1304, 2012

Arkansas Jury Finds Johnson and Johnson Subsidiary Defrauded State Medicaid Program

April 13th, 2012|Jury Verdicts|Comments Off on Arkansas Jury Finds Johnson and Johnson Subsidiary Defrauded State Medicaid Program

As a dangerous drug lawyer, I wrote earlier this year about a trial in Texas over alleged defrauding of that state’s Medicaid program by the makers of the drug Risperdal. Risperdal (risperidone) is an atypical antipsychotic that is approved for use in patients with psychosis. However, it was frequently used “off-label” in elderly patients with dementia until a few years ago, when studies began to show that it actually increased the risk of death among those patients. Since then, prescriptions have dropped dramatically among the elderly, and state and federal medical programs have begun taking careful looks at just what the taxpayers have been paying for. Among the state Medicaid programs doing that review was the one in Arkansas, where the state brought Risperdal’s maker, Janssen Pharmaceuticals, to trial recently. Now, according to Bloomberg News, the trial has ended with a verdict of more than $1.1 billion.
The state of Arkansas alleged that Johnson and Johnson and Janssen misled doctors in the state about the risks and benefits of Risperdal, in part by sending them a letter that downplayed the drug’s side effects. The state also accused the pharmaceutical companies of falsely claiming Risperdal was safer and more effective than its competitors, and marketed it for unapproved uses even after an FDA warning told the company not to do that. After the jury found for the state, the trial judge assessed penalties for more than 238,000 violations of the state’s Medicaid fraud statute. Each violation carries a $5,000 penalty, putting the total fine at over $1.1 billion; the judge also assessed an $11 million fine for violations of the state’s law against deceptive trade practices. Janssen has already announced its intention to appeal if not given a new trial.
Arkansas is one of 11 states to sue over allegedly deceptive marketing of Risperdal; the federal government is also seeking a large settlement of a similar Risperdal lawsuit over deceptive marketing. The fine in Arkansas, however, is the largest in the three cases that have been resolved. Texas settled for $158 million in January; South Carolina won $327 million in court in December. Cases are on appeal in Louisiana and Pennsylvania as well. Makers of other atypical antipsychotics, which have many of the same problems as Risperdal, have also generally settled for less. Legal experts told Bloomberg that Johnson and Johnson appears to have lost a gamble that the juries would be sympathetic to them. A spokesperson for the Arkansas attorney general’s office said the bulk of the verdict would likely to go the state Medicaid program, which is suffering from deep cuts like nearly every state Medicaid program.
That last piece of information is significant to me as a defective drug attorney, and I suspect also significant to the juries who decide these cases. States are making ugly decisions right now, between balancing their budgets and providing adequate care to their poorest and most vulnerable citizens. A juror who knows this, particularly one with firsthand experience in Medicare, might not be terribly sympathetic after hearing accusations that Johnson and Johnson defrauded the state out of millions of dollars. Nor, in my opinion as a pharmaceutical liability attorney, should they be. Risperdal carries serious side effects including an elevated risk of stroke and heart attack, as well as long-term risks like diabetes and high blood pressure. With that much at stake, doctors and patients have the right to be well informed before they use the drug.

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1612, 2011

Jury Awards $72 Million to Women Who Developed Breast Cancer After Taking Prempro

December 16th, 2011|Jury Verdicts|Comments Off on Jury Awards $72 Million to Women Who Developed Breast Cancer After Taking Prempro

