Thomas M. Sobol

Thomas M. Sobol

Pharmaceutical Antitrust · RICO Fraud Litigation · Class Actions

Under federal antitrust and racketeering law, this leaves Sun, which is one of the largest generic drug makers in the world, facing significant damages for Ranbaxy’s past actions

Meijer v. Ranbaxy: A Fraud-on-the-FDA Antitrust Case Settled for $485 Million Before Trial

Thomas M. Sobol originated the purchasers’ case accusing Ranbaxy of deceiving the FDA to hold generic Diovan, Nexium and Valcyte off the market, a claim the federal court in Boston believed was the first of its kind, and Ranbaxy and Sun Pharmaceutical settled it for $485 million two weeks before trial. On causation the court drew on Kaiser v. Pfizer, the Neurontin racketeering case in which Sobol was one of Kaiser’s trial lawyers.

At a hearing in the federal court in Boston on March 31, 2016, a lawyer for the generic drug maker Ranbaxy gave Magistrate Judge M. Page Kelley a reason so little precedent existed for the lawsuit the company wanted dismissed: “I don’t believe anyone has ever tried to take a case of fraud on the FDA and package it as an antitrust case.” Counsel for the purchasers suing Ranbaxy agreed that the claim “hasn’t been brought before, but these facts are pretty rare.” “The FDA hasn’t had to come down on a manufacturer like this ever before,” the purchasers’ counsel told the judge.

Judge Kelley opened her June 16, 2016 recommendation on the same point: the case “presents an issue of apparent first impression: whether Sherman Act claims brought by purchasers of a product may be predicated on an underlying fraud on the Food and Drug Administration.” She recommended that the claims go forward against Ranbaxy Inc. and Sun Pharmaceutical Industries, which had merged with Ranbaxy’s Indian parent in 2015 and assumed its liabilities. Ranbaxy objected that the recommendation “allows every one of the Complaint’s admittedly ‘novel’ claims go forward.”

Thomas M. Sobol had originated the case, and he signed the purchasers’ answer to that objection. “None of this is unprecedented,” the brief said of the magistrate judge’s rulings. “But Ranbaxy’s misconduct was. For years, Ranbaxy hid cGMP issues from the FDA.” Judge Nathaniel M. Gorton adopted the recommendation, and in March 2017 he wrote: “As far as this Court can discern, this is the first time a party has brought antitrust claims predicated on fraud on the FDA.”

The party that pays has been his client for three decades: Massachusetts, New Hampshire and Rhode Island in the tobacco litigation of the 1990s, Kaiser in the Neurontin trial, and, in the generic-drug cases he has led since, the businesses and consumers that paid higher prices while generic versions were delayed. Ranbaxy and Sun settled the purchasers’ litigation for $485 million two weeks before it was to go to a jury.

Ranbaxy at the Front of the FDA’s Line

Under the Hatch-Waxman Act, a generic company that files the first substantially complete application to copy a brand-name drug can obtain a 180-day period of exclusivity, and first-filer status can hold later generic competitors off the market. Tentative approval, the step before final approval, requires the applicant to show that its plants comply with the FDA’s current good manufacturing practices. Ranbaxy filed the first substantially complete applications for generic Diovan, Nexium and Valcyte in 2004 and 2005 and obtained tentative approval for each in 2007 and 2008. Diovan treats high blood pressure and heart failure; Valcyte is an antiviral; Nexium is a proton-pump inhibitor used to treat gastroesophageal reflux disease.

In late 2005 a whistleblower had alerted the FDA to serious and systemic noncompliance with the agency’s current Good Manufacturing Practices at Ranbaxy manufacturing facilities. He was Dinesh Thakur, a former Ranbaxy executive, and in April 2007 he filed a False Claims Act suit against the company. An FDA inspection of Ranbaxy’s plant at Paonta Sahib, India, in 2006 found incomplete testing records and an inadequate stability program, and on June 16, 2006, the agency put a hold on the Ranbaxy applications originating from that plant, including generic Diovan and generic Valcyte.

