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Court Ends New FTC Rule Banning Employer Non-Compete Agreements

In response to the Federal Trade Commission’s promulgation of the Non-Compete Rule (16 C.F.R. § 910) on April 23, 2024, Ryan LLC initiated a lawsuit against the FTC on the same day in the United States District Court for the Northern District of Texas Dallas Division.

Ryan and the Plaintiff-Intervenors filed motions to stay and preliminary enjoin the FTC from enforcing the Rule. Because the Court concluded that there was a substantial likelihood that Plaintiffs would succeed on the merits – including the conclusions that (i) the FTC exceeded its statutory authority and (ii) the Rule is arbitrary and capricious – and that the Rule would cause irreparable harm, the Court preliminarily enjoined implementation and enforcement of the Rule as to the named Plaintiffs on July 3, 2024.

Both Plaintiffs and the FTC then moved for summary judgment. Ryan and Plaintiff-Intervenors’ Motions for Summary Judgment were granted on August 20, 2024. Additionally, for the reasons the Court granted Plaintiffs’ Motions for Summary Judgment, the Court denied the FTC’s Motion for Summary Judgment. The Non-Compete Rule, 16 C.F.R. § 910.1-.6, was set aside “and shall not be enforced or otherwise take effect on September 4, 2024, or thereafter” in the closely watched case of Ryan LLC v Federal Trade Commission filed in the United States District Court for the Northern District of Texas Dallas Division – Civil Action No. 3:24-CV-00986-E.

This is a dispute over the FTC’s rulemaking authority concerning the enforceability of employer/employee non-compete agreements. These agreements are restrictive covenants that prohibit an employee from competing against the employer. Ryan, LLC was the first party to challenge the lawfulness of the Non-Compete Rule. A group of trade associations led by the United States Chamber of Commerce intervened in the case to challenge the Rule as well.

Regarding the prevalence of non-compete agreements, the Parties’ joint appendix provides: [T]he Commission finds that non-competes are in widespread use throughout the economy and pervasive across industries and demographic groups, albeit with some differences in the magnitude of the prevalence based on industries and demographics. The Commission estimates that approximately one in five American workers – or approximately 30 million workers – is subject to a non-compete.

In 2018, the FTC began to study non-competes through public hearings and workshops; invitations for public comment; and a review of academic studies.Three years later, the FTC initiated several investigations into the use of non-competes to determine whether they constitute unfair methods of competition. On January 19, 2023, the FTC proposed the Non-Compete Rule – which would “prohibit employers from entering into non-compete clauses with workers starting on the rule’s compliance date” and “require employers to rescind existing non-compete clauses no later than the rule’s compliance date.” On April 23, 2024, the FTC adopted the final Non-Compete Rule.

Plaintiffs assert the Commission’s claimed statutory authority in promulgating the Rule – Section 6(g) of the FTC Act – does not authorize substantive rulemaking. The question to be answered is not what the Commission thinks it should do but what Congress has said it can do.

“The judiciary remains the final authority with respect to questions of statutory construction and must reject administrative agency actions which exceed the agency’s statutory mandate or frustrate congressional intent.”

The Court concluded that “the text and the structure of the FTC Act reveal the FTC lacks substantive rulemaking authority with respect to unfair methods of competition, under Section 6(g).”

Also a court must “hold unlawful and set aside agency action, findings and conclusions found to be . . . arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A).

The record does not support the Rule. In enacting the Rule, the Commission relied on a handful of studies that examined the economic effects of various state policies toward non-competes. The record shows no state has enacted a non-compete rule as broad as the FTC’s Rule.” Second, “the record shows the FTC failed to sufficiently address alternatives to issuing the Rule.”

“In sum, the Court concludes that the FTC lacks statutory authority to promulgate the Non-Compete Rule, and that the Rule is arbitrary and capricious. Thus, the FTC’s promulgation of the Rule is an unlawful agency action. See 5 U.S.C. § 706(2).”

The court’s summary judgment order applies nationwide. Attorneys representing Ryan LLC said that the FTC may appeal the ruling to the Fifth Circuit. The FTC has not yet indicated whether or when it may appeal.

