Timothy J. Becker

In January 2022 the Food and Drug Administration announced that it had found 305 cases of dental problems, 131 of them classified as serious, in people using buprenorphine medicines that dissolve in the mouth. The reports described tooth decay, cavities, oral infections, and loss of teeth; 71 involved extraction. The average patient was about 42, but people as young as 18 had been affected, and in 26 cases the patient had no prior history of dental problems. FDA told patients to take a large sip of water once the medicine dissolved, swish it around the teeth and gums, swallow, and wait at least an hour before brushing. It required a new warning, and on June 17, 2022, the label of Suboxone film—the strip of buprenorphine and naloxone that FDA had approved in 2010 for opioid use disorder—warned of dental injury for the first time.

Two years to the day after that label change came the date Judge J. Philip Calabrese of the Northern District of Ohio would call a “putative bar date” in states with a two-year limitations period: June 17, 2024. By then the federal cases had been gathered before him, and four lawyers had been appointed to run the plaintiffs’ side. Timothy J. Becker, a partner at Johnson // Becker in St. Paul, Minnesota, is one of them. Calabrese appointed him co-lead counsel in In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, on March 8, 2024, together with Erin K. Copeland of Fibich, Leebron, Copeland & Briggs in Houston, Ashlie Case Sletvold of Peiffer Wolf Carr Kane Conway & Wise in Cleveland, and Trent B. Miracle of Flint Cooper in Edwardsville, Illinois. Calabrese has renewed all four appointments each July since. By the fall of 2026 the litigation held over 20,000 claims against Indivior, and the first bellwether trial was set for March 2028.

Enamel Below pH 5.5

Suboxone came to market in 2002 as a tablet, and FDA approved the film in 2010. In 2013 Joji Suzuki, Leena Mittal, and Sook-Bin Woo, clinicians at Brigham and Women’s Hospital and Harvard in Boston, published a letter about eleven patients from one practice who had been taking sublingual buprenorphine for an average of 45.7 months. The patients, recruited between May and November 2012, were 34 years old on average. Since starting the medicine they had averaged more than five cavities each, and one had twenty-four. Six of the eleven reported a toothache when the clinicians assessed them. The patients reported taking the medicine about three times a day, each tablet taking about nine minutes to dissolve, and the authors noted that buprenorphine and naloxone dissolved in water has a pH of 3.4. They proposed that “the properties of this treatment may have a direct and adverse effect on dentition” and called for larger, controlled studies.

On January 24, 2022, twelve days after FDA’s announcement, the American Society of Addiction Medicine and ten other health professional associations called on the agency to retract it. They called it a “flawed analysis” and warned that the communication could make patients more hesitant to take buprenorphine, which with methadone, they said, cuts deaths from opioid use disorder by more than half.

FDA kept the warning. Its 2022 review had gathered 305 cases, most from its adverse-event reporting system and some from the medical literature, and Mark A. Liberatore, a commander in the U.S. Public Health Service and deputy director for safety in FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine, later set out the agency’s reasoning in a presentation. Normal saliva runs between pH 6.7 and 7.4; below 5.5, acid begins to erode enamel; and buprenorphine is stable in solution between 3.5 and 5.5. None of the 305 cases involved depot buprenorphine, injected for opioid use disorder, or the buprenorphine patch for pain. FDA judged the cases serious and concluded: “The totality of evidence provided reasonable evidence of a causal association between the drug in this dosage form and the adverse event.” The new warning section, headed Dental Adverse Events, said: “Multiple cases were reported in individuals without any prior history of dental problems.”

Thirteen Actions Already in the Northern District of Ohio

The motion to centralize the Suboxone film cases reached the Judicial Panel on Multidistrict Litigation on November 14, 2023, under a caption that described a marketing, sales practices and products liability litigation. On December 18, 2023, while the motion was pending, Becker spoke on a HarrisMartin webinar about the proposed MDL No. 3092; his fifteen-minute slot on the agenda, at 2:45 that afternoon, covered the film’s regulation and how it is alleged to injure teeth. Sletvold, Copeland, Miracle, and Alyson Steele Beridon also spoke, the lawyers Calabrese would later name as Becker’s fellow co-leads and as plaintiffs’ liaison counsel. When the panel ruled on February 2, 2024, the motion covered fifteen actions in five districts, and eleven related actions in nine districts had since been reported to the panel. Plaintiffs supported centralization, and so did the Indivior defendants: Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc., the film’s manufacturer.

