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"FIDDAMAN BLOG" - 5 new articles

  1. Are Lundbeck Luring Pregnant Mothers With a Red Apple?
  2. Paxil: The Statute of Limitations Defence
  3. Antidepressant Aggression, the MHRA Perspective
  4. GSK Sink to New Level in Paxil Suicide Litigation
  5. Eli Lilly to Face Cymbalta Lawsuits
  6. More Recent Articles
  7. Search FIDDAMAN BLOG
  8. Prior Mailing Archive

Are Lundbeck Luring Pregnant Mothers With a Red Apple?






After turning into the Witch, the Queen declares that Snow White should suffer "a special sort of death". Looking through her spell book, she comes to the recipe for the Sleeping Death, and, reading of the Poisoned Apple's effects, decides that it's the perfect way to get rid of the princess. She brews the potion and dips an ordinary apple into the brew as the Raven watches silently. The Sleeping Death seeps into the apple, and the Witch raises the apple from the cauldron to reveal that the poison dripping from the apple has formed an image of a skull. This image fades as the apple turns red, to tempt Snow White. - Disney Wiki




I'm confused.

Can citalopram, marketed and manufactured by Lundbeck in Europe, cause birth defects?

It's a simple enough question that should be simple enough to answer. It is, when all's said and done, a very important decision to make for any pregnant mom who may be faced with a choice of taking or not taking citalopram during pregnancy.

Sadly for Scottish mom Cheryl Buchanan this is not an option.

When Cheryl was just 12 weeks pregnant she was told that scans had detected a series of anomalies in her unborn child.

  • Diaphragmatic hernia or eventration
  • Long bone immobility
  • Cystic hygroma 
  • Unilateral cleft hand
  • Microgynathia

A post-mortem revealed that Cheryl's unborn child that half of her daughter's diaphragm was absent, her lungs were very small, some of her organs had moved up into the thoracic region,  her neck had webbing, and her nose was small while her chin was recessed.

Cheryl had been taking Lundbeck's citalopram prior and during her pregnancy. She wrote a guest post for my blog back in 2013 and has since been trying to get answers from the Danish pharmaceutical giant Lundbeck.

What follows is bizarre to say the least.

Cheryl wrote me and asked me to read through a collection of emails sent to her by Lundbeck. I asked for Cheryl's permission to contact Lundbeck directly - she agreed.

Cheryl had previously asked Lundbeck if citalopram could cause birth defects. Their answer, in a nutshell, was that here was no evidence of this.

"...there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). " - Dr Andrew Jones, Medical Director, Medical Department, Lundbeck

I wrote directly to Dr Jones...

Dear Dr Jones,

I have seen the attached correspondence you wrote and sent to Cheryl Buchanan regarding citalopram and birth defects.
I understand that you will not be able to discuss with me individual cases but I feel I must press you for some clarification.
You wrote, " "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population (i.e. of mothers not taking citalopram). "
Can you clarify if this is just a personal opinion or if it is the position of Lundbeck.

Initially Dr Jones did not respond so I told him I would make the question to him public. Strangely Lundbeck then checked me out [Fig 1].


Fig 1


Dr Jones replied shortly after Lundbeck had paid a visit to my blog, his reply to me was short...

Dear Mr Fiddaman,
I confirm that this is the position of Lundbeck.

 I wrote the following back to Dr Jones...

Dear Dr Jones,
Many thanks for your reply, although it has to be said that Lundbeck are misleading Ms Buchanan with their rather ambiguous statement regarding the risks of taking citalopram during pregnancy.
As you are probably aware the pregnancy risk with citalopram is classed as a 'Category C', ergo risk cannot be ruled out. To suggest otherwise to a woman of child bearing age is irresponsible and misleading.
Do you or, indeed, Lundbeck, wish to amend your response to Ms Buchanan or do you wish to stand by your position that citalopram does not cause birth defects?
Whilst waiting for a response I fired off an email to Sandy Walsh, Sandy is a press officer at the FDA, more specifically for the Center for Drug Evaluation and Research. I also sent a reminder to Dr Jones that if he did not answer my follow-up question I would make it public on my blog.

Here's the email I sent the FDA...

