Ellen Relkin

At 4:29 on the afternoon of November 19, 2013, Judge David A. Katz opened a hearing in his Toledo courtroom with four state-court judges joining him. Brian R. Martinotti of the Superior Court in Bergen County, New Jersey, and Deborah Mary Dooling of Cook County, Illinois, watched by video; Richard A. Kramer of the San Francisco Superior Court listened by telephone; and Crystal Dixon Mittelstaedt, who managed the Maryland cases in Prince George’s County, took part as well. Each had presided over lawsuits about the same metal hip. Katz told the lawyers, “But this is not my hearing. It is your hearing.” Then he called on Ellen Relkin.

“Well, sometimes we thought we wouldn’t be here,” Relkin said. “It’s been a long three years, and especially long for our clients who have been waiting eagerly for this day.” The clients she meant had received an ASR hip implant from DePuy Orthopaedics, the Johnson & Johnson company that recalled the device in August 2010, and the settlement about to be described was for those who had already gone through a second operation to have it taken out. Susan Sharko, for DePuy, told the court that the two sides had negotiated “until we walked in the courthouse this morning and it was signed.”

Relkin had led the plaintiffs’ side since January 26, 2011, when Katz signed the order that named her co-lead counsel for the plaintiffs suing DePuy Orthopaedics over its recalled ASR hip system. Katz paired her with Steven J. Skikos, of the San Francisco firm Skikos Crawford Skikos & Joseph, and placed the two of them, along with four other plaintiffs’ lawyers, on the litigation’s executive committee: Eric Kennedy, Mark Robinson, Chris Seeger and Ben Gordon. By the time Katz signed his order, she headed Weitz & Luxenberg’s Defective Drugs and Devices department in New York, and the ASR docket ran through that department for the next four years, into the settlement program’s final extension in 2015.

Thirteen Percent Within Five Years

DePuy announced the recall from Warsaw, Indiana, on August 26, 2010. Unpublished 2010 data from the National Joint Registry of England and Wales showed that about 12 percent of patients with the ASR Hip Resurfacing System and about 13 percent with the ASR XL Acetabular System had needed revision surgery within five years, with the highest risk in women and in patients given heads smaller than 50 millimeters. DePuy promised to pay the “reasonable and customary costs of monitoring and treatment,” revision surgery included, and urged yearly checkups even for patients without symptoms. It had sold an estimated ninety thousand of the devices worldwide, about a third of them in the United States.

In both versions, metal rubbed against metal. As the parts ground together they shed metallic debris that could damage the tissue and bone around the joint. The Food and Drug Administration refused to let DePuy sell the resurfacing version in the United States, citing a “high concentration of metal ions” in patients’ blood. Seven ASR lawsuits were already pending when the Judicial Panel on Multidistrict Litigation transferred the first cases to Toledo in December 2010; the consolidated docket, In re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation, would eventually hold more than ten thousand.

One Database for Every Court

Much of the ASR litigation sat in state courts beyond Katz’s reach. California, New Jersey and Illinois each ran a consolidated ASR proceeding, and Maryland coordinated a smaller group of cases. The MDL leaders set out, Relkin told Katz at the settlement hearing, to bring the lawyers from all of those courts together “to produce the best result possible for our clients,” and she said that “we made a decisive effort early on to work together, instead of at cross purposes, which sadly can happen in some mass tort litigations.” They agreed with the state courts to share one database holding the “millions of pages of discovery documents.” They split the work into teams by subject, among them design engineers, marketing and medicine, and let whichever lawyer was best suited, in whatever court, take the lead deposition. The depositions reached scores of witnesses “around the country and across the Atlantic.” Katz went to joint hearings in Hackensack, New Jersey, and in San Francisco.

