Zantac Lawsuit


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

Wednesday, May 01, 2019

UK Seroxat Litigation Day 3 - More Silence and Discovery History





Day three of the UK Seroxat litigation sees more silence from the British media. I'm assuming they are waiting until the end of week 1 before they go to print. Opening statements can be repetitive and tiresome.

As I am not in a position to report on the trial given I'm a claimant, I want to highlight a previous case I worked on (for free). It involves Seroxat and just like the current litigation wasn't reported on in the media.

This old post of mine highlights how GSK's attorneys operate, at least in the States. It's important that I air this again as it shows readers who may be unfamiliar with GlaxoSmithKline exactly what kind of beast UK claimants are up against.

I worked on this case for almost three months before going public. Much of what went on behind the scenes has never been made public...until now. It's a long post as it takes some explaining. Imagine, if you will, a jigsaw, that you are told will reward you with a pot of gold upon completion. You get to the end only to find missing pieces. Some years later, after nobody has come forward to collect the prize, you are handed those missing pieces. There was no pot of gold for me but I took great satisfaction in helping a mother who had been harmed by one of the largest pharmaceutical companies in the world. My satisfaction came as a result of their forced u-turn.

First off, rules of discovery do apply to both sides to some extent. But the reality of the situation is that the defence does not end up having to play by the same strict rules. This doesn’t mean defendants can sit on their hands, though. Failure to respond to discovery in a timely manner can result in sanctions, including financial penalties.

Discovery
Discovery, in the law of common law jurisdictions, is a pre-trial procedure in a lawsuit in which each party, through the law of civil procedure, can obtain evidence from the other party or parties. Discovery is conducted in various ways such as interrogatories, requests for production of documents, requests for admissions and depositions. (Source)

Headlines Galore
In December 2013 a petition of allocatur was filed in the case of a woman who claimed that her use of  Paxil (Seroxat) during pregnancy caused birth defects necessitating an abortion. Allocatur basically means permission to be allowed to file an appeal.

The woman, Joanne Thomas from Pennsylvania, filed the allocatur to challenge a Nov. 27 Superior Court ruling that GlaxoSmithKline did not fraudulently conceal from her information about the U.S. Food and Drug Administration birth-defect risk classification of its drug Paxil. Given there was no fraudulent concealment to toll the statute of limitations, the Superior Court ruled the case was time-barred. Additionally, the court ruled that since Thomas' unborn baby did not reach the fetal gestational age of 23-24 weeks, it was not considered "viable" in terms of a wrongful death/survival claim.

In 2009, Glaxo lost a case that claimed it did not do enough to warn mothers of potential dangers when taking Seroxat during pregnancy. The next year, Glaxo paid more than $1 billion to settle 800 similar suits in the U.S.

The 'test case' Glaxo lost in 2009 involved Lyam Kilker.  Lyam was born in 2005 with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries. Shortly before conceiving, Michelle David, Lyam's mother, had been prescribed Seroxat for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy.

Lyam's mother filed a lawsuit against GlaxoSmithKline and on October 13, 2009, a jury in the Philadelphia Court of Common Pleas returned a verdict against GlaxoSmithKline. The jury ordered GSK to pay $2.5 million in damages to the family.

"Please don't forget about me"
During the Kilker trial, it came to light, via GlaxoSmithKline internal emails, that Glaxo had been contacted by a consumer in 2001. The name of the consumer was redacted.

Here are 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."

--

Eventually, 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 ..."

--

These emails were produced at the Kilker trial as was a GSK admittance, albeit via an internal document.

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

So, GSK knew as far back as 2001 that it was almost certain that Paxil caused the birth defects. They never, however, gave this information to the female consumer who wrote to them. This despite the woman asking for information regarding Paxil as she and her husband wished to try for another baby, "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."

---

Contacting a Blogger
In 2014, I was contacted by Joanne Thomas who, if you remember, had lost her case against GSK due to a statute of limitations defence being used.

Joanne was unaware that she had been the subject of many blog posts and had been sought by attorneys, some even hired private detectives to try and track her down. Dr. David Healy had also previously wrote about her, here and here, but she was unaware of this.

Her email to me obviously struck a chord and I asked her to view a video I had uploaded to YouTube. The video, a deposition from GSK's Jane Nieman, had been used as evidence in the Kilker trial.

Within minutes of watching the video Joanne emailed me back saying, "Omg...Bob that's me!!!!
"Jesus Christ 31:07 ... I believe its my call!!
"I am a mess...."

I spoke at length with Joanne and her father and pieced together her case, in all it took around three months to put an article together. I also contacted her attorneys to basically let them know they had "missed a trick."

Within the space of a few weeks after publishing my findings, GSK and Joanne's attorneys agreed on a settlement. Disappointingly, Joanne's attorneys told her not to contact me anymore this after I handed them victory against GSK. A nice 40% of Joanne's award for them for others doing their work. 

Joanne sent me emails which showed GSK in a tizz over the evidence they had previously kept from her attorneys. We spoke again on the phone and she asked my advice about the paltry sum GSK was offering her. Her lawyers, in my opinion, a two-bit bottom-feeding law firm, put pressure on Joanne to accept GSK's measly compensation. What price for killing a child, huh? Sadly, Joanne was to be gagged once she accepted the settlement.

I don't know how Joanne is getting on these days and don't really blame her for ceasing contact with me. I do, however, know that GSK knew exactly who she was but told a judge that her case was barred by the Statute of Limitations when the reality is they had already admitted back in 2001 that they were certain Seroxat caused her child's birth defects. GSK knew but didn't tell her and put her and any future babies at risk. Don't you find this conduct inconceivable?


Keeping evidence 'in-house' that may point to a fault causing death is one thing, but to keep it 'in-house' knowing that it may happen again to the same person is unforgivable.

I had more shares on the following two posts than any other of my blog posts I've ever written. GSK, King & Spalding (GSK Attorneys) all visited my blog, hence the reason, they settled with her.

Here are the two posts that forced the hand of GSK to settle.

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


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

Enjoy.

Bob Fiddaman

Coming soon. GSK's defence in the UK Seroxat litigation - Playing the media blame game and why it doesn't hold water.





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