Seven judges sat on the panel, chaired by Karen K. Caldwell; one of them was Matthew F. Kennelly of the Northern District of Illinois, who in 2014 had appointed Becker to the plaintiffs’ executive committee in the testosterone replacement therapy litigation. The panel found that the actions shared “complex factual questions” arising from the film’s alleged propensity to cause dental erosion and decay. The plaintiffs alleged that the defendants designed the film to be acidic, that it damaged teeth as it dissolved in the mouth, and that the defendants knew it and did not warn. Thirteen actions were already pending in the Northern District of Ohio, which the panel described as “centrally located, accessible, and agreeable to all responding parties.” It assigned the litigation to Calabrese, a judge who, the panel noted, had “not yet had the opportunity to preside over an MDL.” It also cut down the caption. The litigation did not then encompass marketing or sales-practices claims, the panel found, so that language came out, and the docket became a products liability MDL.

Nineteen Duties, Renewed Every July

Calabrese’s first order, entered February 7, 2024, set the terms for the plaintiffs’ lawyers who wanted to lead. Applications were due March 1, each with a résumé and the names of the judges before whom the applicant had appeared or worked in complex litigation. The initial conference was set for 9:00 a.m. on March 7 in Courtroom 16B of the Carl B. Stokes U.S. Courthouse in Cleveland, and leadership applicants were to be in the courtroom: “Counsel who do not attend in person will not be heard at this initial status conference.” The plaintiffs’ motion of February 27 named Becker among the proposed co-lead counsel.

Calabrese named the plaintiffs’ leadership in Case Management Order No. 2 on March 8, 2024. He reviewed the applications of the lawyers who sought leadership roles and applied the four criteria of the Manual for Complex Litigation: willingness and availability to commit to a time-consuming project, ability to work cooperatively with others, professional experience in this type of litigation, and access to sufficient resources to advance the litigation in a timely manner. Behind the four co-leads he placed a five-member executive committee and an eleven-member steering committee, and he appointed Beridon as plaintiffs’ liaison counsel and Sletvold, the one co-lead resident in the district, as the court’s liaison counsel. The order made the co-leads responsible for coordinating the plaintiffs’ activities during pretrial proceedings and listed nineteen functions, among them structuring the leadership, calling meetings, monitoring the work of the committee and co-counsel, determining the plaintiffs’ position on every pretrial matter, signing and filing pleadings, coordinating discovery, choosing the lead examiner for each deposition, retaining experts, and conducting settlement negotiations.

The appointments ran for one year. Calabrese made every leadership position subject to renewal each July 1, and he renewed Becker and the other co-leads in Amended Case Management Order No. 19 on July 2, 2025, and again on July 2, 2026. The next renewal falls on July 1, 2027. In 2024 he also created and filled a Leadership Development Committee, whose members are reappointed with the leadership each year. In August 2024, at the leadership committee’s request, Calabrese added a twelfth member to the steering committee, Sarah Gelsomino of Friedman Gilbert + Gerhardstein in Cleveland.

The co-leads also oversee the time other lawyers submit for common-benefit pay. Calabrese entered a common-benefit protocol in June 2024 and amended it on June 5, 2026. Under the amended order, every case in which a lawyer bound by the order is counsel or holds a fee interest—in the MDL, in a state court, or unfiled or tolled—carries an assessment of 11 percent of the gross monetary recovery: 7 percent for common-benefit work and 4 percent for common-benefit expenses, which the defendants pay directly into the funds. Lawyers submit their time and expenses to the four co-leads, Becker among them, by the fifteenth of each month, recorded in tenths of an hour. Time the co-leads did not authorize does not count. The work that qualifies includes consolidated pleadings and briefs, bellwether selection and trials, authorized discovery and depositions, expert work, and leadership meetings, and the final word on what is compensable belongs to the court.

Professional Experience in This Type of Litigation

Becker brought to his application a practice limited to people hurt by drugs, medical devices, and other products. He graduated cum laude from William Mitchell College of Law in St. Paul, after earning a degree in history at the University of Illinois at Chicago, and was admitted to the Minnesota bar in 1995. His earlier multidistrict work included the vitamins antitrust litigation and cases over welding rods, the Zicam cold remedy, DePuy’s ASR hip implant, and Zimmer’s NexGen knee. On July 31, 2014, Judge Matthew F. Kennelly of the Northern District of Illinois named him to the plaintiffs’ executive committee in the testosterone replacement therapy MDL, serving under three co-lead counsel, one of whom was Miracle.