The purchasers alleged that Ranbaxy answered the inspection by hiring a law firm and an outside auditor and arranging for the auditor’s findings to go to the lawyers, who designated them privileged attorney work product, instead of directly to the FDA. They alleged that federal agents executed search warrants at Ranbaxy’s New Jersey facility on February 14, 2007, and that in June 2007 Ranbaxy mailed the FDA letters falsely assuring it that the compliance problems were resolved. In reliance on those letters, they alleged, the agency granted tentative approval to generic Diovan on October 25, 2007, and to generic Valcyte on June 20, 2008. “It took the FDA nearly three years to uncover the truth,” Sobol’s brief later told Judge Gorton.

In July 2008 the government enforced a subpoena for the auditor’s reports. The FDA then blocked 30 Ranbaxy products from import, and on February 25, 2009, it invoked its Application Integrity Policy against the Paonta Sahib applications and froze their scientific review. Under a January 2012 consent decree, Ranbaxy withdrew several applications and submitted others, including generic Diovan and generic Valcyte, to audits meant to show that they had been substantially complete when filed. On May 13, 2013, Ranbaxy USA pleaded guilty to three felony counts under the Food, Drug and Cosmetic Act and four felony counts of knowingly making material false statements to the FDA, and Ranbaxy agreed to pay $500 million in criminal penalties and civil settlements.

Under its patent settlements with the brand companies, Ranbaxy could launch generic Diovan on September 21, 2012, and generic Valcyte on March 15, 2013. Both dates passed. Ranbaxy did not secure final approval for its generic Diovan until June 2014 and did not bring it to market until July 2014; the brand company’s authorized generic followed the next day, and other generic makers reached the market in January 2015. In November 2014 the FDA rescinded Ranbaxy’s tentative approvals for generic Nexium and generic Valcyte and stripped the company of first-filer status for both. The day it rescinded the Valcyte approval, the FDA gave final approval to Endo Pharmaceuticals and another generic applicant. Ranbaxy sued the agency over the revocations, and in February 2015 the court granted summary judgment to the FDA.

A Purchaser’s Claim Against the Approval Queue

In May 2015 Sobol brought Meijer, Inc. v. Ranbaxy Inc. in federal court in Boston for Meijer, Inc. and Meijer Distribution, Inc., on a new theory: that a generic company’s fraudulent statements to the FDA to obtain exclusivities violated both RICO and the antitrust laws. The Meijer companies, both Michigan corporations, sued as assignees of Frank W. Kerr Co., which had bought Diovan and Valcyte from the brand manufacturers and resold them to Meijer, and on behalf of a class of direct purchasers. The purchasers accused Ranbaxy of “recklessly stuffing the generic drug approval queues with grossly inadequate applications, deceiving the FDA into granting tentative approvals to lock in statutory exclusivities to which Ranbaxy was not entitled.” They alleged that Ranbaxy had misled the FDA about the state of its manufacturing plants in India and its manufacturing compliance.

Ranbaxy argued first that only the FDA could police lies told to it. In Buckman the Supreme Court had held state-law claims of fraud on the FDA preempted, and Ranbaxy read that decision to bar every private claim built on fraud on the agency, federal claims included. At the March 2016 hearing its counsel also pressed causation: “[I]f there weren’t fraud against the government, all that would have happened is we would have gotten our ANDA. We would have gotten our exclusivity.” Judge Kelley answered that “Ranbaxy’s compliance issues do not factor into the but for analysis,” and that its deceit did. “If not for the fraud,” she wrote, “Ranbaxy would have told the FDA honestly about its abysmal manufacturing practices at some earlier point, and it still would not have been able to launch.”

