Three Actos Bladder Cancer Lawsuits in Los Angeles

FOR IMMEDIATE RELEASE :

Los Angeles, California, December 29, 2011 – -  Baum, Hedlund, Aristei & Goldman, P.C. (www.baumhedlundlaw.com) has filed three lawsuits today against Japanese-based Takeda Pharmaceuticals and its subsidiaries on behalf of three California residents and their spouses alleging the diabetes drug Actos caused their bladder cancer.

The 12-count complaints seek compensatory damages on behalf of Gerard Aina and his wife Joyce of Ventura County (BC476063), John Loos and his wife Bibiana of San Bernardino County (BC476062), and Andrea Neubo and her husband Jeffrey of Orange County (BC476064).

The plaintiffs allege that Takeda Pharmaceuticals knew or should have known that Actos use in humans would cause bladder cancer and that Takeda possessed pre-clinical scientific studies, including animal evidence, which signaled that bladder cancer risk needed to be further tested; all prior to Takeda applying for and obtaining approval for Actos. In fact, plaintiffs allege that Takeda has known since the early 2000’s that human clinical trials revealed Actos causes bladder cancer.

The lawsuits, filed in Los Angeles Superior Court, also allege that for over 10 years and to date, Takeda concealed and failed to completely disclose its knowledge that Actos was associated with or could cause bladder cancer or its knowledge that it had failed to fully study and test regarding that risk.

“Diabetes patients take medication to improve their health, not make it worse,” stated the families’ attorney, Cynthia Garber, also an R.N. “The company should have warned healthcare workers and patients of the risks of bladder cancer associated with Actos. Takeda should be held accountable for their wrong-doing.”

A handful of U.S. District judges will likely decide in early January as to where the Actos bladder cancer cases filed in federal courts will be consolidated. The first meeting concerning coordinating the discovery and litigation on the Actos cases was held on December 1, 2011 in Savannah, Georgia before the U.S. Judicial Panel on Multidistrict Litigation (JPML).

Another hearing is scheduled in Los Angeles at Central Civil West Courthouse, Los Angeles Superior Court on January 4, 2012 before the Judicial Council Coordination Proceeding (JCCP) to coordinate and consolidate the Actos bladder cancer cases filed in California state courts.

We estimate that hundreds of cases have been filed and that this number could reach thousands based on the wide use of the drug.

Actos [pioglitazone] received U.S. Food and Drug Administration (FDA)  approval in 1999 to treat Type 2 Diabetes Mellitus and the plaintiffs all allege personal injury caused by the drug, including; bladder cancer and related sequelae, pain and suffering, bodily impairment, mental anguish, diminished enjoyment of life as well as economic loss and other special damages.

Drug watchdogs around the world have recently reviewed the use of Actos.  In France on June 7, 2011 the Caisse nationale de l’assurance maladie published a report which concluded that there is a statistically significant association between exposure to Actos and bladder cancer and that the risk increased with exposure longer than one year.

Two days later the European Medicine Agency suspended the use of Actos.  This was followed by Germany’s Federal Institute for Drugs and Medical Devices suspending the use of the drug. Health Canada is currently undertaking a review of the drug.

The FDA has not yet suspended Actos in the U.S. but on June 15, 2011 the FDA issued a Public Safety Announcement informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.  It further stated that information about this risk will added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. The FDA also recommended that healthcare professionals tell their diabetes patients diagnosed with bladder cancer to stop taking Actos or pioglitazone.

Earlier this month, Bloomberg News reported that millions of people switched from the controversial diabetes drug Avandia to Actos, after Avandia was linked to heart attacks and cardiovascular death. The sales of Actos rose from about $3 billion in 2006 to almost $5 billion last year. GlaxoSmithKline, manufacturers of Avandia, has paid more than $6 billion for legal costs tied to Avandia and other medicines.

About Baum, Hedlund, Aristei & Goldman, P.C.

Baum, Hedlund, Aristei & Goldman has successfully represented clients harmed by medications in over 4,000 individual personal injury and wrongful death cases, in addition to representing consumers in multiple pharmaceutical class actions against major pharmaceutical companies such as Alpha Therapeutic, Armour Pharmaceutical Co., Baxter Health Care Corp, Bayer Corp., Dalkon Shield, Eli Lilly, GlaxoSmithKline, and Pfizer.

