Judge Hamilton & Co Toss $3M Dolin Verdict

Yesterday's decision from the Seventh Circuit declared "the drugmaker (GSK) can’t be sued under Illinois law for insufficiently warning of suicide risk on a drug’s label, when that label’s language was set by federal regulators."

Read on...

pre·con·ceived

adjective

(of an idea or opinion) formed before having the evidence for its truth or usefulness.

Mayor Larry Vaughn (left)

Jaws Synopsis

During a beach party at dusk on Amity Island, New England, a young woman, Chrissie Watkins, goes skinny dipping in the ocean. While treading water, she is violently pulled under. The next day, her partial remains are found on shore. The medical examiner's ruling that the death was due to a shark attack leads police chief Martin Brody to close the beaches. Mayor Larry Vaughn overrules him, fearing that the town's summer economy will be harmed. The medical examiner now concurs with the mayor's theory that Watkins was killed in a boating accident.

Seventh Circuit Judge David Hamilton

On May 30, 2018, the Seventh Circuit Court of Appeals heard a plea from GSK with regard to reasons why they don't feel they shouldn't pay a $3million fine handed down to them last year. During the oral arguments, Seventh Circuit Judge David Hamilton (Pictured above) repeatedly voiced doubts over the issue of so-called “innovator liability,” or the theory that the original makers of a drug – the “innovator” – should be held liable for the effects caused by others’ imitation product. Hamilton stated that it could significantly harm the pharmaceutical industry, and consumers and patients who rely on the medications invented and manufactured by the industry.

Ironically, the actor who played Mayor Larry Vaughn in the movie Jaws, Murray Hamilton, shares the same surname as Seventh Circuit Judge David Hamilton. To my knowledge, they are not related.

I've been a fan of Jaws, particularly the screenplay, for many years. It bears so many striking similarities to the pharmaceutical industry (the shark) and the advocates that try to highlight wrong-doings, Quint, Brody, and Hooper. 

Yesterday's decision from the Seventh Circuit declared "the drugmaker can’t be sued under Illinois law for insufficiently warning of suicide risk on a drug’s label, when that label’s language was set by federal regulators."

Seventh Circuit Judge David Hamilton. Circuit Chief Judge Diane P. Wood and Circuit Judge Diane Sykessaid, said, "GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case. Therefore, they said, the lawsuit should have been dismissed." Further, they added, "Court judges erred when they allowed to go to trial a lawsuit brought by Stewart Dolin's widow (Wendy Dolin)"

Former Glaxo CEO, JP Garnier

"There is a legal right for us to go directly to the public"

Nowhere in the Seventh Circuit's panel conclusion does it state that paroxetine wasn't responsible for Stewart Dolin's induced suicide, in fact, it suggests that it did, but claims GSK did enough to warn Stewart, even though the FDA didn't heed that warning. The ruling failed to mention the deposition, shown at the 2017 Dolin trial, by former Glaxo CEO, JP Garnier, in which, when asked, "You can change your label without even getting approval from the FDA, there's a law that allows you to do that, correct?", he answered, "Yes...it's considerably disrupting, that's why most companies go through the FDA first, in practice, but you are right, there is a legal right for us to go directly to the public."

In response to the ruling, Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman, stated “We are surprised and disappointed with the court’s ruling and respectfully disagree. We will be exploring Ms Dolin’s options.”

"You go in the cage, cage goes in the water, you go in the water. Shark's in the water, our shark."

The FDA has remained silent throughout. They are, it appears, answerable to nobody. With an admission by GSK's former CEO that there is a legal right for GSK to go to the public, ergo, they can bypass the FDA, the question still remains, why didn't they?

GSK, and other pharmaceutical companies are, as we know, in bed with each other. It's a sick, incestuous relationship that puts everyone who ingests a pharmaceutical product or who uses a medical device, at harm - the same harm that Seventh Circuit Judge David Hamilton used in his defence of the pharmaceutical industry. It would appear that they can be protected from harm but the same rules do not apply to consumers, we simply go in the cage, cage goes in the water, we then go in the water. Remember that next time you pick up your next prescription, folks!

The pharmaceutical and regulatory pools are infested with sharks!

