Dena C. Sharp

On March 4, 2018, Dr. Joseph Conaghan, the laboratory director at Pacific Fertility Center in San Francisco, had trouble getting the lid off Tank 4. When he jiggled it, the whole container moved. “It shouldn’t move,” he told a federal jury three years later. Once the lid was off, his dipstick measured an inch or less of liquid nitrogen, far below the 14 inches recorded the day before. “That tank can’t be trusted.”

The tank held 2,500 embryos and 1,500 eggs. Chart Inc. had made it, and its controller, a Chart TEC 3000 that monitored the liquid nitrogen level and sent alerts about tank problems, had been unplugged. Conaghan and his staff moved the 80 metal boxes of eggs and embryos inside it to a backup tank. “More than anything we were devastated by this failure,” he testified.

Dena Sharp of Girard Sharp gave the closing argument for five of the patients whose eggs and embryos had been in Tank 4. Theirs was the first case from the failure to go to a jury, and on June 10, 2021, the jury found Chart liable on all claims and awarded them $14.975 million. Three years earlier, a week before jury selection in the Lidoderm pay-for-delay case, Sharp and her co-lead counsel had reached the last of three settlements that brought the patients and health plans who paid for that pain patch $104.75 million.

What Chart Knew About the SN=0 Defect

Girard Sharp came to represent more than 80 families who lost eggs or embryos in the failure. The federal suits against Chart, consolidated before Judge Jacqueline Scott Corley as In re Pacific Fertility Center Litigation, alleged manufacturing and design defects and a negligent failure to recall. The patients contended that the most immediate cause of the failure was a crack in a defective weld in Tank 4, and that a controller that worked would have alerted the lab to the falling nitrogen in time to move the eggs and embryos to a backup tank.

Chart moved to exclude three of the patients’ experts and for summary judgment. At a remote hearing on March 4, 2021, three years to the day after the failure, Sharp argued for the patients. “There is evidence that Chart knew there was a problem with the controller,” she told Judge Corley. “Chart could have taken action immediately, they could have had the tanks recalled or had them retrofitted.” John Duffy, Chart’s lawyer, called the inputs to the patients’ scientific analysis “flat wrong.” Corley answered that experts assume a set of facts and that their analysis fails if the facts are wrong. “This is the perfect example of why you need a trial,” she said.

The experts Chart wanted excluded were Dr. Anand Kasbekar, a mechanical engineer who gave the opinion on causation, following the failure-analysis method of the ASM Handbook; Dr. Wininger, an embryologist who had worked for decades with cryogenic containers, Chart’s MVE 808 tanks among them, and who reported that Tank 4 had consumed more than 14 inches of liquid nitrogen in less than a day and that the people who use such tanks do not expect a sudden and total loss of vacuum insulation; and Dr. Grill, a clinical psychologist who addressed the patients’ emotional distress. On March 5, 2021, Judge Corley denied all three motions, ruling that her task was to screen the opinions for reliability and that Chart’s attacks on the experts’ assumptions went to the weight the jury would give their testimony.

In March 2021 Judge Corley denied Chart summary judgment on the defect and recall claims. The consumer expectation test, she wrote, “can apply to complex or technical products,” and the record supported the inference that “had the controller worked, Dr. Conaghan would not have unplugged it and—as designed—it would have alerted PFC to the low liquid nitrogen level.”

At trial the evidence on the recall claim came from inside Chart. Its TEC 3000 controllers suffered from an “SN=0” defect that caused them to lose the ability to monitor liquid nitrogen levels accurately. Chart internally called the problem a “critical issue” that “needs an answer urgently why this is occurring,” and two years before the Pacific Fertility failure it had identified the defect as something about which it needed to “take action immediately.” Chart had a retrofit available. It did not notify Pacific Fertility or other customers of the issue, did not offer to retrofit their controllers, and did not issue a recall, although it knew the controllers were used with tanks storing “irreplaceable” biological material, that such tanks could suddenly lose their vacuum insulation, and that a working controller would notify the user of a sudden temperature drop.

