One of George Michael’s lovers today reveals how the tormented singer confessed to him that he was desperately addicted to anti-depressants.
Carlos Arturo Ortiz believes the superstar may have killed himself after telling him he was deeply unhappy.
He said: “George’s death knocked me sideways, although it didn’t surprise me. I found him a lovely down-to-earth man, but also a very melancholic person who I feared might one day take his own life.
“He told me he was addicted to anti-depressant medicine and trying to wean himself off it and confessed he was unhappy.
“We talked about his superstar status and I told him I thought that with his fame and talent and money he had all he needed to be happy in life.
“But when he started talking about the anti-depressants he took I asked him outright if he was happy in life and he replied, ‘No, I’m not.’
“….Georgiou dismissed claims Michael was taking Class A drugs before his death, insisting he had ‘stopped all the naughty stuff’.
He told The Times: ‘He was on antidepressants but he wasn’t doing drugs any more.
‘He had swapped drugs for drink but he was doing better. The craziest thing is that when we were 20, 21 he used to say he’d die young….”
As 2016 came to a close, the death of singer George Michael made headline news across the world. Post-mortem results have been- thus far- inconclusive. However similar to the other celebrity deaths in recent times, it seems a lot of these cases usually involve multiple uses of prescriptions drugs over long periods of time – something termed- Polypharmacy.
George Michael’s erratic behavior has been well documented over the years, as has his experiences of depression, and anti-depressants too…
“…Chawla said the singer – who had used prescription medication to deal with his anxiety, depression and insomnia over a long period – had attempted to wean himself off drugs in March this year. He had some success, but later found “the feelings of anxiety and insomnia appeared to have redoubled”…”
He told police after his arrest:
“I’m so ashamed of it. It is so ridiculously dangerous and that is why I have stayed away from them [the antidepressants], even though I still have insomnia and I had some anxiety.” He had only started taking the drug recently, he said, adding: “They are a recent thing, and it’s taken me a whole week to fuck up again.”
“…He went on a diet of Prozac and cannabis. The Prozac made his head even worse, he says. “At first you’re flying about, snapping at people one minute, really happy the next, and I made some disastrous business decisions,” he said….
The Press and the public, still largely seem to think, that just because medication for depression is available for prescription that it must be safe. The fact that anti-depressants legally prescribed (by a doctor) gives these drugs an aura of legitimacy which illegal drugs don’t have.
However, often prescribed drugs (such as SSRI- anti-depressants, Benzos, etc) can induce horrific side effects and withdrawal symptoms, and they can also be just as dangerous as any illegal drugs (if not more so- in some instances).
The polypharmacy induced deaths and shortened life-spans of celebrities highlights the generally dangerous and irresponsible prescribing habits of many doctors. Of course medication induced deaths, injury, disability and shortened lifespans/quality of life etc – has been happening to the general public, as well, for decades.
Robert Whitakers ‘Anatomy of an epidemic’ is essential reading in this regard.
In Whitakers award winning book- he describes how psychiatric patients’ lives are considerably blighted by the drugs they are prescribed…
It will be interesting to see what they have been prescribing George Michael all these years..
Unfortunately it’s likely his death is linked to the polypharmacy prescribing habits of many celebrity doctors nowadays..
And the rest…
All had very poor health ‘care’ outcomes and treatment (in particular from the psychiatric profession)
Even though they were very wealthy and had access to the best orthodox ‘medicine’ , their deaths are still linked to the drugs they were prescribed…
Perhaps ‘orthodox’ medicine has been poisoning us all for far too long?
“….India, where a lot of clinical trials have already begun, is likely to get a breakthrough anti-malarial drug Tafenoquine by 2018. The drug, a one-day two-dose treatment, has already entered phase-three trials and once approved will replace the current 14-day treatment for plasmodium vivax malaria, which is prevalent in India…’
“…Many of them have since suffered an illness classified as an Acquired Brain Injury. There is sturdy scientific proof that ABI can occur after treatment with mefloquine. Scientists from the US military research institute that developed the drugs found that mefloquine was able to cause a “lasting or permanent” brain injury. Other scientists at the same institute found tafenoquine, an experimental drug that has not been registered for sale anywhere in the world, “is more neurotoxic than mefloquine”….
An ‘Acquired Brain Injury‘?
Now that sounds a lot like what happened to many people when they ingested GSK’s Seroxat doesn’t it?
Let’s hope this GSK poison (Tafenoquine) doesn’t get past the ‘experimental’ stage?
Would you trust GSK to tell you the truth about the side effects? (in particular – brain damaging- neuro-toxic side effects).
We are all potential GSK guinea pigs…
Seroxat survivors know that too well..
It looks like Tafenoquine will be ‘tested’ on the Indian population by 2018…
I shudder to think of the consequences…
The anti-malarial drug trial scandal that has embroiled the Australian Defence Force for the last two years simply won’t go away, despite the government’s best efforts to whitewash the controversy with a flawed “military justice” inquiry.
There are growing calls for a public inquiry to investigate ethical breaches which occurred during a series of Army Malaria Institute (AMI) clinical trials conducted in Bougainville and Timor Leste from 1999 to 2002.
The drugs in question are mefloquine, a neurotoxicant able to cause a “lasting or permanent” brain injury in a sizeable minority of users, and the experimental drug tafenoquine. The latter was found to be “more neurotoxic than mefloquine” by scientists from the US military research institute which developed both drugs.
Tafenoquine was given to more than 1,500 ADF personnel during these trials, while mefloquine was used on 1,300 personnel. Mefloquine has probably been given to an additional 2,000 personnel since its introduction in the early 1990s.
Hundreds of Australian veterans have since been diagnosed with serious neurological and psychiatric disorders, often mistaken for post-traumatic stress disorder. Many maintain they were compelled to participate in the trials. The Department of Veterans Affairs (DVA) has belatedly launched a health outreach program, admitting that the first cases “could be the tip of the iceberg”.
Media attention has to date focused on the health concerns of those affected and the ethical question of whether the subjects provided fully informed consent.
Yet a deeper question is emerging, namely a fundamental conflict between the commercial interests of the pharmaceutical industry and the public interests of the ADF. This could even result in criminal charges against ADF medical officials who conducted the trials and now hold senior military appointments.
How could the ADF leadership have allowed this to happen?
Mefloquine and tafenoquine are both products of the US Walter Reed Army Institute of Research (WRAIR) anti-malarial drug discovery program which commenced during the Vietnam War. The results of early military tests of mefloquine were given to the manufacturer Roche in one of the first public-private partnerships of its kind. These questionable results were then used to shortcut the approvals process by the US Food and Drug Administration (FDA) and other regulators.
By the late 1990s mefloquine was well known for its serious side effects and fell out of favour to the extent it is no longer manufactured by Roche in many countries. Linked to numerous war crimes, murders and suicides over the last 15 years, mefloquine is now banned or regarded as a drug of last resort.
Tafenoquine is already repeating this tragic history, with the direct involvement of WRAIR and the closely affiliated AMI.
The ADF’s deployments to Bougainville and Timor Leste provided an ideal opportunity for AMI and WRAIR to conduct large-scale drug trials on a captive pool of “volunteers”. Tafenoquine and mefloquine were tested on almost every battalion of the Royal Australian Regiment. The results of several of these trials have not been published, presumably because they were unfavourable.
Of the reports that were published, none commented on the serious adverse effects that emerged from the trials. One report that was published found there was “no statistical difference” between tafenoquine and mefloquine in the rate of neurological and psychiatric side effects. Many of the subjects are to this day admitted to psychiatric hospitals or have subsequently suicided — yet the ADF has refused to conduct follow up health studies.
