Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, June 28, 2010

**Exclusive - Sara Carlin Inquest - Jury Returns With Recommendations.

Image: Sara Carlin

Before I go any further, I would just like to thank the 5 person jury at this inquest.

They, it appears, have seen through all the bullshit and underhand tactics of all those whom have tried to protect the name of GlaxoSmithKline's Paxil - more on them in another post, many of which will follow over the coming days/weeks.

GlaxoSmithKline's lawyer, Teresa Walsh and Coroner's Counsel, Michael Blaine, have been resoundly beaten, I believe, by the Carlin's family lawyer, Gary Will of Will Barristers.

In a heart felt phone conversation with Neil Carlin, Sara's father, told me that both he and Rhonda [his wife] "...are extremely pleased with the outcome of the inquest into our beloved Sara’s Paxil (Seroxat, Aropax, paroxetine) related suicide with the recommendations that the jury have given in their verdict." He added, "The jury were under very strict restraints in their ability to name or blame any party in this inquest, including the three doctors from Oakville Ontario Canada - and the drug company GlaxoSmithKline - maker of the SSRI antidepressant Paxil."

Neil also told me, "We feel that through the breadth & depth of their 16 recommendations, the jury has carefully listened to the evidence they have heard over these past several weeks & through the quality of those recommendations have identified the root cause of Sara’s death. It is our belief if these recommendations are implemented & followed in the future, that they will surely avoid the tragic waste of young life as occurred in our Sara’s case."

Neil pointed out to me that he and his wife "...believe that recommendations 8,10,11,12,14,15 and 16 are especially noteworthy"

The recommendations announced today by the jury have, it appears, slammed The Ontario College of Physicians and Surgeons (OCPS) and the Ontario College of Family Physicians (OCFP). Furthermore, they have, it appears, slammed the Canadian drug regulatory authority, Health Canada.

Over the course of the next week, maybe two, I am going to comment on the recommendations.

Tonight, I'm going to start with recommendation number 8. It's of vital importance as I see it as a jury completely shocked by what they have heard during the course of the two week inquest into the death of Sara Carlin.

Before I begin, I draw your attention to the way in which this jury were charged by the Coroner, Bert Lauwers.

Last week Lauwers told the jury:

"Do not include any narrative or any rationale in your verdict. I mean answer the 5 questions & provide recommendations if you think they are warranted. And then do not add a story line to that...don't in fact try to explain the reasons why you have given us the recommendations based on your verdict.

No recommendation expresses or implies a conclusion in law or comment on legal responsibility in law"

In layman's terms this basically means that the jury was not permitted to assign blame to any party including Paxil/GSK.

The reasons for this are obvious. Glaxo could have...and probably would have filed a lawsuit against those responsible for implicating their brand. So the jury deliberated with their hands tied.

The 5 person jury, made up of three men and two women, were all lay people. They, like the Carlin family, have all had to sit and listen to witness statements. They have had to go home at night with the image of Sara Carlin in their heads, an image that doctor's and lawyers tried so desperately hard to tarnish.

It would appear that the jury have, quite rightly so, seen through the appalling tactics of Glaxo and friends.

Here's recommendation 8 of 16 recommendations announced by the jury today.

B. Ontario College of Physicians and Surgeons

Ontario College of Family Physicians

8.The Ontario College of Physicians and Surgeons (OCPS) and the Ontario College of Family Physicians (OCFP) should develop practice guidelines and training to family physicians on administering and monitoring the use of selected serotonin reuptake inhibitors (SSRI's). Those guidelines should include, but not be limited to the folloving:

8.l. Prior to prescribing SSRI's the physician should;

- give the patient a physical examination

- request laboratory investigations, including drug screen, where appropriate

- inform the patient of the benefits and risks, inclusive of rare and serious side effects of SSRl's

- inform the patient of all reasonable alternative treatments and benefits and risks of such alternative treatments

- inform the patient of the treatment plan should SSRI's be prescribed

- discuss with the patient alcohol and substance abuse as cofounders in the illness

8.2. Emphasize to physicians that best practice for monitoring patients for drug-related adverse events arising from the introduction of SSRIs includes a regime in which the physician should monitor the patient with weekly visits for the first month, bi-weekly visits for the second month, and with a following visit in the third month. This eflectively would monitor the period of time with the greatest risk for the development of serious drug-related adverse events.

8.3. Encourage physicians to utilize tools created to monitor both disease symptoms and adverse events of patients undergoing treatment with SSRI's. An example of such a tool is the Using Selective Serotonin Reuptake Inhibitors (SSRl's) in Children and Adolescents and the SSRl Monitoring Form for Children and Adolescents devcloped in June of 2009 by the British Columbia Children's Hospital in Vancouver, British Columbia.

