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Demanding more impact from impact litigation: lessons to be learned from multi-state opioid settlements

By Reuben Guttman and Liza Vertinsky, July 25, 2022

In the 1990s, state Attorneys General learned how to leverage their resources when they retained private counsel to sue the tobacco industry. The private attorneys worked on contingency, meaning they did not get paid unless money was recovered from the tobacco industry. For their part, the states were able to take on novel litigation and draw from private investments in legal innovation without putting taxpayer dollars at risk.

Since the Tobacco Master Settlement Agreement was signed in 1998, state Attorneys General have worked with private counsel in similar relationships to bring an array of healthsafety, and environmental suits focused on health impacts. These suits have included cases against drug companies, the most notorious of which featured opioid manufacturers and distributors.

In July 2022, 52 states and territories, along with many local governments, entered into a $26 billion multijurisdictional agreement with three major pharmaceutical distributors and a pharmaceutical manufacturer to settle claims arising from their opioid business practices. This multistate opioid settlement followed earlier ones reached with the now-infamous Purdue Pharma, as well as with McKinsey ConsultingMallinckrodt, and Insys Therapeutics, and was followed by settlements with two more opioid manufacturers. The result was a multi-state enforcement effort by Attorneys General that is the second largest in U.S. history, exceeded only by the Tobacco Master Settlement Agreement.

While the state Attorneys General who participated in these suits and settlements were quick to herald them as a major success, with more than $30 billion in settlement funds and future monitoring and restricting future opioid deliveries, it is a stretch to say these are industry-changing events. Too little was done to educate policymakers and the public about the nature and sources of industry misconduct and to address the remaining vulnerabilities in the pharmaceutical manufacturing and distribution system. The results did too little to change the market ecosystem that fueled the epidemic.

The opioid litigation, like many cases brought against pharmaceutical and device companies, challenged marketing practices that have caused products to be used in ways that place profits ahead of patients, often putting patients at risk of harm. These lawsuits exposed practices that have resulted in professional standards of care that seem to be influenced more by Wall Street promises than by medical necessity.

Yet far too often, these cases are resolved short of full fact finding — called discovery — or without a public trial and a published court decision. Multi-million-dollar opioid settlement resolutions are touted in press releases as major successes while the culprit corporations admit to nothing, simultaneously telling investors that the settlement was a business decision and will not affect the long-term bottom line. Indeed, history shows that when drug companies pay hundreds of millions of dollars — or even billions of dollars — to resolve claims of drug marketing derelictions, their price per share is not affected, or may even get a boost because investors believe the settlement was a cheap fee for a license to break the law.

As much as these cases have provided an inkling of the profit-motivated misconduct of companies that Americans depend on for health care and a safe environment, knowledge of the depth of corporate misconduct remains just that, an inkling. Confidentiality agreements — often executed to prevent delays in producing the documents required for civil litigation — keep the most sordid details secret. And when there is no trial, the public gets to learn little about identifying wrongful conduct and legislators have difficulty making laws that prevent it.

Supreme Court Justice Louis D. Brandeis famously wrote that sunshine is the best disinfectant. While recovering money for public programs is essential, state Attorneys General must do a better job of also making public the lessons learned from these opioid settlements. If the drug industry is using subtle marketing tactics to manipulate the prescribing habits of physicians, for example, the public — including legislators, regulators, the press, and even physicians — must know the details.

Impact litigation must be designed to effect changes in industry behavior. Just as the National Transportation Safety Board investigates and issues a public report when a train wreck occurs, and just as Environmental Impact Statements are required for federal projects that could significantly affect the quality of the human environment, state Attorneys General should treat corporate health and safety derelictions as deserving of detailed public reports. And they should make it clear to the attorneys involved — whether in-house or under contingency agreement — that confidentiality agreements cloaking the secrecy of wrongdoing are to be used only sparingly, to protect legitimate trade secrets that are not essential to reforming industry practices, and not to hide information that is important to the public.

In the end, the public needs to know all the facts and policymakers need to act on the facts. A simple press release announcing a seemingly high-dollar settlement doesn’t achieve either of those objectives.

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Reuben Guttman, a partner with Washington, D.C.-based Guttman, Buschner & Brooks, has litigated under the False Claims Act to challenge pharmaceutical marketing practices. Liza Vertinsky is a professor of law at the University of Maryland Francis King Carey School of Law. Their article “Public-Private Litigation for Health” was published in the Utah Law Review.

Source: Article available on-line at Statnews.com.