Dear Sandy,
I'm very confused.
Recently a reader of my blog contacted me regarding the antidepressant citalopram, marketed in Europe by Lundbeck.
She had to abort her fetus due to it developing birth defects inside the womb.
Whilst I am aware that you cannot discuss individual cases with me I'd like to bring to your attention an email that the woman received from Lundbeck.
She asked if citalopram could cause birth defects.
The answer, from Dr Andrew Jones Medical Director, Lundbeck UK, was "there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects over the background risk in general population."
My question to you may clear matters. Could you tell me why the FDA have assigned citalopram to pregnancy category C and whether or not Lundbeck/Forest had any input in arriving at that decision?
Hopefully your answer may clear this confusion up.

Sandy Walsh was very helpful with her response, I've highlighted the relevant parts...

Here is the FDA-approved prescribing information (labeling) for Celexa: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf
As noted on page 18, there is a description of why Celexa is category C:   
-----
Pregnancy Category C : 
In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses. In two rat embryo/fetal development studies, oral administration of citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a body surface area (mg/m2) basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental, no-effect dose of 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis. Thus, teratogenic effects were observed at a maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with citalopram(4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD on a mg/m2 basis. The no-effect dose of 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study. There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus.
-----
Category C means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The pregnancy categories are assigned based on current scientific evidence and can be changed if new information is learned.
The company and the FDA both work together to add drug benefit/risk/safety information into the drug labeling.  So yes, the company plays a role in what is contained in the drug labeling.

The pregnancy categories
If a person has an adverse event, that should be reported by the doctor or patient to the FDA (or European authority), or the drug company, so that it can be properly logged into the official adverse event tracking systems.

I wrote the following back to Sandy Walsh...

Sandy,
Thank you for this.
I have found your help in this, and other matters where I have contacted you before, very helpful.
Can you explain why Lundbeck would be telling consumers/patients that there is no risk during pregnancy?
I can forward you the letter if you wish?

Sandy's response was...

I cannot speak for the company, please ask them.
As noted, the US drug labeling says, "There are no adequate and well-controlled studies in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the Celexa (citalopram HBr) fetus."

Not very satisfying so I pushed Sandy for something more definitive...

The company are, at this moment in time, refusing to answer any further questions from me.
This is potentially dangerous and misleading information they are handing out to women of child-bearing years.
If the company won't give me an answer and the FDA cannot speak about Lundbeck's stance then who can I ask?
Do you have a procedure whereby I can ask the FDA to ask on my behalf?

It's a strange way to safeguard human health, don't you think?

Here's Sandy's response...

Apologies, I have a number of other things I’m working on and meetings today.
The FDA is only able to provide the information I’ve given to you – the warnings in the FDA-approved drug labeling   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf.
If someone believes they’ve experienced an adverse event, they should contact the drug authority in that country. 
In the U.S., if there is adverse event information to submit, it should be submitted to our MedWatch system along with medical information from the physician, and the information from the company. Here are instructions as to how to do that: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm

In other words, sorry you are on your own.

Here we have a pharmaceutical company handing out information to a woman that claims that there is no link between citalopram use and birth defects. The American drug regulator, the FDA, inform me that during animal studies there was an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects)

They add that there are no adequate and well-controlled studies in humans and that  potential benefits may warrant use of the drug in pregnant women despite potential risks.

This is baffling?

If no adequate and well-controlled studies in humans has been carried out [and they never will be because it would be unethical to use a human fetus as a guinea pig] then how can they suggest that there is a chance of "potential benefits"?

If no adequate and well-controlled studies in humans has been carried out then why are doctor's prescribing citalopram to women who are pregnant? There is no gauge here so women just have to trust their healthcare professionals who are prescribing a drug blindly. Who informed the doctor's about the potential benefits of non-existent adequate and well-controlled studies?

How did we get to the stage where a drug that has never been through clinical testing for pregnant humans is now being prescribed on the premise that the benefits may outweigh the risks? What benefits?

You can't claim that a drug has benefits and that they must be weighed against the risk when you cannot even show clinical trials that highlight those benefits.

Bizarre.

This really is a game of Russian Roulette, right?