Nine Days Before Judge Corley

Five patients who lost eggs or embryos in Tank 4 took their claims to trial in the spring of 2021. Sharp was co-lead counsel with Amy Zeman of Gibbs Law Group, and they tried the case with Adam Polk and Nina Gliozzo of Girard Sharp and Geoff Munroe of Gibbs Law Group. Chloe Poynton, 39, had lost nine eggs; Rosalynn Enfield, 43, a mother of two, had lost 18; Adrienne Sletten, 43, had lost two and still wanted to be a mother. Laura and Kevin Parsell had two children from earlier in vitro fertilization and had planned to have more with four frozen embryos that were lost.

Conaghan testified in the trial’s first week. The tank had been behaving normally, he said, and nothing had warned him it would fail. The controller had stopped reading the nitrogen level accurately on February 15, 2018; because it was sending false low-level alarms, the staff muted its alerts and checked the level by hand with a dipstick. “I want these people to have their families,” he told the jurors. On cross-examination Duffy asked why the backup tank was kept four stories below the lab and why the tissue had not been moved after February 15. “Since I didn’t have any concerns about the integrity of Tank 4 at the time, the risk of moving that tissue was too great,” Conaghan said.

The next day Duffy pressed the clinic’s staff. He put it to an embryologist that by lying for Conaghan she had saved the lab and her job. “I wouldn’t falsify a value,” she answered. Conaghan testified that he had never asked anyone to falsify data. Sharp asked him whether the missing liquid nitrogen measurements could have affected the tank’s structural integrity or caused it to fail. “Absolutely not,” he said.

On June 2 the jurors heard from the patients. Adrienne Sletten, an office manager at a technology company, had frozen her eggs in 2016, at 38, as a backup in case she could not conceive naturally. “It was buying myself some hope,” she said. She learned of the failure in March 2018 from newscasters on NBC’s Today show. Now 43 and trying to conceive with her partner, she told the jurors she felt stuck. “I’m scared. The whole thing is just paralyzing.”

Kevin Parsell, a 39-year-old farmer from Ohio, testified about the embryos he and his wife, Laura, had created in 2013. “We made a commitment we were going to return for all of them,” he said. Four were in Tank 4 when it failed. After three failed attempts, the couple was advised not to transfer the last embryo because it was damaged, and they tried anyway. “We were hoping for a miracle,” he said. None of the four produced a pregnancy. “It was the end,” Parsell said. “After that, I don’t trust anything or anybody.”

Poynton told the jurors that losing her eggs had harmed her friendships and made her feel more alone. “It’s really painful to be at a baby shower celebrating someone else’s family being built and knowing inside you’ll never get that,” she testified. “So you start to pull back. You start to isolate.”

Chart’s engineering expert, Franklin Miller, a University of Wisconsin professor who had worked on cryogenic systems for NASA, testified that Pacific Fertility misused the tank when it unplugged the controller, that the staff’s manual readings amounted to guesswork, and that the backup tank should have been put into service once the controller malfunctioned.

Sharp gave the plaintiffs’ closing argument on Wednesday, June 9, and asked the jurors to award up to $30 million. “Nothing can bring these eggs and embryos back,” she told them, and the law could offer only money. She totaled what each patient had spent on treatment, freezing and storage, from $10,000 to $40,000, and asked the jurors to consider what each would pay to get those younger eggs and embryos back. For each of the three women she proposed $175,000 to $350,000 in economic damages and $3 million to $6 million for pain, suffering and emotional distress; for the Parsells, $1 million in economic damages and $8 million to $10 million for emotional distress.