9th Circuit Decision Continues “Judicial Hostility” to Employer Arbitration

When Jose Emilio Ronderos applied to work for USF Reddaway, Inc. as a line haul manager, Reddaway required him to sign a document titled “Candidate’s Statement,” which is a pre-printed document that contains the arbitration agreement. Reddaway presented that pre-printed document to Ronderos on a take-it-or-leave-it basis.

Ronderos was hired and worked for Reddaway for two and a half years. Ronderos alleges that, shortly after he was diagnosed with cancer and took a medical leave of absence, Reddaway terminated him. Ronderos filed claims in California state court against Reddaway for age and disability discrimination, retaliation, and failure to accommodate his disability under California’s Fair Employment and Housing Act (FEHA), California Government Code §§ 12900 et. seq., and failure to pay unpaid wages in violation of California state law, among other claims.

After Reddaway removed the case to federal court, it filed a motion to compel arbitration. Ronderos opposed the motion, contending that the arbitration agreement is procedurally and substantively unconscionable under California law and, therefore, unenforceable.

Reddaway conceded that the arbitration agreement is a contract of adhesion – that is, it is a pre-printed form that Reddaway presented to Ronderos on a take-it-or-leave-it basis, with no opportunity for Ronderos to negotiate its terms. Reddaway also conceded that two of the agreement’s provisions – the one-year statute of limitations for filing claims and the preliminary injunction carve-out – are unenforceable under California law. Reddaway argued, however, that the court should sever those provisions and enforce the remainder of the agreement by compelling arbitration.

The district court concluded that the agreement is procedurally unconscionable to a moderate degree. The district court also concluded that the agreement contains multiple substantively unconscionable provisions, and that it lacks mutuality to a substantial degree. Finally, the district court declined to sever the unconscionable provisions.

The 9th Circuit Court of Appeal affirmed the trial court in the published case of Ronderos v USF Reddaway, Inc – 5:21-cv-00639-MWF-KK – (August 2024).

After agreeing with the trial court that the agreement contains multiple procedurally and substantively unconscionable provisions, the 9th Circuit reviewed the district court’s decision not to sever the unconscionable provisions for abuse of discretion. In doing so, the 9th Circuit was mindful of the July 2024 California Supreme Court decision in Ramirez v. Charter Communications, Inc clarifying that no bright line rule requires a court to refuse enforcement if a contract has more than one unconscionable term.

Reddaway argued that the district court should have found that the unconscionable provisions are merely “collateral” to the main purpose of the contract, and that it erred by instead finding that the multiple unconscionable provisions show that the central purpose of the agreement is tainted with illegality.

Nonetheless, the 9th Circuit concluded that the district court did not abuse its discretion by declining to sever the unconscionable provisions and enforce the remainder of the agreement. In doing so, it noted that while case law does “not establish bright lines, they shed some light on the outer bounds of a trial court’s range of discretion. Our understanding of the trial court’s range of discretion is confirmed by our review of cases in which appellate courts have held that the trial court acted within its discretion.”

It reviewed several appellate cases on this issue and concluded that like the California Supreme Court in Armendariz v. Found. Health Psychcare Servs., Inc., 6 P.3d 669 (Cal. 2000)) it conclude that, “given the multiple unlawful provisions, the [district] court did not abuse its discretion in concluding that the arbitration agreement is permeated by an unlawful purpose.”

Dissenting Judge Bennett wrote that “Not once has the California Supreme Court, nor any of the California Courts of Appeal, affirmed a trial court’s refusal to sever easily excisable collateral provisions from an arbitration agreement that includes a severability clause. Nor have we – until today.”

“The district court abused its discretion because it misapplied California law in declining to sever the collateral provisions here. It should have severed those provisions and granted Reddaway’s motion to compel arbitration. Both its decision and the majority’s evince the type of ‘judicial hostility to arbitration’ that led Congress to pass the Federal Arbitration Act.”