Afterword:

A Japanese submarine slammed two torpedoes into our side, Chief. We was comin' back from the island of Tinian to Leyte, just delivered the bomb. The Hiroshima bomb. Eleven hundred men went into the water. Vessel went down in twelve minutes. Didn't see the first shark for about a half an hour. Tiger. Thirteen-footer. You know how you know that when you're in the water, Chief? You tell by lookin' from the dorsal to the tail. What we didn't know... was our bomb mission had been so secret, no distress signal had been sent. Heh.

They didn't even list us overdue for a week. Very first light, Chief, sharks come cruisin'. So we formed ourselves into tight groups. Y'know, it's... kinda like ol' squares in a battle like, uh, you see in a calendar, like the Battle of Waterloo, and the idea was, shark comes to the nearest man and that man, he'd start poundin' and hollerin' and screamin', and sometimes the shark'd go away... sometimes he wouldn't go away. Sometimes that shark, he looks right into ya. Right into your eyes. Y'know the thing about a shark, he's got... lifeless eyes, black eyes, like a doll's eyes. When he comes at ya, doesn't seem to be livin'... until he bites ya. And those black eyes roll over white, and then... oh, then you hear that terrible high-pitch screamin', the ocean turns red, and spite of all the poundin' and the hollerin', they all come in and they... rip you to pieces.

Y'know, by the end of that first dawn... lost a hundred men. I dunno how many sharks. Maybe a thousand. I dunno how many men, they averaged six an hour. On Thursday mornin', Chief, I bumped into a friend of mine, Herbie Robinson from Cleveland- baseball player, boatswain's mate. I thought he was asleep, reached over to wake him up... bobbed up and down in the water just like a kinda top. Upended. Well... he'd been bitten in half below the waist. Noon the fifth day, Mr. Hooper, a Lockheed Ventura saw us, he swung in low and he saw us. The young pilot, a lot younger than Mr. Hooper. Anyway, he saw us and come in low and three hours later, a big fat PBY comes down and start to pick us up. Y'know, that was the time I was most frightened, waitin' for my turn. I'll never put on a life jacket again. So, eleven hundred men went into the water, three hundred sixteen men come out, and the sharks took the rest, June the 29th, 1945.

Bartholomew Marion Quint ~ Amity Island, MA

--

Bob Fiddaman


Backstories in chronological order:

Dolin Vs GSK

Dolin v GSK - Opening Arguments

Dolin Vs GSK - Day Two - "Jack-In-The-Box"

Dolin vs GSK - Healy 'Rocks Da House'

Dolin Vs GSK - JP Garnier Video Deposition

Dolin Vs GSK - The Dunbar Tape

Dolin Vs GSK - Day 4 - Slam Dunk

Dolin Vs GSK - 8.9 Suicide Increase For Adult Paxil Users

Dolin Vs GSK - Day 6 - Ass Kicking Semantics

Dolin Vs GSK - Day 7 - Abraham Lincoln

Dolin Vs GSK - Day 8 - Get to the Point, Todd!

Dolin Vs GSK - Glenmullen Nails It!

Dolin Vs GSK - "Babes"

Dolin Vs GSK - Wendy's Cross and GSK's Petition

Dolin Vs GSK - Robert "Bling Bling" Gibbons

Dolin Vs GSK: Suicide Prevention Warning "Futile", Claims GSK Exec

Dolin Vs GSK : Jury shown List of the Dead in Paxil Clinical Trials

Dolin Vs GSK: Last Man Standing & The Return of Dr. Healy

Dolin Vs GSK: Closing Arguments

Dolin Vs GSK - The Verdict

Exclusive: Interview With Wendy Dolin

From Chicago to New York - The Legacy of Stewart Dolin

Dolin Wins...Again

Dolin Vs GSK: Personal Vendetta or Bigger Picture?

GSK's Attorney Labels His Failure An "Accomplishment"

Generic Paxil Lawsuits Filed

GSK's Nutcracker Dilemma

Seventh Circuit Court of Appeals

Psychiatry: A Faith-Based System?

Prof Wendy Burn, president of the Royal College of Psychiatrists (Image: publicity picture)

Wendy Burn, President of the Royal College of Psychiatrists has recently engaged with fellow sufferers of antidepressants via Twitter. Burn, 58, had blocked a number of followers but in a recent u-turn has now unblocked many of those who criticized her stance on antidepressant withdrawal.

