Reuben A. Guttman

Thalomid had been approved in July 1998 for erythema nodosum leprosum, a complication of leprosy, and in May 2006 for newly diagnosed multiple myeloma in combination with dexamethasone; Revlimid in December 2005 for transfusion-dependent anemia from certain myelodysplastic syndromes, in June 2006 for multiple myeloma after at least one prior therapy, and in June 2013 for mantle cell lymphoma. Brown alleged that her training had covered the drugs' use in ovarian, brain and prostate cancers and in myelodysplastic syndromes beyond the label, and that speaker fees, paid trials, advisory-board seats and ghost-written articles had been used to move prescribers. The complaint stayed under seal while the Civil Division, the United States Attorney's Office in Los Angeles and the inspector general of Health and Human Services investigated. In 2014 the government declined to intervene. Brown, as the False Claims Act permits a relator to do, went on with the case, and Reuben Guttman was her counsel.

Counsel to the Union

Guttman graduated from the University of Rochester in 1981 and Emory University School of Law in 1985 and spent his first five years, 1985 to 1990, as Washington counsel to the Service Employees International Union. For more than a decade he was chief outside counsel to the Oil, Chemical & Atomic Workers in labor and environmental litigation over conditions at the Manhattan Project's nuclear-weapons sites, including the National Environmental Policy Act suit over the Department of Energy's plan to recycle radioactive nickel from Oak Ridge, a project the department then cancelled. He headed the whistleblower practice at Grant & Eisenhofer before founding Guttman, Buschner & Brooks in Washington. He is an adjunct professor and senior fellow at Emory Law's Center for Advocacy and Dispute Resolution, a faculty member of the National Institute for Trial Advocacy, and a professorial lecturer at American University's School of Public Affairs, where he teaches equal protection; he has taught trial advocacy as a visiting professor at the Universidad Panamericana in Mexico City through a State Department program and, in a 2013 Emory program, trained financial-fraud prosecutors in Shanghai. With J.C. Lore of Rutgers Law School he wrote Pretrial Advocacy, published by Wolters Kluwer in 2021.

Depakote in the Nursing Homes

Meredith McCoyd, an Abbott Laboratories sales representative in Atlanta, filed a sealed complaint in the Western District of Virginia in 2007 alleging that Abbott had marketed Depakote, an anti-seizure drug, to nursing homes as a sedative for elderly residents with dementia and Alzheimer's disease and had encouraged its prescription to young children for epilepsy and migraines beyond the label. The Justice Department intervened in 2011, and on May 7, 2012 Abbott agreed to pay $1.6 billion: $800 million in civil payments, a $700 million criminal penalty and $100 million to the states on consumer-protection claims. Guttman, then at Grant & Eisenhofer, was lead counsel for McCoyd with Buschner, and said of the case, “What happened here with Abbott was a train wreck.” He represented one of the six principal whistleblowers in the government's $2.3 billion settlement with Pfizer in September 2009, one of the principal whistleblowers in the case that returned more than $3 billion from GlaxoSmithKline in 2012, Lynn Szymoniak, whose qui tam case over fraudulent mortgage assignments was resolved in 2012 within the government's $25 billion settlement with the largest banks, and the lead whistleblowers in the Rapamune case, in which Pfizer agreed on July 30, 2013 to pay $491 million.

Eighteen Thousand Prisoners

Russell Geissler, incarcerated in South Carolina with hepatitis C, filed his own suit against the Department of Corrections on June 30, 2017. Christopher Bryant was appointed to represent him in January 2018 and brought in Guttman's firm; Guttman, Brooks, Elizabeth Shofner and Paul Zwier appeared, and the court later named Guttman Buschner and Yarborough Applegate class counsel. On December 6, 2018 Judge Margaret B. Seymour certified a class of every current and future prisoner not already diagnosed with chronic hepatitis C, and on August 5, 2019 she approved a consent decree under which the department agreed to offer every one of them, more than 18,000 people, testing under the Centers for Disease Control's two-step protocol and to report its progress every four months. A second decree, given final approval on June 8, 2020, committed $10 million to treatment in the first year, with the same sum to be sought in each of the next four, set the order of treatment by severity of illness, and required treatment within 120 days for anyone later diagnosed with at least six months left to serve. By the January 2020 approval hearing 10,875 of the 13,432 prisoners offered the test had taken it, and Guttman told the court the agreement “is going to save 1,184 lives.”

Millions of Documents, Forty Depositions

Brown's team after the declination was Guttman, Buschner and Brooks; Dan Guttman, Liz Shofner, Caroline Poplin, a physician and lawyer, and Paul Zwier, the Emory evidence professor, of counsel; Tom Bienert and Mike Williams of Bienert, Miller & Katzman in San Clemente; Richard Harpootlian and Chris Kenney of Columbia, South Carolina; and Nancy Gertner, the former federal judge. The protective order governing the Medicare and Medicaid claims data produced by the Centers for Medicare and Medicaid Services carries Guttman's signature. The case ran to millions of documents, roughly forty fact and expert depositions and seventeen designated experts, thirteen of them Celgene's.

On December 28, 2016 Judge George H. King ruled on Celgene's motion for summary judgment. Medicare Part D, he held, pays for a drug only when it is prescribed for a medically accepted indication, one approved by the FDA or supported by the designated compendia, so a Part D claim for any other use is false under the False Claims Act. Brown did not have to tie a particular promotional contact to a particular prescription: causation could be found by a jury from evidence that the promotion was systematic, that physicians who received more promotional contacts prescribed more, and that hundreds of thousands of off-label claims had been submitted to Medicare during the years of that promotion, and no regression analysis was required where Celgene had destroyed its promotional data. “Celgene understood that its promotional efforts were successful in causing physicians to write prescriptions,” the court wrote. Whether the coverage rule was material to the government's payment decisions and whether Celgene had acted knowingly were questions for the jury, as was whether Brown had been entitled to rely on the company's assurances for the claims before April 2004. The court sent the parties back to mediation within sixty days and set the case for trial.

The Eve of Trial

The settlement was negotiated in the first months of 2017, after the ruling and the trial setting, and finalized in the week before July 24, 2017, when the United States Attorney's Office in Los Angeles announced it. Celgene paid $280 million: $259.3 million to the United States and $20.7 million to the twenty-eight states and the District of Columbia whose Medicaid programs had paid the claims, $4.7 million of it to California, where Brown had filed her complaint seven years before.