These findings are even more startling when you consider that Cheryl Buchanan is just one mom, how many more women of child bearing years have been told by Lundbeck that there is no evidence to indicate that usage of citalopram in pregnancy increases the risk of birth defects?

Contrast Lundbeck's dismissal of citalopram being linked to birth defects with a 2006 warning regarding Citalopram and birth defects issued by the FDA.

Dr Andrew Jones, Medical Director, Medical Department, Lundbeck has not responded to further questions from me. If he does respond at a later date I will update this post.

Citaloptram is better known by the brand name of Cipramil in the UK and Celexa in the US.

It could be argued that it's akin to the red apple used to lure Snow White.



Bob Fiddaman





    


Paxil: The Statute of Limitations Defence






The Article

Paxil Birth Defect Action Time-Barred, Fla. Federal Judge Rules
MIAMI — A Paxil birth defect action is time-barred under Florida law because the plaintiffs knew of a possible connection between their injuries and the drug more than four years ago, a federal magistrate judge has ruled.
On Aug. 12, Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Miami found the mother had notice of the possible invasion of her legal rights by Dec. 20, 1997, when her doctor noted in her medical records that her son’s condition was “apparently due” to Paxil.

The Background 

On January 27, 2012, Iolany Ferez, filed, on behalf of her minor son, Andrew Plascencia,(AP) a product liability action against GSK in Pennsylvania state court. Ferez alleged that Paxil caused A.P. to be born with Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur.

Ferez gave birth to A.P. in 1996. Doctors noted at birth that A.P. had a heart murmur, and diagnosed him with a heart defect the next day.  A.P.’s heart defect was classified as a tricuspid atresia type II‐B, a condition that has required two corrective procedures and regular cardiology visits throughout his life.

According to court documents, Ferez suspected Paxil caused A.P.’s heart defect almost immediately because she had taken it throughout the first six weeks of her pregnancy with A.P.She had not taken anything during her first two pregnancies and both children were born without defects.

Ferez asked A.P.’s cardiologist and her gynecologist whether Paxil may have caused A.P.’s heart condition. Both responded that they did not know.

On December 20, 1997, Dr. Marcio Ferez, Ferez’s father, employer, and primary care physician, noted in Ferez’s medical records that A.P.’s heart defect was “apparently due to” Paxil. In September 2005, GSK mailed a letter to Dr. Ferez and other healthcare professionals advising them of a recent study that showed Paxil was associated with an increased risk of congenital malformations, most commonly cardiovascular. A second letter was sent in December 2005, advising of an additional study showing an increased risk for cardiovascular malformations in infants born to women who had first trimester Paxil exposure.

The GSK Defence

GSK argued that the statute of limitations bars the claim of Ferez because she had actual and constructive knowledge that A.P.’s heart defect may have been caused by Paxil.

Conclusion

Although the Court was sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, “liability cannot rest on sympathy alone.”

GSK’s summary judgment motion was granted. (granting summary judgment to defendant in products liability case based on statute of limitations).

Commentary

Iolany Ferez took Paxil during her pregnancy. Her  son was born some time later and it was found that he had a number of birth defects. Ferez put two and two together and came to the conclusion that Paxil may have caused these defects because she had given birth on two previous occasions to healthy babies where, during these pregnancies, she was not taking Paxil.

GSK have claimed that because Ferez made an assumption that it could have been their product that caused her son's defects and didn't file a lawsuit against them straight away, she is out of time to make any such claim for compensation.

Can you imagine if victims of Jimmy Saville, or any other pedophile for that matter, were told that they, or the prosecuting team, couldn't bring any charges against him because they never came forward at the time of the alleged assault?

The Judge ruled in favour of Glaxo, "Although the Court is sympathetic to A.P.’s condition and injuries and recognizes that Paxil may well be responsible for his birth defect, liability cannot rest on sympathy alone."

So, an acknowledgement by the man with the gavel that Paxil may well be responsible for this particular child being born with a birth defect...but, um, tough shit, his mom  should have joined the dots and filed earlier.

What kind of system is this?

Sadly, Judges are bound by statute instead of common sense. Knowing the statute of limitations inside out is a must for any attorney representing the pharmaceutical industry. They cannot defend the drug because physical evidence shows the harm the drug causes - instead they rely on a statute that was, in my opinion, designed to help the mighty to continue being mighty and for the lowly to know their place.

