Erin K. Copeland

A woman named Miller sued the makers of the Paragard intrauterine device in the Eastern District of New York. When her doctor tried to remove it, she alleged, the device came out missing one of its arms, and the arm stayed embedded in her pelvis. A woman named Sigley sued in the Northern District of West Virginia. Her doctor could not get the device out at all, she alleged, and imaging showed that it had broken inside her uterus.

Teva and Cooper, the companies that had made and sold the device, fought to keep both suits out of the consolidated Paragard litigation in Atlanta. Miller’s device, they argued, had perforated her uterus and migrated to her bladder; Sigley’s complaint alleged no break on removal, and the abdominal surgery she underwent did not fit an embedded fragment. Those, the companies said, were different failure mechanisms. On April 1, 2021, the Judicial Panel on Multidistrict Litigation called that reading of the women’s complaints “a level of exacting scrutiny that is not appropriate at this stage of the litigation.” Whether Sigley’s surgery meant perforation would take expert medical evidence, the panel said, and Miller’s case would take discovery into her medical history. It sent both cases to Atlanta. “All that is needed to fall within the scope of this MDL,” the panel wrote, “is that plaintiff allege that the Paragard IUD broke upon removal.”

Since February 18, 2021, Erin K. Copeland, a Houston lawyer at Fibich, Leebron, Copeland & Briggs, has led the federal cases. Judge Leigh Martin May of the Northern District of Georgia appointed her co-lead counsel, with Timothy Clark of Sanders Phillips Grossman, when the consolidated docket in Atlanta held more than 100 cases. By March 2024 women had filed more than 2,500 Paragard suits, and since a May 2024 reorganization of the plaintiffs’ committee Copeland has been the only lawyer holding the lead appointment.

Copeland came to Paragard from plaintiffs’ committees in litigation over products used by women, among them the transvaginal mesh MDLs in West Virginia and the consolidated Essure sterilization-device cases in California. “For too long, women and children have been used as guinea pigs for pharmaceutical and product companies,” she has said. In March 2024 a second federal judge, J. Philip Calabrese in Cleveland, named her one of four co-lead counsel for patients who allege that Suboxone film eroded and decayed their teeth.

A Houston Lawyer and the Pinnacle Mesh Verdict in Miami

Copeland is a native Houstonian. She graduated cum laude from the University of Houston in 1997 with a degree in radio and television, took her law degree at South Texas College of Law in 2000 and was licensed in Texas that year, and joined Fibich, Leebron, Copeland & Briggs, where she has practiced ever since and became the firm’s first woman partner. She began with individual injury cases and still takes on some catastrophic-injury cases; Missouri admitted her in 2010.

Before Essure, Copeland held a seat on the plaintiffs’ steering committee in the transvaginal mesh MDLs in the Southern District of West Virginia. Four of the cases against Boston Scientific over its Pinnacle Pelvic Floor Repair Kit, a polypropylene mesh implanted to treat pelvic organ prolapse, were consolidated and sent to Miami, and on November 3, 2014, they went to one federal jury. Copeland was among the women’s lawyers, with Clayton Clark and Shelley Hutson of Clark Love & Hutson and others. Amal Eghnayem had received her Pinnacle on February 28, 2008, and developed bleeding, incontinence and pelvic pain; a doctor trimmed exposed mesh that October, and in August 2012 another doctor removed a second exposure in surgery.

Over eight days the women’s witnesses described what the plastic does inside the body. A polymer scientist, Dr. Mays, testified that polypropylene degrades and stiffens after implantation and described “a sawing effect,” and Dr. Margolis testified that implanting the mesh was irreversible because scar cells “cement the mesh into place.” The jury found for all four women on every claim except punitive damages and awarded $6,722,222 to Eghnayem, $6,766,666 to Margarita Dotres, $6,533,333 to Mania Nuñez and $6,722,222 to Juana Betancourt.