Chart blamed the clinic. Throughout the trial it argued that lab employees had misused the equipment, and in closing its lawyer, John Duffy, blamed the lab director for unplugging the tank’s malfunctioning controller and then keeping eggs and embryos in a container with no system in place to alert staff about problems for 17 days. “It’s outrageous that he doesn’t go downstairs to get the backup tank,” Duffy said. He also accused lab employees of failing to properly monitor and fill the tank and of conspiring to cover up their mistakes, and he told the jurors that their testimony had been rehearsed and coordinated.

Amy Zeman answered with Chart’s own history: a 2012 internal study that identified problems capable of making a tank fail, customer complaints about the controllers as early as 2015, and a retrofit Chart had ready by 2017. “By 2017, Chart knew its tanks could fail suddenly and catastrophically,” she said. “A reasonable manufacturer would have recalled or retrofit the Tech 3000 controller.” When the jurors went out, Judge Corley spoke to the five patients. “On behalf of myself and the court staff, we’re so sorry about what happened to you,” she said.

The jurors deliberated for about four hours that afternoon and four more the next day. On June 10 they found Chart liable on all claims, for a manufacturing defect in the tank and a negligent failure to recall the controller, and placed 90 percent of the fault on Chart and 10 percent on Pacific Fertility. They rejected Chart’s argument that the tank had been misused or improperly modified. The jury awarded $3.1 million to Poynton, $2.6 million to Enfield, $2,075,000 to Sletten and $7.2 million to the Parsells, a total of $14.975 million.

“The emotion in the courtroom today was palpable,” Sharp said after the verdict. “It has been a privilege to work on the front lines with our clients since 2018, and the impact this devastating incident had on patients’ lives can’t be minimized.”

Chart’s Knowledge and the Duty to Recall

Chart attacked the recall verdict again in post-trial motions. Under California’s jury instruction for the claim, CACI 1223, the plaintiffs had to prove that Chart knew or reasonably should have known the controller was dangerous, became aware of the defect after the sale, failed to recall or retrofit it, and that a reasonable seller in the same circumstances would have recalled or retrofitted it. Chart argued that the plaintiffs had offered no expert testimony on what a reasonable manufacturer would have done and no evidence that a government agency had issued a recall directive.

Judge Corley denied the motions in November 2021. Chart had identified no authority requiring expert testimony on the standard of care for the negligence claim, she wrote, just as it had identified none at summary judgment or in its motion for judgment as a matter of law during trial. Compliance with regulations or directives, under Hernandez v. Badger Construction Equipment Co., is evidence for the jury to weigh with the other facts and circumstances. “Nor has Chart cited to authority suggesting that a governmental directive is required to trigger a duty to recall or retrofit,” she wrote. “In fact, the cases cited in CACI 1223 are to the contrary.” Citing Lunghi v. Clark Equipment Co., she explained that under California law “it is defendant’s knowledge of the defect and the serious risk of harm that gives rise to a duty of care.” She then applied that rule to the evidence at trial: “Substantial evidence supports the jury’s finding that Chart negligently failed to retrofit or recall the controller.”

Chart also sought a new trial because the court had excluded a test its engineer, Miller, ran on an exemplar tank. Corley held to that ruling. The test had not reproduced the conditions in Tank 4, including what the tank held, and it had not replicated the kind of failure at issue, an interior weld crack rather than an external breach.

Chart called the damages excessive. Corley answered by setting out what the jurors had heard. Poynton, now 39, desperately wanted children, feared she might never have them, and had developed chronic hives after the failure; Sletten described feeling paralyzed and unable to move forward; Enfield had been crushed when the eggs were not there when she needed them; Kevin Parsell no longer trusted anyone; and Laura Parsell’s grief was ongoing, and it felt, the judge wrote, “like having four of her family members ripped from her life one by one.” The jury had given each patient a different amount, which, Corley noted, suggested that it had weighed each patient’s evidence separately. “There is no basis for questioning the jury’s valuation of this suffering,” she wrote. She also left in place the jury’s allocation of 90 percent of the fault to Chart.

