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: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/gsk-paxil-trial-transcripts/
The Dolin trial exhibits can be viewed here: https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/paxil-trial-exhibits/
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.
Best,
BAUM HEDLUND ARISTEI & GOLDMAN, P.C.
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
