Attorney, Micheal Sullivan : Pharmaceutical Law
Michael Sullivan,Esquire,
First, may I extend to you Mr. Sullivan, how proud I am of you...utilizing your law degree for the betterment of "Safe Marketing of Pharmaceuticals". The pharmaceutical manufacturer, and pharmaceutical marketing agencies.....make astounding amounts of money off of "Each Drug"....last year I believe GlaxoSmithKline made almost 3 Billion dollars off of JUST Wellbutrin XL ( Extended Release ).....an " Off- Label"....along with, Well. SR, Zyban, SAD....all "Off-Label", "Chance Discovery" Drugs. The, Brand Name Drug: Wellbutrin (Immediate Release)......FDA Approved & marketed in 1985, but due to the High Incedence of Seizures, GlaxoSmithKline took it off the market in 1986. ( I've yet to research....I think there is a high probability, Wellbutrin (Immediate Release)....was also an "Off-Label".....If Clinical Trials were conducted for FDA Approval....the high incidence of seizures would surely have been identified. The risk of seizures were found to be highly dose-dependent, and Wellbutrin was re-introduced to the market in 1986, as an antidepressant. In 23 years....I cannot understand why a "Longitudinal Study / Clinical Trial" is not conducted; as to determine the affects of a patient taking Wellbutrin 3 years, 5 years.....The Pharmaceutical Company's will often document in "The Prescription Drug Guide", ....." Incidentally, no long term studies have been conducted to determine toxicity levels." It has been determined "Toxicity"... a catalyst to an "Overdose"....may symtomatically cause seizures, impairment of the "Brain", both cognitive and neurologically. Failure of a Drug Manufacturer to obtain prudent information....be it clinical trials, or as in the UK; patients taking a drug get a "Gold Card"....and participate an assessment .....documenting pertinent information about the drugs actions, side affects, what constitutes a "Therapeutic Dose" and concommitant/links to its medicinal qualities...in report, denoting very specifically, descriptions that will enhance the drugs properties....and foremost, indicate symptoms very specifically. Let is not forget, a medication can best be utilized to treat medical conditions.....the more that is known, the chemist, the physicians, the patients......will obtain knowledge that will prevent undesired medical outcomes.....but more importantly.......for all to share knowledge, experiences, feelings....so that we may discover.......safe treatments, for a sundry of conditions.
As I eluded to earlier, If there is reason to think a drug may be dangerous, and the drug manufacturer does not take whatever steps necessary to ensure no one will be injured.....If this is not complied to, the employees, and the Drug Manufacturer....as would be the case with our Doctors.....have "COMMITTED DEPRAVED INDIFFERENCE MALPRACTICE".....MANY DOCTORS.....on the Drug Manufacturers Staff...If they knowingly do not take whatever action is needed to prevent any injury to a patient.........depraved indifference malpractice. Why should our doctors be held accountable for such an almost "ridiculous".....medical statute......don't they take an "Oath".....if a medical person knowingly puts a patient into a position of "Reckless Endangerment", their liscense should be PERMANENTLY
NULLIFIED!!!!!
This explains my law suit that needs to be filed against GlaxoSmithKline. The article " Off-Label Prescription Case Reflects Federal Concern Over Unsafe Uses"....5/14/2004 , McClatch Washington Bureau.
I took Wellbutrin SR for approx. One an 1/2 years....a bit of memory problems were noted at the time, but my psychiatrist could not relate it to anything but "Pseudodementia" ; Memory impairment due to " Chronic Depression.".......I was on this medication....taught middle school in Charleston, SC....a "War Zone"....., an Asst. Principal there for 3 years....began having Panic Attacks, Depressed,....after a couple of assaults....wasn't seriously hurt...no need to see Dr....but I knew I was just lucky....I could of been seriously hurt..............So....taking Wellbutrin SR 150mg BID, for one & 1/2 years.....change Dr's....he changed me to
1. Wellbutrin XL 150mg BID..... 2 months later, Wellbutrin XL 300mg am
2.Trileptal 300mg......depression ( anticonvulsant...did not take for that) never had a seizure.