Former CHP Officer Arrested for Workers’ Compensation Fraud

California Highway Patrol (CHP) investigators arrested a former CHP officer on suspicion of workers’ compensation insurance fraud and theft, pursuant to an arrest warrant issued by the Sacramento County District Attorney’s Office for the following charges:

– – 1871.4(a)1 IC – False statement to fraudulently obtain compensation
– – 550(b)(1) PC – Present false statement regarding insurance claim or benefit
– – 550(b)(3) PC – Conceal or fail to disclose event affecting benefits
– – 118(a) PC – Perjury
– – 20 VC – False statements to DMV or CHP

Jordan Lester, 44, was arrested without incident in Quincy and was booked into the Plumas County Jail in Plumas County. The arrest resulted from an extensive, multi-year investigation by the CHP’s Workers’ Compensation Fraud Investigations Unit based at CHP’s Headquarters in Sacramento.

Lester filed a workers’ compensation insurance claim on July 12, 2021, and was placed off work by his physician in January 2022. While off work, an anonymous tip was received by the CHP’s Workers’ Compensation Fraud Investigations Unit, and an investigation was initiated.

The investigation revealed Lester committed worker’s compensation fraud by engaging in activities, while on injury leave, inconsistent with limitations and restrictions given by his medical providers. During the investigation, CHP investigators also discovered that Lester committed perjury and made false statements to the Department of Motor Vehicles when he fraudulently misrepresented the purchase price of a vehicle he purchased.

Lester, a 16-year veteran of the Department, was assigned to the Quincy CHP Area.

The CHP wants to assure the public that it takes all allegations of employee misconduct very seriously. When allegations of misconduct by an employee are suspected, the Department takes swift and appropriate action to investigate the allegations. Additional questions regarding the criminal case should be directed to the Sacramento County District Attorney’s Office.

The CHP’s Workers’ Compensation Fraud Investigations Unit is a specialized team that investigates allegations of workers’ compensation fraud. Allegations of workers’ compensation fraud may be reported by calling a toll-free Fraud Reporting Hotline (1-866-779-9237) or at https://www.chp.ca.gov/notify-chp/workers-comp-fraud

SJDB School Owner and Counselors Face $1M Fraud & Kickback Charges

Los Angeles area vocational school owner, Guillermo (William) Frias, 65, of Paramount, and accounting manager for the same school, Yesid Colon, 54, of Baldwin Park, were arraigned after a California Department of Insurance investigation revealed they allegedly submitted fraudulent claims to receive money from insurance companies for services their vocational school did not provide.

They also allegedly received illegal kickback payments from vocational counselors that paid for referrals of students, which is a labor code violation. Four vocational counselors have also been arraigned for their involvement in the illegal referrals and kickback scheme.

The investigation began after the department received referrals from multiple insurance companies alleging the vocational school, Caledonian, had committed workers’ compensation fraud. The school was misusing Supplemental Job Displacement Benefit Vouchers, which provide injured workers with up to $6,000 for retraining at a post-secondary educational institution. The training helps the injured worker become more competitive in the job market when they are unable to return to their former vocation field due to being on total or temporary disability.

During the course of the investigation, the department served a search warrant upon Caledonian and seized evidence consistent with the speculation that the school offering courses outside of which they were approved, as mandated by the Employment Development Department’s Eligible Training Provider List and Bureau for Private Postsecondary Education’s course approval.

The search warrant also provided additional evidence that the school did not offer full instruction hours for courses, instructed students through third party vocational institutions, provided distance learning when not approved, and instructed students in languages outside of the approved language.

Additionally, evidence found Caledonian paid vocational counselors and employees to refer students, which is a labor code violation. Caledonian paid $496,147 to vocational counselors for those illegal referrals. Accepting payment for referrals is also a violation and the evidence showed multiple vocational counselors accepted and received a total of $489,530 for their illegal referrals.

The investigation determined Caledonian was not only depriving students of their education, they were also receiving money from insurance companies for the services not rendered.

Further, vocational counselors received illegal kickbacks payments from Caledonian for student referrals. The vocational counselors allegedly involved in the scheme are Jenny Villegas, Friends for Injured Workers CEO, Laura Wilson, CEO of Laura Wilsons and Associates, Jesus (Jessie) Garibay, Gordy’s Legal Service Director, and Hazel Ortega, CEO of Ortega Counseling Center.