The menopause drug Prempro is a major area of interest right now for pharmaceutical liability attorneys like me. Prempro was prescribed widely about a decade ago for symptoms of menopause, such as hot flashes, but fell out of favor in 2002 after studies connected it to an increased risk of cancer. Since then, manufacturer Pfizer has faced numerous lawsuits alleging that the drug is responsible for their new breast cancer diagnoses. One of these, in Pennsylvania state court, ended with a victory for three women, according to Bloomberg News. Susan Elfont, Bernadette Kalenkoski and Judy Mulderig received a verdict totaling $72 million in their Prempro cancer lawsuit. This is the tenth loss of 18 Prempro lawsuits that have gone to trial, the article said.
All three women are in their late sixties, and none had a family history of breast cancer before being diagnosed. Kalenkoski, a former nursing home aide, took Prempro for more than four years; the others took a combination of the prescription drugs Premarin and Provera, which were combined in Prempro starting in 1995. In all three cases, experts testified that their use of the drugs was likely the reason for the cancer. The initial cancer finding came from a long-term FDA study of 16,000 women taking either Prempro or a placebo. The study was stopped in 2002 after researchers found a much greater rate of breast cancer, stroke and heart attacks in the Prempro patients. The finding halved the number of American women on hormone replacement therapy and led the FDA to require its strictest warning label starting in 2003. A follow-up study in 2010 found that Prempro patients were twice as likely to die.
As a dangerous drug lawyer, I’m pleased to hear that these patients have won their lawsuit. The article mentions that Pfizer has put aside $772 million to settle or try Prempro cancer lawsuits, so it is clearly expecting many more. That’s good, because at the height of the drug’s popularity, six million American women were taking it. Though not all of those patients will be diagnosed with Prempro-related breast cancer, even a fraction of those six million could add up to many thousands who would have the right to seek fair compensation from Pfizer. To make matters worse, there is some evidence that the company’s Wyeth division tried to plant shoddy research in medical journals to downplay the bad results. Suppressing or downplaying negative research may protect profits, but it can put thousands of patients at risk.
At Carey, Danis & Lowe, we represent clients who suffered serious injuries or lost a family member because they took a prescription drug they thought they could trust. Just like all manufacturers, the makers of prescription medications have a legal responsibility to make sure their products are safe to use as directed and carry adequate warnings to patients. When they fail to do this, they are legally liable for any injuries suffered by patients. That includes the loss of a loved one to an avoidable cancer diagnosis or other serious illnesses. Our defective drug attorneys help clients across the United States claim financial damages, including money for all of their medical costs, lost wages and other financial expenses and compensation for their pain, suffering and emotional losses.

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2810, 2011

Jury Finds for Pharmaceutical Company in New Jersey Levaquin Side Effects Lawsuit

October 28th, 2011|Jury Verdicts|Comments Off on Jury Finds for Pharmaceutical Company in New Jersey Levaquin Side Effects Lawsuit

As a Levaquin injury attorney, I was interested to read about a jury verdict that came down in favor of Levaquin (levofloxacin) maker Johnson & Johnson. According to Bloomberg News, a New Jersey jury decided this month that the manufacturer had not failed to adequately warn patients about Levaquin’s risk of tendon problems. The decision rejects the claims of Robert Beare and Paul Gaffney, both of whom had an Achilles tendon snap after they took Levaquin, leaving them unable to walk. The dispute was not over whether Levaquin caused the injuries, which are a known risk of the drug, but over whether the warnings on the drug’s label were sufficient. The case was at least the third case to go to trial on similar claims, but Johnson & Johnson faces more than 2,600 lawsuits over Levaquin across the United States.
Levaquin is a flouroquinolone antibiotic, a class of drugs used when other antibiotics have failed, but which carry varying degrees of risk for tendonitis and tendon injuries. In 2008, after more than a decade of requests from activists, the U.S. Food and Drug Administration required all flouroquinolones to carry a black box warning, the agency’s strongest, about the risk of tendon damage. The risk is especially high in people taking corticosteroid drugs, certain transplant patients and patients over age 60. Gaffney is 67 and Beare is 72. Both were originally prescribed Levaquin to treat sinus infections that developed into pneumonia, and both required surgery in order to walk again after their tendons snapped. Their attorneys argued that Johnson & Johnson knew Levaquin posed the highest risk of tendon rupture of any flouroquinolone antibiotic, but failed to say so, depriving doctors and patients of needed information. But the jury sided with the manufacturer, which argued that it was not federally required to make that warning.
Unfortunately, the jury was right. As a dangerous drug lawyer, I know very well that there’s a difference between what the FDA requires and the information needed to help patients and doctors make well-informed decisions about their care. And thanks to recent Supreme Court rulings, it has become easier than ever for drug manufacturers to argue that they should not be held responsible for any actions that stay within federal regulatory boundaries. Ideally, the FDA would respond to this by tightening its regulations, but past history suggests that this is unlikely. For example, for flouroquinolone antibiotics, the FDA said in 1995 that it would add warnings about tendon rupture to the drugs’ labels; name-brand drugs got those warnings in 2008, 13 years later. Histories like this make it difficult to trust that federal regulators are enough to protect the public.
At Carey, Danis & Lowe, we help victims of severe drug injuries by holding drug manufacturers responsible for selling defective and dangerous products. This includes cases of failure to warn about a serious risk, like that of Levaquin, but also of drugs that were defective in the first place or negligently treated. We take medications our doctors prescribe because we trust that they will help, but sometimes that trust is misplaced. When it is, patients can suffer real harm — an injury or a serious illness, sometimes turning into a new lifelong health problem. In a lawsuit, our defective drug attorneys can help patients claim money for all the medical costs of the injury and any related financial costs, such as losing a job. You can also claim compensation for your pain, emotional suffering, loss of quality of life and more.

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