Maryland Injury Lawyer Blog

The Washington Post has an article providing more detail on Study 15, the Seroquel study that saw the same fate as many pharmaceutical company drug trials do that the companies don't like: they stick them in their glove compartment - even deeper than I would stick my parking tickets in college. The chickens came home to roost on my parking tickets about 9 months later. AstraZeneca has had this study stuffed away for 12 years.

For the folks that made a ton of money off Seroquel and have since left AstraZeneca, it all worked out just fine, didn't it? Is it that same warm fuzzy feeling I got when I learned that many of the guys that caused the AIG debacle got huge bonuses? No, the feeling is different for two reasons.

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Last Wednesday, I reported on the Seroquel summary judgment in Florida in the much awaited first Seroquel MDL. The opinion appeared to give AstraZeneca Pharmaceuticals a boost (although there are a thousand variables that are involved in the 1% rise in the stock price – the Seroquel lawsuits are a small piece of the large mosaic that is a major pharmaceutical company) and depress not only Seroquel litigants and their lawyers, but also plaintiffs’ lawyers in drug and medical device litigation, who have had a tough year.

But after reading the order granting the summary judgment in this Seroquel case, the reports of the demise of the Seroquel litigation were greatly exaggerated. This case was decided on its particular facts, and the fact pattern in this case was not advantageous for Seroquel lawyers.

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Unfortunate setback today in the AstraZeneca Seroquel lawsuits pending in federal court: two lawsuits set for trial in Orlando next week have been dismissed. This was the first MDL class action trial in federal court, where most of the Seroquel lawsuits have been filed.

The judge’s reasoning for throwing out these Seroquel cases was that the scientific evidence does not “meet the standards" to go to trial. I cannot figure out whether this is a general or specific causation opinion with respect to the link between Seroquel and diabetes. I assume it is the latter because I do not think there is dispute of the link between Seroquel and diabetes.

The Bloomberg article on the ruling mentioned something from one of the plaintiffs' Seroquel lawyers I found particularly odd:

This ruling basically means that there were some glitches in how these two cases were prepared for trial.

I'm sorry? Come again? What glitches? Can we get a little further explanation? Someone needs to clue in reporters in these kinds of cases: it is okay to ask follow-up questions.

I will report more when I learn the exact basis for the ruling. Not much good news for plaintiffs in the drug and medical device world of late.

There has been evidence since 2002 that drugs in Seroquel’s class caused a 3.34 times greater risk of diabetes than other antipsychotic drugs (which is what Seroquel is supposed to be prescribed for in the first place). In September 2003, the FDA began mandating a warning indicating that Seroquel patients are at great risk for type 2 diabetes.

The Seroquel diabetes class action lawsuit alleges that Seroquel’s manufacturer knew that Seroquel caused a high occurrence of diabetes, but failed to adequately warn doctors or patients of the risk. As is often the case, the other countries' version of the FDA required a more explict warning about the risk of type 2 diabetes with Seroquel. The Japanese warning specifically informing doctors of the need to monitor Seroquel patients. The Japanese label also indicates that Seroquel is contraindicated for use in patients with diabetes or a history of diabetes. In other words, Seroquel's manufacturer felt comfortable providing doctors and Seroquel patients in the United States less information than Japanese Seroquel patients were afforded. Why? Two words: market share. The more bad information about Seroquel that was made available, the less prescriptions - particularly the off-market prescriptions for Seroquel which is where the real money is in Seroquel sales.

Continue reading "Seroquel Diabetes Lawyer: Attorneys for Seroquel Induced Type 2 Diabetes " »

Seroquel (generic quetiapine fumarate), is an antipsychotic medication manufactured by AstraZenica. The drug was approved in 1997 for treatment of schizophrenia, but additional off-label uses to treat anxiety, obsessive compulsive disorders, dementia and autism are where the big money is for AstraZenica. And big money it is. Seroquel had $3.4 billion in sales in 2006 alone. Seroquel has been approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for bipolar depression. Last week AstraZenica sought approval for its more recent creation, Seroquel XR (quetiapine fumarate) both in the treatment of manic episodes and the treatment of depressive episodes associated with bipolar disorder.

It may well be that Seroquel is efficacious in treating these symptoms. But there are increasing reports about the increased risk of diabetes pancreatitis in patients taking Seroquel. The FDA has warned of diabetes risks from Seroquel and the labeling has changed in Seroquel. But Seroquel remains on the market today.

At a congressional hearing on drug safety, Dr. David Graham, an FDA drug safety expert, was asked about concerns he had on drugs currently available today. Dr. Graham testified that “I would pay careful attention to antipsychotic medications. The problem with these drugs are that we know that they are being used extensively off-label in nursing homes to sedate elderly patients with dementia and other types of disorders... But the fact is, is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications.... With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank." Fifteen thousand people is an incredible number of people to die. But there is no uproar and the drug remains on the market.

You might be asking how Seroquel has achieved sales of $3.4 billion dollars while the FDA has only approved atypicals for bipolar disorder and schizophrenia, diseases that affect just 1 percent of us. In fact, Seroquel is third on the hit parade – two other atypicals, Risperdal and Zyprexa sell a great deal more than Seroquel. The sales reps for the companies that sell Seroquel, Risperdal, and Zyprexa are pretty good at their jobs and they know how to push these drugs on doctors who they well know are not treating bipolar or schizophrenic patients.

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