Judge overturns $6.5 Million Verdict

It’s a wonder we even bother to hold trials anymore. In the latest miscarriage of justice, a California judge overturned the verdict of a six-week jury trial by accepting defense arguments that an expert whom the jury had seen interrogated in court was not qualified to determine that Actos had caused plaintiff Jack  Cooper’s bladder cancer.

On May 1, Judge Kenneth Freeman overturned $6.5 million dollar jury verdict (entered on April 26) for plaintiff Jack Cooper in Cooper vs. Takeda  (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles). Freeman granted two key Takeda’s motions which lead to his reversal.

Freeman granted Takeda’s motion to exclude the opinions of Dr. Norm Smith, the plaintiff’s causation expert who had hypothesized that Actos was a substantial causal factor in Mr. Cooper’s bladder cancer.  Granting that motion meant that no opinion supported the cancer causation finding; so the judge then granted Takeda’s motion for non suit, which threw out the verdict.

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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.

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Secure your own Pharmacy, Medical Records

When Matthews & Dangerous-drugs-offAssociates signs up a client for a potential new drug or medical device 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.

Record Purging threatens Drug Cases

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. Record keeping entities used to hold recortds for ten years or longer; now many purge them in as little as five years, some in as little as three years.

 

Records Lost to Natural Disaster

For whatever reason, it often seems record keepers only grudgingly cooperate with plaintiffs’ law firms. Foot dragging is the norm. 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 16 feet of water standing in some hospitals, permanently wiping out medical records for many people who had potential cases. 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.

No Guarantees in This Life

There are no guarantees in this 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.

 

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Statins harm more than help People

The jury is in: Statins are Bad News

Statins harm more Lipitorpeople than they help. According to a  recent study of millions of statin users, cholesterol-lowering  drugs are over prescribed, over hyped, over advertised and much more dangerous than conventional wisdom implies.  Big Pharma (with $33 Billion in statin sales worldwide last year – Lipitor alone made $13.6 million) touts statins as “miracle” drugs that prevent heart attacks and strokes. But a study published in the British Medical Journal documents statin users who suddenly or gradually lost their minds, muscle, liver or eyesight.  (See study analysis and potential alternatives.)

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Utah questions Water Fluoridation

With the “Safe Drinking utah-state-sealWater Disclosure Act” – H.B. 72 – the state of Utah is holding the companies that “fluoridate” Utah’s drinking water accountable for pouring tramp contaminants such as lead and aluminum into the water along with the paid-for industrial waste, fluoride, in fluoridation batches.

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Yaz elevates clot risk 600%

Yaz, Yasmin, Ocella elevate clot risks

Medical journals and the FDA have announced birth control pills which combine the estrogen “ethinyl estradiol” with the progestin “drospirenone” lack adequate warnings about blood clots.yaz-300x234-thumb-300x234

Studies published in the British Medical Journal found that women taking birth control pills containing drospirenone as their progestin compound were at more than 600% greater risk of suffering blood clots in comparison with women who took no oral contraceptive. Blood clots in the lungs, known as pulmonary embolism, can potentially kill a person. Blood clots in major body veins can lead to Deep Vein Thrombosis (DVT). Several such instances have led to lawsuits across the U.S.  (Matthews & Associates Law Firm has filed several such lawsuits. Contact the firm if you or someone you love has been injured by Yaz, Yasmin or Ocella.)

See the British Medical Journal research which discourages use of these products:

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Medtronic’s InFuse trouble

Bioengineered liquid bone protein meant to encourage bone growth inside a thimble-sized cage is implanted into the spine in the Infuse bone graft process, but uncontrolled bone growth and other “side effects” have wreaked havoc on many people who have been “Infused.”

Manufacturered by Medtronic, Inc., the nation’s largest medical device maker, Infuse is implanted in some 100,000 people in the U.S. yearly, mostly for spinal fusion surgery. Problems have arisen for InFuse, however, when it has been used off-label, for purposes for which it was not approved. Medtronic, meanwhile, has been accused by a U.S. Senate committee of not properly revealing InFuse’s off-label problems, and the company has gotten into more hot water as it has tried to silence a Medtronic whistleblower lawsuit.

In late November 2012, Medtronic, Inc. filed a motion to dismiss a whistleblower lawsuit alleging the medical device manufacturer used a spine surgeon, who was being paid by the company, as an editor of a medical journal to promote its Infuse Bone growth device. That case has not been dismissed.
Yaz
InFuse is a system which consists of the (thimble-sized) LT-Cage meant to hold a bone grafting substance derived from recombinant bone morphogenetic protein-2.

The FDA approved InFuse in 2002 only for one type of spinal surgery – an anterior approach lumbar fusion. InFuse was not and is not approved for other types of spinal surgeries, such as lateral- or posterior-approach lumbar fusions. The FDA has also never approved Infuse for surgery on the neck or cervical spine.

When any drug or device – such as Infuse – is used off label, the surgeon must fully disclose the risks of the off-label use, so the patient may make an informed decision before  proceeding.

Infuse “Side Effects” not Disclosed

In 2012, The Spine Journal devoted an entire issue to reviewing earlier Infuse studies, which it characterized as “biased or corrupted research” – research which had been conducted by physicians on Medtronic’s payroll.

The Spine Journal noted that in 13 Medtronic-funded trials (of more than 700 patients), the company never disclosed any adverse events. Meanwhile, data accessed by U.S. regulators and other publications showed that as many as 50 percent of patients implanted with InFuse suffered adverse events – complications and side effects that included ectopic bone growth, uncontrolled bone growth, inflammatory cyst formation, cancer and infertility in men.

Medtronic must now answer for its apparently slanted (and well-paid-for) research, and the company must also respond to the whistleblower suit regarding Medtronic’s questionable business practices and the company’s apparently putting profits before people.

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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.

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Baby cured of HIV?

Doctors announced Sunday March 3, 2013 that a baby from Miss. had been cured of an H.I.V. infection. This is the first time such a thing has occurred, a potentially fantastic development that could change not only how HIV-infected newborns are treated, but could also sharply reduce the number of children living with the virus that causes AIDS.

The Miss. baby’s treatment also gives some new hope for treatment of HIV-infected adults, though some experts have said the Miss. baby’s results would probably not translate for adults.

Born in rural Mississippi, the miracle baby was treated aggressively with antiretroviral drugs starting around 30 hours after birth, reported the New York Times, something not ordinarily done. If further studies show the protocol works in other babies, it will likely be recommended globally.

The Times wrote: “The United Nations estimates that 330,000 babies were newly infected in 2011, the most recent year for which there is data, and that more than three million children globally are living with H.I.V.”

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Medtronic cooks Books

Medtronic has almost developed a corporate motif for its cooking the research books to reflect kindly on its own products. U.S. Senate investigators in Oct. 2012 said Medtronic paid doctors to manipulate Infuse studies to present Infuse as safer than it really is. In 2011,  Medtronic agreed to pay $23.5 million to settle accusations that it paid doctors in a kickback scheme to implant Medtronic pacemakers and defibrillators.

Medtronic was charged by the government with causing false claims submissions to Medicare and Medicaid. The scheme was proliferated by Medtronic’s using two post-market studies and two device registries to pay doctors illegal kickbacks.

In this kickback scheme, according to the Associated Press, Medtronic paid doctors roughly $1,000 to $2,000 a patient. The Feds contended  Medtronic had solicited physicians for post-market research studies in order to prompt the doctors into using Medtronic devices. Postmarket studies are intended to assess medical devices or drugs after they have been approved by the Food and Drug Administration.

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