In the brief Sobol signed in August 2016, the purchasers answered Ranbaxy’s reading of the drug laws. “Congress authorized the FDA to ensure public safety and the purity of drugs; it did not authorize the FDA to police the market or protect private parties’ business interests,” the brief said. “Instead, it enacted the antitrust laws and RICO to provide private remedies to those financially injured.” Ranbaxy’s fraud, the brief said, had kept affordable generic drugs off the market, “forcing purchasers to spend hundreds of millions, if not billions, more for drugs.”

Judge Gorton accepted and adopted the recommendation on September 7, 2016. Ranbaxy petitioned the First Circuit for leave to appeal, and the petition remained pending there for more than two years. On December 28, 2018, the First Circuit denied it. In February 2019 the Meijer case and four others were centralized before Judge Gorton as MDL No. 2878, with Hagens Berman among co-lead counsel.

Property in the Hands of the Victim

Once the cases were centralized, Ranbaxy moved to dismiss again. It argued that its applications were petitions to the government protected by the Noerr-Pennington doctrine. It also argued that a license to market a drug during a 180-day exclusivity period was “virtually indistinguishable from the license at issue in Cleveland” v. United States and so could not be “property” in the hands of the FDA, which would take the mail- and wire-fraud predicates out of the RICO claims. In November 2019 Judge Gorton held that the plaintiffs had adequately alleged that the sham-petitioning exception to Noerr-Pennington applied, and he answered the Cleveland argument: “plaintiffs have alleged that Ranbaxy’s fraud affected the interests of individuals and entities other than the government.”

In May 2021 Judge Gorton certified direct-purchaser classes for each of the three drugs and classes of end payors. Ranbaxy argued that individually negotiated prices, chargebacks and credits concealed purchasers who had suffered no injury; the court answered that an antitrust injury occurs the moment a purchaser pays an overcharge, whether or not it is later offset. The classwide overcharge model came from Dr. Meredith Rosenthal, who compared the drugs’ actual monthly average prices with the prices they would have carried without the alleged anticompetitive conduct. The court wrote that her analysis demonstrated that the average but-for prices “were always or almost always below the average prices actually paid.”

Ranbaxy’s FDA Letters and the Neurontin Causation Rule

Ranbaxy and its co-defendant, Sun Pharmaceutical Industries, then moved for summary judgment. They argued that Ranbaxy could not have monopolized the markets for generic Valcyte and Nexium because it never sold either drug, and they relied on later FDA letters stating that Ranbaxy’s applications did not appear to contain any untrue statements of material fact. At the October 2021 hearing on the motions, they argued that brand Nexium had been priced below the generic, so that the delay in generic Nexium had saved the end payors money. Judge Gorton pointed out that the Nexium end-payor class included only purchasers of the generic and excluded the payers who had received the brand rebates: “These rebates are, thus, simply irrelevant.”

Judge Gorton denied the defendants’ motions in a 40-page order on November 22, 2021. “Within the highly regulated market for pharmaceuticals,” the court held, the purchasers had offered evidence creating a genuine dispute over whether Ranbaxy “maintained monopoly power due to its first-filer status and the resulting exclusionary periods.” Ranbaxy’s decision not to enter the Valcyte and Nexium markets, the judge wrote, was “reflective, rather than dispositive, of the market power that the defendants allegedly wielded.” The defendants’ “description of the subject letters as ‘no fraud’ letters,” the court wrote, “is misguided and inaccurately characterizes their significance.” “These letters are not the conclusive exculpation that defendants confidently submit.”

Among the authorities Judge Gorton applied on causation was the First Circuit’s 2013 decision in Kaiser Foundation Health Plan’s racketeering case against Pfizer, a case in which Sobol had been one of Kaiser’s trial lawyers. Once a plaintiff presents evidence of the injury that a defendant’s wrongful conduct would be expected to cause, the appeals court had held, “the burden shifts to the defendant to rebut this causal inference.” “Defendants have failed to rebut compellingly the plaintiffs’ causal inferences on either of the issues addressed,” Judge Gorton wrote. “Causation questions of this sort,” the court added, “are normally grist for the jury’s mill.” Trial was set for January 10, 2022.

