Widow asks SCOTUS to toss GSK’s win in lawsuit over Paxil labeling, lawyer’s suicide


GlaxoSmithKline  

Asserting a Chicago federal appeals panel wrongly invalidated a jury’s verdict, attorneys for the widow of a Chicago lawyer who committed suicide after taking the generic version of the antidepressant drug Paxil, have asked the U.S. Supreme Court to throw out the appellate ruling and order more proceedings on whether pharmaceutical company GlaxoSmithKline should be made to pay for allegedly not revising their drug’s warning label to reflect an increased risk of suicide.

On Dec. 19, attorneys for Wendy Dolin filed a petition with the U.S. Supreme Court, asking the nation’s high court to take up their appeal of the decision from the U.S. Seventh Circuit Court of Appeals in Chicago, which had found a federal jury was wrong to order drugmaker GSK to pay Dolin $3 million. In that decision, the appellate judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.

“The Seventh Circuit’s decision creates a world where a drug manufacturer is permitted under the First Amendment to promote its drug for non-FDA approved indications, … but a drug manufacturer is prohibited from issuing warnings concerning life threatening risks associated with its drug,” Dolin’s attorneys wrote in their petition.

The petition was filed about four months after a panel of three Seventh Circuit judges threw out the verdict in favor of Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a downtown Chicago transit station. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil. She alleged the drug’s label, which was written by GSK and is identical for the name brand and generic versions, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.


Bijan Esfandiari   Baum Hedlund Aristei & Goldman P.C.

GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.

After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.

In the appellate decision, the judges, led by Circuit Judge David Hamilton, found GSK had asked the FDA four times to change the labels, but the FDA had ordered GSK to use standard language the FDA approved for paroxetine and other antidepressants. This showed GSK had no control over the labels, Hamilton said.

In their petition to the Supreme Court, however, Dolin’s lawyers said this finding represented a misreading of the case. They asserted the FDA had not disallowed the revisions, but rather had directed GSK to publish suicide risk warnings as a supplemental warning, known as a Changes Being Effected, or CBE, provision.

Dolin’s attorneys further argued the Seventh Circuit’s decision ignored key legal precedents, including the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies can revise labels to enhance warnings, without FDA approval.

Dolin’s attorneys painted the Seventh Circuit ruling as “unreasonable,” as it came despite contrary findings from “nine jurors and two distinguished district court judges reviewing the same facts” who “found that GSK was not prohibited from issuing stronger warnings.”

“There is no evidence the FDA ever rejected a paroxetine-specific adult suicide warning,” Dolin’s lawyers claimed. “The FDA’s invitation to GSK to use the CBE (which GSK could use unilaterally without the FDA’s invitation) to issue a paroxetine-specific adult suicidality warning in a place within the label that is outside the class labeling section can hardly be considered or interpreted as a rejection of a paroxetine-specific adult suicide warning.

“…It is akin to being invited to dance but construing that invitation as clear evidence of rejection.”

Dolin’s lawyers noted the Supreme Court is scheduled to hear arguments in a similar case, Merck v Albrecht.

In that case, the U.S. Third Circuit Court of Appeals came down on the question opposite the Seventh Circuit. In their decision, Dolin’s lawyers assert, the Third Circuit judges determined such labeling questions were appropriate for a jury, and “a reasonable juror could conclude that ‘the ball was in (drugmaker) Merck’s court’ to submit a revised CBE for the correct enhanced warning.”

Dolin’s lawyers asked the Supreme Court to delay action on their petition until resolving the Albrecht case. But after Albrecht, the lawyers asked the high court to vacate the Seventh Circuit decision and remand the case for new proceedings.

The petition was filed by attorneys Bijan Esfandiari, of the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and David E. Rapoport and Mathew S. Sims, of the Rapoport Law Offices P.C., of Chicago.

GSK has been represented by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.

Advertisements

Mom’s Emotional Warning: Talk to Your Doctor Before Taking Antidepressants While Pregnant


Mom’s Emotional Warning: Talk to Your Doctor Before Taking Antidepressants While Pregnant

Photograph by Meg Boggs and Matilda Berrelez

From weight gain to postpartum depression, Meghan Boggs has been sharing her struggles, fears, failures and successes on Instagram for quite some time. Five days ago, she shared another. Only this time, it wasn’t her story to tell— it was her sister’s.

