Zantac Lawsuit

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

Sunday, January 28, 2018

Generic Paxil Lawsuits Filed

Canadian pharmaceutical company, Apotex, have been delivered a hammer-blow regarding the manufacturing and labeling of generic Paxil, an antidepressant known by its generic name of paroxetine.

Paxil is the brand name of paroxetine and has various different brand names all over the world, in the UK, for example, it's known as Seroxat.

The hammer-blow comes on the back of Baum Hedlund & Rapoport Law Offices glorious victory over Paxil manufacturers, GlaxoSmithKline (GSK) last year. GSK, who denied that it was their responsibility to advise generic makers that Paxil increased the risk of suicide to adults beyond the age of 24, lost in a landmark case in Chicago...and have been crying about it ever since. More on GSK throwing their toys out of the pram further on down this post.

Because of the victory against GSK, Baum Hedlund have now wrote a letter to Apotex, the content of which is pleasing to the eye for a drug safety advocate such as myself.

Baum Hedlund’s letter to Apotex:

Dr. Jeremy Desai
Mr. Bernard Sherman
Mr. Jack M. Kay
Apotex, Inc. 150 Signet Dr., North York,
ON M9L 1T9, Canada
Re: Paxil and Suicide
Dear Messrs. Desai, Sherman, and Kay:
I am writing to Apotex as the exclusive holder of the New Drug Application for Paxil. As of January 2014, Apotex became exclusively responsible for the content and accuracy of the Paxil and paroxetine label, charged with ensuring the label remains up-to-date and adequate at all times.
This letter officially places you on notice that the label for Paxil does not adequately warn about the risks of adult suicidal behavior and that it needs to be corrected. It is my hope that Apotex will take swift action to protect the health and safety of patients taking Paxil/paroxetine.
On April 20, 2017, a federal jury entered a verdict against GlaxoSmithKline, Inc. (“GSK”), and in favor of a widow of a Chicago man who killed himself six days after starting a generic version of Paxil. As part of that verdict, the jury concluded that the Paxil label, as it has existed since 2007, is inadequate because it fails to properly warn about the risks of adult suicidal behavior causally related to ingestion of Paxil/paroxetine. Specifically, the paroxetine label did not warn of the drug’s association with an increased risk of suicidal behavior in adults despite GSK’s knowledge of a statistically significant 6.7 times greater risk in adults with Major Depressive Disorder (“MDD”) of all ages and the FDA’s 2006 analysis of a statistically significant 2.7 times greater risk in adult patients across all indications. Indeed, since 2007, the Paxil label has not only failed to warn about this increased risk, it has stated the opposite—that the suicidality risk did not extend beyond the age of 24. This verdict was rendered after more than five weeks of testimony and evidence that focused on the extensive clinical, scientific and medical evidence pertaining to paroxetine.
The Dolin trial transcripts can be viewed here:
The Dolin trial exhibits can be viewed here:
Please review these transcripts and documents. They reveal a serious problem, one that Apotex is in a unique position to remedy.
This is your opportunity to do the right thing and remedy the deficiencies in the Paxil label. Failure to take action would mean your company is deliberately refusing to correct a known and quantifiable risk. Any suicides or attempted suicides that could have been prevented by a label change are now on you. We urge Apotex to take swift action to protect the public health.
Brent Wisner
Michael L. Baum
Pedram Esfandiary

Further to the letter sent to Apotex, Baum Hedlund are now looking for consumers who have attempted suicide whilst taking Apotex generic Paxil. Moreover, consumers relatives whose loved ones completed suicide whilst taking the Apotex version of Paxil.

If you would like to speak with a Paxil lawyer about filing a claim, please contact Baum Hedlund by filling out the form here, or calling them toll free at 1-800-827-0087.

