Zantac Lawsuit

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

Tuesday, April 08, 2014

Ryan, Glaxo's Non-Viable Fetus - Part I

Joanne Thomas, disputes Glaxo's claim that her fetus was "non-viable"
Disputes the Statute of Limitations Defence used by Glaxo's attorneys.


The following is probably one of the most complex posts I have ever written. It's been months in the making, it's been chopped, changed, edited, re-edited and even circulated among attorneys before finally making publication here today.

I've tried to simplify things as much of what is contained has to do with points of law, to be more specific, Pennsylvania law.

It's fair to say that corresponding and speaking with Joanne Thomas has been eye-opening, to say the least.

The law is the law and cases like this expose its ludicrousness.

This is the story of Joanne Thomas and her unborn child, Ryan. It's part I of II and is leading up to some pretty startling revelations regarding GlaxoSmithKline and their lawyers, King & Spalding.

Everyone is entitled to a good defence team, even GlaxoSmithKline has that right. If I was to ever step into law I'd rather work for a prosecution team, you know, go after the bad guys and not defend them when I know they have done wrong.

I'd love to be able to bring back people from the dead too, children and adults, you know those ones who had their lives cut short through no fault of their own, those who were not forewarned that their actions could, ultimately, lead to their premature deaths.

Wouldn't it be great if we, after death, did meet up with those that had passed before us. Whether we actually do or not is just a belief, one of hope.

This post is about those who didn't have a chance to walk the earth, who, through no fault of their own, were introduced to medicine before they were born. This post is also about GlaxoSmithKline and their highly paid defence lawyers and just how far they go to keep their name and products intact. It's about how they hold on to their coffers because to simply compensate a mother who aborts a fetus that was malformed due to Paxil  (Known as Seroxat in Europe and Aropax in Australia and NZ) ingestion is not a road that Glaxo or their attorneys wish to go down. They use every trick [lawfully] in the book, blame everyone and everything. They operate within a law that gives them the upper hand, that, I believe, allows them to twist a knife in the gut of a mother who has already lost something so precious, the life of a child.

Their abject denial at something so abhorrent as a life dying before it has had a chance at living sickens me. Their defence of Paxil [paroxetine] causing birth defects or forcing the arm of a pregnant mother to abort sickens me too.

Here's an insight into how GlaxoSmithKline and it's lawyers operate. I am posting this because not many people truly understand what we are dealing with here. It's a post that has taken a number of months to piece together, it's a post that highlights the tenacity of a mother driven to seek justice on her own because the law has failed her. I'd like to thank Joanne Thomas for her patience and all those who worked behind the scenes and who offered advice and support to Joanne during this difficult time.

Ryan, Glaxo's non-viable fetus

Joanne Thomas fell pregnant in 2000, during the course of which Joanne was taking 40mg of Paxil. Back in 2000 Paxil was classed as a Category C drug (Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.), in other words Paxil, according to the FDA, may or may not cause birth defects, there was no definitive answer. In order to classify the risk to the fetus, the Food and Drug Administration (FDA) established five categories to indicate the potential of a drug which crosses the placenta to cause birth defects.

The timeline is important in this particular birth defect case as we shall see.

Joanne was sent to have an echo cardiogram by her obstetrician after a routine ultrasound.

The ultrasound had found that Ryan, Joanne's chosen name for her unborn child, had echogenic bowels and one kidney. They were unable to verify if there were issues with his heart as they could not get a good visual. An appointment was then made for Joanne to see her pediatric cardiologist.

During the echocardiogram performed on April 23, 2001, the pediatric cardiologist estimated fetal gestational age to be 22½ weeks, and notified Joanne that her baby had severe congenital heart defects. It was unknown, at the time, what caused the fetal abnormalities and Joanne was referred for another appointment some 5 to 6 weeks later.

3 days later, however, Joanne decided to abort. The fetal death certificate estimated gestational age to be 21½ weeks, which was one week different to the pediatric cardiologist's estimation.

In one of many conversations with Joanne, she told me, "What scared me was when the cardiologist drew what a normal heart looks like and another drawing of Ryan's. That is when I was told he most likely would not be able to take his first breath. He would be intubated [placement of a flexible plastic tube into the trachea] immediately, and flown to a specialty hospital for heart surgery...if he survived."

Joanne saved the drawing that her cardiologist drew and has kindly passed it on to me.

Sketch of Ryan's heart defects drawn by Joanne's Pediatric Cardiologist

Joanne put this behind her as much as she could, she never, during the following years, made any connection to heart defects and Paxil. Why would she? At the time there was no warning.

In 2006 whilst studying her nursing boards she ran across items that suggested that Paxil had now been re-categorized by the FDA. They had moved it from a 'C' to a 'D' (Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.)

Shocked, Joanne decided to ring the GSK Consumer hotline. According to court documents she asked a GSK representative manning the line if Paxil was a Cat C or D drug, she was incorrectly told that Paxil was a “Category C” drug.

Further investigation by Joanne confirmed that Paxil had indeed been moved from a Category C to D drug.

It was at this point that Joanne filed her Short Form Complaint [September 2007], alleging her Paxil ingestion during pregnancy caused her son, Ryan Swindle’s wrongful death. It was to be part of a class action lawsuit against GSK.