8.4. Emphasize to physicians that while having due regard for the relevant health privacy legislation in the jurisdiction of the medical practitioner relevant to capacity and consent; patients undergoing treatment should be encouraged, repeatedly if necessary, to allow communication and engagement of family members, guardians and/or trusted friends by their treating physicians to ensure that the patient and their support are aware of the nature of their disorder, and the potential side effects of prescribed medications and can then assist in monitoring for adverse drug-related events.

The jury here have made these recommendations based on the evidence provided. Remember, the only SSRi mentioned in this inquest was GSK's Paxil. Also remember the charge made to the jury before they retired where they were, in essence, told not to place blame.

It's plainly obvious, to me at least, that recommendation number 8 is damning for the way the doctors were involved with Sara Carlin's care, or not, as the case may be.

Remember it was Dr. Tom Stanton, Sara's doctor, who first prescribed her Paxil. It was Stanton who did not warn Sara that Paxil could possibly cause her to have thoughts of suicide or indeed kill herself.

Sara later saw Dr. Benjamin, remember her? She was the doctor that upped Sara's dose from 20mg to 30mg. She is also the doctor who chooses to use her maiden name whilst appearing at inquests and whilst practising as a doctor. She is in fact Mrs Merrick, her husband being none other than Andrew Merrick, the Director of Corporate Affairs for Eli Lilly Canada.

I see recommendation 8 as a direct result of the way both Benjamin [aka Merrick] and Stanton both treated Sara, that's just my opinion - readers can draw their own conclusions by reading the back stories provided at the end of this article.

I also see it as 5 normal people saying "enough is enough." No parent should have to go through this ever again - no jury should have to sit, watch and listen to sobbing, grieving family members.

Just by this one recommendation alone, the Carlin family has made huge strides into safeguarding the lives of children in Canada, in particular, Ontario.

One has to ask why something so obvious as this has never been either recommended or implemented before. Surely Health Canada have some sort of responsibility with regard to patient care?

Why has it taken the death of a young girl for recommendation number 8 to surface?

Sara Carlin is the 26th person in Canada whose death has been associated with GlaxoSmithKline's Paxil, I think it's safe to assume there is an association, even if the jury were not allowed to make such a claim.

26 reported deaths - that is, to Health Canada. We all know how lax the adverse reporting system [yellow card] is here in the UK with our own regulator, The MHRA. I think it would be safe to assume that the figure of 26 could quite easily be multiplied by 10, some quarters even suggest a multiplication of 100.

The Carlin family have been through a terrific ordeal these past two weeks, an ordeal that they should never have had to go through.

Had these recommendations been offered and implemented some years ago then Sara Carlin would have, at the very least, been offered a physical examination. Her prescribing doctor's could have requested laboratory investigations, including drug screen. She could have been told about the benefits and risks, including the rare and serious side effects of Paxil, such as suicidal thoughts and/or actually carrying out those thoughts. Such as substance and alcohol abuse.

It's too late for Sara Carlin now but in her death she has, with the strength of her parents and the tenacity of lawyer, Gary Will, had her voice heard loud and clear by the 5 person jury.

A voice that from the onset of this inquest has tried to be stifled by Glaxo and friends.

No doubt GlaxoSmithKline will see this as some sort of vindication that Paxil was not mentioned as being part of the reason why Sara Carlin killed herself - In truth, they were heading into this inquest on a 'win, win' basis. They knew Paxil could not be implicated.

What Glaxo failed to realise was 5 normal people from everyday backgrounds sat and watched as witness after witness took the stand making claims that Sara was an out of control teenager who drank and took drugs. A picture painted by Glaxo and friends that just did not sit right with the jury.

The jury will go down in history for being part of better safety regulations for the way Paxil and other SSRi type drugs are prescribed to this vulnerable group in future years.

Sara Carlin will go down in history as the reason these recommendations were made. For that, the citizens of Ontario, Canada, should live forever in her debt.

I'll be posting more about the other recommendations over the coming days and weeks and I will be interviewing Neil Carlin at some point.

Finally, during the past two weeks, there has been abhorrent behaviour regarding Sara's death from an obsessive individual.

Once the dust has settled and I have wrote about these recommendations, I am going to name and shame him. I am also going to name those [group moderators] that have allowed his vile posts through on to Yahoo Groups.

That can wait.

In the meantime, my thoughts are with the Carlin family.

For what they have gone through and what they have achieved today deserves a standing ovation.

More on the recommendations later this week.

You can read more about the Sara Carlin Vs Glaxo & Friends Inquest at the following links:

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline



SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?

Sara Carlin Inquest - We Know How, Now Tell us Why!

On May 6, 2007, Sara Carlin, a beautiful 18-year-old girl with everything to live for, grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK). Paxil/Seroxat is an antidepressant documented by international drug regulatory agencies as causing worsening depression and suicide particularly in children and young adults.

Please help inform others of the risks of these drugs. Forward this video to everyone you know.

RIP Sara Alison Carlin




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