Two Weeks Before Trial

“Under federal antitrust and racketeering law, this leaves Sun, which is one of the largest generic drug makers in the world, facing significant damages for Ranbaxy’s past actions,” Sobol said the day after the ruling. In January 2022 Judge Gorton reset the trial: jury empanelment would begin on April 5, 2022, and the trial would run no more than 63 hours, 36 for the purchasers to present their case and 27 for the defendants to respond. Two weeks before trial was to begin, the parties notified the court that they had reached global settlements.

Ranbaxy and Sun agreed to deposit $340 million into a settlement fund for the direct purchasers and $145 million into a fund for the end payors. In April 2022 Judge Gorton preliminarily approved the $340 million settlement for direct purchasers of Diovan, Valcyte, Nexium and their AB-rated generic versions, part of $485 million for all plaintiffs in the case. Class members were notified of the terms, and no member of either class objected. On September 19, 2022, the court granted final approval of the $485 million global settlement, citing the complexity of the litigation, the lack of objections, the late stage at which the parties settled and the risks of carrying the case through trial. The settlement funds were distributed during the following year.

Kaiser, Second on Parke-Davis’s List

The First Circuit decision Judge Gorton relied on arose from earlier drug-fraud litigation in the same federal court. Sobol left Brown, Rudnick, Freed & Gesmer in 2000, and at Hagens Berman Sobol Shapiro, whose Boston office he leads, he took on the Neurontin litigation. The federal Neurontin cases were consolidated before Judge Patti B. Saris in Boston as MDL No. 1629, and Hagens Berman was appointed liaison counsel and co-lead counsel for a class of consumers and third-party payors.

The FDA approved Neurontin on December 30, 1993, as an adjunctive therapy for partial seizures in adults with epilepsy and set its maximum dose at 1,800 milligrams a day. Parke-Davis, Warner-Lambert and Pfizer then marketed it for uses the agency had not approved. Judge Saris later found that the companies had fraudulently promoted Neurontin for bipolar disorder, neuropathic pain, migraine and doses above 1,800 milligrams, through sales visits to physicians, sponsored continuing-medical-education programs and a publication strategy. Warner-Lambert eventually pleaded guilty to criminal violations of the Food, Drug and Cosmetic Act and paid civil fines and criminal penalties totaling $430 million.

At Kaiser, prescribing ran through a formulary. The Drug Information Service researched drugs and wrote monographs on new drugs and new uses for physicians and for the Pharmacy and Therapeutics Committees of the regional Permanente Medical Groups. Each committee decided whether a drug went on its formulary without restriction, with prescribing limited to a particular group of physicians, or with guidelines for appropriate use. The groups’ physicians followed the formulary at a 95 percent rate.

Parke-Davis identified Kaiser as a marketing target as early as 1994, when its marketing team listed Kaiser Health Plans second on its list of “Top 10 HMOs Targeted for Neurontin.” Kaiser physicians attended conferences where Neurontin was promoted for off-label uses; after one of them, in May 1999, new Neurontin prescriptions rose 62 percent. Judge Saris found that “Kaiser relied on Pfizer’s misrepresentations and omissions during the development of drug monographs in both June and September 1999.” In September 1999 the Pharmacy and Therapeutics Committee removed all remaining formulary restrictions on the drug.

In 2004 Pfizer wrote an operating plan specifically for marketing to Kaiser. Its strategies included building relationships with members of the pharmacy committees, supplying clinical and outcomes information to Kaiser’s drug-information coordinators on a regular basis, and developing relationships with committee members “who are not considered ‘whistle blowers.’” From 1996 to 2004, Kaiser spent about $200 million on Neurontin.