3.Clonazepam 1mg....for anxiety ( anticonvulsant...did not take for that)
4.Nortriptyline 50 mg.....for migraines
5,Tramadol ...never took....contraindication....with ?...I think nortriptyline...only took....had bad migraine
Dr. Sukin raised my Wellbuttrin XL to 300 mg. Approx. 20 days later I had 4
WellbutrinXL Induced Grand Mal Seizures. I saw Dr. Sukin for a typical appt. at 1:00.....he noted ....top left corner....appt sheet....resting / eyes closed, open eyes takes a lot of effort,dizzy.........I can't believe he let me drive. I did not realize was having those symptoms.....which now we think were Post Seizure Symptions........3 hours after leaving Dr. Sukins office, had a 4:00 appt with Mortgage Refinancer, Mr Kevin Blaesing.....who witnessed my 1st Grand Mal Seizure ...approx 4:15......it occurred about 5-7 minutes after getting out of my car...I had just driven over Wappoo Bridge.....use to dream of turning to go off the bridge to avoid hitting any vehicle....I'd float in the air.....it's a beautiful river...Intercoastal Waterway....would end before I hit the water. I hit my head...Kevin thinks on the corner of the door frame...It was later diagnosed, CT / MRI.....subdural hematoma.......I woke...15 minutes later....longer than....desired....no oxygen to brain: Anoxic Encephalopathy - Failure of oxygen to be delivered to the brain resulting in brain dysfunction. I woke up with EMS personnel kneeling beside me.....they transported me to Roper/St Francis Hospital where I had 2 additional seizures in the Emergency Room. I was admitted. I only recalled a nice looking DR......he was nice...taking his time to try to make sure I understood....I was on an overdose of Wellbutrin XL (300mg....this was 20 days from the date I began the 300mg)....which induced the Grand Mal Seizures......my Dr. would stop prescribing the Well.....as of "NOW"....I was not to take any more Wellbutrin....ever again....if I took it again, I would have more GrandMalSeizures......I woke up the next am....Well 300mg tablet came with my medicine....Dr. Jervey came by 8-11-04....Wed...I had the 3 Grand Mal Seizures, Thurs am, 8-12-04...Dr. Jervey...my neurologist...went to for migraines....came by my room...he never said a word about the Wellbutrin causing the seizures.....I called him back into the room....told him what the ER Dr. told me.....Jervey agreed, I did need to stop the Wellbutrin, but Dr. Sukin my Psychiatrist....who put me on it.....but we hadn't heard from Dr. Sukin....he wouldn't take the calls from the EMS, or Emergency Room......he "Dumped Me"....didn't see him the 4 days I was at Roper hospital....he didn't call, except calls, all of my test results were faxed to his office......the receptionist would give him the message....I asked Dr. Jervey to schedule.....me to see another Dr. that day, Thurs 8-12-04....Pharmacist, Neurologist....someone who will....If I'm truly to stop......take me off of it....I told Dr. Jervey..."..you wouldn't expect you wife, child to take this pill and sit around all afternoon.....to see if I'll have another series of Grand Mal Seizures.....I never saw another Dr.....know it is my right/ Fed Law.....have the right to see another Dr. for any or all procedures....I asked Dr. Jervey to take me off....or send me another Dr.....I never saw anyone....I asked nurses to ask the "DON" Director of Nurses to please come by to see me....I asked to see a Hospital Administrator....never saw anyone...."out of it"....didn't think to use the phone in my room....to call the Hospital Administrator.......sooooooo, Friday...midnite 8-13-04....I had another seizure, fell out of bed....hit head...? on side of bed or floor.....I layed there seemed like a long time, I couldn't get up or talk loud.....didn't know where I was when I first came to.....Standard seizure monitoring....I should have been monitored constantly by an EEG Monitor....it would even have indicated by the"spikes", when a seizure is coming....nurse wouldn't take me, or call for a neurologist....at least....to take