meg.boggs

Meet my sister, Tilly. Her #iam1in5 story is one that has changed her, our family, and so many people around the world. Tilly has been on medication since she was 15 years old. During her second pregnancy, she was told that it was safe to continue taking her antidepressants (Paxil). She then discovered at an ultrasound just four weeks before her due date that Adrian, her son, had several heart defects. Adrian had open heart surgery at just 8 days old. Tilly found out just a few months later that this was all caused by the antidepressants she was on during her pregnancy and sued the company. Adrian was one of the very first cases, and she won. The labels were then changed to reflect the dangers of taking them while pregnant. But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe. . It’s now been 14 years since she had Adrian, and he’s had 5 open heart surgeries, 3 pacemaker changers, countless heart catheterizations and will eventually need a heart transplant. She is the definition of strength and I have always looked up to her because she is an unbelievable mother. She is also 1 in 5, but even through all that she has been through, she has always done whatever it takes to be the best mother to all three of her children. She is a warrior and I am so thankful she agreed to share her story. * To read her full story and her advice for anyone who is struggling to cope with being off medication during their pregnancy, head over to my blog. And watch my stories to see photos of Adrian throughout his journey. ♥️ * Disclaimer: This post is not meant to provide medical advice. Always consult your doctor about any questions about your health, medications, and pregnancy. You have options. Let your voice be heard.

“Meet my sister, Tilly,” she wrote. “Her #iam1in5 story is one that has changed her, our family, and so many people around the world.”

Boggs’ sister, Matilda (Tilly) Berrelez, has been on antidepressants since she was 15 years old. She was 21 in 2003 when she found out she was pregnant with her second child.

At the time, Berrelez (then Vasquez) was told it was safe to continue taking Paxil—an SSRI (selective serotonin reuptake inhibitors) drug she’d been taking to treat depression and anxiety. So, she did as she was told and continued taking the medication, unaware of any risk to her unborn child.

Four weeks prior to her due date, however, an ultrasound revealed that her baby had several heart defects.

Adrian Vasquez, born April 19, 2004, was only 8 days old when he underwent his first heart surgery. Five months later, news broke that taking Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Paxil during early pregnancy could cause heart defects, lung defects, clubfeet and cranial defects in newborns.

Boggs told Mom.me that Adrian’s case was “the very first one to go against a pharmaceutical company.” In fact, she added, “CNN covered this and came out to our house to film.”

After winning the case against GlaxoSmithKline—the makers of Paxil—Boggs said companies began changing their labels to reflect the risks and dangers of taking SSRI drugs while pregnant.

“But even though she won the case, she was left with a child who would never live a normal life. She was left with the guilt that came with her decision to continue the medication even though she was told it was safe.”

In a full story on Meg Boggs, Berrelez (now 36), recalls the moment she learned her son was in trouble. After waiting nearly 45 minutes for a technician to finish taking an ultrasound, she asked if there was something wrong.

“She stopped the ultrasound, looked me in the eyes for a split second, looked down, then told me she would be right back with me and left the room,” she wrote. A few minutes later, she returned with the doctor, who said, “I’m sorry to tell you this, honey, but there is something wrong with your baby’s heart.”

A month later, Berrelez was told that her son had a double outlet right ventricle, patent ductus arteriosus, and pulmonary stenosis. That was 14 years ago.

Since then, Adrian has had five open-heart surgeries, three pacemaker changers and countless heart catheterizations. A heart transplant is almost inevitable.

“We are estimating this will occur sometime in his teenage years,” wrote Berrelez, who says she wouldn’t wish this for anyone—mother, child or family.

“There is no greater worry, pain, anxiety or nauseating sensation that compares to what my little boy has gone through since the day he was born,” she wrote.

“If there is a chance of your child being harmed by the medication you are taking, do all you can to discontinue the medication for as long as possible.”

GlaxoSmithKline, Walgreen accused of negligence for allegedly selling Paxil to pregnant women


 

 

CHICAGO — A group of mothers are suing GlaxoSmithKline, which manufactured the antidepressant drug Paxil, and Walgreen Co., citing alleged strict liability.

Alexandria Hamilton, Deanna James and Kenneth West filed a complaint on Aug. 31 in Cook County Circuit Court, alleging the defendant companies failed to adequately warn of the alleged dangers of taking the drug paroxetine while pregnant.

According to the complaint, between 1998 and 2005, the mother plaintiffs were prescribed and used branded paroxetine, sold under the brand name Paxil, during their pregnancies, allegedly resulting in birth defects.

The plaintiffs request a trial by jury and seek an amount in excess of the court’s jurisdictional requisite, costs of the action and such further relief as the court deems proper. They are represented by Kenneth Brennan, Tor A. Hoerman and Steven Davis of TorHoerman Law LLC in Chicago.

Cook County Circuit Court Case number 2018L009501

Professor David Baldwin’s Lovefest With The Pharmaceutical Industry….


davidbaldwin

David… did you miss the part where it says on the doctors oath’ First do no harm?.

What did you think it said, ‘First do for Pharm(a)?’ …

https://www.theguardian.com/society/2003/mar/17/mentalhealth.politics

“…Dr Baldwin declared a personal interest in Lundbeck, manufacturers of the drug Citalopram. According to the minutes, however, he did not declare his connections with five other companies, including Seroxat manufacturers SmithKline Beecham, which is now GlaxoSmithKline…..”