Boston Scientific appealed, arguing that the four cases should have been tried separately, that the jury should have heard about the FDA’s clearance of the Pinnacle through the 510(k) process, and that its warnings were adequate as a matter of law. On October 19, 2017, the Eleventh Circuit affirmed Eghnayem’s judgment, with Copeland among the lawyers defending it. Clearance under 510(k) turns on a device’s equivalence to one already sold, the court held, so the trial court had properly kept it from the jury, and the Pinnacle’s labeling did not tell doctors that taking the mesh out might be impossible or might mean removing healthy tissue as well. The court wrote that “the warnings do not even remotely suggest that removal might be impossible.” Boston Scientific had already dismissed its appeal as to Dotres, and the court granted its motion to dismiss the appeals as to Nuñez and Betancourt.

Essure in Oakland: Preemption, Bayer and $1.6 Billion

Essure, a permanent contraceptive made of nickel and titanium and implanted in the fallopian tubes, reached the American market in 2002, and Bayer bought its developer, Conceptus, in 2013. The women who sued alleged bleeding, chronic pelvic pain, hair and tooth loss, miscarriages and deaths, and the complications reported to the FDA included further surgeries and hysterectomies. After an FDA advisory committee met in 2015, the agency required a boxed warning and a patient decision checklist in 2016. In 2018 it restricted sales to providers who would review the device’s risks with patients, and Bayer stopped selling Essure in the United States that year, citing declining sales.

The California cases went to Judge Winifred Smith of the Alameda County Superior Court in Oakland. Bayer argued that federal law preempted them. On August 2, 2016, Judge Smith held that the women’s failure-to-warn, express-warranty, fraud and negligent-misrepresentation claims were “not preempted by federal law.” That fall she granted the plaintiffs’ request to coordinate fifty-five California cases, brought by about 900 women, over the objection of Bayer’s lawyer, Maja Eaton of Sidley Austin, who called it “a novel argument that coordination should be ordered simply because” the plaintiffs’ lawyers found it hard to communicate with one another.

In 2017 Judge Smith appointed Copeland to the five-lawyer plaintiffs’ executive committee that led pretrial work for every plaintiff in the coordinated cases: Fidelma Fitzpatrick of Motley Rice, who chaired it, Kim Dougherty, M. Elizabeth Graham of Grant & Eisenhofer, Edward A. Wallace of Wexler Wallace and Copeland, with Graham and William A. Kershaw of Kershaw, Cook & Talley as liaison counsel. Preemption still narrowed the case they could take to trial; Wallace said later that it left the women no design-defect claim and limited their warning claim to the failure to report. The plaintiffs’ lawyers took discovery from both Conceptus and Bayer, deposing witnesses across the United States and Europe, among them witnesses from Germany and Brazil, and thousands of internal Bayer documents were unsealed.

Copeland said afterward that the evidence she and her colleagues were prepared to put before a jury began with Essure’s history at the FDA, where complaints mounted as the device’s share of the market grew. “Once the complaints finally made their way to the FDA, the FDA convened an advisory committee in 2015 to analyze the details of those complaints,” she said. The boxed warning and checklist followed, along with an order for a post-market study, and she pointed to its interim results, which showed higher rates of chronic pelvic pain, abnormal uterine bleeding and further gynecologic surgery among women with Essure than among women whose tubes had been tied. Three trials were set for 2020, the first two in March. The pandemic closed courts and pushed the dates back.

On August 20, 2020, Bayer announced agreements to pay about $1.6 billion to resolve roughly 90 percent of the nearly 39,000 filed and unfiled Essure claims in the United States, including the California coordinated cases and the federal cases in the Eastern District of Pennsylvania. Fitzpatrick, Wallace and Copeland led the plaintiffs’ side of the deal. Bayer admitted no wrongdoing or liability. The agreements took the form of individual settlements with each firm that represented women, on terms negotiated for all of them, and each firm administered its settlement for its own clients. Fitzpatrick said the agreement would provide “expedited relief to thousands of women.”