my vitals.....nurse was "covering up the seizure....she forgot to raise bed rails....She tried to convince me I had not had a seizure....no incontinence.....I had no incontinence the day before.....with not one of my seizures.....my tongue still hurt.....? bit again...all I knew was my head (contusion) was killing me....nauseated, vomited....at least twice.....next am....another nurse....schedules me for a neurological Exam/Tests......Jervey comes by, cancells my Neuro. Exam....nurses argued with him several times....but I knew he "won". He told me there was no more beds at Roper, no beds at the other 8-10 hospitals in the area......I was told by him Fri afternoon....I'd be discharged to go home today......he would not acknowledge my seizure, the nite before... but I no longer could go home, and I needed to stop the Wellbutrin, and be monitored in a Hospital for 4 days......he wants me to go to a counceling facility "Palmetto".....it is NOT A HOSPItal.....couple psychiatrist...during the week, councelors, RN for medicines....that's it.........I told him I would not go to Palmetto........he caught me off guard....he "Drugged Me"....Sedated me.....didn't remember leaving Roper and "Poof" I was at Palmetto.........scared to death.........the psychological harm I underwent....person would have to have it happen to them.....Oh, Dr. Sukin...the "Patient Dumper", Admitted me....he worked there part time. I went home in 4 days...no additional seizures..........
It took me almost 3 years to recouperate from those seizures, I'd fall one or twice a day........until approx....8 months ago.....I have taken 2-3 ? neuropsychological test, : diagnosed with Mild Cognitive Impairment......Have brain Atrophy from the Wellbutrin.....the tosicity of the Wellbutrin....gradually destroyed brain neurons.....90% of those with Mild Cog. Imp.......go on to the next stage, Alzheimers Disease.
GlaxoSmithKline.....the WellXL is a "Off-Label"....if I had known that, I'd never took even the 1st, Well. SR 150mg bid......there were no clinical trials, just the need to indicate on paper....it is bioequivalent to, or is with-in the " Therapeutic Index......******** This Equivalence is Diffrent......the first 2 Well. brand name Well Immediate Release, 150mg bid and Well. SR 150mg..,bid........but the Wellbutrin XL ( EXtended Release ) is 300 mg.....with the brand name Well Immediate Release.....150mg......they had to take it off the market in 1986....year after put on the market 1985......they found seizures occurred with SINGLE DOSES ABOVE 150 MG...............SO.....from then on.....it was suggested, to not take more than 150 mg in a single dose. If Dr. wanted patient to take 300mg a day, it was to be taken 150mg....one dose, then at least 8 hours later...the 150mg....totaling 300mg.
With the Wellbutrin XL 300 mg...........like the others, no the first Well Immediate Release, Brand Name......trials....do not take over 150 mg in a single dose.../...........!!!!!!!! Now....there is a Wellbutrin XL300mg......????
I thought a dose above 150mg....caused seizures....."Off-Label"....no clinical trials, on the Well SR.....was OK....they indicated the single dose Rule...not above 150 mg..........
When Dr's switched their patients from the Brand Wel XL 300 to the "Off-Lable"...."Budeprion XL 300mg.(by Teva)...........patients became dangerously depressed..............so ConsumerLab.com tested the Brand Name Wellbutrin (Extended Release) 300mg.........and the Generic "Budeprion"300mg
By 16 hours, both products had released all the medicine.....not enough to carry someone depressed for 24 hours, and 300 mg in 16 hours is too much......remember, a single dose above 150 mg, caused seizures...
The article of above information:"Report questions generic antidepressant" MSNBC.com, Oct. 12, 2007 http://www.msnbc.msn.com/id/21142869/
"Inexact Copies; How Generics Differ From Brand Names",April22, 2008. The Wall Street Journal, by Melinda Beck
http://www.marketwatch.com/news/story/how-generics-differ-brand-names/story.aspx?gui..
