Actos Verdict: $6.5 Million

Actos Verdict: $6.5 Million

First Actos Trial

A Los Angeles jury on April 26, 2013 found Takeda liable for injuries that included bladder cancer suffered by a former Pacific Bell telephone cable splicer, Jack Cooper. The jury returned a verdict of $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).

Jury deliberations lasted eight days following testimony before Judge Kenneth Freeman in Los Angeles Superior Court. The jury found defendants’ failed to provide adequate warnings about Actos’  dangers, and that Takeda’s Actos was a substantial factor in Mr. Cooper’s injuries.  The jury also awarded $1.5 million for loss of consortium.  Cooper was diagnosed with bladder cancer in November 2011 after taking Actos for diabetes for more than two years.

Evidence in the nearly two-month trial revealed in-house emails in which Takeda executives urged colleagues to persuade the U.S. FDA not to demand increased bladder cancer warnings on Actos’ label.

In one email, Takeda executive Kiyoshi Kitzaawa wrote: “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”

Actos’ sales peaked in 2011 at 4.5 billion, which was then about 27% of Takeda’s revenue, according to data gathered by Bloomberg news. Takeda today faces more than 3,000 suits alleging Actos causes bladder cancer or other ailments. Other cases wait in state court in Illinois. More than 1,200 suits have been consolidated before a federal judge in Louisiana. According to court filings, the first federal case is set for trial in January.

See the full Bloomberg article: Takeda Denies Actos Bladder-Cancer Link at First Trial

In August 2011, a report by eHealthMe based on FDA reports and the user community stated that 50 (0.22%) of 22,512 people reporting Actos side effects,  had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients. It found that one-fifth of patients reporting bladder cancer were taking Actos.

Dose-Related Dangers

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer compared with never taking Actos.

A French Medicines Agency study found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

Supreme Court’s Generic Drug Injustice

Supreme Court’s Generic Drug Injustice

ABC News with Diane Sawyer on Tuesday finally gave badly overdue mainstream media airtime to the tremendous injustice the Supreme Court has done to victims of generic drugs. More than 80 percent of prescription drugs consumed in the country are generic, so the overwhelming majority of drug-induced injuries result from generic drugs. Nevertheless, the Supreme Court ruled 5-4 in 2011 (Pliva v. Mensing) that victims of generic drugs were not entitled to compensation from the company that made the drug which hurt them. The court essentially ruled that multiple-billion-dollar Generic companies were helpless but to reap enormous profits while simultaneously carrying no responsibility for their products.

No corporation in the world can be allowed to reap profits from the blood of the very people who trust and use their product without being simultaneously responsible for the content of the product they make. Adding insult to injury, many generic companies aren’t even American-based, and their profits leave our country. A government which fails to protect its own people from multi-national corporations is practicing taxation without representation. If the so-called Tea Party stood for what its namesake implies, and hadn’t been co-opted by the Koch brothers and other corporate giants, it might take note. This shouldn’t be a partisan issue, though the five Republican-appointed members of the highest court all voted to protect multiple-national drug makers at the expense of the people who fund the FDA and pay for the drugs which often cause more problems than they solve.

The system isn’t perfect and nobody can reasonably expect that it should be; but Tort law was in place to protect people from corporations for 100 years until the court turned common sense and natural law on its head with Mensing.

We pray the extreme five will reconsider Mensing as it debates Bartlett. We pray the court comes to its senses and realizes its Mensing decision was a catastrophic miscarriage of justice.

Secure your own Records

Secure your own Records

When PI Law Group signs up a client for a potential new case and receives the necessary paperwork to act on a client’s behalf, the law firm makes every effort to obtain that new clients’ medical and prescription drug records. But all law firms are, for practical purposes, at the mercy of  hospitals, doctors and pharmacy custodians to provide the relevant records.  Therefore, a law firm cannot guarantee any records it orders will arrive in a timely fashion. Consequently, anything  clients can do to obtain pharmacy or medical records could only help the potential case.

In addition, drug and healthcare providers are tending to purge their records faster all the time, claiming space issues, though text takes up remarkably little computer space.
For whatever reason, it often seems that record keepers only grudgingly cooperate with plaintiffs’ law firms. Most records plaintiffs’ firms order take several months to arrive. In that interim, those records may have been purged, or even lost or destroyed in a natural disaster. When Hurricane Katrina blew threw New Orleans, it left more than ten feet of water standing in some hospitals, permanently wiping out medical records for many medical records. Some potential Vioxx clients, as a result, were unable to prove that they were ever prescribed Vioxx, or that they had suffered an injury associated with the drug.

There are no guarantees in life, but one thing is clear: It is always best to obtain medical and prescription drug record evidence as soon as possible. Ideally, it is best to ask for a copy of records for each medical visit when leaving a medical facility, and to save prescription drug records as you fill prescriptions.

Jury begins deliberations in J&J vaginal mesh lawsuit

By Bloomberg News 
on February 19, 2013 at 1:15 PM, updated February 19, 2013 at 1:35 PM

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A New Jersey jury began deliberating on the first lawsuit to go to trial over whether Johnson & Johnson’s Ethicon unit properly designed a vaginal mesh implant and adequately warned of its risks.A panel of nine jurors in state court in Atlantic City is weighing a lawsuit by Linda Gross, who contends Ethicon’s design of her Gynecare Prolift was defective and blames the device for 18 surgeries. Gross claims J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations to her.

“Would Linda have chosen a different procedure if she knew everything that Ethicon knew? Absolutely,” Gross attorney Adam Slater said in his summations on Friday. “They obviously failed to warn.”
J&J, the world’s biggest seller of health care products, claims Prolift is safe and effective, and Ethicon warned properly of the risks. The case is the first of 1,800 such lawsuits to go to trial. Gross seeks $3.38 million for lost earnings and past and future medical expenses. She also seeks damages for pain and suffering.

Superior Court Judge Carol Higbee hasn’t ruled yet whether Gross can seek punitive damages if jurors award her compensatory damages. New Jersey caps punitive damages at five times compensatory damages or $350,000, whichever is higher.
Jurors will weigh these questions: Was Prolift defectively designed? Did J&J fail to provide adequate warnings to Gross, and to her implanting surgeon? Did J&J make a fraudulent misrepresentation to Gross? If the answer is yes to any of those questions, were they a proximate cause of Gross’s injuries?


If answering yes to any of those sets of questions, jurors would then consider damages for Gross’s pain, suffering, lost wages and medical expenses, as well as the loss of companionship and conjugal affections for her husband, Jeff. Gross, 47, worked as a nurse in South Dakota.

Gross had her Prolift implanted on July 13, 2006, to shore up pelvic muscles. Slater claims her chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005.

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies, caused pain, and was difficult for surgeons to remove.

Slater said Ethicon failed to warn doctors of risks it knew and didn’t tell them how to remove mesh. He said the written instructions were “completely inadequate” and should have warned of 28 complications not mentioned.

In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. The company said in June that it would end sales worldwide because of the products’ lack of commercial viability, and not based on their safety and effectiveness.
Bloomberg

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