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Litigators of the Week: A Huge Win for Drug Company Defendants in California Opioid Trial

Partners Donna Welch and Jennifer Levy led a team that was recognized as The American Lawyer Litigation Daily's 'Litigators of the Week' for their successful defense of Allergan against public nuisance claims stemming from the opioid crisis. Attorneys from Hueston Hennigan, O’Melveny & Myers and Morgan and Lewis & Bockius represented the remainder of the defendants.

Defense wins just don’t get much bigger.

Lawyers for Johnson & Johnson’s Janssen Pharmaceuticals, Teva, Allergan and Endo this week were able to fend off public nuisance claims stemming from the opioid crisis brought by three large California counties and the city of Oakland. The plaintiffs claimed drug makers marketed and promoted painkillers in misleading ways leading to medically inappropriate prescriptions, drug abuse and overdoses.

But after months of trial starting in April and multiple days of closing arguments this fall, Orange County, California Superior Court Judge Peter Wilson this week issued a tentative decision Monday siding with the defendants. “There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need,” he wrote.

A Kirkland & Ellis team led by Donna Welch represented Allergan at trial. John Hueston of Hueston Hennigan led the team representing Endo. Janssen was represented by an O’Melveny & Myers team led by Michael Yoder. Teva was represented by a Morgan, Lewis & Bockius team led by Collie James IV. All four are this week’s Litigators of the Week. O’Melveny, citing the ongoing litigation, declined to comment.

Litigation Daily: Who were your clients and what was at stake?

Collie James IV: Morgan Lewis represented Teva Pharmaceuticals and its affiliates as one of four manufacturer groups that were found not liable for the opioid epidemic or for falsely marketing their prescription medications in California. The trial was prosecuted by three California counties (Los Angeles, Orange, and Santa Clara) and the City of Oakland acting on behalf of the People of the State of California, alleging public nuisance, unfair competition, and false advertising and seeking remedies in excess of $50 billion.

Donna Welch: Kirkland had the privilege of representing Allergan plc and Allergan Finance in this high stakes trial, which centered on plaintiffs’ allegation that opioid marketing caused a “public nuisance.” The trial proceeded in two phases — had the court found defendants were liable for creating a public nuisance, or for violating California’s unfair claims act or false advertising statutes, the plaintiffs would have sought abatement and damages of over $50 billion.

John Hueston: We represented Endo Pharmaceuticals and Endo Health Solutions. This case was both an individually significant trial with $50 billion at stake and effectively a national bellwether trial: the first trial in the nation to test plaintiffs’ claims that opioid manufacturers are responsible for the opioid crisis. If we succeeded in this bench trial, we were also hopeful that the court would issue a carefully reasoned opinion that would impact pending cases in other jurisdictions.

Who all was on your team and how did you divide the work?

Welch: The Kirkland team was led by me and partner Jenny Levy and we divided witnesses and directed strategy together with the client. Partners Tim Knapp and Karl Stampfl played key roles as well, assisting with preparation for the most critical witnesses.

Hueston: We believe in fielding trial teams that reflect the diversity of the population of the trial location. I was joined by co-lead trial lawyer Moez Kaba; and a team of partners and trial-seasoned associates with speaking roles: Marshall Camp, Pad Foran, Karen Ding, Samantha Schnier and Michael Todisco. Each trial attorney was a team specialist for the substantive area of the particular examination.

James: Our Morgan Lewis trial team, consisting of myself, my partner Wendy West Feinstein, and associate Adam Teitcher, took a leading role in developing the joint defense trial strategy and presenting the defendants’ winning case. I gave the first defense opening statement on April 19, as well as the closing arguments conducted on September 30 and October 1. Ms. Feinstein, who also serves as our Pittsburgh office managing partner, together with me, assumed lead responsibility for cross-examining some of the most critical plaintiff expert and fact witnesses, while Mr. Teitcher developed the strategy and successfully argued several critical evidentiary issues.

Our trial team was supported by dozens of partners, associates, paralegals, and support staff from nearly every Morgan Lewis office across the United States. Many critical team members braved the difficulties of pandemic travel to be in Orange County for particularly significant moments of the trial, and many others supported as if onsite despite time-zone differences.

[Editor’s note: The O’Melveny trial team that included Yoder and partners Steve Brody, Amy Laurendeau, Amy Lucas, Charlie Lifland, Jonathan Schneller, and Ross Galin.]

This trial involved months of testimony and days of closing statements conducted via Zoom. How did you prepare for such a marathon remote trial? And logistically, how did you run your trial presentations? What was your setup like?