In the meantime, the son of Ferez, who has Tricuspid Atresia, Right Ventricular Hypertrophy, and a heart murmur, has to go through a life of uncertainty. His mom has to pick up all the medical bills which can run into many thousands of dollars.

GSK have once again shown that their corporate motto that GSK is a  "global healthcare company that is committed to helping people to do more, feel better and live longer", is misleading and should be altered accordingly.

How have they helped the son of Iolany Ferez to do more?

How have they helped the son of Iolany Ferez to feel better?

How have they helped the son of Iolany Ferez to live longer?

This isn't the first time GSK have used a statute of limitations defence. They did so in the case of Joanne Thomas.

Thomas had to abort her fetus due to a number of defects caused by Paxil.

GSK argued she was out of time filing a lawsuit, the Judge agreed.

Research, carried out by myself and Thomas, showed that she wasn't out of time and that GSK knew that she wasn't. Attorney's involved in the case drew up a settlement between Thomas and GSK. There was no media coverage, apart from my own, about Glaxo knowing that Thomas had contacted them via email many years before she filed suit.

It's unknown if Thomas agreed to settle. Good luck to her if she did.

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



Bob Fiddaman.







    

Antidepressant Aggression, the MHRA Perspective








Last month I wrote a piece entitled, 'Antidepressants: The Power To Harm' which, basically, highlighted the Japanese drug regulator and the Japanese Ministry of Health, Labour and Welfare. [MHLW]

A 2009 review of antidepressants in Japan [1] resulted in MHLW issuing an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

They found that causality between SSRi antidepressants and harmful behavior to others could not be denied in 2 cases of reported adverse reactions associated with fluvoxamine maleate and 2 cases of reported adverse reactions associated with paroxetine hydrochloride hydrate. For the remaining 35 cases of adverse reactions, causality between the drug and adverse reactions was considered unknown.

After reading this review I wrote to the British drug regulator, the MHRA.

Dear Sir/Madam,
I would like to know if the MHRA have any information, be it by study or review, regarding SSRi adverse reactions of aggression including harmful behavior to others (including injury). 
Please state if any alerts to patients and their families have ever been sent out regarding this issue.
Please state if any revision to package inserts have been made regarding this issue.

The MHRA have now answered and, it has to be said, it would appear that patient welfare is far higher on the list in Japan than it is in the UK.

First off, their cover letter to me.




I like the final paragraph...

"The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder."

I'm not going to bother asking the MHRA if I am allowed to republish, what I deem as, important safety information regarding SSRi use and aggression. They've used this threat before with me, see 'The evidence, however, is clear, the Seroxat scandal'. [2]


The MHRA have provided me with 30 pages of information with regard to the question I put to them, much of which is redacted [blacked out]

It would be pointless to post all 30 pages but those wishing to scrutinize can request a copy from me by emailing me.

Some points...

The information sent to me from the MHRA was taken from meetings that occurred between the years 1996 and 2001.

Contrast that to the Japanese information on SSRis and aggression. Their information is more up to date, in fact it is 8 years more up to date than what the MHRA have given me.

The MHRA, or the data they sent me, points to two SSRis causing aggression. Fluoxetine and Paroxetine, namely, Prozac and Seroxat (Paxil)

Remarkably these findings of aggression with Prozac and Seroxat use have been played down by claiming that the reporting rates of aggression increased when stories started appearing in the media. The MHRA do not balance this claim, for instance, (i) the reporting rates may have increased because patients may not have known that the MHRA actually collected such reports and (ii) consumers may have attributed their aggression and suicidal thinking to their illness, opposed to it being a possible adverse reaction to the drug they were taking.

Page 23 of the 30 page document they sent me is quite telling. [Fig 1]


Fig 1

So, when there is a clear sign that aggression is occurring during Prozac and/or Seroxat treatment it has, if you believe the above, nothing to do with the drug/s, it is possibly a "separate event from the underlying illness" or it's "part of a discontinuation syndrome", or maybe the aggression has appeared because of the removal of the therapeutic benefits of the drug.