As mentioned (above) GSK have been crying like big babies since the verdict against them was returned last year. They, via their poor performing attorneys, King & Spalding, have since asked for a retrial and been denied, they then, remarkably, rejected the decision of the Judge not to grant them a new trial (boo hoo)

Now, it appears, GSK who have blamed everyone but themselves for the untimely Paxil-induced suicide of Stewart Dolin, are now preparing to take their greivances to the United States Court of Appeals for the Seventh Circuit.

This, to me at least, smacks of obstinance on GSK's part and, it has to be said, on the part of their defence team of King & Spalding, whose lead attorney, Andrew Bayman, recently cited his firm's failure in Dolin Vs GSK as an "accomplishment."

King & Spalding's mediocre performance in Chicago last year was an eye-opener for me, this, of course, should not distract the brilliant teamwork of  Baum Hedlund & Rapoport Law Offices who revealed several telling documents during trial, one of which showed that an internal analysis, carried out by GSK in 2006, showed that patients taking Paxil were nearly seven times more likely to attempt suicide than those on placebo.

The Dolin v. GSK Paxil Trial Exhibits can be viewed here.

The Dolin Vs GSK Paxil Trial Court Transcripts can be viewed here.

Bob Fiddaman

Monday, January 08, 2018

Who's Hiding the Clinical Trial Benefits of Antidepressants?

First off, ponder this.

If an opponent in a pool game told you that if you use the 8 ball as the cue ball you will not foul, would you believe them? What about if they kept on insisting this claim to be true? Or would you ask questions to someone else to ascertain if the claims of your opponent were true?

Read on.

Over the past month or so I've been blocked on Twitter by three well-known psychiatrists.

Wendy Burn, a consultant psychiatrist at Leeds and York Partnership NHS Foundation Trust and president-elect of the Royal College of Psychiatrists.

Allen Frances, who was the chair of the DSM-IV Task Force and of the department of psychiatry at Duke University School of Medicine, Durham, NC. He is currently a professor emeritus at Duke.

Peter Kramer, Clinical Professor Emeritus of Psychiatry and Human Behavior. Kramer is also the author of numerous books, many of which he likes to promote on Twitter.

So, why have these three well-known, and some would say, intelligent orators, blocked me?

Well, it would appear that rather than answer a simple question I put to them, they decided to put their fingers in their ears and bury their heads in the sand. It's a question that should be answered and one that, to date, has not been adequately answered by anyone from the medical profession, the pharmaceutical industry or any global regulatory agency. It's a question the media never seem to ask either. It's a question I've put to the Royal College of Psychiatrists on many occasions too, they have just chosen to ignore me.

Wendy Burn, who regularly accepts adoration on Twitter yet fails to answer bereaved parents, was first.

My current view of her online profile looks like this.

Next up was Allen Frances, a man who changes his opinion like the wind, depending on whom he wishes to appease.

My current view of his online profile looks like this.

Finally, after attempting to answer my question with some quite unbelievable and unprofessional answers, was Peter Kramer.

My current view of his online profile looks like this.

So, three psychiatrists, all with one thing in common: An inability to answer a question that forms the crux of their beliefs. I urge anyone reading this to ask their healthcare professionals the same question and to contact me if given an answer. If three eminent psychiatrists or pharmaceutical companies, or even medicine regulators cannot answer, then I doubt very much if your average prescriber will either.

The question should be answered because it forms the basic safety and efficacy point of why antidepressants are on the market.

So, what was the question?

"Please list the benefits of antidepressants."

I asked this question because it was once put to me by an old advocate/friend of mine, Matthew Holford. It's a great question and turns the focus off the risks and onto the benefits. Remember, after the clinical trials of these drugs, which lasted between 8 & 12 weeks, a licence was granted because the "benefits outweighed the risks." We all know what the risks are because today most of them are clearly on the antidepressant labels.

Out of the three psychiatrists, Peter Kramer, who has authored such books as 'Listening to Prozac', came up with, or thought he did, an answer. The benefits are "having a good time with your kids", he told me, adding, "progress in your career."