The Guardian 2003..

https://player.fm/series/mad-in-america-science-psychiatry-and-social-justice/episode-47-conflicts-of-interest-questioned-in-review-of-prescribed-drug-dependence

Prof David Baldwin was instrumental in the promotion of Seroxat in the late 90’s. I hold him partly responsible for the damage that Seroxat did to me, and to many tens of thousands of others. He didn’t warn us of the serious side effects like akathisia, aggression, suicidal thoughts and withdrawals. He benefited (financially) while, I- and many others- suffered, being poisoned on a drug that should never have been licensed.

In the 1990’s Seroxat was a relatively new drug on the market, promoted and pushed heavily, by GSK and its legion of psychiatrists, academics, and doctors on its payroll at the time.

David Baldwin said of Seroxat, in 1998 (the year I was prescribed it -ironically).

“...Dr David Baldwin, senior lecturer in psychiatry at the University of Southampton, said it was one of the safest drugs ever made…

I find it remarkable how David Baldwin could state at the time that Seroxat was one of the safest drugs ever made, when little was known about how Seroxat would be received (in terms of millions of people being prescribed it). How could Baldwin know that Seroxat was one of the safest drugs ever made? He simply couldn’t know that, and to make a statement like that, is really quite audacious.

What Baldwin didn’t tell the public at the time (that he was making these outrageous statements to the media about Seroxat), was that he was also an utter whore to the pharmaceutical industry (and still is). He has more conflicts of interest than I’ve had hot dinners.

Of course, in the UK, there is virtually no transparency in relation to how much financial gain doctors like Baldwin get from promoting pharmaceutical products to the public whilst receiving payments from the drug manufacturers. Even when they do have to declare conflicts, it only has to be declared in relation to the topic at the time, and only in the last 3 years. Therefore, it can seem like doctors are a lot less in conflict that they usually are.

David Baldwin has blood on his hands from his promotion of Seroxat. How much money did GSK give him over the years? why don’t you tell the public, and the media, that David? and while your at it- why don’t you disclose the total sum of financial gain you’ve made from your faustian pact with the entire pharmaceutical industry (throughout your career) defending anti-depressants against criticism in the media?

What would Dr Baldwin say to all the families, parents, and friends of those who killed themselves from being prescribed a drug that is as harmful as Seroxat?

I hope Baldwin enjoys his piles of pharmaceutical money in this mortal sphere, you can’t spend it in hell David can you?

Because, for people like you, hell wouldn’t be hot enough.

Seroxat is not one of the safest drugs ever made David, it’s one of the most dangerous. You profited while people died on it. You promoted it, whilst also getting paid by the drug company. I almost lost my life on Seoxat, and it’s because of the greed and arrogance of psychiatrists like you that many people have been harmed by psychiatric medications. It doesn’t seem to matter to you that GSK are one of the most corrupt pharmaceutical companies on the planet, with a record of dodgy drugs, fraud, lies, and harm to patients.

You would take money from them despite knowing this.

Shameful.


For more on Dr Baldwin’s absolute prostitution of himself to the pharmaceutical industry see here-

https://holeousia.com/?s=David+Baldwin

For extensive links to Seroxat study 329, and its harms to kids, see here-

https://study329.org/

For other links to Seroxat horrors see here-

https://seroxatsecrets.wordpress.com/

For links to a complaint made about Baldwin see here –

http://cepuk.org/wp-content/uploads/2018/03/Complaint-to-RCPsych.pdf


Professor David Baldwin MA DM FRCPsych FHEA

David Baldwin is Professor of Psychiatry and Head of the Mental Health Group in the Clinical and Experimental Sciences Academic Unit of the Faculty of Medicine at the University of Southampton in the UK. He trained in medicine at Charing Cross Hospital Medical School, in psychiatry at St Mary’s Hospital Medical School and the Maudsley Hospital, and in medical humanities at Birkbeck College. He is an Honorary Professor in the University of Cape Town in South Africa and Visiting Professor at Suzhou University Guangji Hospital in China.He is current Chair of the Psychopharmacology Committee of the Royal College of Psychiatrists, Past President of Depression Alliance, a Medical Patron of Anxiety UK, Editor-in-Chief of Human Psychopharmacology, and author of over 260 full articles in peer-reviewed scientific journals.

Professor Baldwin aims to improve clinical outcomes in mood and anxiety disorders: by investigating the role of neurobiological and psychological factors in causing and maintaining illness; through improving trial design when evaluating efficacy and tolerability of treatment interventions; by assessing the effectiveness and acceptability of treatment interventions in wider clinical practice; through identifying more accurately those patient groups at particular risk of poor outcomes; and by offering a tertiary referral specialist clinical service to patients with chronic and treatment-resistant conditions.