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Whistleblowers and fears of losing funds key to enforcing U.S. vaccine rules

Workplace whistleblowers and a fear of losing federal funds are expected to play vital roles in ensuring compliance with COVID-19 vaccine mandates ordered by President Joe Biden’s administration for U.S. businesses, nursing homes and hospitals, according to experts.

Biden announced last Thursday that his administration will enforce the vaccine mandates starting on Jan. 4. The rules apply to employers with at least 100 workers, federal contractors and employees of nursing homes and other healthcare facilities that receive reimbursements under the Medicare and Medicaid government healthcare programs.

On Saturday, a federal appeals court suspended the new vaccine and testing requirement for private companies while the court considers it in more depth. It gave the Justice Department until late Monday to respond. The portion of the mandate for the healthcare sector is not affected by Saturday’s ruling.

If the rule goes into effect, the U.S. Occupational Safety and Health Administration (OSHA), which enforces work safety rules, is not likely to immediately swoop in to ensure that vaccination and testing rules are being followed, experts said.

The Centers for Medicare & Medicaid Services (CMS), the regulator for the two federal health programs, does not typically survey accredited healthcare providers unless there is a complaint or a need for recertification, according to Sandy DiVarco, a partner at the firm McDermott Will & Emery who represents healthcare providers.

Since patients and clients do not have access to staff vaccination records, those complaints would likely come from another staff member, DiVarco added.

“On a stakeholder call, CMS reiterated their desire to work with providers to come into compliance and not to sort of send SWAT teams to go out and look for problems,” DiVarco said.

Healthcare facilities could lose their access to Medicare and Medicaid funds if they fail to heed the vaccine requirements. Medicare serves people aged 65 and older and the disabled while Medicaid serves the poor.

“For most hospitals across the country not being able to participate in Medicare would be crippling,” said Akin Demehin, the American Hospital Association’s director of policy.

The healthcare workers mandate applies to more than 10 million employees, around 70% of whom already have been vaccinated. It covers around 76,000 healthcare providers that receive Medicare or Medicaid reimbursements including hospitals, nursing homes, dialysis centers, ambulatory surgical settings and home-health agencies.

For the private employer rules, OSHA has an estimated 800 safety and compliance inspectors to cover more than 100,000 companies covered by the mandate. The agency likely will rely on whistleblowers concerned about unvaccinated co-workers or that unvaccinated people are not being tested as required, said James Hermon, a labor and employment expert with the firm Dykema Gossett.

Hermon predicted that OSHA will hit a couple of big employers with major fines soon after the mandate takes effect.

“That will be done intentionally to put some virtual heads on spikes,” Hermon said. Each violation can bring a fine of nearly $14,000.

The financial threat from a federal law called the False Claims Act, which rewards whistleblowers for reports of fraud that results in losses for the government, might ensure compliance with the vaccine rules better than OSHA’s penalties, according to one expert.

“We’re interested in these cases and we’ve been looking at them,” said Reuben Guttman, a whistleblower lawyer with the firm Guttman, Buschner & Brooks, who said he has been talking to unions. “The idea of using the False Claims Act to enforce health and safety standards is not novel.”

(Reporting by Diane Bartz, Ahmed Aboulenein and Tom Hals; Editing by Will Dunham)

Source: https://kfgo.com/2021/11/08/whistleblowers-and-fears-of-losing-funds-key-to-enforcing-u-s-vaccine-rules/.

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Reuben A. Guttman, District of Columbia Fellow, Co-Publishes “Pretrial Advocacy”

District of Columbia Fellow Reuben A. Guttman has co-authored a new book, “Pretrial Advocacy,” to be released by the National Institute for Trial Advocacy. (Now available in print and e-book here.) The volume, which was also written by Rutgers Professor J.C. Lore, discusses the “unwritten rules” of pre-trial preparation and grapples with the challenges of efficiently developing cases that can stand up to jury scrutiny in the face of overflowing demand, even though 90% of civil cases never make it to trial.

If anybody is qualified to talk about effective legal advocacy, its Reuben Guttman. The Guttman, Buschner & Brooks founding partner has spent his 36-year career releasing staggering sums of money from the grasps of oil refineries, pharmaceutical organizations, and prisons who have run afoul of laws such as the False Claims Act and the Federal Fair Labor Standards Act. Mr. Guttman, who started his legal career as counsel for the Service Employees International Union, AFL-CIO, is a whistleblower’s best friend—in 2015, he helped Florida’s Lynn Szymoniak gain an $18 million settlement after she uncovered a fraudulent foreclosure scheme that threatened to undermine her own housing and that of thousands of other homeowners.

