Mass Tort News – September

Zantac will have heartburn for some time.

On June 22, 2020, the plaintiffs filed their Master Personal Injury Complaint. The Plaintiffs in the case are people who took prescription or over-the-counter (OTC) Zantac or generic ranitidine over a period of time, later developed certain cancers, and then brought a claim for damages. The defendants in the MDL include brand-name and generic manufacturers, along with distributors, retailers and repackagers. As of August 6, 2020, there were only 291 cases that are a part of the multidistrict litigation, but we anticipate that this number will rise sharply in the future given the sheer number of people who have taken Zantac over the years.

During the pending litigation, the drug has been recalled from U.S. markets. On April 1, 2020, the FDA announced that manufacturers would remove all prescription and over-the-counter ranitidine drugs from the market. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by its brand name Zantac. Even before that, large pharmacies such as Walmart, CVS and Walgreens stopped selling them, and many pharmaceutical companies issued voluntary recalls of ranitidine drugs.

On July 31, 2020, Judge Rosenberg issued an order detailing a discovery timeline. This timeline continues through August 2022, so no trials are immediate. Despite the lack of an upcoming bellwether trial, the parties have been working towards settlement over the summer. At the time of writing, the bad news is that settlements in the ranitidine lawsuits are not expected for at least a couple of years. The Zantac recalls only began in 2019. Litigation has just started. A global settlement in the Zantac litigation will probably not happen until at least the end of 2022 or later. Right now, the litigation is in the beginning of the consolidated discovery phase, with hundreds of new plaintiffs being added every week.

According to MDL attorneys Miller & Zois, the cases will be ranked into settlement tiers based on the severity of the plaintiff’s injuries and strength of claim. Cases in the top tier could be worth around $500,000. Second tier cases may be in the $250,000 range. The lowest tier cases will likely be worth $100,000 or less. Even assuming that the FDA is correct, there may be as many as 2,000 people who developed cancer as a result of Zantac. If you can use $500,000 as a guidepost for a settlement amount, the total settlement in the MDL could exceed $1 billion. It is likely that the settlement would be even more than that if the defendants settle the case.

Unfortunately, as of September 10, 2020, nothing is scheduled in the litigation for the next 2 months. Hopefully, another status will be scheduled in Fall 2020 to discuss settlements, trials, and other developments in the case.

Talc off the shelf

Thousands of people have filed hernia mesh lawsuits claiming the devices failed or caused serious internal injuries. Plaintiffs claim their hernias came back, mesh damaged their organs, they suffered allergic or immune-related reactions, and they needed further surgery to remove faulty mesh.

Three MDLs have been centralized, based on the manufacturer of the device; MDL-2753 (Atrium), MDL-2782 (Ethicon), and MDL-2846 (Bard). In the Ethicon litigation, in December 2019, there were 2,525 pending lawsuits — the first of which is expected to go to trial on November 2, 2020.[1]

Interestingly, the JPML rejected the centralization of cases based on Coviden products on August 7, 2020. In their Order Denying Transfer, the panel rejected the theory that because other hernia mesh cases were centralized as MDLs, others should be as well. In essence, the Panel found “that centralization is not necessary for the convenience of the parties and witnesses or to further the just and efficient conduct of this litigation at this time,” leaving the door open for future consideration. The low number of plaintiffs also played a role.

On September 1, 2020, MDL-2846 cleared the way for the first bellwether trial to begin in January 2021. In his order, Judge Edmund A. Sargus approved several expert witness designations and eliminated most procedural hurdles for the trial’s expected start date. Bard, as a defendant, settled similar claims in 2011, so hopes are high on a settlement as the bellwether trial approaches.

Have we arrived at a settlement? The Roundup case.

That is the big question in the Round-Up litigation. Several trials have taken place over the past few years, and liability and damages have been established. This is a case designed for settlement, and over the course of 2020, discussions have been taking place. And in late June 2020, Bayer agreed to pay $9.5-10.7 billion to settle nearly 100,000 lawsuits that accused Roundup, the popular herbicide it acquired when it bought Monsanto in 2018, of causing non-Hodgkin lymphoma.

The settlement would cover an estimated 95,000 cases and include $1.25 billion for potential future claims from Roundup customers who may develop the form of cancer known as non-Hodgkin’s lymphoma. The potential future claims process has created issues in the settlement however, as Judge Chhabria appeared to balk at how the parties had drafted the agreement. At an August 27, 2020 status conference, he declared “If I leave the stay in place, am I complicit in whatever shenanigans are taking place on the Bayer side. We’ve got a bunch of cases we could send out to other jurisdictions.”