Declaration of interests

Personal pecuniary interests: In the last three years (September 2014–August 2017), I have received honoraria for giving educational lectures in meetings organised by AstraZeneca, Janssen, H. Lundbeck A/S, Pierre Fabre and Pfizer. I have received financial support from the Ministry of Defence relating to my membership of its Research Ethics Committee. I have also received financial support from the Wiley publishing company relating to my editorship of the Human Psychopharmacology journal.

Personal family interest: My wife has received a personal honorarium for participating in an advisory board organised by H. Lundbeck A/S.

Non-personal pecuniary interest: In the last three years, my employer has received reimbursement for my time spent in attendance at advisory board meetings organised by Liva Nova and Mundipharma.

Personal non-percuniary interest: I am a Medical Patron of Anxiety UK and the University-nominated Governor on the Board of Southern Health NHS Foundation Trust (April 2017 onwards).


https://www.socialaudit.org.uk/43800073.htm

 

Dr Baldwin helped the manufacturers to launch Seroxat for social anxiety disorder, when he reportedly said, “Seroxat is one of the safest drugs ever made.” He co-authored two papers on this drug (1999 and 2000) one of which disclosed sponsorship by the manufacturers; the other didn’t but probably should have done. (Baldwin D, et al, (on behalf of the paroxetine study group) Paroxetine in social phobia/social anxiety disorder, Br J Psychiatry 1999 Aug, 175: 120-126. and Baldwin DS, Clinical experience with paroxetine in social anxiety disorder Int Clin Psychopharmacol 2000 July, 15 Suppl 1; S19-24)

Dr Baldwin was principal author of a Wyeth sponsored study, published in 2002. He was also identified as a member of the advisory board of Wyeth (Baldwin DS et al., Can we distinguish anxiety from depression? Psychopharmacol Bull, 2002 Summer, 36 Suppl 2, 158-165.)

Dr Baldwin has been identified also as a member of the Bristol Myers Squibb study group on CN-104-070 (nefazodone) (Baldwin DS et al, A randomised double blind controlled comparison of nefazodone and paroxetine in the treatment of depression: safety, tolerability and efficacy in continuation phase treatment, J Psychopharmacol, 2001 Sept, 15(3), 161-165.)

In 1997, Dr Baldwin co-authored a paper on SSRIs with an employee of Pfizer (Lane R, Baldwin D., Selective serotonin reuptake Inhibitor-Induced serotonin syndrome, J Clin Psychopharmacol, 1997 June, 17(3), 208-221


https://www.medicinejournal.co.uk/article/S1357-3039(12)00194-6/abstract

David S Baldwin MBBS DM FRCPsych is Professor of Psychiatry and Head of Mental Health Group, University of Southampton, Faculty of Medicine, UK and Honorary Professor of Psychiatry, University of Cape Town, South Africa. Competing interests: DSB has acted as a consultant to and holds or has held research grants (on behalf of his employer) from a number of companies with an interest in anxiety and depressive disorders (Asahi, AstraZeneca, Cephalon, Eli Lilly, Grunenthal, GSK, Lundbeck, Organon, Pharmacia, Pierre Fabre, Pfizer, Roche, Servier, Sumitomo, and Wyeth)


 

 

 

 

 

 


 

https://www.independent.co.uk/life-style/health-and-families/health-news/antidepressant-seroxat-linked-to-suicide-attempts-among-adults-5347383.html

The antidepressant Seroxat has been linked to an increase in suicide attempts among adults. Researchers suggest that patients and doctors should be warned of the propensity to suicidal thoughts while on the drug.

Experts have already warned that Seroxat is not suitable for children and adolescents due to an increased risk of self harm.

In the new study of 916 adults on the drug, seven attempted to take their own life. Dr Ivar Aursnes and colleagues at the University of Oslo compared these findings with 550 patients taking a placebo, of whom one tried to commit suicide. Their conclusions are published in the journal BMC Medicine.

They say: “We conclude that the recommendation of restrictions in the use of paroxetine (Seroxat) in children and adolescents … should include usage in adults.”

Dutch Seroxat User- Gerard Eggebeen- Wins Case Against GSK For Seroxat Side Effects..


Note: If you are reading this Gerard, please e-mail me on truthman30@gmail.com

I would love to chat with you.

Thanks

Opmerking: als je dit leest, stuur me dan een e-mail op truthman30@gmail.com

Ik zou graag met je chatten.

Bedankt

 

Gerard_Eggebeen

 

“..Afterwards you start thinking and looking back at your life, suddenly the penny fell: It is not my nature to be aggressive or anxious.” – Gerard Eggebeen

 

Gerard Eggebeen (32) used Seroxat for years. First prescribed it in his teens for depression, and then suffering serious side effects for years, he recently successfully sued GlaxoSmithKline and won.