In August 2022, a year and a half before the Suboxone appointment, Becker and Stacy Hauer of his firm filed the first known lawsuit claiming that Tepezza, Horizon’s infusion drug for thyroid eye disease, had caused permanent hearing loss. Their client, David Weibel, had received infusions from June through September 2020, less than six months after FDA approved the drug. His complaint alleged that Horizon had not warned him or his doctors that Tepezza could cause hearing loss or tinnitus, that its testing before approval consisted of two trials with only 84 patients taking the drug, and that in a later post-market study 10 percent of recipients reported hearing loss, tinnitus, or both. By April 2023 eighteen similar suits had been filed in five federal districts, and a motion to centralize them was before the Judicial Panel. Becker was on the faculty of HarrisMartin’s webinar on the Tepezza litigation with Hauer, Sletvold, Miracle, C. Andrew Childers, and others; by March 2024 Sletvold and Miracle would be his fellow co-leads in the Suboxone litigation and Childers a member of its executive committee.

Schedule A and the June 2024 Bar Date

In the spring of 2024, with June 17 approaching, the Plaintiffs’ Leadership Committee proposed a brief tolling period for clients retained by the bar date, so that their lawyers would have time to investigate the claims, for example by obtaining medical or pharmacy records to substantiate Suboxone use. The committee warned that the alternative was “a rush of complaints filed in a compressed period of time,” screened as well as the circumstances allowed but not to the standard federal practice ordinarily demands. MDL practice, Calabrese observed, had drawn criticism from defendants for producing “a surge of claims of dubious quality that brings with it coercive market and litigation pressures.” The defendants in this MDL nonetheless insisted on keeping their time-bar defenses, “as is their right,” he wrote.

Case Management Order No. 4, entered May 16, 2024, borrowed what Calabrese called “a procedural innovation from another area of the law.” The leadership committee would file a master complaint by June 14 with a Schedule A attached: a table listing every claimant in eight columns—name, any consortium plaintiff, the representing firm, residence and citizenship, venue, current residence, and the places where the claimant was prescribed and used the film. Both sides reserved their rights to argue for earlier and later filing deadlines in the two-year states. The defendants had until July 1 to move to sever.

Claimants on Schedule A then had to show that they belonged in the case. Case Management Order No. 12, entered November 4, 2024, required every Schedule A claimant, and every plaintiff with an individually filed case pending on October 7, 2024, to submit a census form within 270 days, with authorizations for medical, dental, and pharmacy records, records showing use of brand-name Suboxone film, and records showing a dental injury that post-dated that use. Claimants who could not substantiate injury or product identification by the deadline faced dismissal with prejudice. At the status conference of July 14, 2025, which Becker attended by video, the plaintiffs’ leadership reported that Schedule A listed 8,333 claimants; 1,216 census forms had been served, and 5,009 more were in process. Calabrese ordered a second census round, for cases filed after October 7, 2024, in October 2025.

In March 2025, Case Management Order No. 14 allowed up to one hundred plaintiffs to join in a single complaint, with one filing fee paid at filing and the others deferred until each claim is dismissed or resolved. The causes of action were limited to those in two exemplar complaints, Bennett v. Indivior and Powell v. Indivior, and each plaintiff’s information had to be loaded into a shared database within a week of filing. Joint complaints, and the claimants still listed only on Schedule A, keep the count of cases far below the count of claims. On October 1, 2026, the Judicial Panel listed 2,022 actions pending in MDL No. 3092, the seventeenth-largest pending MDL by that measure. In a census report filed June 26, 2026, the plaintiffs’ leadership counted 17,911 federal claims served on Indivior as of June 25, and a census report of September 17 counted more than 20,000, with 4,814 abbreviated claims remaining on Schedule A.

Bradford Hill and Individual Medical Histories

Before the pleadings were tested, the defendants asked Calabrese to narrow discovery. They proposed to take general causation first—whether the film can cause dental injury at all—using investigational and new drug applications, clinical trial data, and pharmacovigilance files, and later suggested adding three to five randomly chosen plaintiffs, with case-specific and marketing discovery deferred. The plaintiffs answered that bifurcation would needlessly prolong the MDL, make poor use of the resources of the court and the parties, and force difficult lines between discovery on general causation and discovery on everything else.