A co-author of the published study has been stonewalling the proposed outreach program for years. Recently, he falsely informed doctorsinvolved in the outreach program that there were “no recorded neuropsychiatric side effects” from tafenoquine; contrary to his original report which found one in eight of his subjects experienced such side effects.
The results of this trial were re-analysed in a 2014 paper co-authored by the current Director of AMI to find that tafenoquine is 100% effective in preventing malaria. The lead author of this paper is a former WRAIR employee who now owns a niche pharmaceutical company awarded a contract by the US Army to develop the drug for registration with both the FDA and the Australian Therapeutic Goods Administration. Should the FDA approve, his company would be given a tradeable “priority review voucher” worth several hundred million dollars.
In the 1990s the Canadian government responded to a similar scandal involving an unlawful mefloquine drug trial on peacekeeping troops in Somalia by disbanding the regiment that was subjected to the experiment.
On the evidence already publicly available, a more appropriate response from the Australian government would be to disband AMI and prohibit the conduct of clinical drug trials on ADF personnel deployed on military operations. The ADF is clearly incapable of providing the corporate oversight needed to protect the interests of its troops against those of the pharmaceutical industry.
VETERANS who believe they have been adversely affected by Defence-sanctioned antimalarial drug trials are angry they were not consulted about the delivery of an urgent “outreach program”.
Official letters about the program only began circulating yesterday after the Bulletin revealed last week an outreach program was to be held in Townsville next week for former ADF members and others concerned about mefloquine or tafenoquine.
The Department of Veterans’ Affairs told the Bulletin it also planned to begin an advertising campaign for the program from today.
Melbourne-based veteran Michael Kruizinga said he was given tafenoquine after contracting malaria on the drug Doxycycline before being given mefloquine on a second tour of East Timor.
He recently helped organise a health forum in Melbourne and said people there were desperate for help and would have liked to be consulted on a possible program.
“It’s absolutely pathetic the way the Government has played this because this program is absolutely necessary,” he said. “Groups have been pushing for this outreach program and it seems they’ve just rushed it through to get us off their backs.”
DVA said the concept for the outreach was developed by the DVA-Defence Links steering committee.
“All material that is provided to attendees of the outreach program will be available online, supplementing current information on both DVA and Defence websites,” a DVA spokesman said.
“This will include the names of Townsville-based GPs who are currently known to DVA as being able to assist individuals who may present with symptoms or conditions that they attribute to having taken mefloquine while in the ADF.”
Six sessions are being offered and can accommodate about 50 attendees at the Townsville VAN Office.
“The Townsville outreach sessions will be evaluated and this will help inform the Government as to what additional steps should be taken to assist veterans with concerns,” the spokesman said.
Retried colonel Ray Martin said the Government made an election commitment to set up an open dialogue, but he believed this had not occurred.
“To announce a program with little notice, when many are unavailable, away or on leave, without consultation, input or feedback — from those most affected is very disappointing,” he said.
“This appears to be a box -ticking exercise …”
PM must support Diggers used as drug guinea pigs, writes army officer Stuart McCarthy
WHEN you sign up to fight for your country, you accept you have to put your life on the line. In recent years, scores of those who have served in dangerous or inhospitable places haven’t made it home. To them we are grateful.
Those such as the 41 who were killed in 14 years of the Afghanistan War, faced traditional opponents. That enemy carried weapons. They laid roadside bombs. And the horrors of what many experience last well beyond deployment and into an unsettled civilian life. Many, as revealed by government figures last week, have taken their own lives.
But PTSD isn’t the only hazard that can cause impairment in our Australian veterans. Since the late 1980s, 5000 personnel were administered two antimalarial drugs — mefloquine and the experimental tafenoquine — when sent on military service in countries with a malaria risk.
Many of them have since suffered an illness classified as an Acquired Brain Injury. There is sturdy scientific proof that ABI can occur after treatment with mefloquine. Scientists from the US military research institute that developed the drugs found that mefloquine was able to cause a “lasting or permanent” brain injury. Other scientists at the same institute found tafenoquine, an experimental drug that has not been registered for sale anywhere in the world, “is more neurotoxic than mefloquine”.
Prime Minister Malcolm Turnbull said in August, on the evidence of an alarming veteran suicide rate, that “we have to go beyond the memorials and the monuments and focus on the men and women, the real challenges they face, ensuring that they are supported”. This week, Veterans’ Affairs Minister Dan Tehan and Health Minister Sussan Ley are expected to launch the government’s veteran suicide prevention initiative. With more than 60 veterans having taken their own lives this year, this response is welcome.
Turnbull’s words are encouraging, but there is a glaring omission from his government’s response thus far — an outreach and treatment program for veterans affected by exposure to mefloquine and tafenoquine. Although Defence has recognised that mefloquine can have long-term health effects, Defence and Veterans’ Affairs have initiated no consultation to ensure the advice they are providing to those affected is suitable. Yet Australian veterans who suffer serious, chronic illness since their exposure to the drugs are in the hundreds.
Difficulties in correctly diagnosing this type of brain injury have meant that few of those affected have been able to access the appropriate rehabilitation, medical and other support services. Most who have sought medical help have been diagnosed and medicated for PTSD or other mental illnesses without having been referred to brain injury specialists. That misdiagnosis has led to further disabling drug reactions, family breakdowns, homelessness and suicide.
During this year’s election, the government committed to formal consultation with affected veterans and their families to address these concerns. Despite news of an “outreach” event in Townsville this month, the consultation has not happened. Discussions with senior Veterans’ Affairs medical officers indicated that “consultation was not required”. Meanwhile, Defence and Veterans’ Affairs officials have trivialised the nature and extent of the problems, unfairly suggesting those affected are exaggerating or inventing their symptoms.
The numerous diagnoses of bipolar disorder, schizophrenia, major depression and anxiety, seizures, hallucinations and psychosis, suicide attempts and suicide indicate this is a serious issue. Equally serious steps need to be taken by the government to embrace those suffering and give them suitable assistance.
Providing the right assistance is not hard. There are existing ABI outreach and rehabilitation programs available in every state that receive significant federal funding. Indeed, some fortunate veterans who have persisted to obtain the right treatment are already receiving those services. Sadly, these are in single figures.
If Turnbull is serious about addressing veteran suicides — and there is no reason to believe he isn’t — he should now direct both ministers to make those programs available to all veterans who were exposed to these neurotoxic drugs during their service to the country.
Stuart McCarthy is an army officer who served in Afghanistan, Iraq, Ethiopia and Eritrea and Bougainville. He is undergoing rehabilitation for an acquired brain injury after being exposed to mefloquine and tafenoquine
Therapeutic Goods Administration warned military doctors before using experimental drug on soldiers
Documents obtained by Fairfax Media reveal the Therapeutic Goods Administration wrote to senior doctors at the Balmoral Naval Hospital in Sydney to warn they had no authority to acquire or use the drug under existing arrangements.
Six months later, the hospital received 13 capsules of tafenoquine from pharmaceutical giant GlaxoSmithKline to use on a 26-year-old on the condition it would not be held responsible for side-effects.
The company urged the doctors to contact US Army Medical Research and Materiel Command within 24 hours of serious or unexpected reactions by soldiers. It also told doctors to supply detailed records of patient history and health outcomes.
Tafenoquine remains banned in Australia and has been linked to blood cell damage and anaemia. Common side effects include nausea, vomiting, diarrhoea, headaches and eye disease. It was trialled on 461 ADF personnel as part of a clinical trial in East Timor during 2000-01.