Copeland said that for years the women had been told they had no chance of success, with preemption the largest of the legal hurdles, and that their lawyers had heard much the same. “We, as the lead lawyers in the California JCCP case, were told for many years that we were in way over our heads,” she said. What she would remember, she said, was the women: “Never before in my two decades of practice have I seen such a strong group of women come together to advocate for themselves.” A social media campaign by women who called themselves the E-Sisters had pressed regulators to take Essure off the market, and Copeland said social media had played a larger part in this litigation than in any she had seen. “Litigation dynamics aside,” she added, the lawyers on both sides had approached the case with “mutual respect and much professionalism.”

Fifty-Five Paragard Lawsuits Go to Judge May

In December 2020 the Paragard lawsuits came before the Judicial Panel on Multidistrict Litigation. On December 3, the panel heard argument by video on whether fifty-five of them, pending in thirty-one federal districts, belonged before one judge. The plaintiff in Traylor, in the Central District of California, asked the panel to centralize the cases there or, in the alternative, in Georgia, Missouri or Louisiana; the plaintiff in Rodriguez, whose case was pending in the Northern District of Georgia, supported that court. Teva and Cooper opposed any MDL. The claims failed as a matter of law, the companies argued; each case would turn on whether a particular woman’s doctor would have prescribed Paragard with different warnings; and a consolidated docket would draw meritless filings that pressured them to settle. The panel answered that it had no authority to weigh the merits. “Almost all injury litigation involves questions of causation that are case- and plaintiff-specific,” it wrote. On December 16 it sent the cases to Judge Leigh Martin May in Atlanta, where six were already pending, noting that she had not yet presided over an MDL.

Paragard is a T-shaped frame of polyethylene, 32 millimeters across its arms and 36 millimeters tall, with copper wire wrapped around its stem and a copper collar on each side of its crossbar; it releases copper into the uterus to prevent pregnancy. The FDA approved it in 1984, and it is meant to stay in place for as long as ten years. Teva sold it to The Cooper Companies in 2017 for $1.1 billion. The women suing the two companies allege that the arms stiffen over those years and break when a doctor pulls the device out, leaving sharp fragments behind and sending women into further surgery, with perforation, infertility and pain among the injuries they describe. They also allege that between 2009 and 2020 the companies received reports of more than 2,000 broken devices. The label revised in February 2020 tells doctors, “Breakage of an embedded Paragard during non-surgical removal has been reported,” and instructs them, “Make sure Paragard is intact upon removal.”

Six days before Judge May chose the plaintiffs’ lawyers, the FDA’s Office of Prescription Drug Promotion sent CooperSurgical’s president, Holly Sheffield, a warning letter about a Paragard-sponsored video, “Paragard: Family Planning During The Pandemic,” that had run on NBC Boston’s The Hub Today the previous October. The video, the agency wrote, “fails to communicate any risk information associated with its use,” and a referral to the Paragard website did not cure the omission. The office had written to the company about Paragard promotion once before, in July 2019, over a television ad that also left out important risk information. This time the FDA demanded a written response within fifteen days and a plan for corrective messages that would reach the same audience.

Judge May’s order of February 18, 2021 named the plaintiffs’ leadership for MDL No. 2974: Copeland and Clark as co-lead counsel, C. Andrew Childers of Atlanta as liaison counsel, five lawyers on an executive committee that included Nicole Berg and Fidelma Fitzpatrick, and seventeen on a steering committee. The judge found that the lawyers’ coordinated recommendations presented highly skilled counsel of diverse backgrounds and experience. Her order charged the co-leads with coordinating the liaison counsel and both committees, scheduling committee meetings and keeping their minutes, appearing at the court’s status conferences, and doing the substantive, administrative and logistical work that kept the committees functioning.

Two of the five executive-committee members, Fitzpatrick and Edward Wallace, had sat with Copeland on the Essure committee in California. The steering committee’s size rested partly on the lawyers’ representation, set down in a footnote, that the MDL was “likely to significantly increase in size.” Judge May made each appointment “of a personal nature”: no appointee could be replaced, even by a lawyer from the same firm, without the court’s approval.