Under the terms of the June agreement, individuals, depending on the strength of their cases, will receive payments of $5,000 to $250,000, according to two lawyers involved in the negotiations. Plaintiffs are being told they must decide in the next few weeks if they’re going to accept the settlements, even though they won’t know how much they will personally be paid until much later. For those who do agree, payments could be made as early as February 2021, though the process of paying all the plaintiffs is expected to stretch out a year or more. But, the agreement does not appear to be what the parties expected, and the Court’s reluctance indicates that we may need to wait for a new or revised settlement agreement.

Under the initial agreement, a third-party administrator will score each plaintiff using factors that include the type of non-Hodgkin lymphoma each plaintiff developed; the plaintiff’s age at diagnosis; the severity of the person’s cancer and the extent of treatment they endured; other risk factors; and the amount of exposure they had to Monsanto herbicides. This analysis was designed to determine the amount of damages due each plaintiff, but the use of a third-party administrator has become controversial in terms of constitutionality. Judge Chhabria expressly questioned “whether it would be constitutional (or otherwise lawful)” to hand the issue to a panel of scientists instead of judges and juries,” at the most recent status conference.

Two months after Bayer’s commitment to the settlement deal, lawyers told federal Judge Chhabria that most of the agreements are now uncertain. On August 27, 2020, lawyers informed the Court that most of the settlements have “unraveled.” Judge Chhabria gave lawyers until September 24, 2020 to resolve any problems with the settlement, but also indicated he might lift a stay on litigation and set cases for trial. Judge Chhabria said “Given the Court’s current skepticism, it could be contrary to everyone’s interest to delay the hearing on preliminary approval. If the motion for preliminary approval is denied, the parties will presumably move to Plan B for devising a system to address future claims. (Although the Court is not aware of any Plan B, it would be surprising if none existed given the stakes involved and the novelty of Plan A.) And if the parties are going to need to move to Plan B, they would presumably prefer to do that sooner rather than later.”

At the most recent status conference hearing hearing, Judge Chhabria advised the parties that he had received confidential letters from a number of plaintiffs’ counsel with cases pending in the MDL who were concerned that Bayer AG was going back on the settlement, noting that the company had terminated settlement term sheets and refused to execute master service agreements that would finalize their settlements; Bayer conceded that there were currently no final agreements. The next status conference, at which the possibility of restarting the litigation would be addressed if the settlement is not finalized, is scheduled for September 24.

Bayer, for their part, has remained committed to a settlement in this case, noting that “There are often some bumps in the road in implementing a resolution of this magnitude, but we remain confident that a comprehensive settlement will be finalized and executed,” Bayer said in a statement.

Hernia Mesh

Thousands of people have filed hernia mesh lawsuits claiming the devices failed or caused serious internal injuries. Plaintiffs claim their hernias came back, mesh damaged their organs, they suffered allergic or immune-related reactions, and they needed further surgery to remove faulty mesh.

Three MDLs have been centralized, based on the manufacturer of the device; MDL-2753 (Atrium), MDL-2782 (Ethicon), and MDL-2846 (Bard). In the Ethicon litigation, in December 2019, there were 2,525 pending lawsuits — the first of which is expected to go to trial on November 2, 2020.[1]

Interestingly, the JPML rejected the centralization of cases based on Coviden products on August 7, 2020. In their Order Denying Transfer, the panel rejected the theory that because other hernia mesh cases were centralized as MDLs, others should be as well. In essence, the Panel found “that centralization is not necessary for the convenience of the parties and witnesses or to further the just and efficient conduct of this litigation at this time,” leaving the door open for future consideration. The low number of plaintiffs also played a role.

On September 1, 2020, MDL-2846 cleared the way for the first bellwether trial to begin in January 2021. In his order, Judge Edmund A. Sargus approved several expert witness designations and eliminated most procedural hurdles for the trial’s expected start date. Bard, as a defendant, settled similar claims in 2011, so hopes are high on a settlement as the bellwether trial approaches.

[1] Again, this is a date to look out for. Settlements always surround bellwether trials. This date was seen in the most recent PTOs from the MDL website.

Your monthly legal news update from Legalcalls.com by Attorney Jeff Keiser