Interesting. My response, which resulted in Kramer throwing his toys out of the pram (blocking me) was, "So, in the 8-week clinical trials for antidepressants the benefits of "having a good time with your kids" was seen. Benefits also seen in the 8-week trial was "progress in your career", is that your position, Peter?"

Ladies & gentlemen, boys & girls, we have all been duped for years and the claim that antidepressants outweigh the risks is, I believe, a fraudulent claim just as the 'depression is caused by a chemical imbalance' claim was.

It's incumbent of us all to seek an answer to this question because without an answer, without the actual truth, pharmaceutical companies and medicine regulators will continue to tell doctors that the benefits outweigh the risks - they, in turn, will continue to tell patients, who, in turn, tell friends and family members. The piss-sodden snowball will grow until we all stop it gathering more momentum.

So, next time you hear the term, "The benefits of antidepressants outweigh the risks", ask the person who is making this claim for a list of the benefits reported during the trials. Don't accept the anecdotal comments, such as, "they saved my life" or "they helped me." These are irrelevant anecdotes. What you are seeking is the list of benefits that persuaded the medicine regulators to grant these drugs a license. Ergo before all the hype came about them apparently saving lives.

Remember, suicidal ideation, self-harm and a whole host of other risks have been reported in clinical trials and we have all been told, 'Hey, there's no need to worry because there were more benefits.' Thing is, ladies & gentlemen, boys & girls, they have failed to show us a list of these benefits. They, if there are any at all, have been hidden from us in much the same way the number of suicidal subjects in clinical trials was hidden. Through various litigation we have unearthed a lot of the hidden risks but, to my knowledge, no drug company has ever been sued because antidepressants work too well.

We need a list of the benefits and we need them now!

We have all just taken their word on trust.

And we should all, rightly, be very angry!

Bob Fiddaman

Saturday, January 06, 2018

GSK Call In the Fireman

I've recently finished reading, for the second time, John Grisham's excellent, 'The King of Torts', a novel that highlights underhand tactics used by the pharmaceutical industry. 

In 'Torts' we are introduced to a character who goes by many names. To keep this simple I'll just be referring to him as 'Max Pace.' Pace is hired by pharmaceutical companies to douse the flames when it arises that a drug that has been on the market has serious and life-threatening side effects. The information is purposely leaked by the pharmaceutical companies via Max Pace whose job it is to target prosecuting attorneys in the hopes of a quick and cheap settlement. Pace describes himself as a fireman, someone whose job it is to 'put out the fire.'

The character reminded me a great deal of Peter Humphrey, the outsider who was brought in by GSK China to douse the flames of a whistleblower who, at the time, was threatening to spill the beans on GSK China's illegal activities which included, but weren't limited to:

  • Bribing Mark Reily, GSK's head of China Operations, in the form of 'sexual relations' in return for maximizing business for China Comfort Travel (“CCT”). - CCT was an important part of the GSK bribery and promotion scheme because it facilitated a money laundering operation in connection with the bribing of hospitals and doctors who prescribe GSK drugs to patients. 
  • Funneling 3 billion yuan (US$482 million) through this network to recipients. Receipts were forged for purchases and transactions that never took place, including fake conferences.
  • Bribing doctors and other medical staff were to sell GSK products, the cost of those bribes was added to the price of the products that consumers paid for.

Enter the fray Peter Humphrey and his wife Yu Yingzeng who were hired by GSK China to investigate a whistleblower whom they believed was behind a series of emails sent to the company big-wigs, including the then CEO of GSK UK, Andrew Witty. Humphrey and Yu operated ChinaWhys, an International Business Risk Advisory Firm.

Humphrey and Yu were told by GSK China that they believed Vivian Shi, then the company’s government relations head in China, was the whistleblower but they needed proof. The allegations made by the anonymous whistleblower did not concern them.

In a nutshell, it was the job of Humphrey and Yu to create a report on Shi to frame her as a vindictive former employee.

