing Actos, including misbranding, mislabeling and failure to provide proper directions and warnings. The plaintiffs also allege the company failed to properly test and monitor their drug, or provide periodic reports to the FDA regarding the safety of Actos. Haddad and his wife are seeking compensatory, punitive and exemplary damages. They join dozens of others seeking favorable jury verdicts or Actos lawsuit settlements across the country.

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Actos bladder cancer lawsuit joins mass tort

The new lawsuit was filed by the plaintiff’s Actos lawyer on January 10, 2013, in Cook County Circuit Court in Illinois. This court is the location for one of two mass torts that have been coordinated for lawsuits against Actos manufacturer Takeda. The other mass tort has been assigned to Los Angeles Superior Court in California. Multidistrict litigation involving Actos lawsuits has also been established in Louisiana District Court. Coordination of cases is typically done to streamline and expedite parts of the legal process, when there are multiple lawsuits filed involving similar allegations.

In this lawsuit, the plaintiff, James Daly, claims he began taking Actos in 2005 for long-term maintenance of type II diabetes. After taking the drug for an extended period of time, Daly learned he had developed Actos cancer. Although the cancer has been treated, Daly continues to suffer with increased risk of premature death and the need for ongoing medical treatments and monitoring. Daly faces economic losses due to past, present and future medical expenses and lost wages. Daly also alleges that his quality of life has been significantly diminished, due to his diagnosis that was directly related to his Actos use.

No warning of side effects of Actos

Daly’s Actos lawyer asserts in the complaint that Daly and his physician had no way of knowing the risks associated with bladder cancer when Daly began taking the drug in 2005. Although knowledge of the potential link between Actos and bladder cancer became known to Takeda during the early 2000s, the company continued to market the drug without adequate warning of the risk. In fact, for more than a decade, Takeda has failed to provide appropriate warnings about the risk of bladder cancer, even though additional clinical studies have been done to indicate this link.

It was not until June, 2011, that the FDA issued a warning for pioglitazone, the generic name for Actos. The agency stated that use of the drug for longer than one year could increase the risk for bladder cancer. Those that used the drug had a 40 percent higher risk for developing the disease than those that did not use Actos.

As a result of Takeda’s “suppression and concealment of the facts” concerning Actos, Daly must now live with the daily fear of a cancer diagnosis and the return of his illness. He must undergo invasive medical monitoring regularly and will continue to require medical attention in the future. Daly is now seeking damages from Takeda to compensate him for pain and suffering, economic loss and medical treatment.

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Many plaintiffs who have been diagnosed with bladder cancer and who filed Actos lawsuits may not live long enough to see their cases go to trial. U.S. Judge Rebecca F. Doherty, who is overseeing the Actos MDL in the Western District of Louisiana, recently issued an order establishing how testimony may be preserved for those plaintiffs.

Patients who developed bladder cancer after taking the diabetes drug are hoping to recover Actos lawsuit settlements or jury awards to compensate them for their medical expenses, lost wages, pain and suffering.

Actos lawsuits increasing nationwide

In December 2011, in response to the number of Actos lawsuits filling U.S. courts, the Judicial Panel on Multidistrict Litigation consolidated all federal cases into one court in the Western District of Louisiana. Today, manufacturer Takeda faces over 1,000 cases in state and federal court, and that number is expected to rise.

In July 2012, Judge Doherty stated the court was going to need significant time to complete discovery and pretrial preparations before any federal Actos lawsuit could go to trial. At that point, it was clear that plaintiffs seeking damages for bladder cancer would need to wait about two years before seeing any real action on their claims.

Testimony from plaintiffs at risk of health deterioration

On January 8, 2013, Judge Doherty issued a case management order detailing the guidelines for taking and recording testimony from each individual whose health “has deteriorated to the point that his or her competency or survival is at risk.”

The order adds that counsel must give notice to opposing lead counsel as soon as possible upon learning of a plaintiff’s or witness’ serious health condition. At-risk plaintiffs must provide a letter from their treating physician.

It is common to allow early depositions from plaintiffs who are aged or infirmed, but this litigation is unique because there are a large number of plaintiffs who are suffering from the life-threatening illness of bladder cancer.

Actos lawsuits settlements or court awards sought

In June 2011, after reviewing the 5-year results of a 10-year epidemiological study on Actos and bladder cancer, the FDA issued a safety announcement warning that patients taking Actos for more than a year may have an increased risk for cancer. They also required new warnings on the Actos label at that time.