Burn fuelled the fire earlier this year when she, along with RCP colleague, David Baldwin, wrote a letter to the Times newspaper claiming, "We know that in the vast majority of patients, any unpleasant symptoms experienced on discontinuing antidepressants have resolved within two weeks of stopping treatment." (back story)

Burn's presence and engagement on Twitter is refreshing, and sometimes very frustrating. For the advocates who criticise psychiatry and the wanton use of antidepressants, it's been eye-opening and, at times, jaw-dropping. None more so than the following snapshot of tweets she and I had.

Here's the order in which they were asked and answered.

Surprisingly, Burn didn't respond to my last two tweets. I'm not chastising her for failing to respond, as I know she is also answering many other queries from disgruntled service-users.

It would appear Burn bases her diagnosing and prescribing system based on faith rather than actual science. Here's why:

First off, by Burn's own admission, she works, in the main, with elderly patients, 65 and older.

Burn asserts that elderly people metabolise more slowly so drugs stay in their system longer, which, assumes Burn, minimises withdrawal.

Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. The primary site of drug metabolism is the liver, the organ that plays a major role in metabolism, digestion, detoxification, and elimination of substances from the body.

Research has found that people fall into one of four general metabolizer types. (1)

The Four Metabolizer Types

- Poor metabolizer: Patients who are poor metabolizers experience a very slow breakdown of medications, making side effects more pronounced. That means standard doses of certain medications may not work as intended.

- Intermediate metabolizer: A slowed metabolism may impact breakdown of medications, causing effects similar to poor metabolizers, but not as pronounced.

- Extensive metabolizer: Considered a “normal” rate of metabolism. Patients are likely to metabolize medication normally and medication is likely to work as intended.

- Ultrarapid metabolizer: Patients in this group metabolize medications too quickly to experience relief from symptoms of depression or other disorders.

Are elderly people more prone to a poor metabolizing system?

According to statistics (2), 40% of the elderly regularly take five or more concomitant prescription medications, add to this the fact that many medications have more than one metabolic pathway, and you can see how prescribing, or adding medication into the mix, can be extremely dangerous for anyone 65 and older.. Furthermore, if, as Burn assumes, 'most (elderly) are slow metabolizers', then without any test in place prior to prescribing she, along with other treating physicians are basically taking it on faith that the person in front of them is a poor, intermediate, extensive or ultrarapid metabolizer.

I asked Burn if she carried out any Pharmacogenomic testing prior to prescribing to her elderly patients. She never responded.

If you, like me, struggle to grasp how the metabolizing system works then a layperson's explanation may help.

Let's say I am a poor metabolizer and my best friend is an extensive metabolizer. Both of us are depressed and both have been prescribed an antidepressant of the SSRI family.

After taking the drug at exactly the same time, my friend excretes it far quicker from his body so when it's time for our next dose I am at a slight disadvantage because my second dose will be topping up my first dose, whereas my friend will have most of his original dose excreted from his system or a higher percentage of it than I.

Now, let's say we are both on these drugs for 6 weeks. The build-up of the drug in my body will be far greater than that of my friend. He may be able to withdraw without any problems, whereas I may find it extremely difficult to withdraw. I may also have toxicity in my system.

If Burn assumes that the elderly are slow metabolizers then when prescribing to them she is doing so by using a belief rather than any scientific testing such as pharmacogenomic testing. If, by her own admittance, she knows they are slow metabolizers then they will more than likely endure what I did in the example above.

One should also take into account a person's genetic factors when prescribing. Genetic factors account for 20 to 95% of patient variability in response to individual drugs. (3) - It seems perfectly logical then that a prescriber would choose to ensure the safety of their patient when prescribing a drug. By claiming that they 'monitor' patients is clearly not good enough, particularly when they have a tool at their disposal that can predict if their patient will struggle on the drug they prescribe, moreover, if the drug will stay in their system longer making the withdrawal process more difficult.

Quite why this isn't mandatory will, more than likely, be blamed on the expense and how 'time-consuming' the whole process can take. I really don't buy into the 'monitoring' angle, I mean, how can a prescriber monitor a patient 24/7?