Once again, the suggestion of media reports on antidepressants and the suicide link are mentioned. It's almost as if they [the committees who reviewed the aggression link in SSRi use] are putting something in place. Rather than look at the blindingly obvious problem they chose to deflect and lay the blame on intense media reporting.

Now, contrast this stance with those of the Japanese.

2009:

The Japanese Ministry of Health, Labour and Welfare issued an alert to patients and their families to pay due attention to changes in patient condition during the course of treatment. On May 8, 2009, MHLW required marketing authorization holders [MAHs] to revise precautions in package inserts.

The above was based on a review where they found an association with SSRis and aggression.

No pussy-footing around, no blaming the media, no blaming a discontinuation syndrome or no blaming the underlying illness causing the aggression. Moreover, the  Japanese Ministry of Health, Labour and Welfare sent an alert out to patients and their families about their findings.

I don't know about you but if one regulator flags a warning about patients becoming aggressive on antidepressants then other regulators around the world should act promptly.

Judging by the material sent to me by the MHRA, they put the SSRi aggression link to bed in 2002 and have done nothing more about it since then.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

Oh really?



Bob Fiddaman


1. 2009 Selective Serotonin Reuptake Inhibitors and Aggression [Japanese Review] [Link]
2. The evidence, however, is clear, the Seroxat scandal. [Link]

    


GSK Sink to New Level in Paxil Suicide Litigation







I despise lawyers who defend pharmaceutical companies. I despise their ethics and lack of compassion, nae humanity.

None more so than lawyers representing GlaxoSmithKline.

When I first read what I am about to divulge a fire erupted so violently inside me. How on earth could one human treat another human this way. Then I remembered that we are dealing with GlaxoSmithKline and a team of fat cat lawyers devoid of any conscience - hey that's my opinion of Alan S. Gilbert and Melissa A. Economy of Dentons; and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP - if they don't like it then they can come and get me. [You hear me Todd?]

So, after taking a walk around the block, to calm me down somewhat, I find myself still reeling at the latest tactics of this corrupt company [I can say that because they are] and their hired defence lawyers.

It centres around a Paxil suicide case that GSK are trying their damnedest to not take responsibility for.

In June 2010 Stewart Dolin visited his family doctor who wrote him a prescription for Paxil for "work-related anxiety and depression".

Dolin's prescription was dispensed but he received the generic form, manufactured by Mylan.

Six days after beginning his course of the generic Paxil, Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin’s autopsy were positive for paroxetine.

Stewart's wife, Wendy, filed suit against GSK who argued that the drug ingested by her husband was a generic form made by Mylan.

A ruling earlier this year by Judge James B. Zagel allowed the suit to proceed on the grounds that GSK owed a duty to Dolin. GSK should have expected generics manufacturers, like Mylan, would make paroxetine once the Paxil patent expired, and, according to the ruling, GSK knew the companies would have to follow its label for the drug.

So, round One to the Dolin family.

With their tail between their legs GSK and their lawyers have now bared their claws to Stewart Dolin's grieving wife.

Law 360 are reporting that GSK's defence lawyers have subpoenaed Wendy Dolin's cellphone and text message records, her home phone and her late husband's company phone.

Last month GSK served a subpoena on AT&T Corp which requested text messages, billing records from Wendy and Stewart's phones.

Wendy has filed a motion stating that she had already complied with what she characterized as GSK's intrusive discovery requests, and accused GSK of excessive prying that would not end without the court's intervention.

Furthermore, Wendy has claimed in her motion that  "GSK has so far sent more than 30 subpoenas and over 70 records requests, and shown the Dolin children Stewart Dolin's confidential therapy notes despite Wendy Dolin's objections.

"GSK has also taken hours of deposition testimony from her and grilled her about her personal medical information and her romantic life since her husband's death, according to her motion."

Can you believe that a defence team would stoop to such a level?

End of the day Paxil can induce suicide in those that take it - see Tobin v SmithKline Beecham [Wrongful Death Suit]




Way I see it is that Glaxo have been spanked severely by a ruling. They expected another pharmaceutical company to face the heat because the drug was made by the other pharmaceutical company. What they failed to grasp is that they had a duty, both morally and ethically, to inform any pharmaceutical company making a generic version of paroxetine that it could induce suicide. Fact is, they didn't.