Chart appealed to the Ninth Circuit. It had sold its cryobiological products business on October 1, 2020 but retained potential liabilities from the Pacific Fertility lawsuits, and in the fourth quarter of 2022 it recorded a loss contingency accrual of $305.6 million for the combined federal and state-court cases, with a related loss receivable of $231.9 million from insurance proceeds. In late January 2023 Chart reached a settlement resolving all but one of those lawsuits, and the settlement was finalized and funded on March 20, 2023, ten days before the appeal was set for oral argument.

“These Are Righteous Cases”

Sharp grew up in Minnesota, the youngest of eight children of immigrants; her mother worked for a time as a doctor at the Mayo Clinic. She holds a B.A. from Brown and a J.D. from the University of California College of the Law, San Francisco, where she won the Best Oral Advocate Award, surfed throughout law school, and externed for Judge Phyllis J. Hamilton of the Northern District of California and Judge John E. Munter of the San Francisco Superior Court. Professor David Levine connected her with Daniel Girard, and in 2006 she joined his firm, Girard Gibbs, as an associate.

“I was as green as you could be,” she said in 2018. The firm’s practice fascinated her, and defense work did not attract her. Her first cases included a Ponzi scheme and suits for investors hurt in the 2008 financial crisis; for retirees whose investments Lehman Brothers had underwritten, she said, the team got back more than 50 percent of their money. Those cases put her in close contact with clients and taught her early what the pressure of a $100 million case feels like.

Her later cases targeted drug companies accused of charging excessive prices or illegally delaying generic competition. “These are righteous cases,” she said. “There’s nothing good about companies colluding to keep prices of key medicines high.” She became a named partner in 2018, when the firm took the name Girard Sharp, and its managing partner in 2025, when Daniel Girard became senior advisor and of counsel. Her co-lead appointments include the Juul vaping litigation and, in antitrust, the Lidoderm, Restasis and Xyrem cases.

Endo’s Doubts About the ’529 Patent

In February 2012, Caroline Manogue, the general counsel of Endo Pharmaceuticals, called the patent protecting Lidoderm “very weak” in an email. Lidoderm is a patch of 5 percent lidocaine used to relieve the pain of postherpetic neuralgia, also known as “after-shingles” pain. Watson Pharmaceuticals’ application to sell a generic version had put that patent, the ’529 patent, into litigation, and by the time Endo and Teikoku settled with Watson in 2012, the case had been tried to Judge Sleet in a six-day bench trial and the parties had filed their post-trial briefs. He had not ruled.

Under the settlement, Watson agreed not to launch its generic until September 15, 2013, about a year after the Food and Drug Administration’s 30-month stay on its application expired. Endo and Teikoku agreed to give Watson $96 million worth of brand-name Lidoderm patches to distribute or sell, and agreed to hold back their own authorized generic until seven and a half months after Watson began selling. During that exclusivity period, Watson would pay them a 25 percent royalty on the gross profit from its generic.

Sharp represented the end payors: the patients and health plans that paid for Lidoderm and, later, for its generic. In May 2014, Judge William H. Orrick of the Northern District of California appointed Girard Gibbs, Sharp’s firm, as one of three interim co-lead counsel for the end-payor class, with Cohen Milstein Sellers & Toll and Heins Mills & Olson. Sharp served as co-lead counsel for the class through its settlement. When the defendants moved for summary judgment in 2017, her declarations put Manogue’s email before Judge Orrick, along with other statements the defendants had made about the patent.

“Some Evidence” That Watson Could Have Won

The end payors built their claim on the Supreme Court’s 2013 Actavis decision, which Judge Orrick quoted: it is “normally not necessary to litigate patent validity to answer the antitrust question,” and “[a]n unexplained large reverse payment itself would normally suggest that the patentee has serious doubts about the patent’s survival.” They offered two routes to injury. Without the payment, Watson would have launched its generic at risk, without waiting for the patent case to end, or the companies would have agreed to an earlier entry date with no payment attached.