Our team of lawyers working on the Actos bladder cancer cases have an in depth understanding of biomedical research, clinical trials, statistics, the pharmaceutical industry and marketing, as well as successful and effective discovery procedures and extensive work with experts on complicated scientific issues because of their years of experience related to Baum Hedlund’s past pharmaceutical litigation.

 AFP has obtained a copy of the IPCC ‘Man-made Climate Change’ draft report’s 20-page Summary for Policymakers, due to be released on November 18, 2011. The report, which is subject to Government revisions before its release, appears to coincide with a series of Global natural catastrophes in the last couple of years that have increased the need to determine whether such events are “weather anomalies” or part of a long-term climate shift.

2010 Weather: record temperatures sparked devastating forest fires across Siberia, areas of Pakistan and India experienced unprecedented flooding.

 2011 Weather: large areas of China are suffering from intense drought, the continuing flood crisis in Thailand. In the U.S. the Mississippi and Missouri Rivers experienced record-breaking flooding, the severe ongoing drought in Texas and neighboring states, Hurricane Irene battering the east coast and now the freak snowstorm in the North East on the weekend. The dollar figure for damage in these disasters is in the billions.

The draft copy of the IPCC report says global warming will generate more frequent similar weather extremes of this type, with the severity of the impacts leaving some regions more vulnerable than others.

Some conclusions of the report are:

• It is “virtually certain” 99-100 per cent that the frequency and magnitude of daily temperature extremes will increase over the 21st century on a global scale
• It is “very likely” (90-100 per cent certainty) that the length, frequency and or intensity of warm spells, including heat waves, will increase over most land areas
• Peak temperatures are “likely” (66-100 per cent certainty) to increase, compared with the late 20th century, up to 3C by 2050, and 5C by 2100
• Heavy rain and snowfall is likely to increase over the next century over many regions, especially in the tropics and at high latitudes
• Droughts will likely intensify in other areas, notably the Mediterranean region, central Europe, North America, northeastern Brazil and southern Africa.

The overall picture that emerges is of increased volatility and frequency of dangerous weather, leading to a sharply rising risk for large numbers of people in coming decades.

Dwarf Planet - courtesy of Wikipedia

Eris, the dwarf planet discovered in 2005,  has passed in front of a star and is providing astronomers with the clearest view of it since it was identified.

The planets size and other characteristics have been difficult to measure because it is located nearly three times farther from the sun than Pluto and about 96 times farther from the sun than the Earth. However, astronomers were able to gather new data using two telescopes in Chile including the Belgian TRAPPIST telescope at ESO’s La Silla Observatory, as Eris passed in front of a faint star in 2010.

Previous methods of measurement suggested that Eris was probably about 25% larger than Pluto with an estimated diameter of 1900 miles; according to the new analysis the two objects are essentially the same size. Eris’s newly determined diameter stands at 1445 miles, with an accuracy of 7.5 miles.

This makes its size better known than that of its closer counterpart Pluto, which has a diameter estimated to be between 1429 and 1491 miles. The planet appears to have a very reflective surface, suggesting that it is uniformly covered in a thin layer of ice, probably a frozen atmosphere.

Based on the new measurements, and combined with data from NASA’s Spitzer space telescope and ESA’s IRAM scientific satellite, the researchers estimate that the surface temperature on the side of Eris facing the sun is no more than –238 C.

Eris is one of the brightest objects in our solar system.  Its discovery was one of the factors that led to the creation of a new class of objects called dwarf planets and the reclassification of Pluto from planet to dwarf planet in 2006. The research is published in today’s issue of the journal Nature.

Texas was leading 7-4 after the 7th inning, but the Cardinals fought back in the 9th and 10th innings to win the game 10-9.
The Cardinal’s managed one run in the 8th, then in the bottom of ninth Cardinals third baseman Dave Freese stepped up to the plate and with two out and with only one strike to go he hit a two run triple off the Rangers Neftali Feliz to tie the game at 7-7.

The next inning the Rangers took the lead on Josh Hamilton’s two-run homer off Cardinals closer Jason Motte. In bottom of the 10th, following Albert Pujols intentional walk, right fielder Lance Berkman stepped up, the Cardinals again faced with two outs and two strikes and hit a game-tying, line-drive single to center.