All six defendants have been charged with violating Penal Code 550(a)(1), Labor Code 3215, and Insurance Code 750.5. As Insurance Code 705.5 stipulates it is unlawful to receive or accept money for referrals, the chargeable fraud amount is $985,677.

Frias, Colon, Villegas, Wilson, and Ortega were arraigned August 19, 2024. Garibay was arraigned June 7, 2024. The defendants are scheduled to return to court on October 7, 2024. The Los Angeles County District Attorney’s Office is prosecuting this case.

Workers File Class Actions Against Employers for Excessive PBM Drug Costs

Large, self-insured employers are beginning to face lawsuits from their workers over claims of mismanaging health and pharmaceutical benefits and violating their fiduciary duties under the Employee Retirement Income Security Act.

ERISA subjects anyone with discretionary authority over an employee- benefits plan to fiduciary duties derived from the law of trusts. ERISA’s “duty of prudence” requires fiduciaries to act “with the care, skill, prudence, and diligence under the circumstances then prevailing that a prudent man acting in a like capacity and familiar with such matters would use in the conduct of an enterprise of a like character and with like aims.” 29 U.S.C. § 1104(a)(1)(B).

In the most recent example, Wells Fargo was sued by employees in a July class action for allegedly paying inflated prices to its contracted pharmacy benefits manager, Express Scripts.

Plaintiffs Sergio Navarro, Theresa Gamage, Dayle Bulla, and Jane Kinsella, individually, on behalf of all others similarly situated, and on behalf of the Wells Fargo & Company Health Plan, filed a federal class action in the United States District Court for the District of Minnesota (case 24-cv-3043) under 29 U.S.C. § 1132 against Wells Fargo & Company, along with other defendants, for breaches of fiduciary duties and engaging in prohibited transactions under the Employee Retirement Income Security Act (“ERISA”),

This case involves alleged mismanagement of prescription-drug benefits. Over the past several years, Plaintiffs claim “Defendants breached their fiduciary duties and mismanaged Wells Fargo’s prescription-drug benefits program, costing their ERISA plan and their employees millions of dollars in the form of higher payments for prescription drugs, higher premiums, higher out-of-pocket costs, and lower wages or limited wage growth.”

“Defendants’ mismanagement is evident from, among other things, the prices it agreed to pay one of its vendors – its Pharmacy Benefits Manager (“PBM”) – for many generic drugs that are widely available at drastically lower prices.”

“For example, someone with a 90-unit prescription for the generic drug fingolimod (the generic form of Gilenya, used to treat multiple sclerosis) could fill that prescription, without even using their insurance, at Wegmans for $648, ShopRite for $677.68, Rite Aid for $891.63, Walmart for $895.63, or from Cost Plus Drugs online pharmacy for $875.09.”

“Defendants, however, agreed to make the Plan and its participants/beneficiaries pay $9,994.37 for each 90-unit fingolimod prescription. The burden for that overpayment falls on both the Plan and its participants/beneficiaries.”

An in another class action example reported by the Minnesota Reformer, a worker at Mayo Clinic’s Arizona hospital filed a proposed class action lawsuit against the health system and insurer Medica in federal court last April , alleging they were saddled with enormous health care bills after their claims were “systemically underpaid.”

Mayo Clinic employees said they racked up more than $10,000 in health care costs a year while others said they avoided going to the doctor for fear of what it would cost, all while working for one of the world’s most prestigious health care organizations.

The lawsuit filed in the United States District Court for the District of Minnesota (:24-cv-01124-JMB-JFD) alleges Medica, which administers Mayo Clinic’s self-insured plan, uses “deceptive, misleading, arbitrary” pricing methods that leave plan members in the dark about health costs and allow for inconsistent reimbursement rates, in violation of federal law and Medica’s fiduciary responsibilities.

And in a third example, Lockton reports reports a class action lawsuit was filed in February against drug manufacturer Johnson & Johnson (J&J) in its capacity as an employer and plan sponsor.

The suit alleges that J&J breached its fiduciary duties by not taking proper measures to ensure its plan costs were reasonable as well as failing to exercise prudence in selecting its pharmacy benefit manager (PBM) and agreeing to undesirable contract terms. Specifically, the suit accuses J&J of mismanaging its employees’ drug benefits, resulting in employees significantly overpaying for certain drugs.

