Seroquel Claims Lawyer

The following is the background of the Seroquel lawsuits as explained in Plaintiff's motion for a class action:

Specifically, Plaintiffs' have alleged that Seroquel, is an "anti-psychotic" medication, belonging to a class of drugs referred to as "atypical anti-psychotics." (Other atypicals include Zyprexa (Eli Lilly), Risperdal (Johnson & Johnson), and Abilify (Bristol-Myers Squibb), which have been in use in the United States since the early to mid 1990's.) The complaint alleges that  Seroquel causes serious and sometimes fatal injuries to the liver, kidneys, and pancreas including adverse effects such as ketoacidosis, pancreatitis, and diabetes mellitus, and other serious health problems associated with the onset of diabetes including heart disease, blindness, coma, seizures, and death.

Because  Seroquel increases  the risk that its users will develop diabetes and diabetes related symptoms and illnesses, Plaintiffs seek to have a class certified of all individuals who have been prescribed and have or are currently ingesting the product.

The class is more specifically defined as: All persons in the United States who purchased and/or used  Seroquel including any other persons asserting the right to sue the Defendants independently or derivatively by reason of their personal relationship with persons   who used Seroquel, including without limitation, spouses, parents, children, dependents, other relatives or "significant others" ("derivative claimants").

Defendants, their officers, directors, subsidiaries, or any person or other entity related to, affiliated with or employed by Defendants are expressly excluded from the class definition.

In June, 1997, the Food and Drug Administration ("FDA") approved the atypical anti-psychotic drug,  Seroquel, for use in the United States to treat schizophrenia. At that time, Seroquel was approved for use in dosages of 50mg, 100mg, or 200 mg. The U.S. labels or package inserts for  Seroquel, upon which physicians rely for safety and warning information,   in effect during the relevant time period 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 this drug. Recent studies clearly link atypical anti-psychotics, including Seroquel, to the onset of hyperglycemia, diabetes and other problems stemming therefrom. Data from certain of these studies suggest that patients on  Seroquel have a higher number of incidences of diabetes than those on older drugs or other atypical anti-psychotics. See Burton, New Antipsychotic-Drug Class Is Tied to Increase in Diabetes, The Wall Street Journal, August 22, 2003, attached hereto as Exhibit A (noting that Seroquel had an over 3.34 times risk of causing diabetes than older anti-psychotic drugs).

Studies have compared these new atypical antipsychotic drugs with older typical anti-psychotics and have shown that this new class of atypical anti-psychotic drugs have a significantly higher incidence of both type I and type II diabetes. See Sernyak MJ, et al, Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia , Am J Psychiatry, April 2002, at 159(4): 561-6, abstract attached hereto as exhibit B. Retrospective studies of databases across the nation clearly suggest that atypical anti-psychotic medications, specifically  Seroquel, are linked to glucose dysfunction. The experts who have conducted these studies suggest careful monitoring for changes in blood glucose levels in patients taking atypical anti-psychotics. See Wilson, et al., New-onset diabetes and ketoacidosis with atypical antipsychotics, Schizophr Res., Jan. 1, 2003, at 59(1): 1-6, and Citrome LL, et al., Relationship of atypical antipsychotics with development of diabetes mellitus, Ann. Pharmacother, Dec. 37, 2003, at 37(12): 1849-57, abstracts attached hereto as composite exhibit C.

AstraZeneca failed to adequately warn doctors and patients in the United States of this increased risk and the need for medical monitoring as a result of this increased risk. AstraZeneca has admitted that the Japanese  Seroquel label warns specifically of the diabetes risk, prominently in the beginning of the package label stating:
(1) Seroquel (Quetiapine) is contraindicated for use in patients with diabetes or a history of diabetes;
 
(2) Seroquel (Quetiapine) should be used with caution in patients with risk factors for diabetes, including hyperglycemia, obesity or a family history of diabetes;
 
(3) Patients receiving Seroquel (Quetiapine) should be carefully monitored for symptoms of hyperglycemia and the drug should be discontinued if such symptoms occur. The symptoms of severe hyperglycemia include weakness, excessive eating, excessive thirst, and excessive    urination;
 
(4) Physicians should educate patients and their family members about the risk of serious hyperglycemia associated with Seroquel (Quetiapine) and how to identify the symptoms of hyperglycemia.


See Defendants' Answer at PP 29-31. Hyperglycemia and diabetes are severe and potentially life threatening injuries. It has been reported that people being treated with atypical antipsychotic medications, including  Seroquel, develop ketoacidosis, hyperosmolar coma or death. Patients, who are being treated with any atypical antipsychotic medication, including  Seroquel, should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. These testes are relatively inexpensive  approximately $ 10-$ 30 per test.

Any patient treated with Seroquel should be carefully monitored for symptoms of hyperglycemia and should undergo regular fasting blood glucose testing. Early detection and recognition of hyperglycemic condition is critical to adequately care and treatment of such individuals See Sneed, PharmD, et al, Type 2 Diabetes Mellitus Induced by an Atypical Antipsychotic Medication, The Journal of the American Board of Family Practices, 2003, at 16: 251-254, attached hereto as exhibit D. It has also been reported that the development of diabetes after initiating an atypical anti-psychotic agent can occur anywhere from 10 days to 18 months. In this same article, Sneed and Gonzalez examine the possible ways atypical antipsychotic cause diabetes:
There are several theories on how and why these atypical anti-psychotic medications cause diabetes. One theory is that diabetes might result from the weight gain caused by these agents. Other studies suggest that these agents affect glucose transport metabolism peripherally in patients, possibly increasing the potential for hyperinsulinemia and peripheral insulin resistance. Further hypotheses  point to the activity of atypical antipsychotic drugs at the serotonin receptors of the beta cells in the pancreas, more specifically 5HT[1A] and 5HT[2] receptors. This activity might lead to derangement of beta cell function, with resulting increases in glucose levels in patients. See id.

A study injecting mice with atypical antipsychotics, including  Seroquel was done to determine if these atypical antipsychotic drugs produce hyperglycemia in mice and to determine the atypical antipsychotic ability to interfere with glucose uptake and utilization. It was determined that  Seroquel, among other atypicals, induced significant hyperglycemia in accordance with atypical antipsychotic effects on glucose transport. See Dwyer, et al, Induction of hyperglycemia in mice with atypical antipsychotic drugs that inhibit glucose update, Pharmacol Biochem Behav., May 2003, at 75(2):255-60, abstract attached hereto as exhibit F

It is generally accepted in the medical community that there is a strong association between atypical agents and their effects on blood glucose levels, and their ability to cause diabetes related injuries. Because of the unacceptable rate of new on-set of  diabetes associated with the ingestion of atypical antipsychotic medication, in September 2003, the Food and Drug Administration (FDA) issued a letter to Eli Lilly and all other atypical manufacturers regarding class labeling for all atypical antipsychotics. The requested label changes are intended to place doctors and consumers on notice of the link between the life threatening complications associated with diabetes. See "Lilly Announces Notification of Class Labeling for Atypical Antipsychotics Regarding Hyperglycemia and Diabetes," September 17, 2003, attached hereto as Exhibit E. This FDA action specifically requires the Defendants' new labeling to state that users of atypicals should be "monitored for a worsening of glucose control . . ." Id. The new labeling will also require "fasting glucose testing at baseline, and periodically throughout treatment." Id.