Calabrese denied the motion on June 24, 2024. He worked through the Bradford Hill factors that experts use to assess causation and found that the defendants’ proposal threatened to confine the science of general causation to “an artificially narrow body of knowledge.” Ruling out alternative explanations for a plaintiff’s dental decay required individual medical histories. A dose-response relationship depended on real-world experience and data, and biological plausibility built on the scientific literature on how the dental injuries develop, which the narrow categories of documents the defendants offered would likely not supply. He found the record unlike the one in the Onglyza diabetes-drug MDL, where the court had taken general causation first and the Sixth Circuit had affirmed its general-causation ruling, because here FDA and a number of professional medical associations took competing views of the science. He left open the possibility of hearing Rule 702 motions in groups. Discovery proceeded under protocols for electronically stored information, depositions, and the defendants’ custodial and non-custodial document productions, entered between August 2024 and October 2025.

Ryan Bennett’s Complaint and the Preemption Motion

The defendants’ motion to dismiss was decided on the amended complaint of Ryan Bennett. He had been prescribed Suboxone film to treat opioid use disorder, stopped taking it before the 2022 label change, and alleged that he “suffers from severe and profound permanent tooth damage and loss.” He sued Indivior Inc., which holds the film’s new drug application and was formerly Reckitt Benckiser Pharmaceuticals Inc.; Indivior Solutions Inc., which promoted and marketed it; and Aquestive Therapeutics, its exclusive manufacturer. He pleaded design defect and failure to warn under Ohio law. Aquestive has told its investors that Indivior agreed to defend it in the litigation.

Bennett’s complaint described the chemistry and the history. The film is placed under the tongue, and, he alleged, the defendants made it acidic to maximize absorption of buprenorphine while minimizing absorption of naloxone, and the acid erodes and decays teeth. He alleged that by 2011 the defendants knew the mean dissolution time of the 8 mg and 2 mg doses was between 5 and 6.6 minutes rather than the three minutes listed in the patent; that published case reports linked chronic use to dental harm in 2012 and 2013; and that 123 adverse-event reports of dental problems—48 from 2010 through 2014 and 75 from 2015 through 2022—had come in before the label changed. For a safer alternative he pointed to Sublocade, a monthly buprenorphine injection FDA approved in 2017, and to injectable buprenorphine products other companies had developed in 2006, four years before the film’s approval. He alleged that he would have taken Sublocade or a product like it to avoid the risk to his teeth.

The defendants’ strongest arguments came from federal drug regulation. Once FDA approves a drug, its regulations require the sponsor to get the agency’s approval before changing the formulation, and under Mutual Pharmaceutical Co. v. Bartlett a manufacturer cannot be required to stop selling in order to satisfy state law. The defendants argued that a design claim aimed at the years before approval rested on speculation that they would have designed a different product and won FDA approval for it, that Sublocade—an injection—was a different product as a matter of law, and that the Sixth Circuit’s decision in Yates v. Ortho-McNeil-Janssen foreclosed such claims as too attenuated. On warnings, they made no preemption argument for the twelve years between the film’s approval and the June 2022 label change. They argued instead that FDA’s approval of the dental warning preempted any claim that the label was inadequate after that date, and that the changes-being-effected regulation, which lets a sponsor strengthen a label without prior approval to reflect newly acquired information, was unavailable because the study Bennett relied on revealed no risk of a different type or greater severity or frequency than earlier submissions to FDA.

Calabrese ruled on December 31, 2024. He started from the presumption against preemption of state-law claims and from the absence, in the Food, Drug, and Cosmetic Act, of any clause expressly preempting state claims about drugs. On design, he treated the Sixth Circuit’s 2010 decision in Wimbush v. Wyeth as binding: that court had found “no physical impossibility between complying with a state law duty to exercise reasonable care” in the process leading up to marketing a drug and complying with the federal approval process. He set Yates apart on the label itself. “In contrast to Yates, where the label warned of the injury the plaintiff suffered,” he wrote, the label for Suboxone film did not warn of dental injuries until June 2022. Bennett had named a specific alternative design, pointed to FDA’s approval of Sublocade as a sign that the agency would have approved a differently formulated product, and alleged that injectable competitors existed before the film did. At the pleading stage, Calabrese held, those allegations stated a claim that the film was defectively designed before approval. On the different-product argument, he found nothing in the record at the pleading stage to support it and noted that the defendants cited no supporting authority.