Hueston: Even for remote trials, we believe in replicating the intense, in-person collaborative outside counsel/in-house counsel teams that would be involved in live trials. This trial was our fourth during the pandemic that we tried remotely. In each, we implemented a rigorous COVID-testing protocol and working group “bubble” that essentially lived and worked together in LA for four months. Being together also allowed us to inject fun and sustain morale in ways impossible in a fully remote setting.

We run our trial presentations with the support of an experienced trial technology team and an on-site trial technician who used TrialDirector to rapidly present and highlight key portions of documents via screenshare during our cross examinations. For opening, closing and expert direct examinations, we presented key evidence with focused PowerPoint demonstratives. We have a conference room that we’ve optimized and fine-tuned for the current needs of remote trials.

James: We conducted the trial out of a large conference room in our Orange County office we dubbed “Mission Control,” and our incredible Morgan Lewis support team made sure that we had a comfortable workspace that allowed us to work effectively and efficiently throughout trial. The remote format enabled us to practice critical aspects of our trial presentation such as opening and closing statements and witness presentations using the actual format, settings, and environment that would be used at trial, which allowed us to identify and work out kinks beforehand.

Our setup focused on efficiency — we arranged our workspaces so that we could see one another and our trial tech unimpeded throughout trial, and we had a library of material available to us both within “Mission Control” and in an adjacent room. We leveraged the collective knowledge and resources of our full support team by remaining in constant contact throughout the day, and were assisted by various members of our broader team who cycled through Mission Control at certain critical points throughout trial. Beyond that, it was indistinguishable from any other trial — late nights, lots of coffee, and ready access to snacks.

Welch: It was a strange experience for us to work from separate remote trial sites in Chicago and Washington, D.C. — but we made it work with near-constant communication. In part because it was a bench trial, with a judge we had years of experience with, the Zoom platform worked far better than anticipated. We had mini trial sites with counsel table set up in conference rooms in both locations, and on-site tech support to make sure things ran smoothly. The oddest part was putting on witnesses who were physically in our office, but who testified from separate rooms, so we were literally doing our examinations fully by Zoom.

What were the advantages and disadvantages of trying this case in this format?

Welch: The key advantage was that the trial was able to proceed, keeping our teams and those of our co-defendants and witnesses safe during the pandemic. But it is far harder to read the room over a Zoom screen. The court and parties hoped that we might be able to do closings in person, but given the risks, and given how well the trial had proceeded, we opted for remote closings as well.

James: While the absence of the “physicality” of a live trial contributed to a different experience, there were many upsides to the virtual trial format, including the ability to quickly discuss critical items off-camera, printing documents and pulling other resources as needed, and from a logistics perspective, saving substantial time by avoiding a daily commute to and from the courthouse with materials in tow.

The availability of the public access stream also allowed our client, all members of the team, members of our firm, and family and friends to watch the trial. But, in the end, the greatest benefit of this experience was proving that we can successfully try a case of any size, under any circumstances, using any format.

Hueston: The advantages included the ability to examine busy witnesses for discrete time periods without lost days of travel and waiting outside a courtroom; face-to-face examinations that allowed reading of witnesses even more precisely than in a courtroom setting; document sharing and publication often faster than use of binders in courtrooms; a concentration of law firm staff and technical support at the ready. The few disadvantages were the occasional wireless and technical disruptions, but they were few and involved little lost time.

Judge Wilson ultimately concluded that the plaintiffs presented “no evidence of medically inappropriate prescriptions caused or induced by any allegedly false or misleading marketing and promotion by defendants.” How much of your trial presentation focused on the legitimate uses of opioids and the plaintiffs’ failure to account for them?

James: Our Morgan Lewis team developed an aggressive defense strategy that emphasized that Teva’s products provide medically appropriate pain relief to Californians every day, and challenged plaintiffs to identify a single medically inappropriate prescription of our clients’ products that would justify the sweeping relief sought. Indeed, this was the first thing Judge Wilson heard from defendants, when at the outset of my lead-off opening statement, I reminded the court of the tens of thousands of Californians diagnosed with cancer every year who depend on products like the ones manufactured by Teva to control indescribable pain.

For us, one of the most memorable moments of the trial came during Ms. Feinstein’s direct examination of our expert, Dr. Ed Michna, who movingly described his experiences treating patients who regained their dignity and life because of these valuable medications. This effort culminated in our post-trial briefing, which emphasized plaintiffs’ critical failure to account for these undeniably important medical uses or identify any medically inappropriate prescriptions that can be attributed to defendants’ marketing, much less allegedly false or misleading marketing.