The defendants answered that a generic sold while the ’529 patent stood would have infringed it. Infringement is unlawful, they argued, so Watson’s infringement “breaks the ‘chain of causation’” for an antitrust claim: unless the plaintiffs could prove that Watson would have won the patent case, the patent holder’s right to exclude cut off the claim.

On November 3, 2017, Judge Orrick declined to make the plaintiffs retry the patent case. He called a requirement that they prove Watson would have won a “turducken” and said it was “not required (or even suggested) by the Actavis opinion.” To take the at-risk-launch theory to a jury, the plaintiffs had to show “some evidence” that Watson could have won before Judge Sleet or on appeal at the Federal Circuit.

The exhibits to Sharp’s declarations supplied that evidence, most of it in the defendants’ own words. Watson’s chief executive had spoken on a November 2011 earnings call of the company’s “strong litigation stance” and its plan to start selling in 2012. A July 2012 Watson memorandum said that “the patents covering Lidoderm are not valid” and that Watson had been preparing to launch upon FDA approval in July or August 2012. Alongside Manogue’s email were deposition testimony from Teikoku’s outside counsel about Endo’s “negative impression” of the patent and draft Endo accounting letters from July 2012 recording management’s view “that there was a significant probability that the courts may find one or more of the patents to be invalid.” Endo had also admitted that it “believed a ruling in favor of Watson was very plausible, thus furthering our desire to settle.” The plaintiffs’ patent expert, Martin Adelman, whose report was an exhibit to a Sharp declaration, opined that Watson would have won on anticipation, on obviousness and on unenforceability.

The defendants’ strongest answer came from the patent trial itself. At closing argument Judge Sleet had asked, “What result should there be if I largely discount the testimony of Dr. Walters,” Watson’s expert, either for lack of opinion in critical areas or because he did not find him credible over Endo’s expert, Dr. Lane. The defendants read the question as a sign that Sleet would have credited Lane and rejected anticipation, a finding the Federal Circuit would have been bound to follow. “Defendants read too much into these comments,” Orrick wrote. Judge Sleet had not ruled, and the record held significant, though disputed, evidence for both sides. The plaintiffs had produced “some” evidence that Watson would have won on anticipation and had made “a strong showing that Watson could have won on obviousness.” Orrick denied the defendants’ motion for summary judgment.

The same order defined the market. The defendants wanted Lidoderm measured against a long list of pain treatments: the opioid Ultram, the anticonvulsants Neurontin and Lyrica, the antidepressant Cymbalta, the muscle relaxant Flexeril, Celebrex, ibuprofen, naproxen and other anti-inflammatory drugs, capsaicin, and lidocaine creams, gels and ointments. Orrick instead granted the plaintiffs’ motion limiting the market to 5 percent lidocaine patches, Lidoderm and its generics. Endo’s own materials called Lidoderm “the first and only lidocaine-based topical medication with FDA approved indication for the treatment of PHN pain.” The economist Jeffrey Leitzinger found little cross-elasticity between Lidoderm and other pain treatments apart from generic Lidoderm, and Lidoderm’s prices had not been set with reference to any other drug. “The market for determining monopoly power cannot be stretched as far as defendants seek,” Orrick wrote.

Brand Loyalists and the 6.1 Percent

Orrick had certified the classes on February 21, 2017. The end-payor class covered anyone in seventeen states who paid some or all of the price of brand Lidoderm from August 23, 2012 through September 14, 2013, or of generic Lidoderm from September 15, 2013 through August 1, 2014, whether for themselves and their families or for the members of a health plan. Its representatives were seven health-and-welfare funds, among them funds for United Food and Commercial Workers Local 1776, Operating Engineers locals and the Iron Workers District Council of New England; the City of Providence; and two individual purchasers, Letizia Gallotto and Steven Roller.

The defendants attacked the class as full of purchasers who had not been injured: patients who would have kept buying the brand after a generic arrived, patients whose plans charged the same copay for brand and generic, patients who had reached their out-of-pocket maximums, and health plans whose rebates or premiums might have absorbed any overcharge. Finding those purchasers, they argued, would take individualized proof that would overwhelm the common questions.