The verdict of the judge only caused a brief moment of happiness. “Imagine the world as colorless, everything is gray and matt and nothing makes sense, that’s how I feel every day.” Gerard has little hope that he will ever get rid of his depression again. His struggle against the pharmaceutical giant keeps him going.

Mission

Since Gerard knows what damage seroxat has caused him, he sees it as his mission to get justice for himself and others.

“I will not rest before this mess is for everyone under eighteen of the market and people who have suffered from it experience a sense of justice,” he says. “The idea that someone is sitting somewhere in a skyscraper at GSK, who now knows what they have done to people…”

See these articles in Dutch (use google translate to get an ok gist of it in English) for more:

https://translate.google.com/translate?sl=auto&tl=en&js=y&prev=_t&hl=en&ie=UTF-8&u=https%3A%2F%2Fwww.rtlnieuws.nl%2Fnederland%2Fgerard-won-rechtszaak-tegen-farmaciereus-ik-stop-niet-voor-deze-troep-van-de-markt-is&edit-text=

https://tmgonlinemedia.nl/consent/consent/?return=https%3A%2F%2Fwww.telegraaf.nl%2Fnieuws%2F2178034%2Fgerard-eggebeen-raakte-voorgoed-beschadigd-door-antidepressivum&clienttime=1529695763335&version=5&guid=c9395a01-3f3e-3664-7d48-ff8667993f2c&detect=true

 

 

 

Paxil/Seroxat And Birth Defects…


What this article fails to mention is that in the original Paroxetine (Paxil/Seroxat) clinical trials done by Glaxo it indicated that baby rat pups were dying when their pregnant mothers were fed paroxetine…

Yet despite this knowledge- Glaxo marketed Paxil/Seroxat directly to pregnant mothers regardless.

‘Attempted Corporate Manslaughter’ is the phrase I would use here..

http://theprovince.com/opinion/op-ed/jenna-wong-and-robyn-tamblyn-its-time-we-fixed-our-system-of-drug-surveillance

Jenna Wong and Robyn Tamblyn: It’s time we fixed our system of drug surveillance

Faith Gibson, with her daughter Meah, 11, who was born with a hole in her heart, fought a nine-year battle with U.K. pharmaceutical firm Glaxo SmithKline, along with other moms who took the drug Paxil during pregnancy, which resulted in their kids suffering heart defects. They’re part of a group who have reached a $6.2-million, class-action settlement with Glaxo SmithKline.

Mark van Manen / PNG

If you take prescription medications, what conditions do you take them for? Are they working for you? Have you experienced any negative side-effects from them?

It may surprise you to know that answers to these critical health questions aren’t well-documented for most Canadians. Yet the answers would provide the crucial information needed to ensure our medications are safe and worth taking after they’ve been approved for use.

Before prescription drugs are approved in Canada, they’re tested under controlled conditions on relatively small numbers of patients (several hundred to several thousand) with selective characteristics (patients of certain ages, races, ethnic groups or genders). But once medications are approved, they aren’t monitored as closely as they should be.

We need to significantly improve our system of post-market surveillance for prescription drugs in Canada to make sure we are continually monitoring their safety and effectiveness in real-world settings.

Why?

First, adverse drug reactions may surface that weren’t previously detected in smaller pre-regulatory trials. Recall the unfortunate case of 15-year-old Vanessa Young. who was taking cisapride for her gastrointestinal symptoms and died after suffering a heart arrhythmia — a life-threatening side-effect of the drug that surfaced only after it was released onto the market.

Second, the use of a drug may broaden over time to include milder forms of the disease or even different medical conditions that weren’t assessed during the drug’s pre-market trials. Take antidepressants, for example. These medications are being increasingly used for conditions other than depression. New research has found that nearly one in three antidepressant prescriptions are written for unapproved (“off-label”) conditions — most of which aren’t backed by sufficient evidence.

To adequately monitor the safety and effectiveness of medications in real-world settings, we need a timely, post-market, drug-surveillance system that can identify the reasons why patients are taking their medications and follow patients to detect adverse drug reactions and determine if their medications are working.

How are we doing so far? Not great.

Identifying the reason for drug use

The medical reasons for prescriptions aren’t often explicitly documented in patient charts, nor is this information required for patients to fill prescriptions or receive reimbursement for drugs. So, when it comes to drugs like antidepressants that can be prescribed for different medical conditions, not knowing why a patient is taking a drug creates major challenges for assessing the drug’s effectiveness and appropriateness of use (i.e., whether the use is backed by regulatory approval or scientific evidence).

Detecting adverse drug reactions

Canada’s Adverse Drug Reaction Reporting System has many flaws, including the fact that it relies upon voluntary reporting by physicians via a reporting process that is time-consuming and outside of routine procedures. In fact, it’s estimated that less than five per cent of all adverse drug reactions are reported to Health Canada.