Prior to that, however, Actos had no such warnings about bladder cancer, leaving patients unaware of the risk. After the FDA warning, many patients came forward requesting settlements or jury awards to compensate them for their injuries.

France implements Actos recall

The FDA approved the use of Actos for type II diabetes in 1999. As early as 2005, a study showed a link between the medication and bladder cancer, and in 2010, the FDA noted they were reviewing the potential connection.

In early 2011, the American Diabetes Association (ADA) published a study showing a link between Actos and bladder cancer, and in June 2011, France announced it was suspending the use of the drug pending an ongoing European review. In July 2011, an Actos recall was issued in France after a cohort study demonstrated a significant increase in the risk for bladder cancer in men exposed for more than a year. Despite these findings, the diabetes medication remains available in the United States.

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The FDA approved Actos in July 1999 for the treatment of type II diabetes. Post-marketing research showed that those taking the drug for more than one year may be at an increased risk for bladder cancer. Plaintiffs who have been diagnosed with the disease seek an Actos settlement or jury award to compensate them for their injuries.

Judge seeks coordination with state Actos lawsuits

This most recent case management order establishes procedures for conducting discovery in federal Actos lawsuits. Judge Doherty first emphasizes the priority of coordinating with state courts that are dealing with similar cases, stating that such coordination will help conserve “scarce judicial resources, eliminate duplicative discovery, serve the convenience of the parties and witnesses, and promote the just and efficient conduct of this litigation.”

The judge then sets specific deadlines for discovery, and creates guidelines for how discovery shall be taken. Plaintiffs are required to serve defendants’ counsel with Plaintiff Fact Sheets, and the parties are to identify experts and conduct expert depositions.

State court lawsuits also allege link between Actos and bladder cancer

The first MDL bellwether trial is currently scheduled for November 2014, with a second scheduled for January 2015. The state of California, however, is moving ahead a bit faster with its Actos cancer lawsuits, with the first case scheduled to go to trial February 19, 2013. This case involves a plaintiff who claims to have suffered from bladder cancer after taking the diabetes drug.

According to a 2012 Bloomberg article, manufacturer Takeda may face as many as 10,000 Actos side effects lawsuits before all is said and done. The company issued an Actos recall in France after a study there linked the drug to an increased risk of bladder cancer.

Actos lawyer likely to blame Takeda for failing to warn

In June 2011, the FDA issued a drug safety communication stating that the 5-year results of an ongoing 10-year epidemiological study indicated an increased risk of bladder cancer for patients taking Actos for more than 12 months. The Actos label was updated to include this warning at that time. An Actos lawyer is likely to claim that Takeda was aware of the link between the drug and cancer long before the 2011 warning, and should have alerted physicians and patients years earlier.

The California case, if it proceeds as scheduled, may provide clues as to how other lawsuits may proceed once they go to court. A plaintiff seeking an Actos settlement or jury award may be able to gauge how juries may respond to certain evidence after the conclusion of the trial.

Actos recall yet to be issued in the United States

Like other claims against Takeda, the lawsuit raises similar allegations against Takeda Pharmaceuticals, a company that enjoyed global sales of nearly five million dollars from Actos – one of its top selling medications. Actos (pioglitazone) is a prescription drug indicated for the treatment of type II diabetes that helps stabilize blood sugar levels. Since it was FDA-approved in 1999, the medication has been the source of increasing litigation, as many patients who ingested it for more than 12 months developed bladder cancer.

Despite the FDA finding that Actos was linked to a statistically significant increase in the risk for developing bladder cancer (as much as 40 percent), the drug manufacturer publicly claimed that the drug posed no real threat. Numerous medical studies have shown a direct correlation between prolonged therapy with pioglitazone and bladder cancer, prompting some European nations to suspend sale of Actos. On July 12, 2011 Takeda issued a limited Actos recall in France, but the drug is still on the market in the United States.

Details of Actos bladder cancer lawsuit

In 2004, Robert Salinas was prescribed Actos for the long-term treatment of his diabetes mellitus. Salinas stopped taking the medication in 2008, after he was diagnosed with bladder cancer, which he contends is a direct and proximate result of the medication. He claims to have suffered severe mental and physical pain and will continue to incur permanent injuries and emotional distress along with economic loss due to medical expenses.

Salinas’ lawyer alleges that the plaintiff was unaware that his bladder cancer could be related to the diabetes drug until after the official Actos recall was issued abroad. Salinas charges Takeda with numerous counts including strict liability and negligence, and requests damages for his pain and suffering in this personal injury-product liability lawsuit.