Also trialled was the approved drug mefloquine, or Lariam, which remains the ADF’s third choice antimalarial despite being banned by US Special Forces. The ADF Inspector-General continues to investigate whether any failures of military justice occurred during the trial.
A Department of Defence spokesman said the TGA warning related to the treatment of soldiers with recurrent malaria rather than the clinical trials. But correspondence reveals Australia’s drug regulator did not shy from expressing concern about the drug.
Military doctors were initially granted full access to tafenoquine although this was overruled once the TGA realised the doctors would not comply with relevant safety regulations.
The letter, sent by the TGA’s director of drug safety Dr Leonie Hunt, told doctors they were not authorised to use the drug outside a controlled clinical environment and without the approval of a hospital ethics committee.
“It has been brought to my attention that you do not satisfy these requirements and therefore the authorisation should not have been issued,” Dr Hunt said.
“Accordingly you are no longer authorised to supply or prescribe tafenoquine for use in defence personnel for the treatment of recurrent vivax malaria.”
According to the Department of Defence, the warning was the result of “an administrative error” caused when military doctors applied for the drug under the wrong subsection of the relevant act.
The doctors were eventually granted the drug for “compassionate use” under a special access scheme that judged patient needs on a case-by-case basis. Another 30 ADF personnel were treated under the scheme after a spike in malaria cases during 2001-02.
A TGA spokeswoman said the only way to acquire the dug remained the special access scheme.
“Were the TGA to become aware that unregistered products were being supplied without obtaining appropriate exemption, the matter would be investigated,” she said.
GlaxoSmithKline told the military doctors all patients needed to be provided with information about the drug including alternative options. Written consent forms were also required.
“An integral component and condition of approval for supply of an experimental drug is the documentation of safety and efficacy data,” the letter said.
“It is extremely important that we, as the manufacturers of tafenoquine, obtain detailed information regarding treatment and we ask for your co-operation to document details of patient history and therapeutic outcome.”
Patient outcomes were recorded by military doctors at the Australian Army Malaria Institute and published in the American Journal of Tropical Medicine and Hygiene in 2007.
According to the journal article, the authors were full-time ADF employees and received funding from GlaxoSmithKline to present their findings. They insist no other potential conflicts of interest existed.
Andrew George, a former infantry soldier and public relations officer with the Army Reserve, was treated with tafenoquine in Sydney and claims it left him with damaging side effects.
Mr George, who features in promotional material for the reserves, said he was given the drug after being diagnosed with malaria but does not recall giving informed consent after a detailed explanation of the drug.
He is one of many veterans seeking answers about the drugs with many believing it complicated their diagnosis and management of post-traumatic stress-disorder.
“I am still proud of my service,” he said. “I am proud to have done what my dad did – a Vietnam veteran,” Mr George said.
Australian Defence Medical Ethics Committee documents, released late last year under freedom of information laws, showed the ADF was concerned about whether the trials were properly explained to soldiers.
“It would be preferable to have all information conveyed openly and honestly to every member involved in current and previous tafenoquine trials,” the document said. “This will markedly reduce the risk of a perceived cover-up”
Since the release of the document, the Department of Defence has made a catalogue of information about the trials and the drug available for veterans online.
Surgeon General of the ADF, Air Vice-Marshal Tracy Smart, has also met with veterans at a community event in Townsville and insisted the military was being transparent as possible.
Last month, a senate committee called on the Australian Defence Force to explain all potentially damaging side effects of the antimalarial drugs to every veteran or soldier who has taken them since 2001.
Defence force admits soldier shouldn’t have been included in East Timor anti-malaria drug trial
The Australian Defence Force has acknowledged it accidentally exposed one of its soldiers to controversial anti-malarial drugs during trials in East Timor, despite the soldier having a medical history of mental illness which should have precluded his involvement.
- ADF apologises for including soldier Chris Salter in anti-malarial drug trial in East Timor
- Mr Salter should have been precluded from trial due to history of mental illness
- First time ADF has publicly accepted it made mistakes during Timor drug trials
The soldier, Chris Salter, developed chronic depression and psychosis after inclusion in the Timor trials of psychoactive drugs mefloquine and tafenoquine.
His illness has led to repeated suicide attempts and more than a dozen stays in psychiatric hospitals. He is unable to work or care for his family.
Since the trials, which included thousands of Australian soldiers between 2001 and 2003, a small group of veterans have developed severe mental illnesses.
They believe the ADF erred by giving them the drugs even though there was a significant body of research which pointed to the drugs’ side effects, which in some cases are permanent.
The letter to Mr Salter is the first public case of the ADF accepting it made mistakes during the Timor drug trials. It may open the way for other veterans to seek similar apologies and could lead to compensation.
Defence only began to scrutinise Mr Salter’s case after 7.30 aired an interview with his wife Lavina Salter two months ago.
“Following the disclosure by your wife on the 7.30 Report (sic) in June that you were prescribed mefloquine despite a history of depression, I determined that I should conduct a review of your medical documents,” the ADF’s Surgeon-General, Tracy Smart, wrote in a letter late last month.
In that same letter Air Vice Marshal Smart wrote: “I apologise on behalf of Defence that you were prescribed mefloquine given your history of depression. This represented an unacceptable risk.”
‘It’s happening to a lot of people … and it will continue happening’
Ms Salter has become a vocal critic of Defence, and says the ADF has failed to provide assistance to people who are suffering chronic illness as a result of taking the drugs.
After her husband received his letter she asked people in a mefloquine and tafenoquine support group on Facebook whether anyone had a similar experience.
“I’ve had three or four responses of people who’ve come back and said yes, they were diagnosed with depression and didn’t have a medical to see whether they were eligible [for inclusion in the drug trials],” Ms Salter told 7.30.
All those veterans could be eligible for formal apologies and compensation.
The high stakes of Ms Salter’s campaign for recognition were highlighted two weeks ago, when one of the Timor veterans, Chris Stiles, took his life.
Since then a group of mefloquine and tafenoquine-affected veterans in Townsville have told 7.30 of their anger over the death of Mr Stiles, who was given the drugs and experienced a significant downturn in his mental health.
“It’s happening to a lot of people, it’s not just Chris. Chris is just the latest one, and it will continue happening,” said one of Mr Stiles’s Timor colleagues, Colin Brock.
The veterans say Defence and the Department of Veterans Affairs have failed to provide meaningful assistance and have left many who served in East Timor to shoulder the burden of mental and physical illness caused or exacerbated by the drugs on their own.
Defence has been approached for a response.
Banned or limited by other militaries around the world
Mr Brock helped carry Mr Stiles’s coffin to his grave a week ago. He was one of two of the pallbearers who were given the drugs in Timor and have since developed mental illnesses that have seen them admitted to psychiatric hospital suffering a host of mental and physical symptoms.
Mefloquine — also known as Lariam — and tafenoquine are psychoactive anti-malarials that, according to the World Health Organisation and neurological researchers, have a history of links to severe depression, anxiety, irrational anger, memory loss, suicidal thoughts, psychosis and hallucinations.
Across the world militaries are seeking to ban or limit the use of the drugs, given serious concerns about their side effects.
In 2013 US special operations forces banned the drugs after the Food and Drug Administration issued its highest alert — a so-called “black box” warning.
“Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent,” the FDA said.
Last year a UK parliamentary inquiry found the Ministry of Defence prescribed the drug too liberally and recommended it be redesignated as a “drug of last resort”.
The ADF’s Inspector-General has launched an inquiry into the East Timor drug trials. He is due to report by the end of this year.
Defence has so far refused to commit to reporting publicly.
Where does the buck stop?
