Ted Baker’s lawsuit resumed today in New Jersey. His is the first of 26,000 legal cases being brought against the British pharmaceutical giant AstraZeneca. Baker’s suit reflects the basis of most of the other cases. He contends that the company did not adequately inform patients and healthcare representatives of the risk of contracting diabetes from weight gain after taking the popular pill Seroquel, an atypical antipsychotic used to treat schizophrenia.

These are serious charges, because weight gain is a significant side effect. The lawsuits allege that the company knew about the of the side effects and still resisted changing their labeling. A study released in 2003 in the American Journal of Psychiatry found drugs like Seroquel were associated with an increased risk of diabetes.

Yet, even the Food and Drug Administration (FDA) has seemed to underscore the importance of the 2003 study. In their drug safety description of Seroquel provided to healthcare providers they mention weight gain, but nothing further related to the side effect, only that the patient should weight themselves.

The Experts Take the Stand against Seroquel

It’s becoming apparent that experts and ex-employees of AstraZeneca are going to have a significant role in the trial. If the trial turns out in Baker’s favor, that could be damaging to AstraZeneca.

One of those witnesses, Seroquel’s former global safety officer Dr. Wayne Geller, testified today that some colleagues fought his urgings in June of 2000 to strengthen AstraZeneca’s internal description of Seroquel’s weight gain side effects. He told the jury that all he and other researchers wanted was the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight.

“I did question why the word limited was not taken out of the core-data sheet” Geller said. “I found out there were people from the commercial side who opposed the change.”

Basically what that means is that the sales department thought it would be bad for business. Geller’s testimony shows a clear intent to sugar coat the seriousness of diabetes related to weight gain in Seroquel.

Geller pushed to change the language because after reading the AJP report and others since that show Seroquel could “produce significant weight gain in select individuals,” he felt that he had to say something.

Geller revealed that the reports showed that the average weight gain was 27 pounds. In some cases that can mean a significant raise in an individual’s body mass index. When accompanied with other side-effects of the drug not independent of the weight gain such as higher cholesterol and higher blood sugar levels, this is a perfect combination for diabetes. So, this shows that diabetes is not a secondary side effect, but because of the combination of side effects, it is a primary side effect. Seroquel causes diabetes and the label failed to warn of the risk.

Upon cross examination, AstraZeneca’s lawyers decided to focus on specific language. The initial report regarding Seroquel’s side effects written by Geller had the word “limited” in it. He admitted having mistakenly left the word in other reports since reading studies to the contrary.

Mike Brock, an AstraZeneca lawyer, asked Geller, whether the company ever used the “limited weight-gain” language in Seroquel’s  warning label in the United States. “It’s never been in there,” the doctor replied.

AstraZeneca Decides to Blame the Victim; Will it Work?

The company may be seeing the writing on the wall. They may be helping schizophrenics, but they’re also making them obese, which lowers their life expectancy considerably.

Officials at AstraZeneca indicated earlier today that they will end research and development into psychiatric medications at its United States corporate headquarters in Wilmington, Delaware, as part of a mass corporate restructuring.

They also announced that they would cut 11 percent of their workforce by the end of this year as part of the $2 billion restructuring, the bill for the whole shake up that’s happening between now and 2013.

The 11 percent cut means 550 jobs will be lost in Wilmington, Delaware. The loss of those jobs is obviously significant to the existence of the global conglomerate, but how it unclear. This is a corporation that made almost $5 billion off of Seroquel alone. The layoff may just a punishment to the United States.

In a classic tactic called “blame the victim”, lawyers for the company told jurors in opening statements that Seroquel doesn’t cause diabetes. They accused Baker (a Vietnam War veteran) that his weight-gain and disease stemmed from his lifestyle and diet. The lawyers went on to say that the company provided adequate warnings about the drug’s risks on the medication’s warning label and marketed it as according to clinical findings.

“From the very first label for Seroquel, AstraZeneca had in its label the risk of weight gain and the risk of diabetes,” Diane Sullivan, of the AstraZeneca legal team, told jurors in opening statements.

The blame the victim tactic has not gone well in the past for other legal cases. It tends to alienate the jury. Some high profile cases have had disastrous results because of it, an example was RJ Reynolds during their unprecedented $144 billion tobacco lawsuit loss. People feel alienated from massive global conglomerates as it is, being British and eliminating American jobs in the process doesn’t help their public relations. We shall see.

Seroquel and the Side Effects

According to both AstraZeneca and the FDA the list of side effects remains the same and there is no warning or even acknowledgement of the many studies showing of significant chance of diabetes.

Some of the side effects include:

• Difficulty swallowing
• Long lasting and painful erection
• Increases in liver enzymes
• Increases in prolactin levels
• Abnormal thyroid tests
• Seizures
• Cataracts
• Low white blood cell count
• Increases in blood pressure in children and teenagers.
• Orthostatic hypotension (decreased blood pressure)
• Tardive dyskinesia uncontrolled movement in face, tongue, or other body parts
• Increase in weight (weight gain)
• HDL (good) cholesterol.
• High blood sugar (hyperglycemia
• Neuroleptic malignant syndrome (NMS) A rare and serious condition that can lead to death.

The FDA also mentions that there is a chance of suicidal thoughts. Not a welcome side effect for a drug that is taken for schizophrenia.

Protect Yourself

The massive legal teams that can be accumulated by a company that makes 5 billion dollars per year off of a single pill amongst in their extensive line of pharmaceuticals can seem disheartening and slightly overwhelming. That makes some patient’s feel as if they can’t be represented or it just isn’t worth it. That is not true if the legal council representing the case is experienced with defective drug litigation.

If you or a loved one has been seriously injured or killed by a defective drug or pharmaceutical company negligence then call Phillips Webster for a consultation on your legal options.

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