In the 11th, the Cardinals scored on Freese’s lead-off home run to set up for Game 7 Friday.  “That’s gotta be one for the record books,” said Daniel Descalso, a little-used Cardinals reserve infielder who led off the bottom of the 10th with a sharp single off Rangers veteran lefty Darren Oliver. “ I’ve never heard of anyone being down twice like that, by two runs and down to your last strike, and coming back to win it.”

Tonight’s game will be played in St Louis, the Cardinals have won the last eight World Series Game Sevens. Pitching for the Rangers will be ‘lefty’ Matt Harrison, and for the Cardinals it will probably be Chris Carpenter, despite only having had three days’ rest since Game Five.

Bernie Madoff told Barbara Walters of ABC television that while he suffers from “horrible nightmares” in his North Carolina prison cell and feels despair over his estrangement from family members, he “can live with” the anger of people he defrauded.

“Not seeing my family and knowing they hate me” is the worst thing about being in prison, Madoff said. “I betrayed them.” Asked what he’d like to tell his grandchildren, he said: “I am sorry to have caused them pain.” The Madoffs’ oldest son Mark committed suicide in December 2010, the second anniversary of his father’s arrest.

Madoff, 73, was sentenced to 150 years in prison for running a Ponzi scheme that bilked $65 billion from almost 10,000 investors.

An investigation found Madoff never made any investments; instead he used the money from new investors to pay returns to existing clients — and to finance a lavish lifestyle for his family.

Madoff’s comments come ahead of his wife’s appearance on this Sunday’s edition of CBS’”60 Minutes.”

Ruth Madoff said, in the interview with Morley Safer, the pair made a suicide pact deciding to kill themselves on Christmas Eve 2008, shortly after the fraud was exposed. They used a combination of the sedative Ambien and the anti-anxiety medication Klonopin – both went to bed, but they woke up the next morning.

A court-appointed trustee is trying to recover money for investors defrauded in the Ponzi scheme, a fraud in which early investors are paid with money from new ones. The schemes often collapse when sufficient investors can’t be lined up or when a number of investors want to cash out.

After more than three years of delays, Boeing`s  787 Dreamliner arrived on schedule Wednesday, touching down in Hong Kong at the end of its maiden commercial flight which left Tokyo four hours eight minutes earlier.

Many believe the debut of the 787 will usher in an era of fuel-efficient aircraft and unprecedented passenger comfort. The planes body is mostly constructed from carbon-composite materials that Boeing says will deliver 20% more fuel efficiency.

Dreamliner passengers can expect roomier seats, more storage and larger, manually dimmable windows. Economy class will see some luxury additions, with a bar, female-only lavatories and Panasonic entertainment on demand for every passenger.

Scott Fancher, the head of the 787 programme, said the launch of the Dreamliner was a “game changer” for commercial aviation. “It sets a new standard in the design of commercial aircraft,” he told reporters. “It is truly graceful, with an interior to complement this. The travelling public will soon get to experience it. We have designed a plane that will change the direction of commercial aviation.”

All Nippon Airways is the first carrier to fly the plane and expects to have seven of them by the end of the year. United Continental Holdings Inc. will be the first U.S. carrier to fly the 787, getting delivery sometime in the second half of 2012.

The Dreamliner, at a sticker price ranging from $140 to $200 million each, is the fastest selling aircraft in Boeing’s history with orders so far for 821 from 56 airlines worldwide.

More than a third of the Dreamliner is built by Japanese companies, including Mitsubishi Heavy Industries, Kawasaki Heavy Industries and Fuji Heavy Industries.

by Bijan Esfandiari

The September 27, 2011 edition of Reason Magazine reported on a “new working paper” from the National Bureau of Economic Research (NBER), suggesting that the FDA’s 2005 black box warnings concerning antidepressants and the risk of suicidal behavior in adolescents and teenagers caused a dramatic drop in antidepressant use and, consequently, a rise in teen suicides, not to mention a host of other maladies such as declining grades, binge drinking, use of illegal drugs, fighting, etc.  Attributing any of these “consequences” to a lack of antidepressant use is erroneous (to say the least) for a number of reasons.

The article, written by Katherine Mangu-Ward, the managing editor for Reason Magazine, recycles unwarranted conclusions by pharma-funded academics which have been debunked by other scientists and by the authors themselves.

