Zantac Lawsuit

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

Friday, April 11, 2014

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Joanne Thomas - Paxil Birth Defects Mom

Continuing on from Part I...

In brief, Joanne Thomas filed a Paxil birth defect lawsuit against GSK in 2006. GSK argued that she was out of time. [Statute of Limitations] The Judge and subsequent appeal panel agreed with GSK.

What I am about to show you should have been brought to the attention of the Judge and the appeal panel. Joanne's law team, unfortunately, didn't join the dots - that was left for myself and Joanne to work out.

Before I present this new [unseen] evidence it's important to know that GSK had a golden opportunity to warn the public about Paxil's propensity to cause birth defects. The following evidence, almost verbatim, was taken from the Kilker v GlaxoSmithKline birth defect trial. A trial that saw the jury find Paxil responsible for causing the birth defects in Lyam Kilker.

A long, long time ago, as they say, Glaxo purchased the compound [paroxetine] from a Danish company called Ferrosan. Ferrosan had done the preliminary animal studies to look at teratogenicity. Study 295 saw Ferrosan give Paxil to pregnant female rats. The rats who didn't get Paxil [they were given nothing] 12% of the rat pups were dead by the fourth day after they were born. However, and here's the important bit, the rats that were given Paxil [5mg] 65% of the rat pups were dead by day 4. The ones that were dosed with 15 milligrams of Paxil, 92% of the rat pups were dead by day 4. And those given 50mg of Paxil... all the rat pups died.

Armed with this information Ferrosan, after selling the compound to GSK, then SmithKline Beecham, wrote a memo in 1980 telling GSK about the study and the high risk of embryolethality [dead fetuses]

What did Glaxo do with this information?

Well, they sat on it.

Step forward to 1994. Paxil was doing great, it was a blockbuster. 'Ka Ching' was echoing around the corridors of GSK. Glaxo, being the money-making corporate company that they are, wanted more sales though. America wasn't enough. So, they decided to target Japan. One small problem though. The Japanese have big issues when it comes to birth defects, they've seen their fair share of them over the years what with environmental disasters such as Hiroshima, Nagasaki and Minamata. If the Japanese found the Ferrosan study then that could have affected GSK's American market.

So, how could they [GSK] hide the rat pup studies from the Japanese? Well, they designed a study for them but it was a study that would have serious implications for GSK and Paxil. They autopsied one of the rat pups, hazard a guess at what they found?

One of the pups was found to have an edema, swelling around the heart, and it had a ventricular septal defect.

Now, one would have thought at this point that this particular finding would have caused alarm bells to ring. 

Not so.

They minimized it. In their conclusions they didn't even mention it. It is buried in the back of the study in an appendix.

My question is pretty simple. How can GlaxoSmithKline's lawyers argue that Joanne Thomas was late in filing her action and that her unborn son was non viable when they knew many, many years before Joanne fell pregnant with Ryan, that Paxil could cause birth defects in rat pups? They knew, the consumer didn't. How can they blame the consumer for not knowing?

Furthermore, even if Joanne did find out at the time that she was taking Paxil that it was dangerous to her unborn child, how did GlaxoSmithKline's lawyers expect her to just stop taking it when Paxil has one of the highest incidents of withdrawal rates in the SSRi group of medicines? 

Glaxo quietly settled a previous Paxil addiction lawsuit in the US back in the mid 2000's with over 3,000 claims against them.

Now Here's Twist Number One

As I mentioned above it came to light during the Kilker trial that Glaxo knew very early on that Paxil was causing rat pups to die and also causing heart defects. That was clearly established in the trial.

Also, during the Kilker trial it came to light, via GlaxoSmithKline internal emails, that Glaxo had been contacted by a consumer in 2001. Many lawyers and advocates have, for years, being trying to track down this woman. Sadly, no name was attached to the emails. Glaxo were afforded the privilege of removing the name, probably for 'data protection' reasons.

Here's the emails that were sent to Glaxo in 2001

"I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I've been taking Paxil, which is truly a miracle drug. I've been panic-free with this drug and have been able to go on with a normal life.