Studies Kept Out of Print

Several of the companies’ own trials had come back negative. In a bipolar-disorder trial led by Dr. Pande, placebo outperformed Neurontin, and Parke-Davis knew those results as early as July 1998. The companies published a positive social-phobia study by Pande in 1999; Judge Saris found that they suppressed the negative bipolar results until October 2000, when the study appeared in Bipolar Disorders, a “fairly narrow” and “small journal” with a circulation of only 455 physicians.

A study led by Dr. Reckless, completed in late 1999 and presented to Pfizer in February 2000, found Neurontin ineffective in treating painful diabetic neuropathy. Reckless was “keen to publish” the results. Parke-Davis chose to “delay[] the publication for as long as possible” and refused to let him write up the manuscript himself, and the court found that the companies suppressed the results because of a desire “NOT to publish anything that damages Neurontin’s marketing success.” A Pfizer-sponsored trial of pain after surgery or traumatic nerve injury, completed in November 2001, found Neurontin ineffective on its primary measure and stayed unpublished until 2008.

Kay Dickersin, a Johns Hopkins epidemiologist, reviewed the companies’ study protocols, research reports, internal emails and publications and found that “what was in the published record didn’t agree with what was actually planned or what had been done.” Jurors also heard from David Kessler, a former commissioner of the FDA. The evidence included an internal email in which a Pfizer employee, writing before Pfizer acquired Parke-Davis, called Neurontin “the ‘snake oil’ of the twentieth century.”

The Jury’s Racketeering Verdict for Kaiser

On November 12, 2009, Judge Saris ordered a bellwether trial of Kaiser’s claims and specified that “the Court will issue special jury instructions on fact issues so that the findings will have preclusive effect on subsequent litigation.” The trial was scheduled to open in Boston on February 22, 2010. Sobol was one of Kaiser’s lawyers at the trial.

It ran five weeks. The parties presented twenty-one live witnesses and eighteen witnesses by deposition; the trial involved sixteen expert witnesses and more than 400 admitted exhibits. Kaiser offered testimony from four of its executives, including the chairperson of the Southern California Pharmacy and Therapeutics Committee and the chairperson of the Drug Information Service. “Remarkably,” Judge Saris wrote afterward, “Pfizer did not offer live testimony from any officer or employee, nor was any Pfizer representative present during the trial.”

Kaiser had to tie a national marketing campaign to prescriptions written inside its own medical groups. Meredith Rosenthal, a professor at the Harvard School of Public Health with a Ph.D. in health economics from Harvard, used regression analysis to connect the pattern of Pfizer’s promotional spending with the pattern of prescribing. She attributed to the fraudulent marketing 99.4 percent of prescriptions for bipolar disorder, 70 percent for neuropathic pain, 27.9 percent for migraine and 37.5 percent for doses over 1,800 milligrams a day. Kaiser’s damages expert, Dr. Hartman, calculated Kaiser’s excess costs against a list of alternative drugs that were more appropriate for each off-label use than Neurontin. That list had been developed by the chairperson of Kaiser’s Drug Information Service, Dr. Marta Millares.

The jury deliberated for two days. On March 25, 2010, it found that Pfizer had engaged in a RICO enterprise that committed mail and wire fraud by fraudulently marketing Neurontin, and it returned a verdict for Kaiser of $47,363,092, which RICO required the court to treble to $142,089,276. Several jurors said afterward that they had been strongly influenced by the testimony of Kessler and Dickersin. “The jury found Pfizer engaged in a racketeering conspiracy over a 10-year period,” Sobol said after the verdict. “That bodes well for future cases.”

On November 3, 2010, Judge Saris issued 146 pages of findings of fact and conclusions of law and entered judgment for Kaiser on its claim under California’s Unfair Competition Law. “The success of the drug was due to the illegal activities of Parke-Davis, Warner-Lambert and Pfizer,” the judge wrote, and Neurontin “was promoted through a publication strategy that suppressed negative clinical trials and showcased positive ones.”