What the documents held came into public view in January 2013, as the first ASR case, Loren Kransky’s, went to trial in Los Angeles Superior Court. Paul Voorhorst, DePuy’s director of biostatistics and data management, testified that the company had reviewed ASR failures in the fall of 2011. An internal analysis from that year, never released, projected that about 37 percent of the implants would need revision or replacement in under 4.6 years. In June 2005 a doctor advising DePuy, who had received reports from the Middle East and Spain, wrote that she was “quite concerned” about the failure rate. A DePuy engineering test in 2007 found the ASR less durable than another metal-on-metal hip, and the company began work on a redesign. In 2008 DePuy dropped it, stating that “the business case for the project could no longer be justified.” In 2009, weeks after the FDA asked for more safety data, DePuy executives decided to phase the ASR out and sell the remaining inventory.

DePuy disputed what the documents meant. Its spokeswoman, Mindy Tinsley, said the 2011 analysis “was based on a small, limited set of data that could not be used to generalize” about the failure rate. The company said it had phased the ASR out because interest was waning, and its lawyers told the Los Angeles jury that DePuy had “acted as an extremely responsible manufacturer.” When the settlement came, DePuy said its actions had been “appropriate and responsible.” The consolidated complaints in Toledo had put two questions on the docket: whether DePuy’s ASR system was defectively designed or manufactured, and whether the company’s warnings about it were adequate.

Courtroom 17A, Cleveland

Katz set the rules for the first federal trials in July 2012. Each side would nominate four revision cases; the trials would begin May 6 and July 8, 2013; and a plaintiff whose case was chosen could not drop it without losing the claim for good, because, Katz wrote, “Plaintiff may not dismiss the case except with prejudice.” On December 27, 2012, the parties selected the litigation’s first two bellwether cases, Dorney-Madgitz and McCracken, under Katz’s case-management order. Faye Dorney-Madgitz and her husband, Harvey Madgitz, Pennsylvania residents who had sued DePuy and Johnson & Johnson on January 7, 2011, were set for May; Ann McCracken for July. In April 2013 DePuy asked Katz to cut the Madgitzes’ eight claims down to negligence under Pennsylvania law.

Ann McCracken was fifty-seven in 2013 and lived in Rochester, New York. She received her ASR hip on August 24, 2009. At the time of that surgery, she has said, she felt like a “poster child” for hip replacement. Within months the pain and inflammation would not let up, and on January 17, 2011, less than seventeen months after the implant, surgeons removed it. For her trial she designated ninety-five potential witnesses, among them Thomas Vail and Thomas P. Schmalzried, surgeons and implant designers.

On July 8, 2013, Katz vacated the September 9 trial date he had given Dorney-Madgitz and put McCracken in its place as the first bellwether, to be tried in Courtroom 17A of the Carl B. Stokes United States Courthouse in Cleveland. Neither reached a jury. The McCracken trial moved to September 24, and on September 20 Katz continued it again, to the call of the court, to begin within ninety days. Scheduling the two sides’ expert witnesses had become “an extremely difficult task,” he wrote, and more depositions and pretrial discovery remained, “necessary for the thorough preparation and presentation of this bellwether case.”

The trial preparation was shared. Michelle Kranz, the plaintiffs’ liaison counsel in Toledo, worked on preparing both Ohio cases for trial; lawyers from the MDL and the state courts shared work product, experts and costs; and the MDL paid much of the expense of the trials that did take place and of those that came close. In the plaintiffs’ view, Relkin told Katz, that work “played an important role in why we’re here today.”

$250,000 Before Reductions

Eleven months after the bellwether selection, DePuy and the plaintiffs’ executive committee, Relkin and Skikos as its co-leads among them, reached the ASR Master Settlement Agreement instead, dated November 19, 2013. Sharko valued it in court at approximately $2.475 billion if about eight thousand patients took part, and Johnson & Johnson announced it that day as a settlement of about $2.5 billion. It covered the roughly eight thousand plaintiffs whose ASR systems had already required revision surgery by August 31, 2013, the date the agreement set as its cutoff for eligibility, and it offered each of them, in Sharko’s words, “one base award of $250,000 subject to potential reductions.” Skikos listed the reductions: smoking, body-mass index, use of the ASR as a revision device, length of use, and death unrelated to the revision. The estimate of eight thousand set no ceiling. “There is no limit to the number of people who can participate,” Skikos said.