Hueston: This was certainly part of our focus. From opening statement – when we exposed plaintiff’s examples of alleged false marketing as misleading snippets – to our closing argument when we focused the judge on a reduction of this case from millions of pages of discovery to merely 11 alleged documents, we relentlessly hammered the point that there was no identified misleading marketing material. And though we did not carry the burden of proof on causation, only the defense put on expert testimony with statistical analysis demonstrating a complete lack of proof with respect to causation.

Welch: That was a key focus not just at trial, but from the outset of the case. We sought discovery regarding alleged medically appropriate prescriptions, which plaintiffs resisted. From the very beginning, the court indicated that they would be allowed to try their case as they wished, but at their peril. We made this issue a large part of the defense, including in the cross examinations of Plaintiffs’ lead experts.

Can you point to any portions of the judge’s decision that draw from themes your particular team tried to bring out at trial?

Hueston: Most critically, the overarching theme that a nuisance case based on medicines approved for specific FDA uses can’t be tried like the leading California nuisance case Con Agra, a lead paint case. Lead paint wherever used is improper and toxic; not so for prescribed opioid medications. In addition, cross examinations of key plaintiff experts and witnesses such as Lembke, Perri, Herzberg, Ghalley and others drew key admissions cited in the judge’s opinion that (1) opioids are properly prescribed for chronic non-cancer pain; (2) that numerous alleged misleading and false statements by manufacturers were drawn almost verbatim by FDA labels, FDA guidance and California state law; (3) that many of the documents alleged to be at issue were in fact balanced and full of risk disclosures; and (4) that opioids when properly prescribed can improve function and help patients.

James: In our trial presentation, our Morgan Lewis team focused on the variety of medically appropriate uses of opioid medications, plaintiffs’ failure to distinguish between medically appropriate and medically inappropriate prescriptions, and, critically, that plaintiffs failed to identify any medically inappropriate prescriptions written as a result of defendants’ marketing.

We then made this a feature of our closing argument and post-trial briefing, emphasizing that medically appropriate prescriptions cannot constitute a public nuisance, and plaintiffs’ failure to identify any medically inappropriate prescriptions necessarily forfeited any attempt to link those prescriptions to any misleading marketing message by any defendant or to the alleged public nuisance itself.

In his decisive ruling, Judge Wilson focused on our arguments, highlighting that “there is no evidence of medically inappropriate prescriptions caused or induced by any allegedly false or misleading marketing and promotion by defendants” and, as a result, “there is no evidence supporting a causal connection between the alleged conduct and adverse downstream consequences flowing from medical inappropriate prescriptions.”

Welch: Judge Wilson’s focus on the lack of proof of any inappropriate prescriptions written based on defendants’ conduct was part of the Kirkland team’s narrative from the beginning of the case.

What can other defendants in public nuisance cases against opioid makers take from this trial and the outcome you achieved?

Welch: California has the most liberal standard for public nuisance liability in the country — but even under that standard, plaintiffs have the burden to prove that some wrongful conduct of defendants actually caused the nuisance. From the beginning of the case, Plaintiffs said they could use “aggregate proof” to prove their claims. We focused on their failure to establish that even a single inappropriate prescription had been written as a result of what they claimed was false and misleading marketing. That is what led to a defense win.

Hueston: The 42-page well-reasoned opinion provides thoughtful guidance for courts and lawyers involved in opioid litigation nationally. This victory upends the notion that these cases can’t be won, and will hopefully lead to reasonable results in many of the rest of the cases.

What will you remember most about this matter?

Welch: The strong professional relationships and mentorship we worked hard to foster on our team started well before the pandemic, but deepened as we supported each other, got real windows into each other’s lives, and learned together how to utilize new technologies to try cases in a different way. I could not have asked for a stronger partnership than I had with Jenny, or better support than we received from our amazing team. I will also never forget doing witness examinations with a suit jacket on top and gym clothes out of view of the screen … our kids said we looked like moms on the bottom and lawyers on top!

Hueston: Our client’s consistent support of us and our strategies throughout trial and their never-flagging belief that we would win this case.

James: The collegiality and comradery. Through the process, amazing colleagues became dear friends. This was a true team effort among the joint defense group, with each making equal and important contributions to the overall victory. Also, our team found small ways to insert humor and compassion into the experience, including creating a “quote wall” in the trial room, decorating the virtual trial space to include little bits of unnoticed humor, and taking the time each week to meet as a group to discuss strategy and check in on one another.

Reprinted with permission from the November 5, 2021 edition of The American Lawyer Litigation Daily. Further reproduction without permission is prohibited.