Expert OK To Testify In GSK Suit By Reed Smith Atty’s Widow
Law360, New York (November 22, 2016, 3:11 PM EST) — An Illinois federal judge on Monday canceled a pretrial hearing scheduled to vet an expert witness for the widow of a former Reed Smith LLP partner who killed himself allegedly as a result of taking GlaxoSmithKline PLC’s antidepressant drug, finding that the expert’s past issues had already been settled.
Dr. David Healy, who’s set to testify on behalf of widow Wendy Dolin when her trial against GSK begins in January, was scheduled first to take part in a pretrial hearing regarding an investigation into a past patient incident by the General Medical Council, the governing board of medicine in the United Kingdom where his practice is located.
However, that investigation has since closed with no finding of wrongdoing, and the Illinois federal court’s in camera review of documents related to the council’s inquiry have turned up nothing either, therefore a hearing to vet Dr. Healy is no longer warranted, U.S. District Judge William T. Hart decided.
“As stated by this court before the GMC investigation was closed ‘investigations, without finding of culpability, are typically not relevant.’ Moreover, there is nothing in the in camera documents to warrant a hearing or disclosure of the documents. Accordingly, no pretrial hearing of Dr. Healy’s testimony will be held,” Judge Hart wrote.
The judge indicated that the court would hang onto the in camera documents until the conclusion of the trial, which is set to begin Jan. 17.
“This case is about Paxil-induced self-harm, not a medical board investigation where Dr. Healy was cleared of any wrongdoing and had nothing to do with Paxil,” Robert Wisner of Baum Hedlund Aristei & Goldman PC, an attorney for Dolin, told Law360. “GSK wants to distract the jury with any and everything that does not center on GSK’s conduct. The court, thankfully, saw through it.”
A representative for GSK declined to comment.
Dolin had asked Senior U.S. District Judge James B. Zagel in August to cancel the December hearing over Healy after the General Medical Council cleared him in an investigation following the suicide of one of his patients.
Judge Zagel had requested the hearing to determine whether GSK could ask Healy about the council’s investigation in front of the jury during the upcoming trial. But Dolin had argued that GSK’s investigation-based attacks on Healy were no longer relevant to the case.
Dolin sued GSK and Mylan Inc. in 2012, two years after her husband, Stewart, threw himself in front of a train. He began taking Mylan’s generic form of GSK’s antidepressant Paxil just a few days before his death.
Wendy Dolin claims GSK covered up an increased risk of suicide associated with Paxil by manipulating data used in a study that was submitted to the U.S. Food and Drug Administration. She also wants GSK held liable for failing to include a warning on its packaging about the risk.
For more than a year now, the parties have battled over Healy, a British psychiatrist who will testify for the widow about his research into the causal relationship between Paxil and adult suicide. While under investigation by the council, Healy wrote on his blog that he was likely being targeted by major drug manufacturers like GSK because of his testimony in various cases against the companies.
After Judge Zagel ensured the case would go to trial by declining to rule on GSK’s summary judgment bids earlier this year, GSK pressed him to force Healy to reveal documents related to the council’s investigation, arguing they were relevant to Healy’s credibility and potential bias against the drugmaker. Dolin countered, saying the public filing of the documents could cost Healy his job.
Judge Zagel denied GSK’s efforts to get the documents, which were submitted to the court for in camera review, but said he wanted to hold a special hearing to determine whether the U.K. investigation is relevant to the Dolin case.
Dolin is represented by R. Brent Wisner, Michael L. Baum, Bijan Esfandiari and Frances M. Phares of Baum Hedlund Aristei & Goldman PC, and David Rapoport, Joshua L. Weisberg and Melanie VanOverloop of Rapoport Law Offices PC.
GSK is represented by Alan S. Gilbert and Anders Wick of Dentons LLP, Chilton D. Varner, Andrew Bayman, Todd Davis and Heather Howard of King & Spalding LLP, and Robert Glanville, Thomas Wiswall, Tamar Halpern and Eva Canaan of Phillips Lytle LLP.
The case is Dolin v. Smithkline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.
— Additional reporting by Emily Field, Kat Greene and Diana Novak Jones. Editing by Ben Guilfoy.
Jury Awards $11.9 Million in Paxil Suicide Malpractice Case–Psychiatric Expert Peter R. Breggin Testifies
Largest malpractice award of its kind: $11.9 million malpractice verdict confirms that SSRI antidepressants can cause suicide. “The jury award confirms increasing judicial and public awareness that psychiatric drugs can cause violent and suicidal behaviors,” according to the psychiatric expert Peter Breggin, MD.
This $11.9 million verdict confirms the significant body of scientific evidence indicating that psychiatric drugs can cause violence and suicide
Ithaca, NY (PRWEB)October 06, 2016
A jury has awarded $11.9 million in a suicide case involving the antidepressant Paxil (paroxetine). The patient killed himself in jail after a psychiatrist restarted him on the SSRI antidepressant.
The $11.9 million award was one of the largest jury awards of its kind in an antidepressant-related suicide case which concluded September 15, 2016.
The defendant was PrimeCare and several of its practitioners and staff who provided services at the jail. The jury determined that the company and most of the defendants acted with deliberate indifference to the patient’s medical needs.
Psychiatrist Peter R. Breggin MD testified, according to court documents, about the negligence and callous indifference of the psychiatrist and the psychologist who treated the 46 year old patient, Mr. Mumun Barbaros. In addition, Dr. Breggin testified about causation in respect to the actions of the psychologist and psychiatrist, as well as the nursing staff and administration.
According to court documents Dr. Breggin testified that restarting the patient on his regular dose of the SSRI antidepressant Paxil 30 mg, despite a hiatus of least four days without the medication, was a direct cause of the suicide later on the same day. He explained further that the patient had difficulty several years earlier when starting the medication, even though the initial dose was only 10 mg. Restarting him on Paxil 30 mg, when most of the drug was out of his system caused akathisia (agitation with hyperactivity) and suicide. He also found that the doctor and the psychologist were negligent in several other ways, including their failure to evaluate the patient and to order careful monitoring.
Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. All antidepressants can cause suicidal and homicidal behavior, especially those that routinely cause stimulation or activation, including akathisia, agitation, insomnia, disinhibition, emotional lability, hypomania, and mania, and a general worsening of the patient’s condition. Of all the antidepressants, Paxil was the only one to show a statistically significant association with suicide in depressed adults in the short and deeply flawed clinical trials used for FDA approval of the drug. Dr. Breggin has written about the subject of medication-induced suicide in his book, “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime,” as well as in other books and numerous scientific articles.
Dr. Breggin bolstered his testimony with numerous scientific citations according to the trial documents. The judge qualified Dr. Breggin as an expert in psychiatry, psychopharmacology and the specific drug Paxil. In the trial, other experts testified concerning the nursing care and administrative policies of the healthcare provider, as well as the violent method of Mr. Barbaros’ death by gagging himself.
Dr. Breggin commented, “This case illustrates the growing understanding within the judicial system and the public arena that psychiatric drugs can cause people to act in harmful ways that are contrary to their character and normal behavior. The verdict confirms the significant body of scientific evidence indicating that psychiatric drugs can cause violence and suicide.” Dr. Breggin also warned, “It is especially dangerous when starting, changing the doses or stopping psychiatric medication, and that medication withdrawal should be done carefully with experienced clinical supervision.”
The jury award included $2.8 million for negligence, $1.06 million for federal deliberate indifference and $8 million for punitive damages.
The attorney for the plaintiff was Brian Chacker of Philadelphia. The case is Ponzini et al. v. Monroe County et al., case number 3:11-cv-00413, in the U.S. District Court for the Middle District of Pennsylvania in Scranton.