A second part, Part B, paid more for worse outcomes: a revision of the second hip, a re-revision, eight categories of extraordinary injury that ran from dislocation and foot drop to deep vein thrombosis, pulmonary embolism, heart attack, stroke and death, and a fund for special circumstances. DePuy took on the negotiation and resolution of medical liens for care tied to the revision. Patients whose ASR hips were still in place kept their claims. The settlement was not a class action, and it needed no court approval. “This is a private global settlement arrangement,” Katz said.

Relkin closed her remarks by naming the lawyers from every court who had worked on the case, and then the people whose cases had gone first: “We thank them, and we thank the clients who volunteered to be bellwether plaintiffs helping us to get here where we are today.”

Night and Day in Hackensack

Relkin’s work on the docket now turned to running the settlement. Katz had appointed a Plaintiffs’ Settlement Oversight Committee to administer the agreement on November 18, 2013, the day before the hearing, naming Relkin and her partner Perry Weitz among its members alongside plaintiffs’ lawyers from more than half a dozen other firms. In Toledo, Peter Flowers asked Katz to unseal that order, and Katz did. On November 21, Relkin appeared before Martinotti in the Bergen County Courthouse in Hackensack and handed up a matching New Jersey order, Case Management Order 26. The committee, she told him, held twenty-two lawyers from New Jersey, the MDL, California and Illinois who had negotiated and drafted the settlement and would administer it, “especially the Part B aspect of the settlement.”

The committee was still writing the document every lawyer would have to present to each client, laying out the settlement’s details. “It’s very detailed because the settlement is detailed, it’s inherently complex, because it has the revision of all the different scenarios of many thousands of people who have had the revisions,” Relkin told Martinotti. “And we’re just trying to write it in an intelligible way because it’s so complicated, and we’re working on it night and day.” Martinotti, who had New Jersey ASR cases ready for trial and had ordered two of them tried together over DePuy’s objection, said, “I personally think it’s creative and a unique method to resolve this litigation.” He singled out how it handled the claims of patients’ insurers: “Most unique about the settlement, in my opinion, is the lien section of the settlement.”

Four days after the committee order, on November 22, Katz appointed a Claims Administrator, retired judge James J. McMonigle, of Cleveland, and three Special Masters, retired judges Marina Corodemus and John K. Trotter and mediator Catherine A. Yanni, to decide individual claims under the agreement. The Special Masters would also help lawyers through the informed-consent process and answer claimants’ questions. Katz’s order made their determinations “binding and final,” with the authority of arbitrators, and removed those determinations from judicial review. The parties intended the program to be “self-executing,” Katz wrote, and “All findings of fact by the Claims Administrator and Special Masters shall be final.” A patient’s claim would be resolved inside the settlement program Relkin helped oversee, with no appeal back into a federal courtroom.

The same day, Katz moved against websites that were making the official one hard to find. “Only DePuy itself can rightfully use its name in any website address in this context,” he wrote, and any other site presenting itself as the ASR settlement website was unauthorized. Patients were to go to usasrhipsettlement.com.

A Walk-Away Right Waived on May 15, 2014

The base award fell with the years an implant had lasted. A patient whose ASR came out at least 180 days and less than five years after it went in qualified for the full $250,000; five to six years, $225,000; six to seven, $200,000; seven to eight, $150,000. The other reductions came after that: 5 percent for smoking at revision; 5, 15 or 20 percent as body-mass index at implant reached 35, 40 and above 50; 4 to 15 percent for patients 70 or older at implant; 5 percent when the ASR had itself replaced an earlier hip. A patient with both hips revised before the cutoff received a second $250,000 with no reductions. Revisions caused by infection alone within 547 days of the implant were excluded, as were revisions caused by trauma unless the hip would soon have needed replacing anyway.

Part B, which the program called the Extraordinary Injury Fund, required a base award first and then paid for re-revision surgery, pulmonary embolism or deep vein thrombosis, dislocation, foot drop, infection after revision, heart attack, stroke, death, and a miscellaneous category that could include lost wages. Health insurers’ liens for revision-related care were resolved at no cost to the patient, and DePuy separately reimbursed Medicare and other health insurers for the revision surgery and related care, bills that typically ran $50,000 or more.

