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Seroquel Side Effects: AstraZeneca Finally Sees a Courtroom
The first trial is under way in a lawsuit filed by former Seroquel user Ted Baker, of Bastrop, Louisiana, are set to begin Monday in state court in New Brunswick, N.J.
Baker’s lawsuit is just a drop in the bucket for AstraZeneca’s legal woes. It is just one of about 10,400 lawsuits against the British company pending in U.S. courts. Many of these lawsuits allege that users of Seroquel contracted diabetes or other injuries by taking it. Up until now, AstraZeneca has been successfully engaging in Matrix-like bullet dodging to avoid defending itself before a jury. In some instances they even conviced judges to dismiss lawsuits before trials were scheduled to begin.
Up to this point AstraZeneca has incurred more than $650 million in legal defense costs for the Seroquel litigation. Of course, its ultimate liability could go higher if juries award damages or if AstraZeneca settles lawsuits.
Now, that legal account has been stretched even further. The company last year put aside $520 million for a looming settlement of a government investigation into allegedly improper sales and marketing practices for Seroquel.
What is Seroquel?
Both Seroquel and Zyprexa are known as atypical antipsychotics, designed to avoid some of the side effects of older drugs that treated schizophrenia and bipolar disorder. If you noticed the irony of a drug that is supposed to avoid side effects causes a life threatening side effect, give yourself a hand.
Seroquel, approved by the U.S. Food and Drug Administration in 1997, had 2009 sales of $4.87 billion, or 15% of AstraZeneca’s revenue.
With that kind of annual income, 10,400 lawsuits and $1.5 billion in legal costs doesn’t seem so bad. Investors are the only ones who are shedding a tear for AstraZeneca whose American depositary shares recently declined 26 cents to $43.65. Not much of a decline, but as the profits start hemorrhaging under legal costs, settlements, and judgments, they may seem a little despondent. Perhaps they will need some Seroquel of their own.
Some of the side effects of the drug that’s supposed to avoid side effects listed by the FDA are:
- Neuroleptic malignant syndrome (NMS) These may be symptoms of a rare and serious condition that can lead to death.
- High blood sugar (hyperglycemia) High cholesterol and triglyceride levels in the blood (fat in the blood).
- Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol.
- Increase in weight (weight gain)
- Tardive dyskinesia uncontrolled movement in face, tongue, or other body parts
- Orthostatic hypotension (decreased blood pressure)
- Increases in blood pressure in children and teenagers.
- Low white blood cell count
- Cataracts
- Seizures
- Abnormal thyroid tests
- Increases in prolactin levels
- Increases in liver enzymes
- Long lasting and painful erection
- Difficulty swallowing
Not a pretty list of side effects. In fact, the list is actually longer than most drugs.
AstraZeneca Denies Seroquel’s Connection to Diabetes
Baker is a Vietnam veteran who suffers from PTSD and another major depressive disorder. He was prescribed Seroquel in 2001. He was diagnosed with type 2 diabetes in 2004, but continued taking the drug until 2006 when a correlation was made.
AstraZeneca of course rejects the plaintiffs’ arguments. “The heart of this case is unproven claims that Seroquel caused diabetes in an individual patient,” said company spokesman Tony Jewell.
AstraZeneca said in a statement that Baker can’t show his use of Seroquel caused any weight gain of the extent or duration enough to cause diabetes. The company says the drug’s product label has always contained language addressing the chance of weight gain.
Yet, miraculously, they seem to ignore the fact that the largest cause of diabetes is weight. If their product caused weight gain one would conclude that any adverse of effects of increased weight would b added to the list, but that’s not so in their minds.
Baker’s lawyers declined to comment.
Did AstraZeneca Know About These Problems?
Plaintiffs in the litigation allege AstraZeneca knew of the drug’s risks in the late 90’s early 2000’s, but failed to adequately warn patients and doctors.
As part of the litigation AstraZeneca was forced to release internal documents last year that plaintiffs’ lawyers said demonstrated the company knew about certain risks of the drug in the 1990s but sought to obscure them.
The company says it fulfilled it’s responsibly by providing data to the FDA to develop product safety label information to help doctors weigh the drug’s risks.
But in the early 2000s, it became apparent that all atypicals including Seroquel carried their own risks. A study released in 2003 in the American Journal of Psychiatry found atypicals were associated with an increased risk of diabetes. At the FDA’s request, manufacturers including AstraZeneca added warnings to the drugs’ prescribing labels, describing the increased risk of high blood sugar and diabetes.
AstraZeneca Takes Out the Pharma Litigation Playbook
Seroquel is one of the 10 best selling drugs in the world, but it belongs to a class of therapies that has come under fire for safety risks and questionable marketing practices. There is a lot of profit to protect regardless of the fact their product makes patients so fat they start losing limbs to diabetes.
This is the first of many high-profile sets of personal-injury lawsuits surrounding a major drug since Merck & Co.’s (MRK) Vioxx litigation in 2004. Rival Eli Lilly & Co. (LLY), another behemoth in the pharmaceutical industry, has shelled out more than $2.6 billion to settle product-liability claims and government probes of illegal marketing practices for its antipsychotic Zyprexa.
AstraZeneca has a plan. Their strategy is much like what Merck’s did for its former pain drug Vioxx. Merck pulled Vioxx from the market in 2004 after a clinical study showed it raised the risk of heart attacks and strokes. Despite the reserach, Merck argued to a judge that it was impossible to prove that an individual’s heart attack was caused by Vioxx use. They contended that the heart attacks could have been due to other risk factors. Merck won enough lawsuits that attorneys in all of the remaining lawsuits against Vioxx agreed to a settlement of $4.85 billion in 2007.
AstraZeneca’s Other Problems: Crestor
In addition to the Seroquel case, a patent-infringement trial for cholesterol drug Crestor is scheduled to begin Monday in federal court in Wilmington, Del. In that case, AstraZeneca is trying to defend the validity of its Crestor patent. They’re trying to fight off generic competition before the patent expires in 2016.
The judge’s ruling in the case is expected by the end of July.
Defective Drugs
There are tons of different medications and they all have slight side effects. Some of them haven’t been adequately tested and sometimes to fatal consequences.
If you or a loved one are going through an ordeal with defective drugs it is important to seek legal council as well as medical council. This way you can protect yourself legally as well as physically. Call Phillips Webster for a consultation on your legal rights.