Burn is on a hiding-to-nothing when she is posed questions by many drug safety advocates on Twitter. I give her kudos for attempting to tackle the hundreds of tweets she receives daily now that she has unblocked many of those who previously opposed her views.

Science can only be the winner here and not assumptions. One prescriber may have different approaches than another - one may be more thorough when deciding to prescribe. Assuming a patient may or may not be a slow metabolizer is tricky ground though. If we can't predict (without pharmacogenomic testing) then should psychiatrists and doctors really be prescribing toxic drugs to patients at all? It's Russian Roulette, but we are told, and always have been, that the benefits outweigh the risks.

Serotonin toxicity, often incorrectly called a "syndrome", is best managed by reducing and/or discontinuing the offending drug(s). If left untreated it can lead to akathisia, an emotional state that can sometimes include the emergence of strange and unusual impulses, often of an aggressive nature. It can also lead to violence and suicide. (4)

Burn, in defence of her statement to criticisms of her Times letter, has claimed that in her clinical experience she has never seen a patient suffering from severe withdrawal from antidepressants. We have to take this at face-value as there is no way of knowing if, a; Burn knows the difference between antidepressant withdrawal and "depressive symptoms" and, b; whether or not she is being truthful.

Many elderly patients trust prescribing physicians, my own mother did when she was alive. Many don't like to 'rock the boat'. We often hear the elderly make claims such as, "The good old doctor went through years of med school, so they know exactly what they are doing", and, "they wouldn't give me a drug that could harm me."

Reminds me of the statement King & Spalding's lead attorney made in his closing statements to the jury in the Dolin v GSK Paxil-induced suicide trial:

“Don’t you think if these medicines caused suicide someone would have spoken up?” ~ Andy Bayman - King & Spalding.

The jury did.

I long for the day when Wendy Burn and her peers acknowledge that the drugs they prescribe to children, adults and the elderly may be the cause of depressive symptoms and feelings of hostility. Judging by her current stance, however, I think we may be in for a long wait.

Bob Fiddaman


(1) Fast, Slow or In-Between: How Your Genes Affect Medication Success
(2) Pharmacogenomic Treatment Support, Today’s Geriatric Medicine, Vol. 7 No. 4 P. 20
(3) Hypothesis: comparisons of inter- and intra-individual variations can substitute for twin studies in drug research.Pharmacogenetics. 1998 Aug;8(4):283-9.
(4) What is akathisia?

The Unscrupulous Activities of Monsanto (Video)

A fascinating insight into the unscrupulous activities of Monsanto is doing the rounds on YouTube.

The show, The HighWire, hosted by Del Bigtree, invited Baum Hedlund's Lead and co-counsel, Brent Wisner and Robert F. Kennedy Jr into the studio to discuss the recent $289 million verdict against Monsanto.

The success for the plaintiff, Dewayne Johnson, will be short-lived as the former groundskeeper has terminal cancer and is, sadly, expected to die soon. The victory could set a massive precedent for thousands of other cases against Monsanto. I hope they name a law after Johnson, his courage to step up to the plate and take on the unethical and immoral Goliath needs to be remembered...forever.

Monsanto, as expected, has appealed the verdict.

The interview starts at 38.40 and features, amongst other revelations, jaw-dropping internal emails from Monsanto employees who wanted to keep the cancer link 'in-house' rather than tell an unsuspecting public.

Bob Fiddaman

If you have been diagnosed with non-Hodgkin lymphoma after being exposed to Roundup weed killer and would like more information about whether you might have a potential Roundup lawsuit, please contact a personal injury attorney at Baum, Hedlund, Aristei & Goldman

Guest Post: Irresponsible Reporting Harms Parents & Children

Kristina Kaiser Gehrki

Irresponsible Reporting Harms Parents & Children 

By Kristina Kaiser Gehrki

In 1987 I was an optimistic college student earning my first degree in journalism from a top 10 university program that was then, and remains today, highly ranked by the Associated Press.