Seroxat, is arguably, more controversial than Lariam, and also caused similar psychiatric side effects such as suicide, etc. They remove Lariam, yet keep Seroxat on the market…why?
Note also that it was Roche (the manufacturer of lariam) who chose to remove the drug- not the Irish authorities…
-thanks to Examining Medicine for this point–
Controversial drug Lariam removed from sale
Friday 16 September 2016 16.56
A drug at the centre of a number of legal actions against the State by members of the Defence Forces has been withdrawn from sale in Ireland.
It has emerged Lariam, an anti-malarial drug, was taken off the market at the end of July.
For many years Lariam was given to Irish Defence Forces personnel deployed to missions in sub-Saharan Africa to prevent the life-threatneing illness.
Lariam’s acknowledged side effects can be very severe and include anxiety, depression, paranoia and suicidal behaviour.
Fifty serving or former members of the Defence Forces have lodged claims against the State having been given the drug.
Legal proceedings have been served in 37 cases.
It has emerged that the drug manufacturer Roche took Lariam off the market in this country on 31 July. It remains available in other jurisdictions.
A spokesperson for the company said the decision followed a review of the products it offers here and was not related in any way to pending legal actions.
The company says Lariam was taken off sale following “a portfolio reassessment” by the company and three other products have also been discontinued.
They also point out that it remains available in 16 European countries.
The decision to withdraw Lariam ( which is also known as Mefloquine) from sale has been welcomed by some of those who allege they suffer from side-effects but they want assurances it will no longer be used by the Defence Forces.
Anthony Moore, who curates the Action Lariam Group for Irish Soldiers Facebook page, says they have asked the Defence Forces to take it off and will continue to do so.
Mr Moore is a former naval diver and soldier who served on numerous missions abroad.
A Department of Defence statement said the Defence Forces were made aware by Roche Products Ltd that Lariam was being taken off the Irish market but the drug is still available to them via two main wholesalers.
The statement says there are no plans to withdraw Lariam from the range of anti-malarial medications they use.
The statement points out the health and welfare of Defence Forces members is of the highest priority and significant precautions are taken by medical officers in assessing the medical suitability of members to take any anti-malarial medications.
Meanwhile a Department of Defence working group initially set up in 2011 and reconvened in 2013 is continuing to examine all issues surrounding the use of the drug.
Nursery nurse ‘killed herself after developing sleep disorder after she received swine flu vaccine’
Katie Clack, 23, became depressed after developing narcolepsy in 2009 and jumped to her death from a car park five years later
A nursery nurse killed herself after becoming depressed over a sleep disorder which “most likely” developed after she received a swine flu vaccination, an inquest heard.
Katie Clack, 23, became depressed after developing narcolepsy in 2009.
She jumped to her death from the top of a multi-storey car park in Peterborough in September 2014.
Her narcolepsy had led to her sleeping for up to 19 hours per day on occasions and her mental health worsened.
An inquest in Stamford heard that the Peterborough woman did not want the vaccine but was required to take it for her job.
Recording a narrative conclusion, Paul Cooper, acting senior coroner for South Lincolnshire, said studies showed there were “significantly raised odds of narcolepsy after (being given the) Pandemrix” vaccine in those aged 18 and above.
“On the available evidence on the association between vaccination with Pandemrix and onset of narcolepsy it seems most likely that receipt of this vaccine in December 2009 caused Miss Clack’s narcolepsy,” said Mr Cooper.
He added that narcolepsy triggers depression, though he noted the case of Ms Clack was “complex and very rare”.
A statement issued on behalf of Ms Clack’s family said: “Katie was an energetic young woman who had just discovered her passion working with children.
“Narcolepsy turned her life into a terrible daily struggle and drastically reduced her quality of life.
“We cannot believe she would have decided to take her own life had the balance of her mind not been disturbed.”
Ms Colvin added: “The Clack family has waited a long time for this inquest.
“It is important that the coroner has recognised the casual link between the vaccine and narcolepsy and the devastating impact this had on Katie’s short life.”
Earlier this year a boy who developed the sleeping disorder caused by the swine flu vaccine was awarded £120,000 in damages.
Josh Hadfield, 10, from Frome in Somerset, developed narcolepsy after receiving the Pandemrix vaccine six years ago.
In 2013, lawyers launched a class action on behalf of 38 Britons – including 19 children – who developed narcolepsy after having the vaccine.
Scientists from the former Health Protection Agency (HPA) said there was evidence of a link between the Pandemrix jab – manufactured by GlaxoSmithKline(GSK) – and narcolepsy in children.
HPA figures suggested one in 55,000 children vaccinated – about 20 in the UK – are thought to have developed narcolepsy.
Josh was awarded the money after an appeal against the Government, which had initially refused to pay as he was not “severely disabled” enough.
Speaking at the time, a spokesman for GlaxoSmithKline said: “We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.”
It was also supporting investigations into reported cases.
Across Europe, about 31 million people are thought to have received the Pandemrix jab.
Narcolepsy is a rare but serious neurological disorder that affects about 31,000 people in Britain.
The condition can cause massive disruption to sleep and daily life.
A Department of Health spokesman said: “Katie’s death was tragic and we offer our sympathies to her family.
“Pandemrix vaccine was used to prevent serious illness and deaths during the swine flu pandemic in 2009/10.
“At the time, the possible association with narcolepsy was not known.”
Interesting article about super-model Cara Delevigne…
I wonder what ‘meds’ she was prescribed?…
Cara Delevingne ‘doesn’t agree’ with anti-depressants
4th Aug 16 | Entertainment News
Cara Delevingne stopped taking anti-depressants because she didn’t want to become dependent on medication.
The model-turned-actress has been candid about her battle with depression, and how it left her feeling so low that she even contemplated suicide around the age of 16.
She was placed on a strong cocktail of medication but decided to come off the tablets when she was 18 because she never wanted to become reliant on them.
“I hate meds,” she told Britain’s Esquire magazine. “I don’t agree with them. It’s so easy to abuse them.”
She added that she immediately felt the difference once she came off her medication because her feelings returned and she had sex for the first time.
“That week (I stopped taking them), I lost my virginity, I got into fights, I cried, I laughed,” she admitted. “It was the best thing in the world to feel things again. And I get depressed still but I would rather learn to figure it out myself rather be dependent on meds, ever.”
During the interview, she spoke about having a mental breakdown as a teenager. Dealing with her hormones and the pressure of achieving good school grades sent her into a downwards spiral so severe that she even considered taking her own life.
“I couldn’t deal with it anymore. I realised how lucky and privileged I was, but all I wanted to do was die,” she explained. “I felt so guilty because of that and hated myself because of that, and then it’s a cycle. I didn’t want to exist anymore. I wanted for each molecule of my body to disintegrate. I wanted to die.”
During that time, Cara, 23, dropped out of boarding school and pursued a career in modelling, following in the footsteps of her older sister Poppy.
© WENN Newsdesk 2016
Despite tens of thousands of reports of SSRI induced suicidal thoughts, behaviours and completed acts over the decades, GSK are still trying to deny the reality of Seroxat/Paxil (Paroxetine) induced suicides..
Paroxetine is a killer drug….
I hope that Wendy Dolin wipes the floor with GSK (and their sociopathic lawyers) in court…
On a muggy evening, Wendy Dolin was walking her dog a month after the bewildering suicide of her husband, the former Reed Smith partner Stewart Dolin, when a friend accompanying her uttered a strange word suggesting an explanation: akathisia. Looking up the condition online that night in 2010, Dolin was stunned by how closely its symptoms of intense restlessness and anxiety seemed to match her husband’s puzzling behavior in the days before he took his life by jumping on the tracks of an O’Hare airport- bound Blue Line train in Chicago.