Enrollment closed April 1, 2014, and DePuy kept a right to walk away from the deal until June 1. On May 15, 2014, DePuy waived its walk-away rights and committed to fund the program. By June 27, 98.3 percent of the plaintiffs with cases in the MDL had registered and more than 92 percent of the expected eligible claimants had enrolled, and Skikos and Sharko reported jointly that day that the first batch of awards had been funded “over a week early” and that base-award payments would begin on a rolling basis the following month. On July 16, Kranz reported participation in the MDL “in excess of 94%,” about five thousand MDL patients and more than two thousand others enrolled, and a settlement that “is fully vested.” BrownGreer, the claims processor, had sent more than a thousand claim notices. In August, after conferring with the oversight committee, DePuy extended the last day to enroll to September 30, 2014, and Katz ordered lawyers to send the new date to every eligible client who had not yet signed up.

DePuy’s settlement program grew once its first cutoff date passed. On February 20, 2015, the court extended the U.S. Settlement Program to patients who underwent ASR revision surgery through January 31, 2015, adding roughly a thousand claims that had not qualified under the original agreement. DePuy agreed to pay as much as $420 million more, for as many as 1,400 patients. In May 2015 the program reported that more than 94 percent of claimants had been submitted for enrollment, and it moved on to reviewing claims and issuing payments. Across the two agreements, the program BrownGreer processed held $2.8 billion for about nine thousand claimants. The ASR docket itself was still open in September 2026, assigned to Judge Jeffrey J. Helmick.

Rejuvenate, ABG II and LFIT in New Jersey

Stryker’s Rejuvenate and ABG II hip systems drew Relkin into a parallel docket during those same years. New Jersey’s Superior Court, in Bergen County, appointed her lead and liaison counsel for its Rejuvenate and ABG II multicounty litigation, a state-court proceeding separate from the cases Stryker also faced in a federal multidistrict litigation in Minnesota. Stryker had recalled both systems in 2012, and by 2014 had resolved the litigation nationwide. New Jersey’s courts also made her lead and liaison counsel in the litigation over Stryker’s LFIT cobalt-chromium femoral heads, and she sat on the executive committee of the federal LFIT V40 multidistrict litigation. Earlier she had held the same lead and liaison role in New Jersey’s litigation over the oral contraceptive Yaz.

Rutgers, Judge Pressler and a Unifying Theme

Relkin had been in practice since 1984, the year she graduated from Rutgers University Law School and began a clerkship with Judge Sylvia Pressler on the New Jersey Superior Court’s Appellate Division. She had studied history at Cornell, graduating in 1980. From 1988 to 1994 she co-chaired the New York State Bar Association’s committee on toxic torts; she later chaired the toxic, environmental and pharmaceutical torts section of the American Association for Justice and served as president of the Roscoe Pound Civil Justice Institute, now the National Civil Justice Institute. She wrote the failure-to-warn chapter of New Jersey Mass Torts and Class Action, published in 2015, and the New Jersey Supreme Court has certified her as a civil trial attorney. She also sits on the board of advisors of RAND’s Kenneth R. Feinberg Center for Catastrophic Risk Management and Compensation.

Of her three dozen years representing people hurt by medications, medical devices and toxic chemicals, Relkin has said, “I have observed a terrible unifying theme.” Manufacturers, as she describes them, put products on the market without adequate testing, fail to warn the consumers and workers who use them, and, worst of all, defer “corrective action because that would impact their bottom line.” “All these failures sadly boil down to the defendants’ concern for profits over safety,” Relkin has said of the manufacturers she has spent four decades suing.

In 2021 she joined a conference panel on diversity in appointments to lead class actions and multidistrict litigations. “It is critical that leadership in class action and mass tort MDLs reflect the diversity and breadth of the legal community,” she said.