On warnings, Calabrese quoted the Supreme Court’s statement in Wyeth v. Levine that “the manufacturer bears responsibility for the content of its label at all times.” He found that the study the defendants attacked, published in December 2022 in the Journal of the American Medical Association, might present newly acquired information: as he read it, the study drew on data from a cohort of patients from 2006 to 2020 and showed a heightened risk of serious adverse dental reactions from the film, reactions FDA had thought serious enough to require a warning a few months earlier. Whether it revealed a risk of a different type, or of greater severity or frequency, than earlier submissions to FDA would require further factual development and analysis of those submissions, and he would not say on a motion to dismiss that the changes-being-effected route was closed. Under Merck Sharp & Dohme Corp. v. Albrecht, the defendants needed clear evidence that the manufacturer had fully informed FDA of the justifications for the warning and that FDA had told the manufacturer it would not approve the change. “At the pleading stage here,” Calabrese wrote, “Defendants cannot make such a showing.”

Bennett could proceed on his claim that the film was defectively designed before approval, against Indivior Inc., Indivior Solutions, and Aquestive, and on his failure-to-warn claim against Indivior Inc. He had told the court that he brought the warning claim only against Indivior Inc., the holder of the new drug application, which federal law makes responsible for the label. In March 2025, Calabrese made Bennett’s complaint one of the two exemplars whose causes of action every joint complaint in the MDL must follow.

Volumes 317 to 333

On April 1, 2025, the co-leads, Becker among the signers, served two notices for depositions under Rule 30(b)(6), which required the Indivior defendants to produce witnesses who would testify for the companies themselves. The first covered how the companies were organized from the film’s development to the present: parent companies and subsidiaries, reporting lines, the research, regulatory, pharmacovigilance, manufacturing, quality, and marketing departments, and the outside vendors that helped design, test, make, and sell the film. The second covered the June 2022 label change. Its thirteen topics ran from the change’s rationale and internal timeline through the companies’ regulatory submissions and communications with FDA, from a 2017 dental safety signal that the notice tied to a disproportionality analysis published that year in Clinical Therapeutics through FDA’s January 2022 communication, to the involvement of the board and executives, the training of sales representatives on the new language, and any dealings with the signers of the January 24, 2022 call for FDA to retract its safety communication.

The documents came in waves. At the conference of July 14, 2025, Calabrese ruled on the record on two disputes over the wording of the deposition topics. The same conference took up the first wave of the defendants’ custodial productions, in which 515,000 of 791,000 documents had come with their attachments withheld as nonresponsive. The defendants said they had followed the agreed protocol and had learned of the problem on July 11. Calabrese directed the two sides to confer on whether the protocol needed changing, whether limited metadata should be produced, and whether a limited restoration of the attachments would help the review.

The search for the tablet files ran for months. Suboxone had been sold as a tablet for eight years before the film, and at a status conference on December 17, 2025, the parties reported on the effort to secure certain volumes of the new drug application for Suboxone tablets. “Those documents were requested in discovery long ago,” Calabrese wrote that day, and he ordered the defendants’ vendor to explain its efforts with particularity, and why the volumes had not been located or produced, by December 22. By the conference of February 25, 2026, volume 144 had been found and was being produced. Volumes 317 to 333 “have still not been located,” Calabrese recorded; whether they would turn up, or were in boxes a vendor was still tagging at its new facility, was unclear. He set a date. If the volumes were not found by March 31, “the Court and the parties will presume that these volumes will not be located and no longer exist.”

In the summer of 2026 the co-leads noticed the videotaped depositions of two witnesses in Florida, Vickie Seeger at a Fort Myers hotel on July 23 and Mark Schobel at a Vero Beach hotel on August 13. Becker signed both notices as plaintiffs’ co-lead counsel. Each notice demanded the unproduced documents in the witness’s Suboxone custodial file, any earlier testimony about Suboxone, including testimony to FDA, and every document the defense lawyers at Bowman and Brooke had shown the witness to prepare.

Earlier testimony was its own fight. The parties had agreed that the defendants would produce prior litigation testimony of their document custodians and corporate designees in four categories, which the court later listed as “organizational structure; clinical studies; safety issues regarding dental injuries; and product development.” The plaintiffs’ leadership then found a complete deposition transcript in a witness’s custodial file and told Calabrese that the version the defendants had produced left out pages in those categories. He read both transcripts in camera. On August 28, 2026, he ordered the defendants to produce the passages on Dr. Graham Cairns’s role in researching and developing Suboxone, on the companies and personnel involved in its development, on Justin Speight’s role in technical business development, and on internal discussions of the product’s overall safety, risks, and benefits, together with the pages around them and any exhibit the testimony mentioned. “Reasonable people may fairly debate the boundaries of such information,” he wrote, and he listed the pages by number.