The "Off-Label", Wellbutrin XL, Extended Release.......when the FDA... bioequivalence test.....it was with the Wellbutrin 150mg........not the 300 mg. Only REAL clinical trials.....with paatients taking the 300mg WellXL.......................would indicate the true effects...........It's Prudent...........remember in 1085....put on the market..........there was a high incidence of seizures..........researched, seizures were single doses above 150 mg..............sooooooWell XL300mg.....all the active medicine gone in 16 hours........is NOT AN EXTENDED 24 HOUR RELEASE OF WELLBUTRIN300MG. When Sandy Walsh, FDA Spokesperson was asked why clinical tests were not conducted on the WellbutrinXL 300mg., she replied, "The FDA explained that it didn't want to expose test subjects to the risks of seizures with the 300 mg dose. Bioequivalence tests are conducted on healthy people, not those who need the medication, and each gets just a single dose, so there is no chance to work to 300 mg slowly, as actual patients are advised to do.
Reading, Ms Walsh's comments....why didn't she just say, clinical tests are not required on "Off-Label" drugs, just bioequivalence test....or "Therapeutic Index".....levels. People think all drugs the FDA approves, has had clinical trials...Ms Walsh.....clinical tests with patients just switching from the Well.SR 150mg bid......to the Well.XL 300mg......................
The 300mg was an overdose for me. The Drug Prescription Guides.....should indicate, under the name of the drug, that it is an "Off-Label".....generic..."Chance Discovery".............they are not being clear about what drugs have actually gone through clinical trials.
I informed GlaxoSmithKline I had 3 Grand Mal Seizures, when changed from the Well SR 150 BID....I did not report until Oct.3, 2007...I have a Case #, TR/AO684719A
The one case....reported, she had seizures in April 2004, Mine was 8-11-04 3 seizures, approx one & 1/2 hours apart.
Not taking me off the WellXL300.....and 48 hours later I had another seizure.......after stopping Well.........have not had another seizure.
Could you refer me to an Attorney, who is familiar with the "Off-Label"....etc.....my case is just like the Neurontin, Pfizer Suit....Mr Michael Sullivan.....Attorney.....suppose he can only handle Mass. suits.
The statute of limitations is 6 years from the date the patient finds out about a Permanent Injury.....this was April, 2007.....before that, the neurologist........said....give it time......Dead Brain Neurons, remain dead. I looked at the MRI with my neuropsychologist, Mark Wagner PhD, Medical University of SC.....I....or a 8 year old could look at the two lobes and tell someone one is significantly smaller than the other....my Temporal Lobe and Parietal Lobe showed Atrophy in 8-12-04. The Jan. 3, 2007 Mri....."Mild Diffuse Brain Loss". Diffuse means the ENTIRE brain volume.....not sure if the Entire brain is smaller......It appears so, or the MRI results, would have noted only atrophy of the Temporal and Parietal Lobe. Temporal Lobe allows us to take in information and store it = or "LEARN"...........If I do have the early stage Alzheimers, "Mild Cognitive Impairment".....90 %....go on to Alzheimers....
I hope to hear you know someone....who would consider representing me, attorneys in the South, aren't as sharp....and discussing "Off-Label"....talking Greek.
Tele and Fax ( 843 ) 225-8217
1704 Garden Street
Charleston,SC 29407
e-mail moultrie5050@aol.com
OH......Very Important!!!! International News....Wellbutrin is extremely toxic......I do not know how long, or If....from day one of taking Wellbutrin, the toxicity destroys brain Neurons. Log on to blogs....people taking Wellbutrin are having memory problems.....many people who have taken Wellbutrin ? year? 2 years?....you do not need a seizure, to tell you there is a good chance you have Brain Atrophy.....have an MRI taken, and you may also have "Mild Cognitive Impairment"......take a Neuropsychological Test....5 hour test....Yuck!.......This " type of brain impairment"....or If I'm diagnosed in July (scheduled to take another Neuropsychological test).....early age Alzheimers....it is different than "Old Age Alzheimers"....impairs both short and Long term memory.......The early age, allows you to retain most of your long term memory, but short term memory is....poor. ( Monday, I thought it was Sunday..............I cannot remember my tele #.
Thank you.