The name of the condition, more familiar to neuropsychiatry professionals and pharmaceutical injury lawyers than to Wendy Dolin, a licensed clinical social worker in Illinois, shone to her through the fog of an inexplicable act by a man she had known for 42 years. He had seemed his usual self until just days before the incident, she said, when he had begun taking paroxetine, the generic version of the antidepressant Paxil.
He became so distressed soon after going on the medication that he pled to her one night that week in July: “I don’t get it, Wendy. I still feel so anxious,” she recalled.
After poring over internet search results about lawsuits that alleged that akathisia was a known side effect of Paxil, which belongs to a class of antidepressants called selective serotonin reuptake inhibitors, Dolin decided on a seemingly improbable course of action. She would sue the drugmakers responsible for the manufacturing and labeling of Paxil, a drug whose generic version her husband had taken for only six days before his death.
“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” Dolin said, referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.
“It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else,” she said.
Baum Hedlund Aristei & Goldman PC, a small personal injury firm based in Los Angeles, had been litigating wrongful death and injury suits involving suicides and suicide attempts related to antidepressants for about 20 years when Dolin contacted it in 2010 to take on her mission. Nearly two years later, the firm filed her negligence and wrongful death suit against Mylan Inc., the Netherlands- based generic-drug maker that manufactured the drug her husband was taking, and GlaxoSmithKline, which sold the drug’s branded versions and devised its labels, as the U.S. Food and Drug Administration requires.
The timing of her suit was inopportune for a plaintiff alleging an injury from a generic drug. The U.S. Supreme Court had just issued a landmark decision in 2011 in Pliva v. Mensing that shielded generic- drug makers from claims about their labeling of drug side effects and contraindications because FDA rules require them to follow the same warning language of their branded counterparts. Meanwhile, dozens of courts around the country were taking cues from a 1994 decision by the Fourth Circuit in Foster v. American Home Products Corp., which had found that although branded-drug makers are responsible for the labeling of their products, they don’t have a duty to warn patients taking generic versions of their drug.
The mountain of unfavorable case law had threatened to nip Dolin’s suit in its early pleading stages. Instead, she prevailed through multiple summary judgment motions by GSK — although the Mensing decision did jettison Mylan from her suit — as her lawyers strategized to counter the difficult precedent and found a willing ear in the Illinois federal judge overseeing the suit, James Zagel. Guided by the handful of courts before him to find branded-drug makers could be held liable under other tort theories besides strict product liability, he issued a surprising endorsement of Baum Hedlund’s arguments in the Dolin case, finding in February 2014 that GSK could be held liable for common law negligence claims.
Judge Zagel found that, unlike some other states, Illinois common law did not compel him to treat all claims stemming from a product injury as product liability claims.
“The injury here did indeed occur in connection with a product. And GSK manufactures products,” he wrote in his ruling. “Yet Plaintiff has not brought suit against GSK for tortious conduct committed strictly
The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable.
— Wendy Dolin
as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer.”
Under his watch, the case is set to proceed to a monthlong trial in January, and it will be the first to involve a suicide allegedly caused by a generic antidepressant, and the first to test whether a jury would actually hold a branded-drug maker liable for a generic-drug injury. Many of the earlier suits filed over suicides allegedly linked to generic antidepressants have either settled or been dismissed.
Wendy Dolin with her husband Stewart on a 2007 vacation in Aspen, Colorado.
If Dolin prevails, the stakes will be high for generic-drug patients across the country. Her attorneys believe it would likely set the stage for the Seventh Circuit to address the issue for the first time in the event of a GSK appeal. In that scenario, the question before the court would be whether branded-drug makers can be held liable for injuries caused by generic-equivalent drugs that they did not themselves make. If the Seventh Circuit were to answer the question differently from the few other federal appeals courts that have done so — the Fourth and Sixth circuits have ruled against the idea that a branded-drug maker could be liable for a generic-drug injury — the suit could very well wend its way up to the nation’s highest court.
“The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable,” Dolin said. “I’d love this case to be the one that says, ‘This is no longer acceptable.’”
The Paradox of Litigating Over Generics
Generic drugs account for roughly 80 percent of all prescription drugs dispensed in the U.S., according to the FDA. Their prevalence is due in part to their cost, which can be as low as a tenth of the price of their branded equivalent. In 2010, the use of generic drugs saved the U.S. health care system roughly $158
billion, according to an estimate by the generic-drug trade group the Generic Pharmaceutical Association, which the FDA cites on its website.
Those savings often interact with state laws in ways that ensure the widespread use of generics. A number of states have laws that encourage pharmacists to choose cheaper equivalents to a brand name prescription, unless a prescribing doctor includes explicit instructions not to do so. Such is the case in Illinois, where state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs.
The Alabama Supreme Court, the highest state court in the country to address the issue of whether a branded-drug maker can be held liable for a generic-drug injury
— and one of the few to answer it in the affirmative —
emphasized those implications in a 2014 ruling.
“Additionally, many insurance plans are structured to promote the use of generic drugs,” the court wrote in the decision. Dolin’s own health insurance plan covers only generics, she said. The Alabama Supreme Court ruling, however, which came in the then-groundbreaking case Weeks v. Wyeth, has since been negated by a 2015 law by the state Legislature that rejects the notion that a branded-drug maker can be held liable for a generic drug.
The unique position of generics has a relatively recent history. The Federal Food Drug and Cosmetics Act once required all drugmakers to show that their drugs were safe and properly labeled before the agency would approve them. Then the 1984 Hatch-Waxman amendments to the FDCA sought to simplify the process for generic-drug makers, in order to expand affordable treatment options for patients. The amendments allowed generic-drug makers to sidestep requirements to conduct clinical trials to show the drugs’ safety and effectiveness, but it required them to show that they have followed the formulation and labeling of branded counterparts that have already undergone such trials.
Consumer advocates believe that such requirements have
created a significant gap in protecting patients for injuries they
may have sustained because of inadequate warnings, while protecting generic-drug makers from most liability claims involving their products. Public Citizen, the consumer advocacy group that petitioned the FDA in 2011 for the agency to allow generics to independently go about making changes to their labels, holds that view.
“A majority of prescriptions are filled with generic drugs because it makes health care more affordable, but when the drug doesn’t have adequate warnings on it, then physicians and patients can’t make proper decisions,” said Allison Zieve, the director of Public Citizen’s litigation group.
“Brand name manufacturers are required to update their labeling when they become aware of new information of drug risks, but once a generic is on the market, the market share for the branded version drops very quickly, and the brand name often stops selling the drug altogether,” she said. “There’s nobody under the current regime monitoring the drug to make sure that labels are updated.”
But the U.S. Supreme Court cited the Hatch-Waxman Act in cementing the protections for generic-drug makers in its 2011 Mensing decision. That case involved claims by Gladys Mensing and Julie Demahy, plaintiffs from Minnesota and Louisiana, respectively, that their long-term use of a generic version of the heartburn drug Reglan sold by drugmakers including Pliva caused them to develop tardive dyskinesia, a neurological condition that causes involuntary movements such as uncontrollable twitching or blinking.
The court found in its ruling that generic-drug makers cannot satisfy state law requirements to strengthen their warnings when they are already required by
federal law to match branded-drug labels.
In 2013, the Supreme Court expanded these protections further in Mutual Pharmaceutical Co. Inc. v. Karen Bartlett, largely blocking design defect claims by citing, among other factors, “Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic-drug manufacturers incapable of modifying either the drugs’ compositions or their warnings.”