The end payors had already drawn the class to leave out consumers who paid a single flat copay whatever they bought, consumers with a flat generic copay after the generic launched, fully insured health plans, Medicaid-only purchasers and pharmacy benefit managers. For the rest, their economist, Hal J. Singer, built a model from the defendants’ internal documents and published research that estimated what brand and generic Lidoderm would have cost with earlier generic entry. He estimated that brand loyalists accounted for 6.1 percent of class purchases, checked the figure against OptumRx data, and removed those purchases from aggregate damages.

Orrick accepted that approach. The defendants’ expert put the brand-loyal share higher, but both experts estimated it from common proof, and even at 6 or 7 percent the uninjured purchasers were “at most a de minimis portion of the EPP class.” For the health plans, the end payors answered that whether a plan had been damaged on average was irrelevant, because “the TPP need only suffer damage on one purchase to be injured,” and Orrick found Singer’s analysis sufficient for certification. He appointed Girard Gibbs, Cohen Milstein and Heins Mills co-lead counsel for the certified end-payor class.

Sharp later co-wrote, with Jocelyn Larkin of the Impact Fund, the chapter on investigating and filing a class action in the American Bar Association’s Class Action Strategy and Practice Guide, which covers choosing class representatives and drafting class definitions. She has chaired the Impact Fund’s board of directors.

A Week Before Jury Selection

Orrick first set the case for trial in December 2017 and later reset it for February 23, 2018. Some of the parties had mediated before Judge Layn Phillips in May 2017, and later negotiations took place before Chief Magistrate Judge Joseph C. Spero. The end payors reached agreements in principle with Teikoku after a settlement conference in December 2017, with Watson after one in January, and with Endo after a February conference held one week before jury selection. By then the defendants had produced more than 3.3 million pages of documents, and the plaintiffs had deposed 32 fact witnesses.

The three settlements came to $104.75 million in cash: $41 million from Actavis and Watson, $40 million from Endo in three installments, and $23.75 million from Teikoku. The end payors put the total at 46 percent of $229 million, their most aggressive single damages estimate for trial. Sharp signed the March 20, 2018 motion seeking preliminary approval, which Judge Orrick granted on May 1.

The end payors proposed to divide the money by damages: about 75 percent to third-party payors and 25 percent to consumers, matching each group’s share of classwide damages, with each group’s share divided pro rata among its claimants. A consumer’s claim form asked only how many brand or generic Lidoderm prescriptions the consumer had filled. Judge Orrick granted final approval on September 20, 2018, finding the plan of allocation fair, reasonable and adequate, in the same month he approved a separate $166 million settlement for the direct purchasers, who had their own counsel.

Allergan’s Petitions and 16,612 Consumer Claims

In the Restasis litigation in the Eastern District of New York, Sharp was one of three co-lead counsel for the end payors, with Eric Fastiff of Lieff Cabraser Heimann & Bernstein and Joseph Saveri of the Joseph Saveri Law Firm. Restasis is Allergan’s cyclosporine eye emulsion for dry-eye disease, and the end payors alleged that Allergan delayed generic competition with patents and petitions. In 2009 Allergan had conceded that the claims of a proposed patent covering the Restasis formulation were obvious in light of an earlier patent known as Ding I. In 2013 it applied for new patents, supported by a declaration in which Dr. Rhett Schiffman described the Phase 3 results as surprising; the plaintiffs alleged the declaration relied on statistically insignificant data. In October 2017, after a bench trial, Federal Circuit Judge William C. Bryson, sitting by designation in the Eastern District of Texas, found the formulation obvious and the later patents issued only because Allergan had “painted a false picture” of the relevant data.