According to Fisher Phillips plaintiffs’ attorneys are turning their eyes to group health plan fiduciaries in light of the Consolidated Appropriations Act of 2021 (CAA-21), which has ushered in a new wave of ERISA excessive fee litigation.

The CAA-21 and the Transparency in Coverage (TiC) Rule comprise the most comprehensive health plan legislation and reforms since the Affordable Care Act. They place new obligations on group health plans and health insurance companies for plan fee disclosures and pricing transparency. Notably, these laws may contribute to new class action lawsuits against health plan fiduciaries.

Fisher Phillips points out the Johnson & Johnson case as an example of this emerging trend.

MIT Researchers Study Why Laws are Written in an Incomprehensible Style

Legal documents are notoriously difficult to understand, even for lawyers. This raises the question: Why are these documents written in a style that makes them so impenetrable?

MIT cognitive scientists believe they have uncovered the answer to that question. Just as “magic spells” use special rhymes and archaic terms to signal their power, the convoluted language of legalese acts to convey a sense of authority, they conclude.

In a study appearing this week in the journal of the Proceedings of the National Academy of Sciences, the researchers found that even non-lawyers use this type of language when asked to write laws.

“People seem to understand that there’s an implicit rule that this is how laws should sound, and they write them that way,” says Edward Gibson, an MIT professor of brain and cognitive sciences and the senior author of the study. Eric Martinez PhD ’24 is the lead author of the study. Francis Mollica, a lecturer at the University of Melbourne, is also an author of the paper.

Gibson’s research group has been studying the unique characteristics of legalese since 2020, when Martinez came to MIT after earning a law degree from Harvard Law School. In a 2022 study, Gibson, Martinez, and Mollica analyzed legal contracts totaling about 3.5 million words, comparing them with other types of writing, including movie scripts, newspaper articles, and academic papers.

That analysis revealed that legal documents frequently have long definitions inserted in the middle of sentences – a feature known as “center-embedding.” Linguists have previously found that this kind of structure can make text much more difficult to understand. “Legalese somehow has developed this tendency to put structures inside other structures, in a way which is not typical of human languages,” Gibson says.

In a follow-up study published in 2023, the researchers found that legalese also makes documents more difficult for lawyers to understand. Lawyers tended to prefer plain English versions of documents, and they rated those versions to be just as enforceable as traditional legal documents. “Lawyers also find legalese to be unwieldy and complicated,” Gibson says. “Lawyers don’t like it, laypeople don’t like it, so the point of this current paper was to try and figure out why they write documents this way.”

The researchers had a couple of hypotheses for why legalese is so prevalent. One was the “copy and edit hypothesis,” which suggests that legal documents begin with a simple premise, and then additional information and definitions are inserted into already existing sentences, creating complex center-embedded clauses.

“We thought it was plausible that what happens is you start with an initial draft that’s simple, and then later you think of all these other conditions that you want to include. And the idea is that once you’ve started, it’s much easier to center-embed that into the existing provision,” says Martinez, who is now a fellow and instructor at the University of Chicago Law School.

However, the findings ended up pointing toward a different hypothesis, the so-called “magic spell hypothesis.” Just as magic spells are written with a distinctive style that sets them apart from everyday language, the convoluted style of legal language appears to signal a special kind of authority, the researchers say. “In English culture, if you want to write something that’s a magic spell, people know that the way to do that is you put a lot of old-fashioned rhymes in there. We think maybe center-embedding is signaling legalese in the same way,” Gibson says.

In this study, the researchers asked about 200 non-lawyers (native speakers of English living in the United States, who were recruited through a crowdsourcing site called Prolific), to write two types of texts. In the first task, people were told to write laws prohibiting crimes such as drunk driving, burglary, arson, and drug trafficking. In the second task, they were asked to write stories about those crimes.

To test the copy and edit hypothesis, half of the participants were asked to add additional information after they wrote their initial law or story. The researchers found that all of the subjects wrote laws with center-embedded clauses, regardless of whether they wrote the law all at once or were told to write a draft and then add to it later. And, when they wrote stories related to those laws, they wrote in much plainer English, regardless of whether they had to add information later.