"I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

"The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

"To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

"I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

"My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don't want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

"Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

"Please contact me as soon as possible ... Please don't forget about me."

The woman sent a second email, on 1 June 2001.

"This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

"I am in no way insinuating your product did this to my child. I love the product, and I don't think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

"I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

"Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help."

The following GSK internal memo from June 2001 refers to her emails.

"Report 2001014040-1 describes the occurrence of a terminated pregnancy in a female of unknown age prescribed paroxetine (Paxil) for panic disorder.

"This report was received from the patient and has not been confirmed by a physician or other health care professional. Concurrent medications and medical conditions were not known.

"Four-and-a-half years ago, the patient started Paxil (dose unknown). Since taking Paxil, the patient noted she has been panic-free and has been able to go on with a normal life.

"Patient discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis.

"Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time."

GSK emailed the following response to the woman on 6 June 2001.

"Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.

"Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

"Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

"We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

"Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department ..."

But an internal GSK internal document relating to the correspondence, headed "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

So, an admittance by GSK that Paxil was related to the birth defect, right?

The mystery woman, whose name was redacted on the documents presented at the Kilker trial, has been the subject of much debate ever since the emails were made public. Just exactly who was she?

Professor David Healy, who actually gave evidence in the Kilker trial, has tried hunting her down in two excellent posts of his, American Woman and American Woman 2. I'd even wrote about the mysterious woman in my book, The evidence, however, is clear, the Seroxat scandal.

For the first time I can now reveal that the mystery woman was Joanne Thomas, mother of the "non-vialble fetus". The same mother who has been told she cannot pursue her complaint against GSK because she is out of time [statute of limitations]

It makes a mockery of the law, don't you think?

  • File an adverse event to a pharmaceutical company.
  • Have that very same company admit via internal emails to one another that Paxil was the cause of the adverse event.
  • Have no feedback from that same pharmaceutical company, despite asking them if Paxil is safe to take during pregnancy.
  • Learn six years down the line that Paxil has been classed as a teratogen.
  • File suit against the company for causing birth defects.
  • Have the pharmaceutical company attorneys tell you that you are out of time.

Talk about having your cake and eating it!

So, in 2001, GSK received one spontaneous report from a mother who had terminated her pregnancy, this mother was taking Paxil at the time she terminated because her fetus was deemed to have  a rare congenital heart disease.

Why, at that point, didn't GlaxoSmithKline, change the product information labelling on Paxil?

More importantly, how can GlaxoSmithKline argue that Joanne Thomas is out of time to file a case against them [statute of limitations] when, it could be argued, that she already made Glaxo aware of her son's birth defects back in 2001?

I'd love to know if Glaxo handed over full disclosure to the attorneys representing Joanne Thomas?

Glaxo corresponded with Joanne via emails back in 2001, did they present these emails to Joanne's attorneys, if not, why not?

Twist Number Two

Glaxo had Joanne's name on file, they had it since 2001. Are we to believe that during Joanne's case they didn't know that she was the mother who contacted them back in 2001, the same woman who, through Glaxo's own internal emails, aborted her child because the Paxil  she ingested was almost certainly the cause of the birth defects?

Here's where the case takes a rather bizarre turn.

Reading the the Appellee Brief [GSK] we see that GSK claim that Joanne admitted that she had no contact with GSK until nearly four years after the Statute of Limitations expired on April 26, 2003.

I think it's fair to say that Joanne suffered a major trauma here and one could possibly argue that she cannot remember because of the trauma suffered around the time of her termination.

In any event, why did Glaxo not reply to her with their finding, "almost certain"?

What she has now is evidence that she did indeed contact GSK and they [GSK] knew that she did, although I guess they could argue that they didn't know, that's what King & Spalding are paid to do. Maybe they could use trauma as an excuse or if any of the King & Spalding team were taking Paxil  they could probably use memory loss as an excuse.

