A drug used to treat schizophrenia and acute manic episodes associated with bipolar I disorder, is in the crosshairs of St. Louis attorney John Driscoll of Brown & Crouppen.
Two separate suits filed in federal court July 27 against AstraZeneca Pharmaceuticals claim that users of the drug developed diabetes mellitus.
Jacob Keim of Kansas and Lester Carrow of Maine are seeking damages for personal injuries and economic damages they claim are the result of using a defective and dangerous pharmaceutical product.
The suit claims the use of Seroquel, which was approved by the Food and Drug Administration in 1997, has been known to cause "serious and sometimes fatal injuries to the liver, kidneys and pancreas."
According to the suits, the pharmacological action of Seroquel is thought to be dependent on its ability to block or moderate the level of dopamine, a chemical found in the brain that in excessive amounts is believed to cause abnormal thinking and hallucinations.
Keim and Carrow complain that the product warnings for Seroquel "were vague, incomplete or otherwise wholly inadequate, both substantively and graphically, to alert prescribing physicians as well as consumer patients of the actual risks associated with the drug."
They say the warnings given by AstraZeneca did not accurately reflect risks, "let alone the incidence, symptoms, scope, or severity of such injuries" in terms of blood sugar related risks.
Keim also names Osco Drug Inc. as a defendant. He claims Osco Drug "knew or should have known" about his health condition and should have known that Seroquel caused unreasonably dangerous risks and serious side effects.
Keim seeks in excess of $825,000 in damages. Carrow seeks in excess of $675,000.
"The anti-psychotic drug market is enormous," the complaints state. "Defendant viewed Seroquel as a blockbuster product with significant projected growth potential."
The marketing and promotion of Seroquel served to "overstate" its benefits while minimizing the risks, the suits claim.
Plaintiffs allege that in August 2003 reports were issued which confirmed previous studies describing a link between the class of atypical antipsychotics and diabetes.
They say that several similar drugs were introduced in the 1990s for treating schizophrenia.
"These look-alike, copycat drugs are nothing new in the pharmaceutical industry, as major manufacturers, who have poured so much money into marketing, and away from research are forced to introduce copycat drugs to the market rapidly, to avoid losing market share to its competitors," the complaints state.
"The copycat drugs are often accompanied by promises of better efficacy and less side effects, but typically, they are approved without the requirements of significant testing, riding the coat tails of drugs already on the market."
The suits claim that Japanese Seroquel labels provide detailed warnings regarding the risks of diabetes.
"The Japanese label...specifically informs physicians regarding the necessity of medical monitoring of patients on Seroquel," the complaint states.
The plaintiffs are seeking damages on counts of negligence, strict product liability, intentional infliction of emotional distress, common law fraud, breach of express warranty, breach of implied warranty, unjust enrichment and statutory consumer fraud.