Tracking medication effectiveness

Once drugs are released onto the market, their real-world effectiveness isn’t systematically monitored. It’s troubling to know that we currently have no large-scale mechanisms in place to track whether patients are experiencing the anticipated benefits from their medications.

So, what’s the solution?

We need a national, post-market, drug-surveillance system that mandates the systematic collection of data on the reasons for drug use, adverse drug reactions and effectiveness, and governs the use of health-information technologies to collect these data.

Health-information technologies offer the chance to seamlessly collect such data as part of the care process and even enhance patient care. For example, electronic prescribing systems could prompt physicians to record the reason for treatment when drugs are prescribed and alert doctors to potential prescribing errors or present alternative treatment options when prescriptions aren’t evidence-based.

When prescriptions are cancelled, renewed or modified, electronic medical record systems could prompt physicians to record details about adverse drug reactions and effectiveness, which would also ensure that details about a patient’s treatment history and experiences with past therapies are documented.

Many Canadian provinces have implemented centralized drug-information systems to track all medications that patients are receiving. If these systems are to contribute toward an effective, post-market, drug-surveillance system, they need to additionally collect information on the reasons why medications are being prescribed and the outcomes that they produce.

Medications can be life-saving. But they’re only as good as our knowledge about them. It’s time we stepped up our game and kept better track of our experiences with medications. 

Jenna Wong will begin a post-doctoral research fellowship in the department of population medicine at Harvard Medical School beginning in 2018. Robyn Tamblyn is an expert adviser with EvidenceNetwork.ca and James McGill is a professor in the departments of medicine and epidemiology, biostatistics and occupational health at McGill University in Montreal.


CLICK HERE to report a typo.

Is there more to this story? We’d like to hear from you about this or any other stories you think we should know about. Email vantips@postmedia.com.

People Write Into People’s Pharmacy About Paxil/Seroxat Suicide..


“….One person wrote about her son: “He was a 35-year-old young man with everything to live for, good job, happily married, no financial problems. He was experiencing some anxiety and chest pains and saw a doctor, who prescribed Paxil. Three days later, my son committed suicide. Something needs to be done to stop this from happening to others….’’

http://www.journalnow.com/zzstyling/pharmacy/people-s-pharmacy-can-antidepressants-lead-to-suicide/article_227a9814-b1e1-52af-ad03-25ee0c20f223.html

Will GSK Have To Face The People They Have Hurt?..


https://plattner-verderame.com/blog/beware-drug-manufacturers-may-actually-face-people-hurt/?%20%E2%80%A8utm_source=twitter&utm_medium=social&utm_campaign=people-hurt

 

Beware, Drug Manufacturers – You May Actually Have to Face the People You Hurt

Beware, Drug Manufacturers – You May Actually Have to Face the People You HurtThe Supreme Court of the United States may be best known for hearing cases that capture the attention and imagination of the American public, but that is not all they do. In fact, on October 2, 2017, the Supreme Court of the United States heard motions on a case that we have been paying close attention to, even if the public at large has not. That case involved GlaxoSmithKline, LLC, the manufacturers of the popular anti-depressant Paxil.

GSK is a UK company, but its American division is headquartered in Philadelphia and incorporated in Delaware. Paxil is sold in pharmacies throughout the country. In a 2014 lawsuit filed in Illinois, 16 people – 8 mothers and 8 children, from 6 different states (including Illinois) – claimed that Paxil, when ingested by the mothers during their pregnancy, led to congenital, catastrophic birth defects in the children. The lawsuit against GSK alleged:

  1. “strict liability and failure to warn,
  2. strict products liability and design defect,
  3. negligence,
  4. breach of implied warranty,
  5. breach of express warranty, and
  6. negligent misrepresentation and concealment.”

GSK, of course, moved to dismiss the case, claiming “it was not subject to general jurisdiction because Illinois is neither the state of its incorporation nor its principal place of business.” Furthermore, they claimed:

“Illinois lacks specific jurisdiction because the out-of-state plaintiffs’ claims did not arise from its Illinois activities. Moreover, defendant GSK claimed that its actions or omissions in Illinois were not the ‘but for’ cause of the alleged harm: plaintiffs did not serve as study subjects in Illinois, did not receive Paxil prescriptions in Illinois, did not ingest Paxil in Illinois, and did not suffer injury from Paxil in Illinois. Finally, defendant GSK argued that the out-of-state plaintiffs may not create personal jurisdiction by tacking their claims onto those of the two Illinois plaintiffs.”

A lower court ruled against GSK, which then attempted to appeal to the Illinois Supreme Court. When that, too, failed, they went to the Supreme Court of the United States – and the Supreme Court denied their petition for a writ of certiorari, which means the lower court’s decision stands.