The view that lack of antidepressant use has contributed to an increase in youth suicides is an old argument put forward by pharma-funded “key opinion leaders” (or “KOLs”) such as Gibbons, Keller, Nemeroff, etc. (who figure prominently in the NBER’s working paper). [ i ]

A.  Antidepressants Are Not Effective In Treating Adolescent Depression  

The most glaring problem with NBER’s working paper is its presumption that antidepressants are effective at treating adolescent depression. Yet, antidepressants as a class have not been shown in clinical trials to be effective at treating adolescent depression [ ii ] Indeed, of the 36 antidepressants subject to the black-box warning, only two antidepressants – Prozac and Lexapro – have been approved for adolescent [ iii ]  The other 34 antidepressants, which form the bulk of the market, have failed to show efficacy.  NBER’s working paper fails to make any mention of this important fact and simply presumes that all antidepressants are effective at treating adolescent depression.

Exaggerated expectations of the efficacy of antidepressants have been fueled in part by selective publication of positive studies while negative studies remain hidden or misreported.  Many failed clinical trials are never made public because they undermine the drug’s commercial profitability.  For example, GlaxoSmithKline (“GSK”), the manufacturer of Paxil, conducted various clinical trials, all of which showed that Paxil was not effective at treating adolescent depression.  When GSK became aware of the negative results, it made a concrete decision to conceal the information and, in an October 1998 internal memo (uncovered during litigation), an executive concluded “it would be commercially unacceptable to include a statement that efficacy has not been demonstrated as this would undermine the profile of [Paxil]. [ iv ] Years later, a Pennsylvania federal judge overseeing a case involving the suicide of a 16-year old boy cited the internal memo and other GSK documents concluding that the evidence showed that “GSK knew of the risk of pediatric suicidality as of 1998” and that “GSK documents suggest that [GSK] acted with a wanton and willful disregard for the safety of its consumers.”

Unfortunately, the concealment of negative clinical trial data is not unique to GSK.  Rather, pharmaceutical manufacturers have for decades, through selective and biased publication of clinical trial data, managed to dupe the medical community into believing the efficacy and safety of their respective elixirs.  As Jon Jureidini, a professor of psychiatry at Adelaide University and colleagues pointed out, “efficacy of newer antidepressants in childhood depression have exaggerated their benefits”; “adverse effects have been downplayed,” and; “antidepressant drugs cannot confidently be recommended as a treatment option for childhood depression. [ v ]

Eric H. Turner, an assistant professor in the psychiatry department at the Oregon Health and Science University and colleagues, in their analysis of antidepressant clinical trials, found “bias toward the publication of positive results” and “studies that were not positive … were often published in a way that conveyed a positive outcome.”  Turner concluded that “the efficacy of this drug class is less than would be gleaned from an examination of the published literature alone,” which “can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health.”

B.  NBER’s Contentions Regarding the Level of Prescriptions and Suicides Are Factually Flawed

Moving past the efficacy issue, NBER’s contention that youth suicides have increased following the advent of the black-box warning is also factually flawed.  The Reason article cites NBER’s fallacious working paper for the proposition that “Youth suicides had been flat or declining among 10-19 year olds in the years preceding the warnings, but in 2004, 10-19 year old girls experienced a sharp increase in suicides, of over 30 percent.”  This is simply not supported by the data, which, as outlined below, reveal that suicide rates were not only rising prior to issuance of the black box warnings, but actually went down following issuance of the black box warnings.

In 2004, the year suicides increased, “there was no significant drop in SSRI prescribing.” [ vi ]  As Jureidini pointed out, Gibbons “incorrectly analyzed the relationship” between prescription rates and suicide rates among children and, when carefully examined, Gibbons’ suggestion of a clear causal association from the data analyzed “show no such association.” Id.  Like Gibbons, the NBER working paper is making erroneous “[a]larmist predictions regarding the consequences of decreased prescribing.” Id.