GSK, via their highly paid law firm, King & Spalding, moved for summary judgment. They argued that Joanne's claims should be dismissed for two fundamental reasons. First, Joanne could not bring a wrongful death or survival action because her fetus was non viable at her therapeutic abortion. (Non viable means not capable of living, growing, or developing and functioning successfully. It is antithesis of viable, which is defined as having attained such form and development of organs as to be normally capable of living outside the uterus. (1))

This is where GSK's law team really earned their corn. This from one of the court documents:

GSK argues as a matter of law there must be either [1] a child born alive; or [2] a viable fetus, capable of an independent existence at death. (2)  Under Pennsylvania law, viability occurs no earlier than 23 weeks gestational age. (3) Relying on Plaintiff’s fetal death certificate, GSK argued she cannot sustain a wrongful death or survival action because she [was] at 21½ weeks, before viability occurred.
Next, GSK argued even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death. GSK contends the two-year period commenced on the day Ryan Swindle died, regardless of when survivors knew, or should have known, cause of death. 

Let's tackle GSK's first argument.

Firstly, there was two estimations on the age of the fetus.

  • Joanne's pediatric cardiologist estimated fetal gestational age to be 22½ weeks.
  • The fetal death certificate estimated gestational age to be 21½ weeks

Why were Glaxo allowed to pick the one age that best suited their argument?

Let's say, for argument sake, that GSK were wrong and the actual age was what the pediatric cardiologist estimated (22½ weeks). According to Pennsylvania law the fetus still wasn't viable. Remember these are just estimations, they are not, and never have been, set in stone yet Glaxo used this to their advantage. 

Secondly, they argue "even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death."

So, isn't this like saying we committed a murder but you didn't know it was us during your first two years of mourning. The fact you found out it was us (some years later) holds no water because the two year statute of limitations covers our ass?

I guess all those investigating the 1888 murders of Jack the Ripper should give up. It's a pointless, dare I say it, futile exercise, according to the Glaxo mantra that is. Let's abolish all the cold case files whilst we're at it.

At a fetal age of 20 weeks here's what was probably going on inside Joanne Thomas. I just want Glaxo's lawyers to be aware of this.

  • Ryan would have reacted to loud sounds.
  • Ryan would have started having a regular sleeping and waking rhythm.
  • Joanne's movements could have woke Ryan.
  • Taste buds were forming on Ryan's tongue.
  • Ryan was around 28cm long (crown to heel) and probably weighed around 450 grams.

Non viable huh?

Furthermore, if GSK argued that Joanne's fetus was non viable what does this say about the following claim taken from the fetal development website

You are 20 weeks pregnant. (fetal age 18 weeks)

Your baby now weighs about 11 ounces and at roughly 7 inches long they are filling up more and more of the womb. Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.

Glaxo claimed the fetus was 21½ weeks, let's say they were correct. They argued that 21½ weeks meant that the fetus was non-viable. Let's see what the fetal development website have to say about a fetus at 21 weeks.

You are 23 weeks pregnant. (fetal age 21 weeks)

If born now, your baby would have a 20% chance of survival, the odds going up with each passing day. By this week, your baby weighs a little over 1 pound (500g). Its crown to heel length is 11 inches (28cm).

20% chance of survival, yet Glaxo dismissed this. Joanne fetus had a 20% chance of survival ergo she terminated when Ryan had a 20% chance of life. These odds were drastically reduced because Ryan had developed  a rare congenital heart disease that was caused by the Paxil she was taking.

The court disagreed and sided with GSK's argument in July 2012. Joanne's case was lost on the grounds of the non-viability issue and the statute of limitations issue. Glaxo also successfully argued that the child either must be born alive or it must be a viable fetus, capable of an independent existence at death. Joanne appealed the decision but in Nov 2013 a three-judge Superior Court panel agreed that a Philadelphia Common Pleas Court judge was correct in July 2012 to issue summary judgment to GlaxoSmithKline.

Grounds for a second appeal seemed futile until Joanne wrote me and we spoke for many hours discussing her case. It appeared that Joanne, without actually knowing it, was someone who many lawyers and advocates had been trying to hunt down for years.

In cases like Joanne's the plaintiff bears the burden of proof and must demonstrate fraudulent concealment by clear, precise, and convincing evidence.

In Part two I shall, on behalf of Joanne, try to present that evidence.

GSK's company tagline is "We are a leading healthcare company that helps people to do more, feel better and live longer"

Coming up in Part II - **NOW ONLINE**

  • How Glaxo knew about the possible birth defect risk many years ago but failed to act.
  • I unearth new evidence that shows, I believe, how Glaxo's statute of limitation defence holds no water.
  • The link between Joanne's birth defect case and the Kilker v GlaxoSmithKline birth defect case.
  • Did Glaxo and/or their attorneys, King & Spalding, hold back items of discovery from Joanne's law team and the presiding Judge?
  • I contact Joanne's law team with new evidence, they submit an appeal to the Supreme Court.
  • Glaxo U-Turn - An offer is made to Joanne Thomas after an appeal is submitted to the Supreme Court, an offer which, after much consideration, Joanne rejected.

Bob Fiddaman

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