The Dolin Litigation
It was around the time of this flurry of major precedent against generic-drug plaintiffs in the courtroom that Brent Wisner of Baum Hedlund, then an associate at the firm in its San Francisco office, took on Dolin’s suit in 2012, his first case as a practicing attorney.
The suit faced hurdles not only because of the Mensing decision and the eventual Bartlett decision but also because of the sweeping influence of the Fourth Circuit’s Foster ruling, which had barred just the type of allegations that Dolin was making, he said.
Dolin’s suit claimed her husband had killed himself after exhibiting
uncharacteristically high anxiety within days of taking generic Paxil,
which had been prescribed to him by his family doctor and friend
of 20 years, Dr. Martin Sachman. GSK’s warning label, which the generic version’s maker, Mylan, was required to follow, had misled patients and doctors, she claimed. It did not sufficiently warn that akathisia, which according to her complaint is marked by “profound inner restlessness and agitation,” could give rise to suicidal tendencies, she said. GSK has argued that the 2010 labels for Paxil contained warnings about akathisia that said the condition was “most likely to occur during the first few weeks of treatment.” Dolin insists that GSK did not connect the dots clearly enough between akathisia and suicide or sufficiently note the incidence of such risks in adults.
Her suit also claimed that although GSK apparently knew of a statistically significant risk of suicidal behavior in adults taking the medication — roughly 6.7 times higher compared with patients on a placebo — the drug’s label concealed that risk by claiming that “the suicidality risk did not extend past the age of 24.” GSK has said that this language was ordered by the FDA as part of its warnings on all SSRIs that “short term studies” of antidepressants did not show such risks of suicidal behavior.
The Fourth Circuit’s ruling in the Foster case involved the death of a six-week-old infant who had been given a generic version of a colic medication called Promethazine Syrup Plain. The appeals court squarely rejected the notion that a brand-name pharmaceutical
could be held liable for negligent misrepresentation claims in that
instance. But in the pre-Mensing era of that ruling, the court had found that generic drugs were responsible for their own labeling, emphasizing the benefits they enjoyed because of the Hatch- Waxman amendments allowing them to circumvent expensive clinical trials.
“Name brand manufacturers undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information,” the panel wrote. “Generic manufacturers avoid these expenses by duplicating successful pioneer drugs and their labels.”
At the time Wisner prepared to fight motions by Mylan and GSK challenging the viability of Dolin’s case, some 70 other courts had more or less adopted the Fourth Circuit’s view in Foster, according to court documents.
“Coming out of law school you want to deal with complicated legal issues,” said Wisner, who had just graduated with his law degree from the Georgetown University Law Center in 2010. “But I had a lot of people telling me I had no chance to prevail.”
I had a lot of people telling me I had no chance to prevail.
— Brent Wisner, Wendy Dolin’s attorney
So he hatched a plan. Anticipating that Mylan and GSK would seek to quickly dispose of his claims, he approached them in February 2013 with a calculated compromise. He would agree to put discovery on hold while the parties addressed questions of whether Dolin’s claims were preempted or not viable, but in exchange, Mylan and GSK would have to file their motions challenging her claims roughly at the same time.
That way, Wisner reasoned, he could address both defendants’ motions in a single opposition, creating a path for the judge to issue a cohesive response addressing the arguments of both defendants in the same opinion. Mylan filed its motion to dismiss in August 2012, citing the Mensing ruling. GSK followed suit with its summary judgment motion in January 2013, arguing that there was “virtual unanimity” among the numerous courts to consider this question and that they had rejected the kind of misrepresentation theories that Dolin was advancing. The drugmaker also argued that Illinois product liability laws require claims related to injuries caused by a product be brought against the company that actually manufactured it.
“Regardless of how plaintiff couches her claims, they are all barred under Illinois law because GSK did not manufacture, distribute or sell the immediate-release paroxetine that allegedly caused Mr. Dolin’s death,” it argued. “Without this fundamental predicate, Plaintiff cannot establish the necessary elements of her claims.”
Wisner believed his approach could nudge Judge Zagel to make a more comprehensive analysis about whether case and state laws truly end up leaving most generics plaintiffs with no legal recourse for alleged injuries.
“I wanted him to be ruling on the ability of my client to get any sort of justice,” Wisner said. “My thinking was, when you consider both of these issues together — innovator and generic immunity — it is easy to see how unfair the law has become.”
Judge Zagel took the cue and found in his now-renowned ruling in February 2014 that Illinois law doesn’t call for common law negligence claims to be treated like product liability claims just because the suit involves a product and an alleged injury it caused.
“GSK vigorously contends that the design and warning label are not in themselves ‘products,’” Judge Zagel wrote. “[But] GSK has not shown why Plaintiff should be precluded from claiming at common law that GSK, independent of its capacity as a manufacturer of one particular iteration of paroxetine, was negligent in connection with its responsibility for these ‘non-products,’ and that this negligence contributed to her injury.”
The ruling was a breakthrough for Dolin, too. “The phone rings [that day], and Brent [Wisner] says, ‘I think you just sorta made history here,’” she said.
The Dolin trial is set to boil down to a few crucial questions for the jury, foremost of which is whether the drug Paxil, which the FDA first approved in 1992, causes suicidal tendencies in adults. Dolin’s experts, who are expected to testify on this issue of general causation, have so far withstood GSK’s challenges.
Among them is Dr. Joseph Glenmullen, a psychiatry professor at the Harvard Medical School who has written two books about antidepressant side effects. In a 2007 report to Baum Hedlund, unsealed in a different case over Paxil in Kansas state court, Glenmullen argued that GSK’s own data to the FDA in 1989 showed a substantial increase in risk of suicidal tendencies in patients on Paxil compared to those on placebo pills but that the drugmaker underreported or downplayed such risks to regulators.
It was only in 2006 that the company acknowledged in a so-called Dear Health Care Provider letter, which is meant to inform doctors of updated safety information, that Paxil could increase the risk of suicidal tendencies in certain patients by about six times as compared with a placebo, according to his report. That year, GSK modified its label to warn that it had found Paxil posed a “statistically significant” increase in the frequency of suicidal behavior in adult patients with major depressive disorder. This language made way for the FDA’s classwide labeling for all SSRIs the following year that would update all black box warnings — the agency’s most serious safety warnings — on the drug. The classwide label would warn patients and consumers only about increased suicidal tendencies among young patients aged 18 to 24.
In 2011, Wendy Dolin founded a nonprofit dedicated to spreading awareness of akathisia titled MISSD, shorthand for “the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.”
Glenmullen’s report, along with a similar one that followed the same year by the British drug safety regulator finding GSK knew of such risks in adolescent patients since 1998, prompted Iowa Republican Senator Chuck Grassley to urge the FDA in June 2008 to determine if the drugmaker had suppressed any safety information when it sought approval for the drug.
Glenmullen has maintained his position in the Dolin case, in which he has testified that taking paroxetine was a “proximate cause” in Stewart Dolin’s suicide. GSK sought to exclude his testimony in September, arguing that Glenmullen had not shown any idea linking Paxil to suicides, only to suicide attempts, which the drugmaker argued was not an adequate substitute.
Judge Zagel denied such motions in November, finding that Dolin’s experts had offered “reliable” testimony.
Dolin’s experts also include Dr. David Healy, a psychiatry professor at the University of Wales in England. Healy, who has worked as an expert witness for Baum Hedlund for years in lawsuits involving antidepressants, has stated in the case so far that GSK’s own labeling documents from 2006, including letters to physicians, had acknowledged that “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo … this difference is statistically significant.”
