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Thursday, February 11, 2016

Glaxo Declined FDA Invitation to Discuss Paxil Adult Suicide Warning






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Well, I love the rain 
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Ian Astbury
Billy Duffy


In appealing a judgement made by Judge James B. Zagel in the WENDY B. DOLIN, Plaintiff v. SMITHKLINE BEECHAM CORPORATION, Defendant, case Glaxo have found themselves in hot water after a recent court document was made public.

The document is yet another ruling by Judge James B. Zagel who, it appears, is the current thorn in the side of GlaxoSmithKline who have been pulling all the strings to try and halt, be it temporary or permanent, this case going to trial.

Back stories of Glaxo's shenanigans at the foot of this post.

The latest attempt by Glaxo to undermine the previous judgments in this Paxil suicide case comes as no surprise, to me at least.

Basically they, via their highly paid legal team of King & Spalding, have just had two further motions denied by Judge James B. Zagel. In giving his opinion Zagel offers his reasoning, and it just doesn't look good for Glaxo, particularly where their defence of Paxil causing suicide in adults is concerned.

Zagel's Memorandum and Opinion Order shows that...

"On June 22, 2007, the FDA extended an invitation to GSK to discuss the option of keeping the 2006 Paxil-specific adult language in its current label by requesting a formal meeting. Specifically, the FDA told GSK: “If you would like to discuss this matter further [keeping the 2006 Paxil-specific adult warning in the Paxil label], please submit a formal meeting request.” GSK, however, never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data. Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of the 2006 Paxil-specific adult warnings."

Zagel denied Glaxo's  “implied conflict preemption” motion,

The second motion (summary judgment) filed by GSK centres around their claim that the prescribing doctor  knew that Paxil increased the risk of adult suicidal behavior prior to prescribing the drug to Wndy Dolin's husband, Stewart. GSK also argued that the Paxil warning label is "adequate" as a matter of law. Glaxo also went over old ground that Judge Zagel has previously ruled on, that being that  they (GSK) cannot be held liable because Mr. Dolin ingested the generic form of Paxil and not the name-brand drug itself.

On denying Glaxo's four-part summary judgement motion, Zagel said that according to testimony the doctor in question did not know that Paxil increased the risk of suicidal behavior in adults over 24 prior to prescribing Paxil to Mr. Dolin in 2010. Furthermore, he  relied upon the 2010 Paxil label before prescribing Paxil to Mr. Dolin and that the 2010 Paxil label does not adequately warn about the risk of suicidal behavior beyond age 24.

Zagel added, "This is enough to defeat GSK’s motion for summary judgment."

It's raining pretty hard for Glaxo at the moment. In the UK, on Feb 4th 2016, Glaxo had similar requests turned down - once again the drug involved is Paxil, although it is sold and marketed as Seroxat in the UK. (See UK Seroxat Litigation to Press Ahead)


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

GlaxoSmithKline is represented by Alan S. Gilbert of Dentons, Andrew T. Bayman, Todd P. Davis and Heather M. Howard of King & Spalding LLP and Robert E. Glanville, Tamar P. Halpern and Eva Canaan of Phillips Lytle LLP.

Source: Public Access to Court Documents (Pacer) 


Bob Fiddaman

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