From 500 Records to Four Trials

Calabrese entered the bellwether protocol, Case Management Order No. 15, on March 14, 2025, and amended it in May 2025 and again on March 27, 2026. It begins with chance. A computer-generated application drew 500 plaintiffs for a records-collection pool: 100 with individually filed cases and 400 from Schedule A. Those drawn had until May 19, 2025, to dismiss without prejudice; after that, a dismissal would be with prejudice unless the plaintiff showed good cause. From the 500, 100 cases were drawn at random, and 50 of those were to form the core discovery pool—20 chosen by computer, 15 by plaintiffs’ co-lead counsel, and 15 by the defendants—with the other 50 held as alternates.

From the core pool, fifteen cases go to a trial pool: five chosen by the co-leads, five by the defendants, and five at random. The last cut is adversarial: the co-leads and the defendants each name three prospective trial cases, and each side may strike one of the other’s, leaving four. The protocol rations testimony along the way. Defendants may depose a core-pool plaintiff for four hours on the record, a treating provider sits for four hours split equally between the plaintiff and the defendants, and no plaintiff may be deposed for more than seven hours across both stages without good cause.

Getting the plaintiffs’ records took orders of their own. Under Case Management Order No. 13, entered February 13, 2025, a provider had thirty days to produce records after receiving a signed authorization and a copy of the order. When providers did not, both sides moved, and on October 17, 2025, Calabrese ordered the providers on a list to show cause why each should not be held in contempt, among them dental offices, CVS, Walgreens, and Publix pharmacies, and Massachusetts General Hospital’s internal medicine practice. Each had to send its records custodian or another knowledgeable representative to Courtroom 16B at 11:00 a.m. on October 30 to explain. If a provider produced the records before the hearing, the court would withdraw the order as to it; one that neither produced nor appeared faced a motion for contempt under Rule 45(g). Show-cause hearings for providers continued into 2026, with one on February 25 and another set for April 22.

The 2026 amendment put dates on each stage. Plaintiff fact sheets were due April 20, 2026, and defense fact sheets May 20. The random draw of twenty cases was set for June 10. At the July 1 conference, Calabrese said that thirty-five cases would be appropriate for case-specific work, rather than the fifty in the protocol, and extended the selection deadline to July 6. The order identifying the core discovery pool followed in July. On July 16, Calabrese entered Case Management Order No. 23 by agreement of the parties, governing depositions of the medical and dental providers who had treated the pool plaintiffs, each limited to four hours split evenly between the sides. The protocol allows core-pool depositions from July 13, 2026, to January 15, 2027. By the status conference of September 21, 2026, twenty-two core-pool plaintiffs had been deposed and depositions of their providers were under way. The next status conference was set for October 27.

What Calabrese Left for Discovery

Complaints filed since the ruling have added to the warning allegations. On June 12, 2026, Mandie Boatman, Corey Goode, Katie Kjonaas, Troy Wallace, and Scott Knutson, suing for himself and the estate of Cam E. Knutson, filed a joint complaint in the Northern District of Ohio alleging dry mouth, enamel erosion, and other dental damage from the film, and alleging that the injuries could have been avoided with the Sublocade injection. They pointed to Canada: unlike the American labels, they alleged, the combined Canadian product monograph for the tablets and the film reports that 7.8 percent of patients in the tablet trials that supported approval experienced “tooth disorder” and warns of dry mouth, gingivitis, gum hemorrhage, and tooth caries. In Canada, Aquestive has been named in three proposed class actions, two in British Columbia and one in Quebec.

Nineteen days after that complaint, on July 1, 2026, the lawyers met with Calabrese on the record and in person. Becker was among the plaintiffs’ counsel; Randall Christian, Mary Pawelek, Denise Dickerson, Patrick DeLaune, and Jason Lundry appeared for Indivior, Indivior Solutions, and Aquestive. The defendants reported that the complete investigational new drug and new drug application files for Subutex tablets had been produced to the plaintiffs’ leadership. Calabrese entered the report in his minutes and added one more sentence: “And there was much rejoicing.”

Calabrese wrote in December 2024 that deciding whether the 2022 study was newly acquired information would require further factual development and an analysis of the earlier submissions to FDA. The trial-pool cases are to be chosen by January 29, 2027, and trial-pool discovery opens February 5. Corporate fact discovery closes June 4, 2027. Expert reports are due June 30, Rule 702 and summary-judgment motions November 8, and the first bellwether trial is set for March 2028. Becker’s appointment as co-lead counsel comes up for renewal on July 1, 2027.