In addition to being a legal superstar, Mr. Guttman is a familiar figure in the academy and the press. When he isn’t giving his time to Emory University School of Law as an adjunct professor, journal advisor, or board member, he’s writing for or being quoted in more than 30 journals and media outlets as varied as The New York Times and Peking University Public Interest Law Journal. Mr. Guttman’s international influence stretches from the U.S. federal government, where he has testified before Congress and advised President Clinton’s transition team, to as far away as China, where he has offered his thoughts on Chinese labor laws at the Dutch Embassy and lectured at universities in Shanghai and Beijing.

Source: American Bar Foundation.

Now Available in print and e-book here.

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Book: New Pretrial Advocacy Book Addresses New Norms in Transformed Field of Litigation

A new book on pretrial advocacy, published this week by the National Institute for Trial Advocacy (NITA) and Wolters Kluwer, takes on a world of litigation that has been radically transformed in recent years by remote proceedings and other practice norms that often deliver resolution long before litigants face off in the courtroom. (Available in print and e-book here.)

In Pretrial Advocacy, authors Reuben A. Guttman and J.C. Lore address the challenges of litigating in a civil justice system that is overburdened yet essential to implementation of the rule of law. Even as nearly 90% of all civil matters never come before a jury, lawyers must nevertheless prepare cases as though they will. Because modern civil litigation is, the authors say, “front loaded,” lawyers are challenged early on in the pretrial process to consider the rules of evidence and civil procedure as they gather information to plead a plausible complaint.

“The pretrial process is laden with unwritten norms. All parties, from litigants to jurists, struggle to provide efficient resolutions while balancing due process,” said Lore, a Distinguished Clinical professor and Director of Trial Advocacy at Rutgers Law School. “We wanted to write something that explains it all.” The strategies and techniques outlined in Pretrial Advocacy put forward responsive new approaches to teaching advocacy in both law school and continuing legal education settings.

In addition to practical tips and insights from some of the nation’s foremost jurists and practitioners, Pretrial Advocacy features a foreword by retired U.S. District Court Judge for the District of Massachusetts and Harvard Law faculty member Nancy Gertner. “Pretrial Advocacy fills an important space for litigators,” Gertner said. “It teaches how to try cases from the moment  a client contacts the lawyer through the trial, encouraging lawyers to engage in strategic decisions about pretrial discovery and motion practice. Why depose this witness rather than another?  What is the purpose? What are the salient documents—not every single one, not just the few ‘gotcha’ documents, but those that build the narrative.”

Pretrial Advocacy closes with chapter dedicated to public interest litigation. “We thought a chapter on public interest litigation was necessary because there are too many people—from immigrants to victims of race and gender discrimination and whistleblowers—seeking to have their voice heard, and they need competent representation,” said Guttman. Guttman is a founding partner of the Washington, D.C. law firm of Guttman, Buschner & Brooks, PLLC, where he has represented clients in False Claims cases in matters returning more than $6 billion to the United States government.

Guttman and Lore are available to the media to comment on matters in civil litigation and the civil justice system.


Book Available HerePretrial Advocacy is the ideal textbook for law school clinics, law school  pretrial litigation courses, and practicing lawyers. Both practical and theoretical, it teaches litigation as a process informed by rules and cases, but also by strategic considerations. Its hands-on and accessible text makes it a perfect reference for learning skills and a continuing reference.

Learn more here.

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On the Rule of Law: Now is the Time to Rethink the Role of Law Schools

In his opening remarks to a Senate Judiciary Committee charged with reviewing his nomination to be Attorney General of the United States, Judge Merrick Garland noted that “communities of color and other minorities still face discrimination in housing, in education, in employment and in the criminal justice system, and they bear the brunt of the harm caused by the pandemic . . . .” All of these problems still exist over 150 years since the passage of the Thirteenth, Fourteenth, and Fifteenth Amendments; over sixty years since Brown v. Board of Education was decided; and over half a century since the civil rights legislation of the 1960s.

The truth is that we — as a mature nation — had a lot to overcome; today our nation remains tainted by an ugly upbringing, the history of which has too often been glossed over in palatable terms…

Read the full piece below.

https://medium.com/@rguttman/on-the-rule-of-law-now-is-the-time-to-rethink-the-role-of-law-schools-1f9e707ee4a1

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