Wendy Dolin Takes on GlaxoSmithKline And Wins — For Now at Least

Jim Gottstein, JD
3
2058

In July of 2010, Stewart Dolin, a partner at the mega law firm Reed Smith, jumped in front of a subway train in Chicago, killing himself. He was apparently suffering from akathisia caused by the so-called antidepressant drug paroxetine. The brand name for paroxetine is Paxil, but Stewart was given a generic version manufactured by Mylan.

Stewart’s widow, Wendy, sued GlaxoSmithKline (GSK), the manufacturer of Paxil, and Mylan, on the grounds that the paroxetine caused Stewart to commit suicide. The case came to trial on March 14th and ended on April 20th with a $3 million verdict for Wendy and their children. The trial itself was gripping, with excellent coverage by Bob Fiddamen:

Since Bob did such a great job, I am not going describe the trial except to say that it exposed GSK lies and the morally bankrupt conduct of GSK, its attorneys and expert witnesses. GSK knew Paxil caused adults to commit suicide and hid that from the Food and Drug Administration (FDA) and doctors. The trial transcripts can be found here and exhibits here.

This is one key to the case, because there is a legal principle shielding drug companies called the “Learned Intermediary Doctrine” which establishes that the doctor, with access to full information, recommended the prescription-only drug after carefully weighing the risks and benefits. The primary official way that doctors are told about the risks of a drug is through the FDA-approved “label.” The drug manufacturer can also issue what is called “Dear Doctor” letters alerting them to risks.

But if the drug manufacturer withholds information, then one can get over the Learned Intermediary hurdle. That is the crux of this case. The argument is that because the manufacturer did not tell the doctor about the substantial risk of suicide, the Learned Intermediary Doctrine does not apply. Ms. Dolin’s top-notch legal team from Baum Hedlund (well known for taking on drug companies, especially over antidepressants) and David Rappaport established that GSK did not inform the FDA or doctors that Paxil caused people to commit suicide, thus getting over the Learned Intermediary hurdle. In fact, GSK still denied it. Cases against drug companies for withholding important information are not unusual.

However, Wendy Dolin faced another really big problem, which was that Stewart took the generic version of Paxil, manufactured by Mylan. Wendy sued Mylan, but Mylan was prohibited from providing any information other than the approved FDA label. How can Mylan be liable for not telling doctors something that it is prohibited by law from telling them? For that reason, Mylan was held to not be liable and dismissed from the case. Wendy also sued GSK, but GSK argued, “Hey, we didn’t manufacture the drug Mr. Dolin took so we can’t be liable.”  This is a classic Catch-22. The generic drug manufacturer isn’t liable because it was prohibited from giving any additional information and the original manufacturer isn’t liable because it didn’t sell the drug.  And, indeed, the judge ruled that GSK could not be held for product liability since it wasn’t its pill that caused Stewart’s suicide.

This is where excellent lawyering came in. R Brent Wisner of Baum Hedlund and local counsel David Rappoport came up with what I think is a brilliant argument based on what is called common-law negligence. The elements needed to establish negligence in Illinois are:

  1. Duty of care owed by the defendant to the plaintiff;
  2. Breach of that duty; and
  3. The breach of duty proximately caused an injury.

See, Memorandum Opinion and Order (Order), page 8.

The judge held that GSK owed a duty to warn doctors (but not consumers) of the risks of which it knew, or should have known, satisfying the first requirement. This duty is not tied to the branded Paxil, manufactured by GSK, but is applicable to the generic versions as well. This allowed the case to go to the jury where the dishonesty of GSK was put on full view.

The jury was charged with determining whether GSK was negligent in failing to warn the doctors and then, if so, did that negligence cause Stewart to commit suicide. The judge instructed the jury as to what negligence and proximate cause mean, as follows:

“Negligence” as used in these instructions means the failure to do something which a reasonably careful person or corporation would do, or the doing of something which a reasonable careful person or corporation would not do under circumstances similar to those shown by the evidence. The law does not say how a reasonably careful person or corporation would act under those circumstances. That is for you to decide.

As used in these instructions, “proximate cause” means that cause in the natural or ordinary course of events produced the death of Stewart Dolin. It need not be the only cause, nor the nearest or last cause. It is sufficient if it combines with another cause resulting in Stewart Dolin’s death.

The entirety of the judge’s instructions to the jury can be found here.

Then, the jury indeed found GSK negligent in not informing doctors of the suicide risk and this negligence caused Stewart’s death. In order to get there, the jury had to believe Stewart’s doctor that he would not have prescribed the paroxetine if he had known about the risk, or would have monitored him.

Frankly, in the overall scheme of things, the $3 million verdict is not that large. Stewart was a successful partner in a big law firm, presumably making a lot of money. But Wendy Dolin’s lawsuit was never about the money. Bob Fiddaman published an interview with Wendy after the verdict that is quite worthwhile reading. I direct your attention to it especially for her description of the awful tactics of intimidation perpetrated by GSK’s lawyers. The other thing about Wendy’s interview that I would draw attention to is her description of the importance of the ruling on generics:

I knew from the moment this lawsuit was filed that GSK was always concerned that this was a generic drug. . . . It has been suggested that GSK wants to take this case to the Supreme Court because they are so afraid of what this guilty verdict means. As it stands, the legal ramifications for this verdict are so damaging for pharmaceutical companies that reaching the Supreme Court is very possible.

For sure, holding drug companies liable for failure to warn about risks with their drugs even after they have gone generic is a good thing. Actually, I think drug companies have an incentive to do this to depress generic sales in favor of new drugs that are still on patent and therefore subject to monopoly pricing. In fact, it has been a longstanding pattern that the real risks of drugs do not get revealed until they come off patent. This case, if sustained on appeal, gives even more incentive for the drug companies to diss their drugs after they come off patent.

We will have to see where this goes, but for sure it is a big victory for exposing the truth. Baum Hedlund and David Rappaport deserve kudos for taking this case and pursuing it so effectively.

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3 COMMENTS

  1. Jim,

    Thanks for highlighting the work I did on this. For the first two weeks I was at the trial – quite an unbelievable experience. Glaxo’s attorney’s were actually like the way I described them in my blog posts. Repetitive and boring being just two words I would use to describe them.

    It was an important case. The 22 deaths knowledge had been previously sealed away from the public – Unbeknown to me this was information that the British regulator (MHRA) have had for a long time. Despite knowing that 80% of the suicides in Paxil clinical trials happened to consumers who were all over the age of 30, the MHRA and, more than likely, the FDA, highlighted the fact that Paxil wasn’t safe for kids.

    Here’s the rub. There were no completed suicides in Paxil pediatric trials.

    It’s up to the people to do the math on this one.

    Here’s some recent correspondence with the MHRA regarding this issue.

    http://fiddaman.blogspot.com/2017/05/mhra-yell-barracuda.html

    Thanks again, not only for highlighting my input into the Dolin Vs. GSK case but also for your own advocacy work.

    Bob Fiddaman