Why this denial is important for victims of dangerous drugs

“Personal jurisdiction” has been used as an argument by drug companies before, to avoid lawsuit filings in states that are deemed “less friendly” to those companies – or, in layman’s terms, in states where a strong civil justice system exists to protect people, not profits. The decision of the Supreme Court, to allow the original decision to stand, sets a precedent for other drug companies seeking to use the same loopholes to avoid lawsuits over dangerous and defective drugs.

It also holds these drug companies accountable for their actions in the states where those actions are committed. GSK held between 18 and 22 clinical trials in Illinois. Even though the plaintiffs in this case were not a part of those trials, one cannot deny that GSK has significant ties to that state. This renders their argument that Illinois has no jurisdiction moot. And as trials like these can (and do) happen in all 50 states, drug companies can be tied to actions in all 50 states, meaning plaintiffs can file lawsuits with confidence in regard to jurisdiction.

There will always be exceptions, of course. Not every case will proceed as this one did, nor will every case move on to be heard by the Supreme Court. But for those of us who fight on behalf of victims, this is a “win”: for our clients, and for the civil justice system.

Plattner Verderame, P.C. offers honest guidance and aggressive representation for injured clients throughout Arizona. If you were harmed because of a defective medical device or dangerous drug, our Phoenix product liability lawyers are here to help. Please call us at 602-783-8793, or fill out our convenient contact form, to learn more.

Paxil Birth Defect Cases In The US Press Ahead..


http://chicago-land.legalexaminer.com/fda-prescription-drugs/us-supreme-court-refuses-to-restrict-personal-jurisdiction-in-landmark-paxil-case/

US Supreme Court Refuses to Restrict Personal Jurisdiction in Landmark Paxil Case


Today, the U.S. Supreme Court allowed to stand an appellate court decision stating that a product manufacturer is subject to personal jurisdiction for product-related claims in a state where development or testing occurred, dealing a huge blow to the well-funded big pharma legal teams who may well now find themselves defending their drugs and medical devices in all fifty states.

The U.S. Supreme Court denied cert on M.M. ex rel. Meyers v. GlaxoSmithKline LLC, letting stand an Illinois appellate court case that held that GlaxoSmithKline, a UK company with U.S. headquarters in Philadelphia, would need to defend itself in Illinois state court for catastrophic birth defect injuries resulting from pregnant mothers’ use of its anti-depressant, Paxil.  The Meyers case alleges the drug injured eight minor plaintiffs from six states, including Illinois.  The Illinois Supreme Court had already refused to hear GSK’s appeal from the appellate decision.  Unsatisfied, GSK appealed to the U.S. Supreme Court, which refused to upset the decision of the Illinois appellate court.

The Illinois appellate court previously found that Illinois had personal jurisdiction over GSK based on the defendant’s substantial in-state contacts, namely its contracts with 17 Illinois physicians to participate in 18 to 21 clinical trials on Paxil in Illinois as part of multicenter studies, and the fact that the plaintiffs’ claims arose from the defendant’s acts or omissions related to those trials.

Clinical studies involve research using participants (humans) to evaluate the health outcomes of a particular drug, device, procedure, or behavior.  Generally, these clinical studies are performed by investigators funded by drug companies that are required to submit studies to the Food and Drug Administration.  The principal investigators are generally medical doctors who may be part of a hospital, university, clinic, or general practitioner’s office.  These studies generally happen in all 50 states, and the data are usually consolidated and submitted to the FDA.  Drug companies often also publish results in medical journals.

Today, the U.S. Supreme Court chose to let that case stand by denying the defendant’s petition for a writ of certiorari, which is a written request for the U.S. Supreme Court to review a lower court’s ruling.  The denial of a petition for a writ of certiorari by the U.S. Supreme Court means the decision of the lower court stands as the final decision.

The plaintiffs in Meyers are represented by TorHoerman Law. Robert Peck of the Center for Constitutional Litigation also represented the Plaintiffs before the U.S. Supreme Court. TorHoerman Law partner Ken Brennan wrote the successful Illinois appellate brief.  Brennan says,

“While industry does not like the result, the result makes perfect sense with respect to clinical trials from which the plaintiffs’ claims arise.  Drug manufacturers treat multi-center clinical trial data as a unitary whole and aggregate the data collected in various states to reach statistically significant conclusions.  The portions of the clinical trials that occur in a particular state, however small, cannot be separated from the rest.  And, because inadequate clinical trials naturally lead to inadequate warnings, failure to warn claims arise from or relate to those trials.”

The fact that the claims made in the case arise from or relate to those trials provides a basis for the lawsuit to be heard in the state where the trials occur.