“When writing laws, they did a lot of center-embedding regardless of whether or not they had to edit it or write it from scratch. And in that narrative text, they did not use center-embedding in either case,” Martinez says.

In another set of experiments, about 80 participants were asked to write laws, as well as descriptions that would explain those laws to visitors from another country. In these experiments, participants again used center-embedding for their laws, but not for the descriptions of those laws.

Gibson’s lab is now investigating the origins of center-embedding in legal documents. Early American laws were based on British law, so the researchers plan to analyze British laws to see if they feature the same kind of grammatical construction. And going back much farther, they plan to analyze whether center-embedding is found in the Hammurabi Code, the earliest known set of laws, which dates to around 1750 BC.

“There may be just a stylistic way of writing from back then, and if it was seen as successful, people would use that style in other languages,” Gibson says. “I would guess that it’s an accidental property of how the laws were written the first time, but we don’t know that yet.”

The researchers hope that their work, which has identified specific aspects of legal language that make it more difficult to understand, will motivate lawmakers to try to make laws more comprehensible. Efforts to write legal documents in plainer language date to at least the 1970s, when President Richard Nixon declared that federal regulations should be written in “layman’s terms.” However, legal language has changed very little since that time. “We have learned only very recently what it is that makes legal language so complicated, and therefore I am optimistic about being able to change it,” Gibson says.

Separate Public Entities Exempt From Wage Order and PAGA Claims

All California counties have a mandatory duty to provide medical care for their indigent residents.

After years of managing a medical center for this purpose, the Alameda County Board of Supervisors (Board of Supervisors) determined that transferring governance of the center to a hospital authority would “improve the efficiency, effectiveness, and economy of the community health services provided” and would be “the best way to fulfill its commitment to the medically indigent, special needs, and general populations of” the county.

The Board of Supervisors sought the legislative authorization to do so. In 1996 the Legislature enacted Health and Safety Code, section 101850 which authorized the establishment of defendant Alameda Health System (AHS) as a “separate public agency” (Health & Saf. Code, § 101850, subd. (a)(2)(C); see id., subd. (a)(2)(D)) “strictly and exclusively dedicated to the management, administration, and control of the medical center.”

Plaintiffs worked at Highland Hospital, a facility operated by AHS. Tamelin Stone was a medical assistant and Amanda Kunwar was a licensed vocational nurse. In their wage and hour suit against AHS, plaintiffs alleged these positions were subject to requirements of the Labor Code and wage orders, in particular Industrial Wage Commission (IWC) wage order No. 5-2001 (Cal. Code Regs., tit. 8, § 11050).

The operative complaint alleged that AHS frequently denied or discouraged the taking of meal and rest breaks and “automatically deducted ½ hour from each workday” even when meal periods were not taken.

AHS demurred on the ground that it was a public entity not subject to suit for the Labor Code violations asserted. The demurrer was sustained without leave to amend.

The Court of Appeal reversed in part, reasoning that construing the enabling statute, rather than the Labor Code provisions themselves, the court discerned no legislative intent to exempt AHS from the meal and rest period and payroll requirements underlying plaintiffs’ first three causes of action. (Stone v. Alameda Health System (2023) 88 Cal.App.5th 84, 93-94 (Stone).)

The California Supreme Court reversed in Stone v. Alameda Health System -S279137 (August 2024).

The Labor Code and wage order impose meal and rest break obligations on “employers,” and, under the relevant wage order, an “employer” must be a “person as defined in Section 18 of the Labor Code.” (Wage Order No. 5, subd. 2(H).) Accordingly, section 18’s definition of the term “person” is central to resolving the issues here.

However the Supreme Court went on to say “While section 18’s definition of ‘person’ is central to our interpretation of the relevant Labor Code and wage order provisions, this definition by itself is not dispositive.”

Wage Order No. 5, which covers hospital workers, states that, unless specifically noted otherwise, “the provisions of this order shall not apply to any employees directly employed by the State or any political subdivision thereof, including any city, county, or special district.” (Wage Order No. 5, subd. 1(C).) The plain language of the governing wage order thus expressly excludes public employers from most of the wage and hour obligations it places on private employers, including meal and rest break obligations.