It's almost as if GSK have used Joanne's poor memory against her then made her admit to something that they knew would be an untruth as they already had evidence that she had wrote them in 2001.

Internally they blamed Paxil for her termination but never told her this. That, by anyone's standards, is fraudulent concealment, isn't it?

It's Glaxo that failed to act and not Joanne Thomas. The only course of action Joanne took was to terminate her pregnancy, a termination that Glaxo are now arguing was of a non-viable fetus, in other words Ryan, the unborn fetus, was not really a living being in the sense of the word, the word according to Glaxo and Pennsylvania law.

The internal documents, remember, revealed that Glaxo were "Almost certain" Paxil caused the birth defects in Ryan. Why, in 2013, twelve years later, are they settling other birth defect cases but refusing to compensate Joanne Thomas for her loss? [The Kilker family received  $2.5 million in compensatory damages]

So, do I, as a writer, just take what Joanne has told me at face value? Of course not, it would be unprofessional to do so. Joanne was unaware that the emails from the Kilker trial had been made public, she was unaware that the video deposition of Jane Nieman, a former GSK employee, had been made public. Joanne and I began to join the dots after reading the emails and watching the video deposition. I asked Joanne to check through her old emails. Joanne, being the astute woman that she is, went one better than that.

On the 10th December 2013, Joanne contacted GSK and spoke with Jacqueline Moniz, a Sr. Clinical Safety Scientist. She asked Moniz for her Medwatch reports. Surprisingly, Moniz emailed them to Joanne within a couple of hours of speaking to her. Here's the cover letter:

Hello Ms. Thomas,

It was a pleasure to speak with you.  Again, I appreciate your assistance with identifying duplicate reports in our safety database.

I have attached a pdf that contains all of the reports.  When we spoke, I did not realize that the last report was not completed to “MedWatch” stage.  It was identified as a duplicate prior to completing the case.  I included the narrative for this report at the end of the other reports.

Please let me know if you require further assistance with these.

Thank you,

Jacqueline Moniz
Sr. Clinical Safety Scientist
US CMG & Operations
RD Chief Medical Office

5 Moore Drive, PO Box 13398, RTP, NC 27709-3398, United States
Tel       +1 919 483 7116

I've seen the documents sent to Joanne by Jacqueline Moniz. The documents reveal Joanne to be the sender of the email used as evidence in the Lyam Kilker trial.

The internal documents that surfaced at the Kilker trial showed that Glaxo officials had stated  "re-investigation of case number A0348482B", dated 13 June 2001, states: "Relatedness assessment to medication – almost certain."

The documents sent to Joanne from GSK reveal the same case number.

Finally, as with all deaths, those who are left to pick up the pieces often blame themselves. What if I did this or that, what if I turned a different corner that day, would this still have happened? It's part of the grieving process I guess, although I am not an expert in such matters, the experts are those who have had to endure such tragedies.

Joanne wrote a letter to her child that never was, it's tough to read but she has given me permission to publish here today. The letter sees Joanne apologising to Ryan for terminating him, part of which reads...

"Daddy and I went to a doctor in the city where we would take you out. I was so scared, but I hoped, I prayed that it was the best for you. You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me". But then I felt like you were saying, "Mommy, let me get home.""

This is for Glaxo and their lawyers. It also serves as a warning to expectant mothers out there, call it informed consent, if you will.

"You kept kicking my stomach and I felt like you were saying "Mommy, don't do this to me""

And here's Ryan...

Glaxo have, in my opinion, abused the law in this case. Sadly, the law, being as perverse as it is, has allowed Glaxo to use it for their benefit. They have, in essence, acknowledged Paxil caused the heart defect which, in turn, forced the hand of Joanne Thomas. But to save money they have used a statute of limitations and a non-viable human excuse as their extraordinary defence. Both arguments are deeply flawed and, maybe, could have been met with a counter-argument such as the ones laid out in Part I -  ( Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.) and (If born now, your baby would have a 20% chance of survival, the odds going up with each passing day.)

Former Glaxo employee, Jane Nieman, provides an insight into the pharmacovigilance at GSK.