JUUL, Altria and the San Francisco Schools Trial

Relkin’s docket had already reached beyond orthopedics. On December 20, 2019, she was named one of four co-lead counsel in the JUUL Labs Marketing, Sales Practices and Products Liability Litigation in the Northern District of California, with Sarah London of Lieff Cabraser Heimann & Bernstein, Dena Sharp of Girard Sharp and Dean Kawamoto of Keller Rohrback, before Judge William H. Orrick. The plaintiffs alleged that JUUL and its backers drew teenagers and young adults to nicotine with flavors and aggressive marketing while promoting the e-cigarette as safer than smoking and as a way to quit. Altria had taken a 35 percent stake in JUUL in late 2018. “The litigation advanced at a remarkable speed, despite its complexity and size, and the intervention of COVID during most of the discovery time frame, thanks to the efforts of plaintiffs and their counsel,” Relkin said.

JUUL settled first. On December 6, 2022, the co-leads announced four agreements with the company, covering more than 8,500 personal-injury cases, more than 1,400 cases brought by school districts, cities and counties, 34 tribal cases, and a class of consumers who had bought JUUL products. “We are so pleased to achieve compensation for our young clients battling addiction and support the ability of schools, cities, counties and tribes to create abatement programs to deter and stop youth vaping,” Relkin said. Altria did not settle until the first bellwether trial, brought for the San Francisco Unified School District, was under way. After the plaintiffs rested their case, Altria agreed in May 2023 to pay $235 million. “The injuries included significant lung damage, seizures, and cardiovascular problems,” Relkin said of the young people in the personal-injury cases. The settlements, negotiated with Relkin as co-lead counsel before Orrick, committed the defendants to pay consumers and government entities more than $500 million over the marketing of nicotine vaping devices to teenagers.

She also served as court-appointed co-lead counsel in the Farxiga products liability litigation venued in the Southern District of New York, over claims involving the diabetes drug dapagliflozin, and sat on the plaintiffs’ executive committees in the national prescription opiate litigation and in the Invokana and Ortho Evra cases.

Exactech’s Polyethylene and the Delaware Trust

On December 12, 2022, Judge Nicholas G. Garaufis of the Eastern District of New York appointed Relkin co-lead counsel, with Kirk Pope of Atlanta, in the Exactech Polyethylene Orthopedic Products Liability Litigation, a docket built around Exactech’s recalled knee, hip, and ankle components. The Optetrak, Optetrak Logic and Truliant knees used ultra-high-molecular-weight polyethylene inserts, and the Connexion GXL, AcuMatch, MCS and Novation hip liners were made of the same plastic; the Vantage ankle was part of the litigation too. Some of the hip liners had been packed in vacuum bags that lacked an ethylene vinyl alcohol layer meant to keep oxygen out, and Exactech acknowledged that this could leave them more prone to oxidation and premature wear. Exactech recalled the components in stages from 2021 to 2024.

“Our leadership team is ready to go, and not a moment too soon,” Relkin said when the appointments were announced. The plaintiffs’ lawyers said the polyethylene had worn out early, pitting, shredding and delaminating. “A lawsuit cannot undo the significant physical damage our clients have suffered, but we hope compensation can help alleviate some of their financial concerns and help pay for their medical care and treatment,” she said.

Garaufis set the first bellwether trials for 2025, on June 2 and August 5, with a third in October, to test how juries would value the claims of the more than sixteen hundred patients then in the litigation. After another Exactech recall in April 2024 the parties swapped the order of the first two cases, and by October 2024 the first trials were set for September 29 and November 10, 2025. On October 29, 2024, Exactech and its parent companies filed for Chapter 11 protection in Delaware, and on November 1 Garaufis stayed the cases, halting the trial schedule with them. The MDL kept accepting new filings and held 1,839 cases by January 2025.

In Wilmington, Judge Laurie Selber Silverstein of the bankruptcy court cleared Exactech to leave Chapter 11 in September 2025 and approved the sale of the company to a lender group led by Strategic Value Partners and Stellex Capital Management. The plan set up a trust to pursue litigation claims for unsecured creditors, the injury claimants among them, and left those claimants free to pursue Exactech’s private-equity owner, TPG.

In September 2026 the Exactech cases were still pending before Garaufis as MDL 3044. Fifteen years after Katz named her co-lead counsel over a recalled hip system in Toledo, Relkin was again leading a committee of plaintiffs’ lawyers over another recalled implant, on behalf of patients who had to have it removed.