First Zofran Bellwether Delayed Indefinitely Due To COVID-19

Carolyn Casey, J.D.

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— Updated on January 5, 2021

First Zofran Bellwether Delayed Indefinitely Due To COVID-19

For massive multidistrict litigation taking on GlaxoSmithKline, the makers of anti-nausea drug Zofran, the bellwether trial has been delayed until likely next year due to COVID-19. After widespread claims emerged that the drug caused birth defects after pregnant women took it for morning sickness, the cases were consolidated in Massachusets district court back in 2015. But now, Judge F. Dennis Saylor IV has delayed the bellwether trial, citing the concern of spreading COVID-19 via a jury trial. Judge Saylor did, however, leave the door open for a late 2020 start date and invited the parties to propose creative ways to hold a safe trial during the pandemic.

The Road to MDL

Prior to the COVID-19 crisis throwing the judicial system into disarray, the Zofran lawsuits followed the common path of many pharmaceutical class action lawsuits—consolidation. In 2015, the District of Massachusetts consolidated 12 lawsuits claiming Zofran usage led to birth defects. Afterward, similar plaintiff claims continued to surface, and eventually swelled to a total of 423 plaintiff cases.

After consolidation in 2015, the Zofran case continued to move towards trial. In November 2016, Judge Saylor entered orders governing motions and discovery, stipulating a five-phase discovery schedule. The parties proceeded under the orders, moving into the fifth phase where discovery was conducted on the individual issues for the set of cases selected for bellwether trials. This bellwether discovery was scheduled for completion by October 2018.

Next, expert disclosures and Daubert motions were ordered to be completed by May and July 2019, respectively. Bellwether trial depositions, witness lists, exhibit lists, proposed jury instructions, and related objections motions were scheduled for completion dates of December 30, 2019. Summary judgment and dismissal motions were also dealt with for a few cases. Judge Saylor ordered completion dates of January 6, 2020, for trial briefs and a final pretrial conference. These deadlines were later bumped to March and April 2020.

Federal Preemption Motion Looms

Amidst the pretrial motions, GlaxoSmithKline (GSK) filed a motion to dismiss all consolidated civil suits based on federal preemption grounds. The pharma-giant defendant argued that the lawsuits are preempted because, on several occasions, the U.S. Food and Drug Administration (FDA) decided not to require warning labels concerning possible birth defects on Zofran. GSK has asked the FDA for input to support its claims but acknowledged that the FDA’s bandwidth is currently maxed due to the pandemic. Should the FDA accept GSK’s petition urging the federal agency to assert its claims, the consolidated cases could be dismissed.

But per the Supreme Court ruling in Merck v. Albrecht, Judge Saylor has the final responsibility to interpret the FDA’s rules. Though Judge Saylor commented that he would like to receive the FDA’s input for the preemption ruling, he explained he cannot delay indefinitely and may need to move forward with his singular judgment on the issue.

Pandemic Delays for the Zofran Bellwether

The bellwether trial in this multidistrict litigation was originally slated to start on May 4, 2020. But in mid-March, as the coronavirus began sweeping through the U.S. and shuttering courthouses, Judge Saylor let all parties know that the trial would be delayed. He emphasized that the uncertainties surrounding the pandemic meant he couldn’t speculate on when the bellwether, Rodriguez et al v. GlaxoSmithKline LLC, would be rescheduled and that court delays would create a “pent-up” demand for criminal trials.

The latest word on the Rodriguez bellwether came on June 23, 2020, when the Judge said “I was hopeful we could get this case tried in November or December of this year. I haven’t given up on that, but it’s looking like it’s less achievable than hoped.”

Conducting a Safe Trial

Judge Saylor has not entirely ruled out a 2020 trial, even calling on both parties for suggestions to approach the logistics amidst a public health crisis. He has also commented that given courtroom size limitations, each side may be limited to two attorneys with their colleagues observing via videoconference. The last resort, in the judge’s view, would be an entire trial conducted over teleconference technology.

Judge Saylor also pointed out the court’s ongoing health imperatives like sanitation of courtroom projectors and other equipment between cases. He also touched on the possibility of moving the entire trial into a large space like a hotel ballroom to allow for greater social distancing. Presumably, the plaintiffs’ counsel feels the extra motivation to come up with alternatives and move this bellwether case to trial.

A Pivot Towards Settlement?

Another outcome of the delayed Zofran bellwether could be an impetus to move towards settlement discussions. Birth defects are a heartbreaking occurrence and can require extensive surgery. This, obviously, takes a toll on parents and children alike, and could motivate plaintiffs to agree on settlement rather than wait through continued trial delays. Plaintiff counsel, though not the settlement decision-maker, may also be feeling the strain of funding expenses after five years.

As for GSK, finding a faster resolution for a reputation-harming lawsuit may be an attractive option. Settlement also presents an alternative to the costs of trial and the possibility that a jury awards monies to the plaintiffs that could exceed negotiated settlement amounts. Also, the judge’s determination on the federal preemption claim may well be the gating issue on GSK’s willingness to settle.

COVID-19 has wreaked havoc on the trial schedule for countless U.S. lawsuits and the Zofran MDL is no exception. In this strange, surreal pandemic world, only time will tell when the time will come to start the Zofran bellwether trial.

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