In this video deposition she is interviewed by a US attorney who was representing Lyam Kilker [Kilker v GSK] Skip to 31 minutes of this video deposition and you will see both discussing Joanne's emails to GlaxoSmithKline, although at the time Joanne was still the 'mysterious woman'.

I sent the video to Joanne because what she was telling me during our conversations seemed to strike a bell.

As Joanne reviewed the video it became apparent that the woman being discussed by Jane Nieman was actually her.

Joanne flicked me the following email...

"Omg...Bob that's me!!!!
"Jesus Christ 31:07 ... I believe its my call!!
"I am a mess...."

In the space of just 7 days Joanne and I pieced together all the information. Her actual case had been with attorneys for 7 years - Nobody had joined the dots.

Here's Joanne's take on the video.

"They knew all along that Paxil did this to Ryan and yet they never told me or warned any other expectant mother out there.

"I heard that many attorneys had hired Private Detectives to try and hunt me down as they wanted to put a name to the mysterious woman and maybe possibly use me as a witness. 

"Luckily I got in touch with Bob Fiddaman and the mystery was finally solved."

Joanne's father, Mike, added, "When Joanne showed me the information about the "mystery woman" and the trail it brought to light, part of me thought "makes perfect sense for a company like GSK". My daughter and others are morally showing what GSK is."

It sickens me to the core that this woman has been treated so abhorrently by GlaxoSmithKline and the expensive suits team of King & Spalding attorneys hired by GSK.

The FDA failed her and her unborn son too. As for GlaxoSmithKline, they chose to sit on the rat pup studies. If they had carried out further tests, as Ferrosan suggested, then they may have just saved a human life or two. Sadly, to lose such a stranglehold on the American antidepressant market saw them opt out of the transparency they boast about today, a transparency that has TV and media doctors applauding GSK and singing their praises. For what exactly? Those same high profile doctors currently singing the praises of GSK should watch the above video in its entirety. Even when faced with a human birth defect they decide to keep the results "in-house", yet another failure to warn the public about Paxil's propensity to cause birth defects.

Glaxo had a legal duty to revise the labelling for Paxil when they, through their own pharmacovigilance, learned that Paxil was the 'almost certain' cause of the birth defects in this particular case. They didn't. Was this to cover themselves from being sued? It's a fair enough question given the circumstances surrounding the 'statute of limitations' defence used against Joanna Thomas, isn't it?

Furthermore, Joanne emailed GSK with, "My husband and I are ready to try again to get pregnant in the next month or two." Why didn't GSK warn her that their initial assessment resulted in Paxil being the cause of her first child's birth defects? What kind of person would keep this information from a woman?

GSK have a lot to answer for in this case. By simply throwing a statute of limitations defence at it is not good enough. Kudos to their law team for doing their job, bad Karma for the person who decided to go down that route.

No apology has been offered to Joanne Thomas by GSK. No admittance that they had claimed, in-house, that it was 'almost certain' that Paxil caused Ryan's birth defects.

The Appeal, Joanne's Acquiesce

Armed with this evidence Joanne gave me permission to contact her attorneys. After reviewing the evidence they have now filed an appeal in the Supreme Court. Glaxo wouldn't be Glaxo if they didn't object to such an appeal... and they have done so in remarkable fashion.

They, via King & Spalding, are, in essence, claiming that Joanne cannot charge them with fraudulent concealment just because they knew about the Paxil/pregnancy hazard and didn't tell her. In a nutshell they are claiming that  they had no legal  duty to look out for Joanne's interests.

They also claim that they asked Joanne for her medical records and she never replied. Wow! admit internally that Paxil has caused birth defects and then ask for medical records! Seems a kind of half-assed way to conduct pharmacovigilance, don't you think?

In any event, pharmaceutical companies only ask for medical records so they can blame other drugs the consumer may have been taking or, in many instances, blame the illness or genes of the consumer.

I'm left wondering why GlaxoSmithKline have, in my opinion, such a disdain for women who are pregnant?