The Physician Between the Pitch and the Payment

On appeal, Pfizer described its connection to Kaiser Foundation Health Plan’s losses as a chain of at least four steps. Pfizer communicated tainted information about Neurontin to Kaiser’s Drug Information Service; the service produced monographs that relied on the misrepresentations; the monographs influenced the formulary decisions of Kaiser’s physician groups; and the prescribing physicians, “who exercise independent medical judgment,” wrote the prescriptions within the formulary. Pfizer argued that a causal chain running through that many independent decisions could not make it answerable to the health plan that paid for the prescriptions.

Besides the four-step chain, Pfizer argued on appeal that Rosenthal’s regression could not prove causation because it did not account for the individual, idiosyncratic decisions of physicians; that Kaiser had continued to permit, and even recommend, Neurontin for some off-label uses after it became aware of the fraud, and had cut back to contain costs rather than out of doubts about efficacy; and that the damages model was speculative because no expert had testified that the alternative drugs were at least as effective or as well tolerated as Neurontin.

The First Circuit rejected those arguments on April 3, 2013. Writing for a panel that included retired Justice David H. Souter, Chief Judge Lynch held that Kaiser was a primary and intended victim of Pfizer’s scheme to defraud. “Pfizer’s fraudulent marketing plan, meant to increase its revenues and profits, only became successful once Pfizer received payments for the additional Neurontin prescriptions it induced,” the court wrote. “Those payments came from Kaiser and other TPPs”—the third-party payors. Applying the Supreme Court’s RICO causation decisions in Holmes, Anza and Bridge, the court noted that the plaintiff in Holmes stood at a remove from the parties directly injured and the plaintiff in Anza was injured collaterally, while Pfizer’s plan depended on Kaiser’s payments to succeed. No physician, Drug Information Service member or committee member had paid for a Neurontin prescription, so there was no risk of multiple recoveries. “The fact that some physicians may have considered factors other than Pfizer’s detailing materials in making their prescribing decisions,” the court wrote, “does not add such attenuation to the causal chain as to eliminate proximate cause.”

Kaiser’s own later conduct became part of the proof. When Kaiser moved to limit Neurontin, its efforts “result[ed] in a 33-34% decrease in new starts of Neurontin,” the district court had found, though Neurontin use continued to increase nationally. The First Circuit counted that decline, set against the national rise, among Kaiser’s evidence of but-for causation.

The court held Rosenthal’s regression admissible and left Pfizer’s criticisms of it—a missing time trend, the growth in gabapentin prescriptions after marketing spending plummeted in October 2004, a promotional spike in 2003—for the jury to weigh. Pfizer’s own expert, Dr. Keeley, had presented no causation or damages model of his own, and the court applied the rule that “speculation has its place in estimating damages, and doubts should be resolved against the wrongdoer.” “We affirm the verdicts for Kaiser,” the court concluded. The verdicts it affirmed included a racketeering award that the district court had trebled to $142,089,276.

David C. Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel argued the appeal for Kaiser, and Linda P. Nussbaum of Grant & Eisenhofer was among the lawyers on its brief. Pfizer asked the Supreme Court to take the case, arguing that lower courts were confused about how civil RICO plaintiffs prove causation. In December 2013 the Court declined.

Judge Saris had set up the Kaiser trial so that its findings would bear on the cases behind it. In June 2014 the parties moved for approval of the $325 million settlement Sobol had negotiated for a nationwide class of health plans and other third-party payors that had covered the cost of Neurontin since its first sale in the United States. In a November 10, 2014 memorandum on the settlement, Judge Saris wrote: “The riskiest portion of the litigation against Pfizer was the bellwether trial for which Kaiser served as a plaintiff.” The jury’s finding that Pfizer had violated RICO, the judge wrote, “substantially increased the certainty that Class Plaintiffs would be able to recover their payments through civil litigation.”