The Sex Tape

Whilst in talks with GSK China, Humphrey, and his wife learned of a sex tape that the anonymous whistleblower had sent in via an email attachment. The sex tape showed Mark Reily and an unnamed woman and was sent to GSK executives along with the corruption allegations. A further 23 emails were sent to Chinese governmental entities throughout China.

GSK told Humphrey and his wife that the allegations had previously been investigated and were false.

According to a court document, during an April 15, 2013, meeting, Humphrey asked GSK officials for copies of the anonymous whistleblower allegations, but GSK refused to provide them. Instead, the document claims, GSK officials stressed that GSK had improved its compliance mechanisms following earlier corruption and other illegal activities that led a DOJ settlement in 2012 ($3 Billion to resolve fraud allegations and failure to report safety data)

The court document. PETER HUMPHREY; YU YINGZENG; CHINAWHYS COMPANY LTD Vs GLAXOSMITHKLINE PLC; GLAXOSMITHKLINE LLC, was filed in United States Court of Appeals for the Third Circuit on 1st January 2018.

More on this 'appeal' later.

In essence, GSK was playing down the allegations, even though they knew them to be true, and using Humphrey and Yu into advancing GSK’s efforts to conceal its bribery activities.

The court document, which I have a copy of, also states:
On June 26, 2013, a GSK employee finally sent two of the whistleblower emails to Humphrey while he was in the United States.
Over the next two days, police raided multiple GSK China offices. Following those raids, GSK senior legal counsel Jennifer Huang asked ChinaWhys to investigate the Public Security Bureau (PSB) and to “prepare an Organic analysis ASAP on the Chinese political regime, particularly on Chinese Communist Party Regime, PSB, and state council with official’s name identified.” 
Humphrey and Huang had a phone call that same day, while Humphrey and Yu were in the United States. Huang said she wanted to investigate the PSB “to find out who’s who in the investigation.” At that point, Humphrey became concerned that GSK was seeking now to obstruct the investigation by Chinese authorities and replied that he could not do anything that could be deemed as violating state secrets and thus could only use public information for his research.
On July 1, while Humphrey and Yu were still in the United States, GSK China’s head of business development, Leslie Chang, asked Humphrey to investigate various government organs. Humphrey refused. Then, after returning to China, Humphrey met again with Mark Reilly (the head of GSK China) in a hotel room as Reilly was preparing to flee the country. At that time, Humphrey advised Reilly that ChinaWhys could no longer provide service to GSK. 
On July 10, 2013, ChinaWhys was raided by the police who told Humphrey, “This was ordered from above. This is related to GSK.”

Around the same time, four senior GSK China executives were also arrested.  In response to those arrests, GSK’s global CEO, Sir Andrew Witty, claimed that GSK’s head office in London lacked knowledge of the whistleblower’s allegations and “had no sense of this issue.” This, according to the court document, was untrue.

Humphrey and Yu were arrested for illegally buying and selling private information and detained for almost a year before their trial. During this year of detention and whilst awaiting trial, GSK stated that its China business “hired ChinaWhys in April 2013 to conduct an investigation following a serious breach of privacy and security” (the Reilly sex tape) but that ChinaWhys was “not hired to investigate the substance of the allegations of misconduct made by the whistleblower.” This, according to the 2018 court document, was a misleading statement by GSK and prolonged Humphrey and Yu’s incarceration because British diplomats attempting to intervene on Humphrey and Yu’s behalf did not have accurate information about what had led to their arrest.

One British official involved in those efforts to intervene on behalf of Yu and Humphrey claimed,“GSK were really cagey. They just kept saying it was routine work and kept the information deliberately vague. When we went to the Chinese we were arguing with one hand tied behind our backs.”