If the jury agrees on that question of general causation, it would then have to decide whether GSK adequately warned of the risk. If it decides the warnings were insufficient, the jury would then have to consider whether the failure to warn led to the suicide — that is, whether better warnings would have led Dr. Martin Sachman to prescribe a different treatment.
Baum Hedlund has also enlisted former FDA physician David Ross to testify on the regulatory history between GSK and the FDA and what data the drugmaker shared with the agency.
One of the key points of contention is whether GSK did its thorough due diligence to make sure its labels contained warnings specific to Paxil’s potentially increased risk for suicidal tendencies — the FDA’s own analysis found a 2.76 times higher risk for patients taking paroxetine.
Although GSK had asked the FDA about adding Paxil-specific warnings to the agency’s classwide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.
GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded-drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.
Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.
“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise,” said Henninger Bullock of Mayer Brown LLP, who has represented branded-drug makers in similar suits. “But GSK can say: ‘Well, we tried, and the FDA told me twice already that I couldn’t modify the classwide label, so to request a meeting would be futile.’”
A spokeswoman for the FDA declined to comment on pending litigation.
Besides experts, Dolin and her two adult children with Stewart are expected to testify, along with Sachman, who said at deposition last year that he didn’t know of the drug’s risks and if he had he would never have prescribed it to his best friend, Wisner said.
Wendy Dolin may be questioned at trial over the circumstances surrounding her husband’s death. “I knew my husband, and I don’t even consider it a suicide anymore,” she said.
GSK, which has taken a whopping 30 depositions in the case over a one-and-a-half-year period, has designated more than two dozen witnesses, including company witnesses and about nine experts.
“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court,” spokeswoman Jenni Ligday told Law360 in a statement.
Dolin herself may be grilled on the specifics of her husband’s mental state and activities leading up to his death. Some salient details of his final hours stand out to her as especially convincing evidence that he did not plan his suicide in a state of anxiety over long-simmering work-related problems, as GSK has argued.
The drugmaker had argued that Stewart Dolin had experienced work-related anxiety and depression for years, according to a heavily redacted segment of its summary judgment motion in October.
Shortly before his bizarre and tragic visit to the subway station, he had had lunch with an accountant at the Rivers Restaurant near his office in the Chicago Loop. There, he had ordered a chicken salad, requesting the dressing on the side, Wendy recalled, remarking ruefully, “You had the dressing on the side an hour before you [supposedly] planned to die?”
“I knew my husband, and I don’t even consider it a suicide anymore,” Dolin said. “I consider it a fatal drug reaction.”
Sindhu Sundar is a feature writer at Law360. Follow her on Twitter.
Sunday, July 17, 2016
Paxil Widow Steps Up Fight Against GSK
Law360 is a lawyer driven website that keeps many law firms across the globe up-to-date with legal news as it breaks. It’s subscription based and deals a lot in US litigation. I’ve read many articles from Law360 in the past none more interesting than their recent publication, ‘Reed Smith Atty’s Widow Wages Battle Against Paradox Of Generic Drug Injury Law‘.
It peaked my interest as it pertains to a case I’ve covered many times on this blog. (Links at the foot of this post)
Wendy Dolin is suing GSK over the death of her husband Stewart after he was prescribed Paroxetine (better known as Paxil and Seroxat) in 2010 for “work-related anxiety and depression”. Six days after beginning his course of medication Stewart killed himself by leaping in front of a northbound train in downtown Chicago.
Wendy has maintained all along that her husband showed marked signs of akathisia during the short time he was taking Paxil. For those of you who don’t know, akathisia is basically when a patient, after administering psychiatric medication, becomes agitated, distressed, and shows signs of restlessness. Often the patient has an inability to sit still and, in some cases, will pace up and down for no apparent reason. In fact, as Wendy recalls, her husband told her one night, “I don’t get it, Wendy. I still feel so anxious.”
The Law360 article focuses, in part, on Wendy’s claim that her husband experienced signs of akathisia. This is quite an unusual step for Law360 as, in the main, they report impartially on trials (past and present) and rarely feature interviews with actual plaintiffs of trials that are pending litigation.
In the article Wendy tells Law360’s reporter, Sindhu Sundar, that she had heard the term ‘akathisia’ from a friend sometime after Stewart’s death. Like many people she had never heard of the word before. She told Law360…
“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” (referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.) “It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else.”
Here’s where it gets tricky and somewhat complex. Stewart, you see, was taking a generic version of Paxil manufactured by Mylan and, in a nutshell, Glaxo argued that it should be Mylan that she sued and not them. However, after much legal wrangling, it was deterred that Glaxo were responsible for the warning literature that accompanied Paxil and any of it’s generic forms. Ergo her claim of negligence and wrongful death should stand.
It’s not as straight forward as one might think when pharmaceutical companies try to make changes to their warning labels. GSK, after learning that they would have to go to trial, then argued that they had approached the American drug regulator, the FDA, on two occasions to change the warnings on their branded version of paroxetine (Paxil). GSK allege that the FDA refused on these two occasions to make any changes to the labelling.
A pretty decent defence one would think, however, GSK did not try a third time, as was the normal protocol. According to court documents and Law360…
Although GSK had asked the FDA about adding Paxilspecific warnings to the agency’s class wide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.
GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.
Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.
“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise.”
It’s interesting to note here that GSK are admitting that, in 2007, they wished to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults yet they are defending the allegations that Paxil (paroxetine) caused Stewart to take his own life. GSK, it seems, don’t defend the fact that Paxil can cause suicide in adults, they use points of law to hide this fact instead.
Having your cake and eating it, anyone?
Since the claim was filed in 2012 GSK have sent Wendy more than 30 subpoenas, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself. Moreover, GSK have also tried (unsuccessfully) to exclude testimony from Wendy’s expert witnesses. Joseph Glenmullen is one of those witnesses and GSK argued that he “had not shown any idea linking Paxil to suicides, only to suicide attempts.”
Another expert GSK tried to exclude was David Healy. Their treatment of him became more of a personal attack. They claimed that Healy wasn’t qualified to testify because of his radical advocacy and extreme bias against GSK. They had taken extracts from Healy’s websites and cherry-picked certain paragraphs to make it look as though Healy had called upon people to extract violence upon GSK executives and journal writers. They were wrong and Judge Zagel has allowed all three testimonies into trial.
When experts give evidence in litigation they are first depositioned by the opposing party. In the case of Healy, his deposition with GSK’s lawyers last almost 10 hours, the majority of which focused on his personal life and not the science behind his expert opinion.
It’s just another classic case of GSK dragging out time in efforts to get the plaintiff, in this case, Wendy Dolin, to accept their first measly offer, should they make an offer (which history tells us that they more than likely will)
Glaxo just love to grind down the opposition in litigation ~ they are finding that Wendy Dolin and her law team of Baum, Hedlund, Aristei & Goldman, PC are not in the game of lying down and having their tummies tickled nor are they bothered by the amount of money Glaxo’s cigar chomping suits throw at the case.
Glaxo are also defending group action brought against them in the UK with regard to Paxil ~ it’s litigation that has been dragging on for almost ten years now – who knows, maybe Glaxo’s UK and US lawyers drag these cases out so everyone who works for their firms gets a regular wage, after all it’s GSK who are billed every month to pay their attorneys wages.
Wendy Dolin is, despite the death of her husband and the abhorrent tactics of GSK’s lawyers, still standing – her lance at the ready for battle – a female Don Quixote, if you will.
Stewart would be proud of her.
Back stories related to this case.
GSK Claim Phone Calls May Shed Light On Suicide