Gibbons, himself, has since acknowledged that his data did not support a causal link:  “We really need to see the 2005 numbers on suicide to see what happened.” [ vii ] (The alleged culprit of the NBER’s “list of terribles,” i.e., the black box warning, was implemented in early 2005, and antidepressant prescriptions did decrease that year.)  The FDA’s Dr. Thomas Laughren confirmed at a 2008 hearing that antidepressant prescribing did not change until 2005 and the 2005 suicide numbers “are down from where they were in 2004.” [ viii ]

Moreover, one of the studies cited by the working paper authors by Gibbons et al. was so scientifically illegitimate that it was described by the British Medical Journal as “astonishing,” “misleading” and “reckless.” [ ix ] Further, one of the Gibbons study authors, Ron Herings admitted the study’s findings are “not right” and that it “doesn’t follow from the data, it is not true and serves just to scare people.  It is hard to admit this, as I am one of the authors of the article and I attached my name to it …” [ x ]

Finally, NBER’s reliance upon ecological studies to support their arguments is methodologically flawed.  Authors of ecological “studies” universally agree you cannot conclude that increasing or decreasing suicides (or any other malady) is the result of a lack of antidepressant consumption based on these types of analyses. [ xi ]

C.  Selling Sickness

Prior to antidepressants hitting the market, “depression was considered a rare disease, affecting about 1 percent of the population (as opposed to 10 to 15 percent of the population today) …” Id. [ xiii ] According to Australian professor of psychiatry, Gordon Parker, the “[r]easons for the overdiagnosis [of depression] include … marketing of treatments beyond their true utility in a climate of heightened expectations.” [ xiv ]

Depression has “grown to epidemic proportions in modern, developed Western countries in particular.  Within two decades the percentage of the population having depression that requires treatment has risen five-fold on average: in 2009 more than 5% of the general population.” [ xv ]

In his article Overprescribing Antidepressants, Christopher Lane, Ph.D., a research professor at Northwestern University, pointed to a Rand Corporation survey conducted in 2002, showing that just 20% of those surveyed who had received an antidepressant prescription “tested positive” for clinical depression.  “Fewer than 30% of those receiving the medication had any depressive symptoms at all.”  In other words, “70% of patients in the survey presented no medical need for antidepressant treatment, and a further 10% fell into a significant gray area, with an insufficient number of symptoms to warrant a DSM diagnosis.”

D.  Conclusion

Like the tobacco industry, which “helped invent the strategy of using scientists as third-party advocates” in order to “create doubt” (id. at 230) about the health risks associated with tobacco, drug manufacturers and their KOLs have used a similar strategy by propagating a steady stream of “studies” to counteract the impact of strengthened warnings about their drugs’ risks.  The argument bears a remarkable resemblance to that put forward by tobacco companies in the 1960s – that deaths from respiratory and cardiac causes had been falling from 1900 through to the 1960s and life expectancy rising, all during a period when cigarette consumption was on the rise. [ xvii ]

While the NBER paper’s objective is not readily apparent, what is clear is that the presumptions and methodology are erroneous and the conclusions misleading.  Relying on NBER’s paper, an unsuspecting mother might feel the cure to her child’s poor grades is an antidepressant and insist that he/she be placed on a drug that is not only clinically ineffective, but that has some potentially very serious side effects.  Observing societal problems such as illicit drug use, violence and poor grades and working toward workable solutions is a good thing, but believing a single magic pill will somehow cure all those ills is misguided.

The last B53 nuclear bomb was dismantled on Tuesday, at the Pantex nuclear weapons facility, near Amarillo in Texas.

The 9 megaton bomb called the “bunker buster” was designed to hit targets deep underground, when detonated estimates are it would have caused lethal burns to life within 18 miles, destroyed all buildings within nine miles and could penetrate up to 750 feet underground.

The exact strength of the bomb remains classified.

Put into service in 1962, when Cold War tensions were at their height during the Cuban Missile Crisis, the B53 weighed 10,000 lb, was the size of a minivan and 600 times more powerful than the atomic bomb dropped on Hiroshima.

The bomb was kept airborne on B52 bombers round the clock until 1968 as a nuclear deterrent against the Soviet Union.  Since it was made using older technology by engineers who have since retired or died, developing a dis-assembly process took time.  Engineers had to develop complex tools and new procedures to ensure safety.

‘We knew going in that this was going to be a challenging project, and we put together an outstanding team with all of our partners to develop a way to achieve this objective safely and efficiently,’ said John Woolery, general manager at the Pantex plant.  The plant is the only nuclear weapons assembly and disassembly facility in the US.

In April last year, President Barack Obama signed a historic treaty with Russian leader Dmitry Medvedev to reduce the number of nuclear weapons deployed by the former Cold War enemies.  The landmark agreement signed in Prague committed the superpowers to reducing the number of strategic warheads to 1,550 each – 30 per cent lower than the previous cap.