On September 19, 2014,  GSK PLC issued a Statement of Apology to the People of China in which it announced that “GSK China Investment Co. Ltd (GSKCI) has been identified according to Chinese law to have offered money or property to non-government personnel in order to obtain improper commercial gains, and has been found guilty of bribing non-government personnel.” GSK was fined $492 million for its bribery activities in China in the biggest such penalty ever imposed by a Chinese
court. The then GSK CEO, Andrew Witty, stated that “Reaching a conclusion in the investigation of our Chinese business is important, but this has been a deeply disappointing matter for GSK.” In addition, Mark Reilly, the head of GSK China, was convicted for his part in the bribery scheme. He was sentenced to three years prison with a four-year reprieve and ordered deported, meaning he will never serve his sentence.

Humphrey and Yu. however, were treated less favorably. In August 2013 they were both convicted and imprisoned in China under harsh conditions for almost two years in squalid conditions and crowded jail cells. They were both denied urgent medical attention and were separated from each other  Humphrey developed prostate cancer, for which he did not receive proper treatment and as a result, the cancer became life-threatening.

In June 2015, the couple was released from prison.

Humphrey watched the TV coverage of the GSK trial from his Shanghai prison cell. He was shocked by the contrast between his punishment and theirs.

"Suspended jail sentences for three or four of the main culprits when I and my wife had been sentenced to years in prison," he says, adding, "Someone asked me recently why someone like Mark Reilly (GSK China's boss) could be set free and we were in jail. I think it's very simple, we don't have half a billion dollars. That story was about money from the beginning. Money got them into trouble and money got him out."

In November 2016, Humphrey and his wife filed suit against GSK where they sort to seek damages from GSK relating to the loss of their business (ChinaWhys), compensation for the emotional and physical harm and damage to their reputation.

Almost one year later, U.S. District Judge Nitza Quinones Alejandro, threw out the case claiming that a U.S. Supreme Court ruling barred lawsuits filed under the federal Racketeer Influenced and Corrupt Organizations Act (RICO) over injuries that occur entirely outside the United States such as this one involving incidents in China.

“For this reason", he said, "Plaintiffs lack standing to assert civil RICO claims, and these claims are dismissed."

Undeterred, Humphrey and Yu have now appealed this decision, hence the Jan 1, 2018, filing. They are requesting that the United States Court of Appeals reverses the order of the District Court dismissing the Complaint for failure to plead a “domestic injury”.

I covered the Chinagate scandal in great depth when news broke back in 2013. A chronological list of the blogs can be seen below. To date, it's some of the most rewarding research and reporting I've ever done on this old blog of mine.

Remarkably, GSK re-hired the services of Vivian Shi, whom they thought was the whistleblower. Reily, according to MalayMail Online, became part of GSK's senior executive team in London

Bob Fiddaman


Glaxo - The Sex Tape Scandal

GSK's Mark Reilly Accused of Running a "massive bribery network"

I'm Just a Blogger - Here's GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK's Sales Reps Want Their Money Back

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

“GSK were really cagey", Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA - Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang...Allegedly

Book Your Holidays With GSK Travel

Andrew Witty... I know narrrrrrrrthing

GSK's Sales Reps Want Their Money Back

Glaxo - The Sex Tape Scandal

GSK's Private Investigator [The Video]

Peter Humphrey's 2012 Presentation - Pharma Bribery

GSK's Chinese Whispers and David Cameron

"GSK were really cagey", Claims Whitehall Official

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations

GSK CHINA - Bribery was Rife 13 Years Ago

GSK's Hired Detectives - Day One, As It Happened

So, What Do You Think, Mr Harvey Humphrey?

GSK Plead Guilty For Being "Very Decent"

Glaxo's PI Released From Prison

The Penny Drops for GSK's Private Investigator

GSK's Mark Reilly and the Word, 'Opaque'

Glaxo and Former Whistleblower Suspect Reunite

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK's Witty Lied to the Media - Part I

ChinaWhys Vs GSK - The Claims - Part 2

More Woes for GSK as Peter Humphrey Files Suit

Please contact me if you would like a guest post considered for publication on my blog.