Buying Silence

In between all the legal wrangling between Joanne's attorneys and King & Spalding a new offer was put forward - the terms of agreement didn't sit right with Joanne. In a nutshell, GSK wanted her to sign an agreement that dissolved them and Paxil from any blame. These agreements are more commonly known as 'gagging orders'. Joanne, after careful consideration, rejected GSK's offer. Had she had signed it then it would have been her acquiesce. She would have not been able to discuss this new evidence with anyone.

Begs the question then if GSK were merely offering Joanne a compensatory award in return for her silence?

Why, if this was the case, would they want to buy Joanne's silence?

I, personally, do not like GlaxoSmithKline. I do not like the lawyers that represent them. I do not like the Pennsylvania law [2 year statute of limitations] or the way that King & Spalding [Glaxo's lawyers] used it to their advantage resulting in heartache for a mother who only ever wanted to hold and love her baby.

This should not be about points of law, this should be about humanity.

GlaxoSmithKline should be bowing down before Joanne Thomas. They should be thanking her for bringing the birth defect link to their attention. Joanne's fetus was, in essence,  part of the study that they should have ran when they learned about the Ferrosan rat studies.

Ryan was the human guinea pig, he was sacrificed to warn others but, yet again, Glaxo failed to warn in time. They argue that they don't have a duty to yet expect consumers to file claims against them in time.

Let's give the little guy some respect here. Let's give his mother, Joanne, some respect too.

I am glad Joanne Thomas made contact with me. I am glad that we were able to join the dots. I'm glad the mysterious American woman who contacted GSK back in 2001 isn't so mysterious anymore. Hopefully, the mainstream press will pick up on this and Joanne will be paid handsomely for any interviews she does in the the future, she deserves it.

Furthermore, Joanne is a  valuable witness, she, to my knowledge, is the only living woman who has evidence that Paxil was almost certainly the reason why her son developed heart defects. She has this in the form of GlaxoSmithKline's own internal emails.

Put a face to the mother who GSK were discussing in emails, put that same face in the witness stand for any future Paxil birth defect litigation and you will have very powerful leverage to strike a deal between GSK and plaintiff.

Litigation isn't about justice - it's merely about striking a deal so that everyone walks away moderately happy.

The Pennsylvania law has failed Joanne here and it has failed her miserably.

GSK's  US HQ is in Pennsylvania. Nice to have their headquarters in an American state that has laws that have supported their argument, huh? Why build an igloo in Jamaica when you can have a more robust igloo in Greenland?

The GlaxoSmithKline company tagline is, "Do more. Feel better. Live longer."

Obviously this does not, and never will, apply to Ryan, the alleged non-viable fetus.

Bob Fiddaman.

Most lawyers know when their clients are guilty of the crime charged, and will work hard to represent them in order to get the best deal possible. There are some, however, who will believe every word their client says, regardless of the videotaped evidence, the confession, and the litany of witnesses who say otherwise. I suppose it relates to maintaining credibility, but if you refuse to accept a cold hard fact, and instead tell an ADA or the judge (or heaven forbid a jury) the complete opposite based only on the say-so of your client, then you are not being effective. A healthy mistrust of the State is, undoubtedly, healthy for a defense lawyer, but blind acceptance or willful ignorance of the facts is unhealthy for a positive resolution of the case. - D.A. Confidential

Glaxo and their attorneys, King & Spalding, can be contacted via Twitter. @kslaw and @GSKUS
References for Part I & 2

(1) Wolfe v. Isbell, 291 Ala. 327, 329 (Ala. 1973)
(2) Coveleski v. Bubnis, 634 A.2d 608, 610 (Pa 1993).
(3) McCaskill v. Phila. Housing Auth., 615 A.2d 382, 384 (Pa. Super. Ct. 1992) (following the U.S. Supreme Court’s holding in Planned Parenthood v. Casey, 505 U.S. 833, 860 (1992), that viability occurs at 23 to 24 weeks).

Bob Fiddaman

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