I vividly remember class discussions about the Washington Post—a newspaper that had diligent reporters such as Bob Woodward and Carl Bernstein who exposed wide-scale corruption to include President Nixon’s Watergate scandal. Back then, venerable Washington Post reporting was often seen as a public service for the greater good. It was good journalism about which Academy Award-winning movies like “All the President’s Men” were made. 

Flash forward to the present decade and it appears journalism ethics and responsible reporting has gone the way of the dinosaurs. Yesterday’s article in the Washington Post titled, “Your Child is Nervous About the New School Year, Which May be Normal—or Not,” is just one of a long string of examples.

In an effort to sell and publish articles, journalists often write stories called “evergreens.” Such articles have a long shelf life and keep their leaves when autumn arrives. I suspect the “Your Child is Nervous” article by Jill U. Adams was likely written as an evergreen, and the back-to-school marketing headline was later crafted to catch the attention of concerned parents who want to ensure their kids are happy and healthy.

As a parent, trained journalist and former teacher, Adams’ article caught my attention because of what she claims and what she chooses to omit.

Jill Adams -  freelance science journalist

Former Pharma Employee-Cum-Reporter Promotes Risky Drugs for Kids

Adams states kids with anxiety can benefit from cognitive therapy—and certain drugs. She specifically asserts: “Medications can help, too, particularly the class of antidepressant drugs known as selective serotonin reuptake inhibitors, or SSRIs.” 

Really? Given that Adams is also a trained pharmacologist, one presumes she is aware of research that finds SSRIs are neither safe nor effective for children. Adams neglects to mention such nor does she inform her Washington Post readers that she studied psychoactive drugs for Johnson & Johnson. 

I can’t help but wonder, was Adams working for Johnson & Johnson when the company criminally marketed Risperdal for unapproved use by children? More than 30 children died and more than 1,000 reported serious complications. The US Dept. of Justice effectively forced Johnson & Johnson to pay more than $2.2 billion to resolve these criminal and civil charges. 

Parents Denied US FDA Black Box Warning Info

US FDA Black Box Warning

While promoting SSRIs to reduce childhood anxiety, Adams also fails to mention that SSRIs carry the US FDA’s most serious Black Box warning. (Above image). She doesn’t note SSRIs cause akathisia which often causes psychosis and unwanted deaths. Reporters are not legally required to communicate FDA Black Box warnings with the readers who trust them. Doctors are not legally required to share FDA Black Box warnings with the parents who trust them. But that doesn’t mean it is ethical for either to withhold such life-saving information.

Failure to Share Conflicts of Interest

Adams also neglected to inform readers that her quoted source, psychiatrist John Walkup, has several potential conflicts of interest to include taking free drugs and money from many pharmaceutical companies.

Adams’ Health and Science section article is simply the latest of many accountability and ethics problems found in mainstream newspapers. Years ago after my teenaged daughter died a prescription-drug-induced death, I contacted the Washington Post about similar omissions and reporting errors. My valid concerns backed up by published data were met with a virtual pat on the head and false promises to contact me should they ever again cover this topic.

A Constant Pattern of Zero Accountability

Systemic errors of omission don’t just occur in newspaper articles; they also rear their ugly heads in the Letters to the Editor and Op-Ed pages.

The Washington Post Letters to the Editor section requires writers to “disclose any personal or financial interest in the subject matter of their letters.” However, in 2014, the newspaper published a letter that appeared to be written by your average Joe, a man named David from Vermont. David’s letter was in response to a Washington Post article about SSRIs, depression and children. His letter expressed concern for children who are depressed and supported the use of pharmaceutical products as effective treatment.

I noticed the letter writer’s last name was “Fassler” and realized this seemingly average Joe from Vermont was Dr. David Fassler, a child psychiatrist and frequent testifier to the FDA in support of the pharmaceutical industry. Fassler describes himself on his LinkedIn page as a specialist in “child and adolescent psychiatry” and “forensic psychiatry” and notes he’s worked with the Executive Director of NAMI-Vermont. NAMI, is the National Alliance for the Mentally Ill and has been the subject of Congressional investigations into its deep financial ties to the pharmaceutical industry. 

Fassler testified at the 2004 FDA SSRI hearings in support of prescribing SSRIs to children. Specifically, “David Fassler of the American Psychiatric Association cautioned that the FDA should not scare patients away from treatment.” Ironically, this was a quote from the Washington Post.