Relevant history of the statutes and wage orders also supports a conclusion that the Legislature did not intend for meal and rest break requirements to apply to public employers.”

“Plaintiffs largely concede that the Labor Code provisions at issue are generally not applicable to public employers. Their primary argument is that the provisions apply to AHS because AHS is not a public entity.”

The enabling statute repeatedly describes AHS as a public agency. In a subdivision devoted to definitions, it states that – Hospital Authority means the separate public agency established pursuant to the enabling legislation.

Accordingly, as a public employer, AHS is not a ‘person’ subject to liability for the meal and rest break and associated payroll records violations alleged in plaintiffs’ complaint.” In addition “based on the statutory text, legislative history, and public policy, we conclude public entity employers are not subject to PAGA suits for civil penalties.”

Huntington Beach Company Succeeds With First Artificial Heart Transplant

In a groundbreaking medical achievement, the first fully mechanical heart developed by Huntington Beach based BiVACOR®, has been successfully implanted in a human patient. This milestone marks a significant advancement in the field of cardiac care, offering new hope for those awaiting heart transplants.

The Texas Heart Institute and BiVACOR®, a clinical-stage medical device company, announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS).

BiVACOR’s TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart. The non-contact suspension of the rotor via maglev is designed to eliminate the potential for mechanical wear and provide large blood gaps that minimize blood trauma, offering a durable, reliable, and biocompatible heart replacement. With activity, the device is auto-regulated to provide up to 12 liters of blood flow per minute, which is similar to that pumped by a healthy human heart.

The first-in-human clinical study aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended. Following this first implantation completed at Baylor St. Luke’s Medical Center in the Texas Medical Center into a critically ill 57-year-old man who was in cardiogenic shock and awaiting a heart transplant. Four additional patients are to be enrolled in the study.

The nearly six-hour operation allowed the patient to be liberated from the vent on post-operative day three, and sit in a chair that same day. On post-op day seven, he could ambulate 150 meters. On July 17, eight days after the implant, a donor heart became available. The patient celebrated his 58th birthday and he is reported to be continuing to recover from the transplant in the hospital.

“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”

Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR said, “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute. Utilizing advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”

Heart failure is a global epidemic affecting at least 26 million people worldwide, 6.2 million adults in the U.S., and is increasing in prevalence. Heart transplantations are reserved for those with severe heart failure and are limited to fewer than 6,000 procedures per year globally. Consequently, the U.S. National Institutes of Health estimated that up to 100,000 patients could immediately benefit from mechanical circulatory support (MCS), and the European market is similarly sized.

The successful implantation of BiVACOR’s TAH highlights the potential of innovative technologies to address critical challenges in cardiac care, such as long transplantation waitlists. BiVACOR and The Texas Heart Institute remain committed to advancing the field of cardiac medicine and improving outcomes for patients worldwide.

Conspiracy and Fraud Charges Added Against Bio-Lab Operator

The operator of a Reedley lab, who was indicted in November 2023, faces additional charges of conspiracy and wire fraud after a federal grand jury returned a 12-count superseding indictment on August 15.

Jia Bei Zhu, 62, a citizen of China, was previously indicted for distributing adulterated and misbranded COVID-19 test kits in violation of the federal Food, Drug, and Cosmetic Act and making false statements to authorities about his identity and involvement with the biolabs.

The superseding indictment also charges Zhu’s romantic and business partner, Zhaoyan Wang, 38, a citizen of China, who operated the biolabs Universal Meditech Inc. (UMI) and Prestige Biotech Inc. (PBI) in Fresno and Reedley along with Zhu. UMI and PBI distributed COVID-19, pregnancy, and other types of test kits.

According to court documents, from August 2020 through March 2023, Zhu and Wang conspired to defraud buyers of UMI and PBI’s COVID-19 test kits. They imported hundreds of thousands of COVID-19 test kits from Ai De Ltd., which was a company in China that they controlled, and falsely represented to the buyers that the test kits were made in the United States. They illegally imported the COVID-19 test kits, which they were not approved to import, by falsely declaring them as pregnancy test kits, which they were approved to import.