Breakage on Removal: The Short-Form Complaint and the November 2021 Ruling

Nineteen days later the court entered the parties’ consent order on the pleadings. The master complaint, due March 22, 2021, was to name four Teva companies—Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, and Teva Branded Pharmaceutical Products R&D, Inc.—together with The Cooper Companies, Inc. and CooperSurgical, Inc., which had acquired Paragard from Teva in 2017. The defendants had until May 6 to answer or move against it.

On June 14, 2021, the panel’s test went into the court’s own rules. Judge May entered a case management order on direct filing that lawyers for both sides had signed, Copeland among them as co-lead counsel. A woman could file straight into the MDL on a short-form complaint against the Teva and Cooper companies, but she had to allege an injury caused by breakage of her Paragard on removal, breakage of the thread or string excluded, and a case without that allegation faced a presumptive order sending it to the federal district where she lived. No second firm could file for a woman whose case was already pending, and her lawyers had to search the federal courts and, at a minimum, the Pennsylvania and California state courts before filing. The form asked each woman when and by whom her Paragard was placed, every date someone removed it or tried to, its lot number if she knew it, and whether she was alleging tolling or fraudulent concealment. A woman who pleaded fraud had to name the false statement, who made it, to whom and when.

Teva and Cooper moved to dismiss the second amended master complaint, arguing that it failed to state a claim for defective design, defective manufacture or failure to warn, that it was a shotgun pleading, and that its allegations were “vague, rote, and conclusory.” Judge May took the motion under advisement on September 22, 2021. On November 16, with claims by nearly 500 women before her, she refused to dismiss them. She rejected the shotgun-pleading argument, found factual support in the complaint for the design claims and detailed allegations behind the warning claims, and said that deciding whether a defect lay in the device’s design or in its manufacture would take evidence. Whether federal law preempted the design and warning claims, she held, could not yet be decided. The cases moved into discovery, and to documents that until then only the companies had held.

Custodial Files and Sworn Fact Sheets

Discovery ran under orders the court entered as the docket grew: on electronically stored information and paper documents in June 2021, short-form complaints in December 2021, plaintiff fact sheets in July 2022, custodial-file production in November 2022, and defendant fact sheets in February 2023. Both sides submitted the initial scheduling order, over the signature blocks of Copeland and Clark as co-lead counsel for the plaintiffs and Childers as their liaison, and of the defendants’ lead and liaison counsel. Judge May entered it on September 28, 2022, fixing deadlines for fact discovery, expert disclosures, challenges to expert testimony and dispositive motions.

Under the custodial-file order of November 21, 2022, entered on the parties’ agreement, Teva and Cooper had to produce the files of Thomas Mehs and Jennifer Gates by November 30. A first request for twenty more custodians, six of them Teva and Cooper employees named in the order, carried a seventy-five-day deadline, and later requests could add up to twenty and then ten more. A person who had worked on Paragard for both companies counted once.

Then the companies had to answer for each woman. Under the order on defendant fact sheets entered February 23, 2023, Teva Women’s Health and CooperSurgical had to tell every plaintiff who had completed her own fact sheet, in a declaration signed under penalty of perjury, where and when the lot her device came from was made and where it was shipped; the numbers of any MedWatch or other reports to the FDA about her or her device; any consulting agreements with her doctors in the five years before the implant, any payments to them, any information about Paragard given to them outside the label, and any contact with them about her Paragard; and whether the company had ever contacted her. With the answers went product-quality complaint files, sales invoices, sales representatives’ call records, prescribing data, payment records and any “Dear Doctor” letters. Judge May treated the responses as sworn answers to interrogatories.

On May 8, 2024, Judge May reorganized the plaintiffs’ committee. She removed eight members of the steering committee, appointed three new ones, moved Childers to the executive committee while keeping him as liaison counsel, and reassigned Clark from co-lead counsel to the steering committee. The order left Copeland’s appointment unchanged.