The Meyers decision undermines previous industry efforts to limit personal jurisdiction to drug manufacturers’ preferred jurisdictions under the Daimler AG v. Baumann and BMS v. Superior Court of California cases, both decided by the U.S. Supreme Court.  Since the U.S. Supreme Court chose not to hear the Meyers case, it left open the opportunity for plaintiffs alleging injuries that arise out of or relate to clinical trial data to sue manufacturers in the states where the trials occurred.  Meyers restores some degree of fairness to consumers injured by drug manufacturers.

TorHoerman Law founder Tor Hoerman released the following statement in response to the Supreme Court’s refusal to hear the Meyers appeal:

“Four years ago, lawyers for GSK told me that they would not pay these children and their families.  We told GSK that we would file these cases in Cook County.  The lawyers told us we were crazy, that they would tie us up in the appellate courts and we would be in litigation for years.  I promised GSK that day that we would pursue these cases for these deserving families until a court told we could no longer do so.  Well, GSK has kept its promise, and we will keep ours.  The highest court in the land told them they have to litigate in Cook County.  What will they do now?  The right thing?  We shall see.  GSK and our clients can rest assured that Ken Brennan and the lawyers at THL will not quit on these cases.”

 

References:

https://clinicaltrials.gov/ct2/about-studies/learn

Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (which curtailed general jurisdiction) and Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773, 198 L. Ed. 2d 395 (2017)

M.M. ex rel. Meyers v. GlaxoSmithKline LLC, 2016 IL App (1st) 151909, 61 N.E.3d 1026, appeal denied sub nom. M.M. v. GlaxoSmithKline LLC, 65 N.E.3d 842 (Ill. 2016)

Glaxo’s 6.2 Million Payout In 200 Paxil Induced Baby Defect Cases In Canada..


How many babies did Paxil/Seroxat deform world-wide since it was licensed 20 years ago?

 

Do you think Emma Walmsley ever gives a second thought to those babies? or their suffering?


 

https://www.thestar.com/business/2017/03/01/bc-firm-reaches-62m-paxil-settlement-in-class-action-against-glaxosmithkline.html

 

VANCOUVER—A proposed settlement has been reached in a lawsuit filed by a woman who alleges her daughter suffered a birth defect after she was prescribed the anti-depressant Paxil during pregnancy.

Rosenberg Law, a Vancouver firm that filed the class-action lawsuit involving about 50 mothers and their children, says it has reached a $6.2-million settlement with GlaxoSmithKline Inc.

In a statement on Wednesday, the pharmaceutical company says it has agreed in principle to settle the lawsuit but it does not admit to any liability or wrongdoing as part of the agreement, which must still be approved by the Supreme Court of British Columbia.

Read more:Using antidepressants early in pregnancy may raise birth defects risk

Faith Gibson of British Columbia was named as the representative plaintiff in the suit after her daughter Meah Bartram was born with a hole in her heart in 2005.

Gibson’s initial statement of claim filed in B.C. Supreme Court in 2012 alleged that Paxil increased the risks of damage to the heart and lungs of newborns, who it contends were unable to breath properly due to constricted blood vessels.

GlaxoSmithKline says patient safety is its “highest concern” and it continues to believe that it provided accurate and updated information on Paxil to regulators, and also communicated safety information to regulatory agencies, the scientific community and health-care professionals.

The company says it agreed to the proposed settlement “to avoid the time and expense associated with the trial and the subsequent steps in the class-action proceeding.”

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects.”

Rosenberg Law says as many as 200 children in Canada could benefit from the settlement.

In a decision released in 2013 upholding the class-action lawsuit, the B.C. Court of Appeal said the company sent a letter to health professionals in September 2005 that referred to preliminary results about a study that showed an increased incidence of cardiovascular defects in babies born to women who took Paxil during the first trimester of pregnancy.

Gibson’s daughter was born about two weeks before the company sent the letter to doctors.

In February 2006, the company amended the product label to outline the potential problems that might arise.

The plaintiffs alleged in court that the company knew or ought to have known of the risk before then.

 


 

dralisonbarrett

the ecosystem approach to obgyn

My Life in my 60's

Finding joy in my 60's

The Vile Mint

Poetry, Short Stories and Violent Ideas

POSITIVELY HERE

"HAVE NO FEAR OF PERFECTION, YOU'LL NEVER REACH IT" - Salvador Dali

Rebel City Writers

A radical perspective on local, national and international issues from the pens of a few disgruntled agitators!

Critical Dispatches

Reports from my somewhat unusual life

~ L to the Aura ~

sustainability. compassion. inspiration.

Heroes Not Zombies

becoming not being.......

DES Daughter Network

Because Social Media increases Awareness and brings the DES Community Together

recovery network: Toronto

people can and do recover from what is sometimes called "mental illness"

Deidra Alexander's Blog

I have people to kill, lives to ruin, plagues to bring, and worlds to destroy. I am not the Angel of Death. I'm a fiction writer.

%d bloggers like this: