Law360 is a lawyer driven website that keeps many law firms across the globe up-to-date with legal news as it breaks. It's subscription based and deals a lot in US litigation. I've read many articles from Law360 in the past none more interesting than their recent publication, 'Reed Smith Atty’s Widow Wages Battle Against Paradox Of Generic Drug Injury Law'.
It peaked my interest as it pertains to a case I've covered many times on this blog. (Links at the foot of this post)
Wendy Dolin is suing GSK over the death of her husband Stewart after he was prescribed Paroxetine (better known as Paxil and Seroxat) in 2010 for "work-related anxiety and depression". Six days after beginning his course of medication Stewart killed himself by leaping in front of a northbound train in downtown Chicago.
Wendy has maintained all along that her husband showed marked signs of akathisia during the short time he was taking Paxil. For those of you who don't know, akathisia is basically when a patient, after administering psychiatric medication, becomes agitated, distressed, and shows signs of restlessness. Often the patient has an inability to sit still and, in some cases, will pace up and down for no apparent reason. In fact, as Wendy recalls, her husband told her one night, “I don't get it, Wendy. I still feel so anxious.”
The Law360 article focuses, in part, on Wendy's claim that her husband experienced signs of akathisia. This is quite an unusual step for Law360 as, in the main, they report impartially on trials (past and present) and rarely feature interviews with actual plaintiffs of trials that are pending litigation.
In the article Wendy tells Law360's reporter, Sindhu Sundar, that she had heard the term 'akathisia' from a friend sometime after Stewart's death. Like many people she had never heard of the word before. She told Law360...
“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” (referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.) "It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else."
Here's where it gets tricky and somewhat complex. Stewart, you see, was taking a generic version of Paxil manufactured by Mylan and, in a nutshell, Glaxo argued that it should be Mylan that she sued and not them. However, after much legal wrangling, it was deterred that Glaxo were responsible for the warning literature that accompanied Paxil and any of it's generic forms. Ergo her claim of negligence and wrongful death should stand.
It's not as straight forward as one might think when pharmaceutical companies try to make changes to their warning labels. GSK, after learning that they would have to go to trial, then argued that they had approached the American drug regulator, the FDA, on two occasions to change the warnings on their branded version of paroxetine (Paxil). GSK allege that the FDA refused on these two occasions to make any changes to the labelling.
A pretty decent defence one would think, however, GSK did not try a third time, as was the normal protocol. According to court documents and Law360...
Although GSK had asked the FDA about adding Paxilspecific warnings to the agency’s class wide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.
GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.
Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.
“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise.”
It's interesting to note here that GSK are admitting that, in 2007, they wished to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults yet they are defending the allegations that Paxil (paroxetine) caused Stewart to take his own life. GSK, it seems, don't defend the fact that Paxil can cause suicide in adults, they use points of law to hide this fact instead.
Having your cake and eating it, anyone?
Since the claim was filed in 2012 GSK have sent Wendy more than 30 subpoenas, they have also made over 70 record requests and have shown the Dolin children their father’s private medical notes. To top it all, GSK’s lawyers have been asking (goading) Wendy about her love life since her husband killed himself. Moreover, GSK have also tried (unsuccessfully) to exclude testimony from Wendy's expert witnesses. Joseph Glenmullen is one of those witnesses and GSK argued that he "had not shown any idea linking Paxil to suicides, only to suicide attempts."
Another expert GSK tried to exclude was David Healy. Their treatment of him became more of a personal attack. They claimed that Healy wasn't qualified to testify because of his radical advocacy and extreme bias against GSK. They had taken extracts from Healy's websites and cherry-picked certain paragraphs to make it look as though Healy had called upon people to extract violence upon GSK executives and journal writers. They were wrong and Judge Zagel has allowed all three testimonies into trial.
When experts give evidence in litigation they are first depositioned by the opposing party. In the case of Healy, his deposition with GSK's lawyers last almost 10 hours, the majority of which focused on his personal life and not the science behind his expert opinion.
It's just another classic case of GSK dragging out time in efforts to get the plaintiff, in this case, Wendy Dolin, to accept their first measly offer, should they make an offer (which history tells us that they more than likely will)
Glaxo just love to grind down the opposition in litigation ~ they are finding that Wendy Dolin and her law team of Baum, Hedlund, Aristei & Goldman, PC are not in the game of lying down and having their tummies tickled nor are they bothered by the amount of money Glaxo's cigar chomping suits throw at the case.
Glaxo are also defending group action brought against them in the UK with regard to Paxil ~ it's litigation that has been dragging on for almost ten years now - who knows, maybe Glaxo's UK and US lawyers drag these cases out so everyone who works for their firms gets a regular wage, after all it's GSK who are billed every month to pay their attorneys wages.
Wendy Dolin is, despite the death of her husband and the abhorrent tactics of GSK's lawyers, still standing - her lance at the ready for battle - a female Don Quixote, if you will.
Stewart would be proud of her.
Back stories related to this case.
GSK Claim Phone Calls May Shed Light On Suicide
GSK Use Delay Tactics on Grieving Widow
Glaxo's Beef With David Healy
GSK Sink to New Level in Paxil Suicide Litigation
GSK: Motions Denied in Paxil Suicide Case
Paxil Suicide Case Set For Trial