A month later, on June 6, 2024, Judge May entered the parties’ agreed order on choice of law. A case transferred from another federal court would carry the choice-of-law rules of the state where it had been filed; a case filed directly in Atlanta would take the rules of the state where the court named in Question 7 of the woman’s short-form complaint sat, and with narrow exceptions a woman could not change that answer to change the law. Which state’s law governed a woman’s case would decide which statute of repose Teva and Cooper could raise against her.

Two Thousand Reported Breaks and the Repose Statutes

Teva and Cooper later moved to dismiss, as untimely, cases from twelve states, Georgia, Illinois, Iowa and North Carolina among them. They argued that the states’ statutes of repose, which run from the date the device was placed or first purchased, barred the claims. A statute of repose, Judge May noted, exists to abrogate the discovery rule and similar exceptions to a statute of limitations.

The plaintiffs answered with the break reports. Their pleadings alleged that Teva and Cooper, receiving more than 2,000 reports of broken devices between 2009 and 2020, did not follow established procedures for reporting adverse events to the FDA and concealed the reports instead, while promoting the device through labels, websites, medical meetings, sales representatives, advertising and commercials as a safe, effective and easily reversible form of non-surgical birth control. That concealment, the plaintiffs argued, tolled the repose periods or estopped the companies from relying on them.

On February 11, 2025, Judge May found the fraud allegations sufficient in the cases from those four states. The women had adequately pleaded fraud, she held, including the companies’ allegedly false representations, and the allegations were enough for a reasonable fact-finder to conclude that the defendants intentionally lied to delay the plaintiffs’ discovery of their claims. Under Georgia law she found a plausible inference that the fraud had deterred the women from filing sooner and refused to dismiss the Georgia strict-liability claims, fifty-eight cases in all. Under Illinois law she treated the companies’ consumer advertising and marketing to doctors as affirmative acts designed to prevent discovery and kept the strict-liability claims in fifty-six Illinois cases. Iowa’s repose statute carried its own fraud exception, and she declined to dismiss the three Iowa cases under it. In North Carolina, where fraudulent concealment cannot toll the repose period, she held that the same allegations could support equitable estoppel and kept the twenty-three North Carolina cases.

Suboxone Film and Four Co-Leads in Cleveland

On February 2, 2024, the Judicial Panel on Multidistrict Litigation sent the federal Suboxone film cases to Judge Calabrese in the Northern District of Ohio, where thirteen of the actions were already pending. The plaintiffs allege that the film, approved in 2010, was made acidic to maximize absorption of buprenorphine and that the acid eroded and decayed their teeth. On March 8, 2024, Calabrese named Copeland co-lead counsel with Ashlie Case Sletvold of Peiffer Wolf Carr Kane Conway & Wise, Timothy J. Becker of Johnson // Becker and Trent B. Miracle of Flint Cooper, after measuring the applicants against the Manual for Complex Litigation’s criteria, among them experience in this type of litigation and the ability to work cooperatively with others. His order gave the co-leads nineteen duties, from determining the plaintiffs’ position on every pretrial matter and signing their pleadings to coordinating discovery and conducting settlement negotiations. The appointments run a year at a time; he reappointed all four on July 2, 2025, and again on July 2, 2026, and the next renewal falls on July 1, 2027.

On June 24, 2024, Calabrese refused the defendants’ request to take discovery on general causation first. Dental injuries are non-specific, he reasoned, so weighing other explanations would require each plaintiff’s medical and social history. On December 31, 2024, ruling on the complaint of Ryan Bennett, who alleged severe and permanent tooth damage and loss, he let Bennett’s failure-to-warn claim against Indivior Inc., which holds the film’s new drug application, and his pre-approval design-defect claim against Indivior Inc., Indivior Solutions and Aquestive Therapeutics go forward over the defendants’ preemption defense. At the pleading stage, he held, a December 2022 JAMA study could be newly acquired information allowing a stronger warning without the FDA’s prior approval, and the defendants could not show the clear evidence the Supreme Court requires that the FDA would have rejected it. The first bellwether trial is set for March 2028.