Litigator of the Week: Alexandra Walsh Keeps Xarelto Winning Streak Alive
Wilkinson Walsh + Eskovitz co-founder Alexandra Walsh takes the crown as Litigator of the Week, persuading a Philadelphia jury to find for the defense in a bellwether trial involving the blockbuster blood thinner Xarelto.
September 07, 2018 at 02:30 PM
8 minute read
The original version of this story was published on Litigation Daily
Wilkinson Walsh + Eskovitz co-founder Alexandra Walsh is our Litigator of the Week, persuading a Philadelphia jury to find for the defense in a bellwether trial over the adequacy of the warning labels for the blood thinner Xarelto.
According to The Legal Intelligencer, more than 1,900 Xarelto cases are pending in the mass tort program in the Philadelphia Court of Common Pleas. (Another 18,000 cases are pending in a federal MDL.) The blood thinner, which is made by Bayer and Johnson & Johnson, is a lucrative target–it generated $5.39 billion in sales in 2016.
The stakes were high, but Walsh and her team delivered. After a three week trial, it took the jury less than three hours to reach a complete verdict for the defense on Aug. 30.
In a Q&A with Lit Daily, she discusses the win.
Lit Daily: Who were your clients and what was at stake?
Alexandra Walsh: Our client was Bayer and our co-defendant Janssen, a subsidiary of J&J. This case was part of a national series of cases challenging the safety warnings that accompany the blood thinner Xarelto. It was the third bellwether trial in the Philadelphia Court of Common Pleas (PCCP) and the first by a plaintiff who took Xarelto to protect against abnormal blood clotting after suffering near fatal pulmonary emboli (clotting in the lungs).
What were the plaintiff's primary allegations?
The plaintiff suffered a massive gastrointestinal bleed after taking Xarelto without issue for 13 months. He alleged that Xarelto caused his bleed and that it could have been avoided if Bayer and Janssen had provided additional warnings to his physician, including a warning that a lower dose of Xarelto could be equally effective for patients with his condition.
In support of that claim, the plaintiff sought, and eventually was permitted, to introduce evidence that the Xarelto label was recently changed to specify a lower dose than the one he took for patients at risk of repeat clots.
What was the outcome in the previous state-court bellwether trials?
There have been two prior Xarelto trials in the PCCP, both involving patients taking Xarelto for another purpose—to protect against stroke. Our firm, led by Brian Stekloff, won a complete defense verdict in April in the previous case tried. In January, our firm, led by Beth Wilkinson won a judgment notwithstanding the verdict, based on the plaintiff's absence of causation evidence. The court also granted, in the alternative, a motion for a new trial, based on improper commentary made by plaintiff's counsel during closing argument.
What themes did you stress in presenting your case?
In this trial, we stressed the critical benefit Xarelto provided the plaintiff, who was at serious risk of additional, potentially deadly pulmonary emboli, following his first event.
We also returned again and again to the extensive warnings that accompany Xarelto, including the warning that the medication is associated with a risk of serious bleeding. We focused the jury on evidence that the plaintiff's prescribing physician understood that serious risk but understandably determined that the benefit Xarelto provided outweighed that risk.
What stands out as a high point during trial?
It's difficult to identify one single high point, but I can say it was incredibly gratifying to present the testimony of our witnesses—practicing physicians who treat people like the plaintiff every day and were able to help the jury understand the critical role blood thinners like Xarelto play in helping this patient population.
What were some of the biggest challenges in litigating this case?
Helping the jury to understand why the recent label change did not mean the prior label failed to provide the information the plaintiff's physician needed to make a good decision was a challenging task—and one that we relished meeting.
It was also a challenge, as it is in most cases involving a prescription medication, to determine how to present, in a clear and compelling way, some pretty complex medical and scientific concepts to a group of 12 people who were learning these concepts the first time. Our goal, as always, was to devise helpful ways to illustrate and explain these things in a way the jurors could remember and repeat during deliberations.
Did you make any counter-intuitive or unconventional strategic choices?
We spent considerably more time than the other side did making sure the jury understood the plaintiff's medical condition, his medical history, his relationship with his doctor, and the basis for the decisions he and his doctor made together about his medical treatment.
I'm not sure whether this was counter-intuitive, but I believe it was critical to our success. And I know it had an impact when we were able to present to the jury testimony from the plaintiff that he was not surprised when his doctor told him his GI bleed may have happened because he was taking a blood thinner—since his doctor had warned him that a bleed like that could happen.
Were expert witnesses an important part of your presentation?
Absolutely. We called a pulmonologist who helped the jury understand how dangerous pulmonary emboli can be—25 percent of cases result in sudden death—and how important blood thinners are in preventing this kind of clotting.
We also called a clinical research expert who walked through how extensively Xarelto was studied before it was approved by the FDA, how effective Xarelto is in preventing repeat emboli, and how low the risk of bleeding is on any dose of the medication.
What about visual aids?
Plaintiff's counsel and their experts used a simple but superficially impactful line drawing to portray a direct correlation between bleeding risk and the dose a patient is prescribed.
On cross examination, we were able to redraw the line with plaintiff's experts, using actual data from the Xarelto studies. This data-based drawing revealed that plaintiff had misrepresented the relationship between dose and risk of major bleeding—and plaintiff's experts had to concede that their drawing was not based on actual data. This demonstrative became an important part of our closing argument.
How did you feel at the end of closing and when you saw jurors come back in?
Incredibly grateful to an amazing team. My partner, Tamarra Matthews Johnson, and I are the ones who stood up to deliver the closing, but we each knew that every piece of evidence we were able to present and every point we were able to argue was possible only because of the hard work, dedication, and creativity of every member of our team. When the jurors came back after less than 3 hours of deliberations, we felt optimistic—and jubilant (and relieved!) when our foreperson announced a full verdict for our clients.
How did you celebrate your win?
By raising a glass of some very nice champagne to the whole team—and then hurriedly packing and dashing home to DC so I could see my kids before bedtime and their second day back at school.
Who were the key members of your trial team?
Tamarra, of course, and also my partner Rakesh Kilaru. Rakesh led all aspects of our legal strategy before and during trial, including securing a key summary judgment win on one of plaintiff's two claims. That victory, together with the many critical arguments Rakesh presented throughout trial, were essential to our victory.
Also essential were the considerable talents of Mike Zellers of Tucker Ellis and Chanda Miller of Drinker Biddle, who were lead counsel for Janssen and fabulous trial partners.
I think you and I last spoke when your firm launched in January 2016. Now that WWE is approaching its third birthday, how do you feel about where you are today?
I could not feel better. We have tried 12 cases since we opened our doors with a diverse bench of first and second chair trial lawyers. And we have six more trials on our docket for the next 12 months.
We are living our dream of trying, and winning, high stakes trials for our valued clients, thanks to an amazing team of lawyers and other professionals who are critical to all of our successes. We're incredibly excited about the future of our firm.
Want to be our next Litigator of the Week? Send nominations to [email protected]– and don't hesitate to nominate yourself. We pick the winner every Wednesday, looking at wins that occurred in the preceding seven days.
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