This isn't the first time Glaxo and their lawyers have shown a contempt for grief-stricken women who have been left to pick up the pieces of Paxil causing death.

Back in April I wrote a disturbing story about Joanne Thomas and her unborn fetus Ryan.

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.

Joanne Thomas contacted me and for three months we both pieced together evidence that she was not out of time at all - back stories here and here

Armed with the evidence Joanne went back to her lawyers who negotiated with GSK's defence team, King & Spalding. A monetary offer was made to Joanne. It's unknown whether or not she accepted the paltry amount.

So, are GSK merely showing others here that if you decide to go up against their mighty name that they will try to drag you through the mud?

End of the day everyone is entitled to a defence team but the levels to which Glaxo's attorney's stoop is nothing short of mental abuse. Glaxo are making Wendy Dolin's life a complete misery. First they fail to warn about Paxil's potential to induce suicide then, when a suicide occurs they try to lay blame on another pharmaceutical company - when they are ruled to be wrong on that issue they target the person making the complaint.

Alan S. Gilbert and Melissa A. Economy of Dentons; and Andrew T. Bayman, Todd P. Davis and Christopher R. Benson of King & Spalding LLP, who represent GSK in the Dolin case - Shame on you all.

Wendy Dolin is represented by Bijan Esfandiari, Michael L. Baum, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC; and Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

I sincerely hope that they can, once again, kick GSK's ass.

Bob Fiddaman.








    

Eli Lilly to Face Cymbalta Lawsuits



Cymbalta US Lawsuits


Eli Lilly and Company are facing a number of lawsuits regarding their antidepressant Cymbalta [Duloxetine]

Consumers of the drug, which is also used to treat various pain disorders, are claiming that Eli Lilly misled them about the withdrawal side effects of Cymbalta, side effects which include, but are not limited to electric-shock like sensations in their body and brain (also known as “brain zaps”), dizziness, nausea, vomiting, vertigo, excessive sweating, insomnia, nightmares, and diarrhea.

Over 20 lawsuits have been filed in federal courts across the US which sees claims that Lilly deliberately omitted information about the true risk of withdrawal in the product label and in marketing materials.

According to the LA law firm Baum Hedlund, the label wrongly claims that Cymbalta only has a 1% withdrawal risk, when in actual fact Cymbalta studies show a much higher risk rate - between 44% to 50% withdrawal risk!

Plaintiffs also claim that Lilly manipulated medical literature and exaggerated the benefits of Cymbalta.

Plaintiffs are being represented by by Baum, Hedlund, Aristei & Goldman, P.C., along with Keller Rohrback L.L.P. and Pogust, Braslow & Millrood.

“We believe that Lilly’s warning that Cymbalta withdrawal occurs at a rate greater than or equal to 1% is deceptive.  It is just a sleight of hand.  One of Lilly’s own studies shows that over 50% of patients experience withdrawal when they stop Cymbalta.  1% is not 50%, not even close.  A drug label is not the place to play games with words.  It is a place to honestly inform doctors and patients about the benefits and risks of medicines so they can make informed choices.  Our clients feel strongly that they were betrayed by Lilly and we will do all we can to ensure their voices are heard by the courts.” - R. Brent Wisner, Baum, Hedlund, Aristei & Goldman, P.C

Struggling to come off a psychiatric drug is a scary experience, it can lead to akathisia, which is a known precursor to suicidal thoughts and acts.

The electric-like zaps are something I personally endured when coming off Seroxat [known as Paxil in the US] - basically, it feels like your head is being zapped with a cattle prod, it's your brain's way of saying 'FEED ME'... it's the reduction of the drug compound that causes this effect, something that Glaxo and, in this case Eli Lilly, kept from the consumer.


The full press release can be read here.

If you, or someone you know, has suffered the horrific side effects of Cymbalta then you may be eligible to file a personal injury lawsuit. You can contact an attorney at Baum Hedlund here.

Baum Hedlund has litigated over 4,500 antidepressant personal injury and wrongful death cases against pharmaceutical companies.


Bob Fiddaman






    


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