The FDA also heard testimony from many family members who carried photos of their dead loved ones while recounting the torturous SSRI Adverse Drug Reactions they suffered before dying. After the hearings, the FDA responded, albeit far too late, by placing the Black Box suicide warnings on SSRIs.

Fassler’s more recent FDA testimony supported prescribing atypical antipsychotics to children.

Who “Works” for Whom?

But back to 2014. I contacted Fassler to inquire why his Washington Post letter to the editor didn’t disclose his medical credentials nor any personal and financial interests in the subject matter. Our correspondence is below:

On 7/11/14 12:32 PM, Kristina G. wrote:
--------------------
Hi David,

I read with interest your letter to the Washington Post. I was wondering why you didn't share your expertise as a child psychiatrist, experience testifying, and work with pharmaceutical companies? If you write the Post again, perhaps you should include your background so readers can better respect and understand your viewpoints. 

Regards,
Kristina Gehrki

--

On 07/11/14 5:36 AM, David F. wrote:
--------------------
Hi Kristina

I did tell the Post I was a child psychiatrist, but they chose not to include any identification. 

I don't do any work w/ pharmaceutical companies.

David

--

It’s important to note Fassler stated: “I don’t do any work w/pharmaceutical companies.” Perhaps he also has no personal or financial interests in the subject matter he wrote about? What is not debatable is that Fassler is an active member of The American Academy of Child and Adolescent Psychiatry (AACAP) and ran for their national position as AACAP Treasurer in their 2013 election. It must be an important position considering AACAP states that in 2012 their “60th Annual Meeting Sponsorships” included “Pharmaceutical sponsorships” that “totalled $175,000.”

I can’t help but wonder if Fassler sat next to Dr. John Walkup at this annual conference when Walkup was a featured speaker at AACAP’s 2013 Psychopharmacology Update Institute. I also wonder if Fassler read AACAP’s 2013 Report to the Council that stated:

“August 14, 2012 Informed on August 4 that Wayne Batzer, M.D. resigned as a member of AACAP stating, “The Academy is clearly reliant on continued pharmaceutical industry funding and I am no longer able to accept this.” 

Looking back on it, I’ve come to accept Fassler’s statement “I don’t do any work w/pharmaceutical companies” at face value. To me, its relevancy depends upon how one first personally defines the word “work.”

Experience is the Best Teacher

Today I’m no longer an optimistic college student. While I’ve earned more advanced degrees and certificates, the most important knowledge I’ve gained since my daughter, Natalie's, prescribed demise comes from experience and research. Independent research and unbiased “journalism” uncovers unimaginable fraud, collusion, corruption and ethical violations in nearly every nook and cranny—from university medical schools to medical associations, from pharmaceutical headquarters to neighbourhood pharmacies, from national papers to your hometown rag, and right on down to your local doctors.

As a former high school marketing teacher, I understand parents want their children to start the school year off right. Parents want to believe things that will provide comfort. Seeking comfort is a basic human trait. But I implore parents who might read yesterday’s Washington Post dribble or another newspaper’s misleading article tomorrow: Remember, just because something sounds comforting doesn’t mean it is true.

When Natalie was 10, I took her to a therapist because of concern about mild school anxiety. I wanted the best for my child. Unfortunately, what we anticipated would be talk therapy soon turned into drug “therapy” prior to the FDA’s SSRI Black Box warning. It’s tragic that misinformed parents who read such articles might unwittingly go down the same dangerous drug path from which there may be no return. I speak up simply because I don’t want to see other trusting parents caused permanent discomfort when later they find themselves visiting their children’s graves.

Natalie’s prescribed demise is featured here & here. Like Anne Frank, Natalie's diary documented her torture and it is hoped society can learn from these systemic atrocities.

Kristina Kaiser Gehrki is a public health and safety advocate and educator. She holds degrees in crisis and strategic communication, journalism and education but feels her most relevant knowledge stems from personal experience. Her teenage daughter, Natalie, died a prescription-drug induced death after suffering SSRI Adverse Drug Reactions and SSRI withdrawal that was undiagnosed by her doctor and improperly treated with SSRI dose increases.