Seroquel lawsuits

          

Transcript of Seroquel Video

Hi, my name is John Cord, and I’m an attorney at Miller & Zois, LLC.  Today, we’re going to describe to you the dangers and lawsuits surrounding the AstraZeneca drug, Seroquel.  First, a little background on the litigation.  Right now, there are approximately 6,000 cases filed in the MultiDistrict Ligitaion, called MDLs, in the United States District Court for the Middle District of Florida.  These cases are not class actions lawsuits; rather, they are individual lawsuits that were originally filed in federal courts around the country.  They have been consolidated before the Honorable Anne Conway in the Florida court.  Anne Conway is overseeing these cases and providing for common discovery—that is, such things as corporate designee depositions of the AstraZeneca employees, and the discovery of AstraZeneca documents that all cases will need.  At the conclusion of the MDL, those cases that have not settled will then be sent back to their home states for individual case-specific discovery and trial. 

Additionally, there are approximately 4,000 cases filed in state courts around the country, giving us a total of approximately 10,000 Seroquel lawsuits at present day.

Seroquel was approved by the FDA for the treatment of schizophrenia and for the treatment of acute manic episodes associated with bipolar disorder.  These are the only two FDA-approved uses for Seroquel.  However, Seroquel has been marketed by AstraZeneca, its manufacturer, for many off-label uses.  An off-label use is simply a use that the FDA has not approved.  Some examples of off-label uses that AstraZeneca has marketed Seroquel for include the treatment of dementia, which is a disorder that many elderly patients have.  In addition, AstraZeneca has marketed the drug for use by children under the age of 18, for which it is not approved.  Frequently, children under the age of 18 suffer from disorders such as Autism or Asperger’s syndrome, or who “act out” are given the drug for a calming effect on their behaviors.  

  It is important to remember that, as far as children, dementia, anxiety disorders and post traumatic stress disorder, the FDA has not approved Seroquel. 

Why would AstraZeneca market the drug to patients with disorders and diseases that have not been approved by the FDA?  Clearly, there is a financial motive, here.  If AstraZeneca were only to market the drug to people with schizophrenia and bipolar disorder, that’s only approximately 5.5% of the United States population as seen in the pie chart.  However, by marketing the drug to those with anxiety disorders (26.2% of the American population, or approximately 57.7 million people); dementia (1.5% of the population, or approximately 4.5 million people); or children with autism under the age of 18 (0.14% of the population, or approximately 450,000 people), AstraZeneca can effectively increase the target market audience for the drug.  It is important to remember that AstraZeneca markets Seroquel outside of the United States, as well.  This is not limited to the United States, but there are more people that they market the drug to in foreign countries. 

A little background on the timeline of some important events in Seroquel’s history: prior to the approval of Seroquel by the FDA, an internal AstraZeneca employee memo revealed that the employee was not 100% comfortable with internal data being made publicly available; however, he understood that they had to disclose the data, but they did a good smoke and mirrors job with the data, making it harder to find and understand.  The FDA approved Seroquel in 1997 for the treatment of schizophrenia.  A few years later it was approved for treatment of manic episodes associated with bipolar disorder.  In 1998, an internal AstraZeneca paper in draft form revealed that there was clinically significant weight gain, that is more than a 7% increase in body weight seen with Seroquel.  This is a significant finding. 

In 1999, an internal e-mail revealed that AstraZeneca employees were concerned with how they would deal with public outrage when the public realized they were suppressing internal data regarding Seroquel. 

In 2004, an internal sales representative talking points document was created.  Sales representatives are AstraZeneca employees who are tasked with marketing the drug to hospitals and doctors.  Those sales representatives were often given talking points, things to discuss with those health care providers about the benefits of Seroquel.  One of those talking points was that “Seroquel, unlike some other antipsychotics, is not associated with meaningful weight gain.”  This is clearly a lie, and clearly contrary to the studies that had been done, including the draft paper from 1998.  In December of 2008, the FDA issued a warning letter regarding on of the Seroquel advertisements, stating that it was “false or misleading because it minimizes the risk of hyperglycemia and diabetes.”

Seroquel works to treat schizophrenia and bipolar disorder, two of the approved uses, in the following way: it targets the parts of the brain that secrete dopamine and serotonin.  These chemicals regulate the nervous system’s response to the environment.  Scientists believe that schizophrenia and bipolar disorder may be caused by excessive amounts of those chemicals.  Seroquel therefore has an “antagonistic” effect on those dopamine and serotonin receptors. 

For the treatment of children, dementia patients and people with anxiety disorders, it works in a similar fashion.  It has an “antagonistic” effect on the brain’s histamine receptors, which produces a sedative effect.  This is not unlike Benadryl, which has the same effect on the histamine receptors.  However, Seroquel is obviously much stronger.

The problems with Seroquel are that it causes uncontrolled weight gain in approximately 6% of its users.  Scientists don’t fully understand the reason for this weight gain; however, it is a recognized side effect.  Many of those patients who experience weight gain develop hyperglycemia, which is abnormally high blood sugar.  From there, those with hyperglycemia develop pancreatic problems.  The pancreas is a glandular organ in the digestive and endocrine systems that breaks down nutrients.  It is also the organ that manufactures insulin, which affects a person’s metabolism.

The problems from here are numerous.  People with pancreas problems can develop diabetes, peripheral artery disease, heart problems, stroke, kidney disorders, it can cause death and they can suffer from pancreatitis. 

The American Diabetes Association describes the symptoms of diabetes as frequent urination, excessive thirst, extreme hunger, increased fatigue, irritability, and blurry vision. 

Heart problems resulting from Seroquel can result in heart attacks, uneven heartbeats, and low blood pressure. 

Peripheral artery disease, another possible side effect of Seroquel, is described by the Mayo Clinic as including the following symptoms:  painful cramping in the hip, thigh or calf muscles; leg numbness or weakness, differences in temperature of the lower legs, sores on the legs, feet or toes that do not heal; differences in leg color, or hair loss on the feet and legs. 

Kidney failure is described by the Mayo Clinic as having the following symptoms:  decreased urine output, darkly colored urine, sudden weight change, fatigue and weakness, muscle weakness and cramps, or a yellowish-color of the skin.

Strokes can also result from Seroquel, including trouble walking or speaking, paralysis or numbness on one side of the body, vision difficulties, and sudden, severe headaches. 

Pancreatitis can be caused by Seroquel as well.  This is inflammation of the pancreas, and symptoms include:  abdominal pain that radiates to the back, nausea, vomiting, abdominal tenderness and indigestion.

Death, when it occurs, is typically caused by the heart attack or heart failure component, though any of these issues may cause death.

What did AstraZeneca do wrong?  AstraZeneca illegally marketed Seroquel for off-label uses.  It failed to adequately warn doctors and patients of the risks of Seroquel, and it failed to conduct adequate pre-market testing.  Furthermore, AstraZeneca hid evidence, including their own studies, that revealed the consequences, side effects and dangers of Seroquel.

In order to determine if you can file a lawsuit, call us at Miller & Zois at 1.800.553.8082.  For more information, please visit our website.   Thank you. 

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If you think you may have a Seroquel case and would like to be included in the Seroquel class action, you can call one of our Seroquel lawyers for a free consultation at 800-553-8082 or click here for a free online consultation.