Allergan listed the new patents in the FDA’s Orange Book and in August 2015 sued four generic applicants, Apotex, Akorn, Mylan and Teva, which triggered an automatic 30-month stay of FDA approval. Between January 2014 and August 2017 it filed three citizen petitions asking the FDA to do away with in vitro bioequivalence testing for Restasis, and the FDA denied every substantive request. The plaintiffs alleged that on September 8, 2017, Allergan conveyed the patents to the Saint Regis Mohawk Tribe, which gave Allergan an exclusive license back; that Allergan paid the Tribe $13.5 million plus up to $15 million in annual royalties; and that in return the Tribe gave Allergan one thing: a promise not to waive its sovereign immunity in inter partes review or other Patent Office proceedings on the patents.

Allergan moved to dismiss for lack of causation, arguing that the FDA had granted no tentative approval to a generic during the stay and still had not approved one after the stay lifted. Judge Nina Gershon denied the motion in September 2018. The plaintiffs had plausibly alleged, she wrote, that the FDA in practice delays generic approvals while it responds to citizen petitions, and it was reasonable to infer that the stay from the patent litigation had led the agency to divert its resources away from the generic applications. The plaintiffs’ inference “that Allergan’s efforts bore fruit in causing delay,” she concluded, was logical and amply supported the claim’s plausibility.

The end-payor class was certified on May 5, 2020, after a two-day evidentiary hearing in September 2019. Girard Sharp took the lead in working with the class’s economist, Richard G. Frank, on certification, and the Second Circuit denied Allergan’s petition to appeal the ruling. Allergan produced nearly 690,000 documents, more than 7 million pages; 22 fact witnesses were deposed; and the parties briefed summary judgment and eleven Daubert motions before a mediation in April 2021 led to a settlement. Allergan agreed to pay $29,999,999.99. Judge Gershon approved the settlement on August 2, 2022, and no class member objected.

The plan of allocation divided the net fund into three pools, for consumers who paid cash, insured consumers and third-party payors, each distributed pro rata. When the co-lead firms, Girard Sharp among them, moved in May 2023 to distribute the fund, 16,612 consumer claims and 1,393 third-party-payor claims had been found eligible, and each eligible claimant was to receive at least $15. Consumers whose claims had first been denied and who then sent documentation, such as a picture of their Restasis package or a copy of their prescription, had their claims approved for payment. Judge Gershon authorized the distribution on July 31, 2023.

Brand Loyalty Again, in the Xyrem Case

In February 2021, Judge Lucy H. Koh appointed Sharp and Michael Buchman of Motley Rice interim co-lead class counsel in the Xyrem litigation in the Northern District of California, where the plaintiffs alleged that Jazz Pharmaceuticals’ patent settlements with generic manufacturers of Xyrem, its narcolepsy drug, violated state and federal antitrust and consumer-protection laws. Jazz and its co-defendants raised the brand-loyalty argument that Singer had met in Lidoderm with a 6.1 percent deduction. Patients would have stayed with the brand, they argued, leaving many health plans uninjured: Xyrem treats a rare disorder, dispense-as-written data showed a preference for the brand, and Jazz’s coupons brought some patients’ cost to zero. In May 2023, Chief Judge Richard Seeborg rejected the argument and certified a damages class of third-party payors in 29 states, the District of Columbia and Puerto Rico, observing that courts facing brand-loyalty arguments about such payors had “universally concluded” that it was “highly unlikely” they were uninjured. He named Girard Sharp and Motley Rice class counsel for a $3.4 million settlement with two defendants, Amneal and Lupin.

Jazz agreed on April 7, 2025 to pay the class of indirect Xyrem purchasers $145 million in a lump sum, and Hikma, a co-defendant, agreed a month later to pay $50 million, just before the class’s trial against Hikma was set to begin. The $195 million was 46 percent of the $422 million damages estimate the class had been prepared to take to trial, and with the earlier $3.4 million from Amneal and Lupin, the end-payor settlements came to $198.4 million. No class member opted out or objected, and Chief Judge Seeborg granted final approval on October 27, 2025.