Three States and the Cost of Smoking

Sobol was born in Framingham, Massachusetts, in 1958. “Both of my parents were quite liberal and active, but in different ways, in the sixties and seventies,” he has said. His father started as a schoolteacher in Boston, moved the family to Westchester County, and worked his way up through school administration to become commissioner of education under Governor Mario Cuomo. His mother, who in her son’s words “was involved in quite a lot of protests,” later ran rehabilitation programs at the maximum-security Bedford Hills Correctional Facility for Women. “My father instilled in me a belief that hard work is in and of itself something of tremendous high value,” Sobol has said. “My mother taught me that there isn’t anybody who you can’t find value in.”

He graduated summa cum laude and Phi Beta Kappa from Clark University in 1980 and cum laude from Boston University School of Law in 1983. He spent a year working for Allan Hale, chief judge of the Massachusetts Appeals Court, before joining Brown, Rudnick, Freed & Gesmer, where he practiced civil and criminal litigation until 2000, chaired the firm’s pro bono program and served on its hiring committee. From 1995 to 2002 he chaired the board of the New England Shelter for Homeless Veterans.

In 1995, Massachusetts Attorney General Scott Harshbarger asked Brown Rudnick to join the Commonwealth’s lawsuit against the tobacco industry, which sought to recover the costs of smoking-related health care. “By the early 1990s, the United States tobacco industry had successfully fought off every litigation effort that was ever brought against it,” Sobol has said; the companies had defended those suits by blaming the smoker. The Cigarette Papers, released in 1994, “showed the absolutely outrageous misconduct by the tobacco industry going back into even the early 1950s where they knew that cigarettes were a drug delivery device,” he has said. Sobol served as a special assistant attorney general for Massachusetts, New Hampshire and Rhode Island in the litigation, which ended with injunctive relief and recoveries of more than $10 billion, and his firm came to represent five states in all.

Medicare’s Power to Negotiate

Courts have appointed Sobol lead or co-lead counsel in ten pending antitrust cases alleging that businesses and consumers were injured by the delayed availability of generic drugs. In 2022 he became president of the board of Public Justice. Taking on a case few expect to win is, in his phrase, tilting at a windmill, which “also means that you’re pointing True North.”

When drug manufacturers sued to stop Medicare from negotiating prices under the Inflation Reduction Act, Sobol and his colleagues filed friend-of-the-court briefs defending the program. In October 2023 they filed for nearly 50 law professors and scholars in the cases Bristol Myers Squibb and Janssen brought in federal court in New Jersey, answering the manufacturers’ claim that negotiation took their property in violation of the Fifth Amendment. In December 2023 they filed for scholars in cases brought by Boehringer Ingelheim and the Dayton Area Chamber of Commerce, and for the Center for American Progress and the NAACP in Boehringer’s case. “The law scholars who have chosen to take a stand against BMS and Janssen in this amicus brief have done so for one reason: already today, about three in 10 Americans cannot afford their prescription drugs,” Sobol said.

A Fourth Amendment Challenge to ICE’s Form I-205 Memo

Sobol’s current docket also includes a pro bono Fourth Amendment case. In January 2026, with Lawyers for Civil Rights, he and his Hagens Berman colleagues sued the Department of Homeland Security and Immigration and Customs Enforcement in federal court in Boston on behalf of three Massachusetts nonprofits: the Greater Boston Latino Network, the Brazilian Worker Center and Massachusetts Communities Action Network. The groups challenge a May 12, 2025 memorandum by Todd M. Lyons, ICE’s acting director, which they allege authorizes officers to enter homes, including by force, on the strength of a Form I-205 warrant of removal, without a judicial order, consent or exigent circumstances, in violation of the Fourth Amendment and the Administrative Procedure Act. The groups allege that the memo has forced them to divert scarce resources from job training, education, housing and health care support to counseling and know-your-rights training for the tens of thousands of people they serve. On June 5, 2026, the plaintiffs moved for partial summary judgment.