Paragraphs 5 through 7 read: "In December 2004, the suit states, Bagri prescribed the atypical anti-psychotic drug Geodon at a 40 mg per day dose, 'which would constitute an off-label use'.""The geodon.com Web site states that the drug manufactured by Pfizer is approved 'to treat acute mania and mixed episodes associated with bipolar disorder' and approved to treat schizophrenia."
"The suit alleges that Dr. Bagri did not warn Moss 'of the potential for the major side effects of extrapyramidal symptoms and tardive dyskinesia'."http://www.setexasrecord.com/news/214670-malpractice-case-alleges-prescription-of-drug-for-off-label-use-caused-permanent-disability
Malpractice case alleges prescription of drug for off-label use caused permanent disability
9/8/2008 1:00 PM
By Marilyn Tennissen
A Beaumont man has filed a suit against a local psychiatrist, alleging the doctor prescribed a medication for an off-label use that has left him permanently disabled.
According to the original complaint, plaintiff Donald Moss was under the psychiatric care of Dr. Kashi Bagri of Beaumont from August 2004 to July 2006.
Moss had been referred to Bagri by his primary physician for treatment of depression and anxiety. Moss also had a history of diabetes, hypertension and hyperlipidemia.
The 54-year-old refinery worker filed a medical malpractice suit against Bagri on Sept. 4 in Jefferson County District Court.
In December 2004, the suit states, Bagri prescribed the atypical anti-psychotic drug Geodon at a 40 mg per day dose, "which would constitute an off-label use."
The geodon.com Web site states that the drug manufactured by Pfizer is approved "to treat acute mania and mixed episodes associated with bipolar disorder" and approved to treat schizophrenia.
The suit alleges that Dr. Bagri did not warn Moss "of the potential for the major side effects of extrapyramidal symptoms and tardive dyskinesia."
Extrapyramidal symptoms are movement disorders such as inability to initiate movement or inability to remain motionless. The National Institutes of Health define tardive dyskinesia as a neurological syndrome caused by the long-term use of neuroleptic drugs generally prescribed for psychiatric disorders.
"Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano."
The suit states that Moss continued the regimen of Geodon for two years, "even after plaintiff had a transient ischemic episode or minor stroke."
Within two months of discontinuation of Geodon, Moss claims he began to experience dry eyes and later drooping of his eyelids.
"The drooping eyelids became so bad that plaintiff would have to pull them open to be able to see and had to quit driving," the complaint states. "Plaintiff also developed involuntary lip pursing, teeth grinding, frowning and difficulty reading."
The suit says that Moss was initially diagnosed with facial spasm and Parkinsonism and was referred to a neurologist at the Baylor College of Medicine in January 2007.
The specialist diagnosed Moss as having "tardive blepharospasm and tardive dyskinesia induced by Geodon and Zoloft," the suit states.
Zoloft is a commonly prescribed medication used to treat depression. Before being referred to Bagri, Moss had tried Zoloft, Risperdal, Diazepam, Lexapro and other anti-depression and anti-anxiety medications while under the care of his primary physician.
However Moss' attorney, Ken Lewis, wrote in the complaint that the neurologist at Baylor who diagnosed the side effects as "induced by Geodon and Zoloft" did not have the benefit of the actual medical records and prescription records.
According to the suit, the records showed that Moss "had not taken Zoloft for more than a year before his neurological symptoms developed and could not have been a contributing cause."
Bagri's care of Moss, the complaint states, was "inappropriate in that defendant recommended an inappropriate drug for an off-label use" and failed to warn the plaintiff about "severe potential side effects."
"More specifically, the prescribing of the anti-psychotic drug Geodon for depression was inappropriate medical care, the failure to first try the use of less dangerous drugs before use of an anti-psychotic such as Geodon was inappropriate, the prescribing of Geodon to a patient with plaintiff's 20 year history of diabetes mellitus was inappropriate, the failure to warn of the serious potential side effect was inappropriate, and prescribing the drug for the length of time and strength of dose prescribed was inappropriate for the plaintiff."
Moss claims the doctor's inappropriate actions have left him with permanently disabling neurological conditions which forced him to quit work and are "terribly debilitating and embarrassing."
The plaintiff is seeking damages for loss of earning capacity, disfigurement, medical expenses and the loss of enjoyment of life.
Should the defense raise arguments to the statute of limitations, Ken Lewis said he will argue that both the discovery rule and fraudulent concealment bars such a defense.
Interestingly, the attorney said that the filing deadline for the complaint was Monday, Sept. 1, which was Labor Day. Then on Tuesday, Sept. 2, and Wednesday, Sept. 3, the Jefferson County Courthouse was closed due to the mandatory evacuation for Hurricane Gustav.
"This lawsuit was filed on the first day the Jefferson County Courthouse was opened on or after Sept. 1, 2008," the complaint states.
The case has been assigned to Judge Milton Shuffield of the 136th District Court.
Case No. D182-354