Zhu and Wang also falsely represented to the buyers that UMI and PBI could make up to 100,000 COVID-19 test kits per week in the United States and that the test kits were made in connection with other labs that were certified by the Centers for Disease Control and Prevention. Finally, they falsely represented to the buyers that the test kits were approved by the Food and Drug Administration (FDA). Zhu and Wang made over $1.7 million through their fraud.

When buyers requested to inspect UMI and PBI’s facilities in Fresno and Reedley, Zhu and Wang denied them access and fabricated reasons for the denial. The fabricated reasons included that the facilities were undergoing construction and renovation, and that proprietary and confidential information and technology was inside. In reality, however, they did not want the buyers to know that UMI and PBI were obtaining the COVID-19 test kits from China.

Zhu is currently detained in custody pending his federal trial. His next status conference is scheduled for Sept. 11, 2024. Wang is not in custody.

If convicted, Zhu and Wang each face maximum statutory penalties of 20 years in prison for the conspiracy and wire fraud charges, and an additional three years in prison for the distribution of adulterated and misbranded medical device charges. Zhu also faces another five years in prison for the false statements charge. Any sentences, however, would be determined at the discretion of the court after consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables. The charges are only allegations. Zhu and Wang are presumed innocent until and unless proven guilty beyond a reasonable doubt.

This case is the product of an investigation by the Federal Bureau of Investigation and the FDA Office of Criminal Investigations. Assistant U.S. Attorneys Arelis Clemente, Joseph Barton, and Henry Carbajal III are prosecuting the case.

New CIGA Board and WCIRB Governing Committee Members Announced

The California Insurance Commissioner announced several appointments including naming Timothy Hyamn as the newest member of the California Insurance Guarantee Advisory (CIGA) Board of Directors, Bryan Little as the newest member of the Workers’ Compensation Insurance Rating Bureau (WCIRB) Governing Committee, Michael Golden and Nona Tirre Mirande as reappointed members to the California Automobile Assigned Risk Plan (CAARP) Advisory Board, and Ophir Bruck, Stephanie Chan, and Thomas Connell Wilson as reappointed members to the California Organized Investment Network (COIN) Advisory Board.

The Governor and California State Legislature created CAARP to provide auto insurance for motorists unable to obtain coverage in the private market due to their driving records or other extraordinary circumstances. One program within the plan — the California Low Cost Auto Program — aims to provide affordable liability insurance to income-eligible good drivers by assigning them to private insurers based upon the companies’ share of the auto insurance market. The CAARP Advisory Committee provides policy advice to Commissioner Lara on matters affecting the operation of its programs.

The CIGA Board of Governors oversees the guarantee association’s general operations and management in order to protect policyholders in the event of an insurance company insolvency. Established in 1969 by the Governor and California State Legislature, CIGA comprises all insurance companies admitted to sell homeowners, workers’ compensation, automobile, and other specified property and casualty lines of insurance in California.

The California Organized Investment Network (COIN) was established in 1996 within the Department of Insurance to guide insurers on making financially sound investments that yield environmental benefits throughout California and social benefits within the State’s underserved communities. Commissioner Lara has prioritized COIN investments which drive affordable housing, support small businesses, combat climate change, and encourage investors to utilize diverse investment managers more. The COIN Advisory Board provides guidance to the Commissioner and the COIN program to meet its mission and chief priorities.

The WCIRB Governing Committee sets policy, oversees WCIRB management, and reviews all issues involving pure premium rates, classifications, rating plans, rating systems, manual rules and policy, and endorsement forms. The WCIRB is a private organization licensed by the Department for the purpose of collecting, analyzing, and compiling rating data, with funding coming from assessments of its insurance company members. All workers’ compensation insurance companies in California are required by law to be members of the WCIRB.  

The next CAARP Advisory Committee meeting is August 20 and August 21, 2024, the next CIGA Board of Governors meeting is August 13 and August 14, 2024, the next COIN Advisory Board meeting is November 7, 2024, and the next WCIRB Governing Committee meeting is September 25, 2024.

More details are available at: www.insurance.ca.gov/boards. Public members of the CAARP Advisory Committee receive $250 per meeting. All other positions are uncompensated.